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Introduction: Hemorrhage is assessed, at least in part, via hematocrit testing. To differentiate unexpected drops in hematocrit because of ongoing hemorrhage versus expected drops as a result of known hemorrhage and intravenous fluid administration, we model expected post-operative hematocrit values accounting for fluid balance and intraoperative estimated blood loss (EBL) among patients without substantial post-operative bleeding., Materials and Methods: We reviewed patient-level data from the electronic health record of an academic medical center for all non-pregnant adults admitted for elective knee or hip arthroplasty from November 2013 to September 2022 who did not require blood products. We used linear regression to evaluate the association between post-operative hematocrit and predictor variables including pre-operative hematocrit, intraoperative net fluid intake, blood volume, time from surgery to lab testing, EBL, patient height, and patient weight., Results: We included 6,648 cases. Mean (SD) estimated blood volume was 4,804 mL (1023), mean net fluid intake was 1,121 mL (792), and mean EBL was 144 mL (194). Each 100 mL of EBL and 1,000 mL net positive fluid intake was associated with a decrease of 0.52 units (95% CI, 0.51-0.53) and 2.4 units (2.2-2.7) in post-operative hematocrit. Pre-operative hematocrit was the strongest predictor of post-operative hematocrit. Each 1-unit increase in pre-operative hematocrit was associated with a 0.70-unit increase (95% CI, 0.67-0.73) in post-operative hematocrit. Our estimates were robust to sensitivity analyses, and all variables included in the model were statistically significant with P <.005., Conclusion: Patient-specific data, including fluid received since the time of initial hemorrhage, can aid in estimating expected post-hemorrhage hematocrit values, and thus in assessing for the ongoing hemorrhage., (© The Association of Military Surgeons of the United States 2024. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site–for further information please contact journals.permissions@oup.com.)

Aims/introduction: Blood glucose meters are commonly used at the bedside, but most of the meters used in Hung Vuong Hospital (Ho Chi Minh City, Vietnam) are built for self-monitoring and might not be suitable for determining glucose levels in patients. In this study, we aimed to validate the performance of six frequently used meters in our hospital using the Clinical & Laboratory Standards Institute (CLSI) standard, and investigate the hematocrit impact on the accuracy of these meters., Materials and Methods: A total of 135 pregnant women who underwent a 75-g oral glucose tolerance test consented to participate in the study at Hung Vuong Hospital. Whole blood glucose levels were measured in duplicate using meters, and hematocrit levels were measured using an Alinity h-series analyzer. Within 5 min, plasma glucose levels were measured twice in a row using the Cobas c502 reference analyzer. For accuracy and precision, the hematocrit effect was assed using CLSI POCT12-A3., Results: Out of six evaluated meters, three meters qualified. For CLSI criterion at glucose concentration of 5.55 mmol/L, Accu-Chek Inform II, Accu-Chek Performa and OneTouch VerioVue achieved 97.31%, 98.08% and 99.62%, respectively. For CLSI criterion at 4.17 mmol/L, these three achieved 100%. Accu-Chek Inform II and Accu-Chek Performa showed an inverse correlation between glucose level and hematocrit with slopes of -0.500 (95% confidence interval -0.678 to -0.322) and -0.396 (95% confidence interval -0.569 to -0.224), whereas OneTouch VerioVue was not affected by hematocrit, with a slope of 0.207 (95% confidence interval -0.026 to 0.440)., Conclusions: Blood glucose meters' measurements can be affected by hematocrit, and might provide readings not within an acceptable bias. Medical organizations need to verify or validate before using on patients., (© 2024 The Author(s). Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.)

Background & objectives Red cell concentrates (RCCs) must comply with applicable quality control (QC) standards to achieve the desired therapeutic effect in the recipient. In this study, we assessed the effect of change in the component preparation process on the quality of RCCs and their compliance with different QC standards. Methods A retrospective analysis of data for QC testing of RCCs over a period of 10 years, (from 2009 to 2019), was undertaken. QC testing parameters [volume, haematocrit (Hct), haemoglobin (Hb) content, white blood cell (WBC) content and percentage (%) haemolysis] were used to assess compliance with three national and three international QC standards. Linear regression analysis was done to assess the influence of donor variables. Results Data from 5,218 RCC units was included in the analysis. A majority (>50%) of RCCs prepared did not meet the three national QC standards either for volume or for Hct. The criteria for volume, Hct and Hb content, as defined in different international standards, were fulfilled by a majority (>75%) of RCCs evaluated. RCCs prepared by the buffy coat method had overall better compliance with QC standards compared to the platelet-rich plasma (PRP) method. The method of component preparation was found to influence Hb content, WBC content and percentage haemolysis. Male gender was associated with better Hb content. Interpretation & conclusions RCC prepared at our centre was found to have better compliance with international QC criteria compared to national standards. There is a need to reconsider the current national QC criteria for red cells with due consideration to the volume of whole blood collected and the method used for RCC preparation.

Background: The definition for anemia in pregnancy is outdated, derived from Scandinavian studies in the 1970's to 1980's. To identity women at risk of blood transfusion, a common cause of Severe Maternal Morbidity, a standard definition of anemia in pregnancy in a modern, healthy United States cohort is needed., Objective: To define anemia in pregnancy in a United States population including a large county vs. private hospital population using uncomplicated patients., Materials and Methods: Inclusion criteria were healthy women with the first prenatal visit before 20 weeks. Exclusion criteria included preterm birth, preeclampsia, hypertension, diabetes, short interval pregnancy (<18 months), multiple gestation, abruption, and fetal demise. All women had iron fortification (Ferrous sulfate 325 mg daily) recommended. The presentation to care and pre-delivery hematocrits were obtained, and the percentiles determined. A total of 2000 patients were included, 1000 from the public county hospital and 1000 from the private hospital. Each cohort had 250 patients in each 2011, 2013, 2015, and 2018. The cohorts were compared for differences in the fifth percentile for each antepartum epoch. Student's t-test and chi-squared statistical tests were used for analysis, p-value of ≤0.05 was considered significant., Results: In the public and private populations, 777 and 785 women presented in the first trimester while 223 and 215 presented in the second. The women at the private hospital were more likely to be older, Caucasian race, nulliparous, and present earlier to care. The fifth percentile was compared between the women in the private and public hospitals and were clinically indistinguishable. When combining the cohorts, the fifth percentile for hemoglobin/hematocrit was 11 g/dL/32.8% in the first trimester, 10.3 g/dL/30.6% in the second trimester, and 10.0 g/dL/30.2% pre-delivery., Conclusions: Fifth percentile determinations were made from a combined cohort of normal, uncomplicated pregnancies to define anemia in pregnancy. Comparison of two different cohorts confirms that the same definition for anemia is appropriate regardless of demographics or patient mix., Competing Interests: The authors have declared that no competing interests exist.

Background: Dried blood spots (DBSs) have gained recent popularity as a sampling method for therapeutic drug monitoring. For patients, DBS sampling has several advantages over venous blood sampling. However, technical issues primarily influenced by hematocrit levels, interfere with the implementation of this method in daily clinical practice. The results of concentration measurements of drugs that are influenced by hematocrit should be corrected for hematocrit levels. In this article, we developed a fast, nondestructive, near-infrared (NIR)-based method for measuring the hematocrit in DBSs., Method: Using a partial least squares algorithm, an NIR-based quantification method was developed for measuring hematocrit levels of 0.19-0.49 L/L. Residual venous blood of 522 patients was used to build this partial least squares model. The validity of the method was evaluated using 40 patient samples. DBSs were created by adding a small amount (50 µL) of blood on a Whatman filter paper and drying for 24 hours in a desiccator cabinet. The robustness was evaluated by measuring 24 additional samples with a high hemolysis, icterus, and lipemia (HIL) index. The hematocrit values obtained using a Sysmex XN hemocytometry analyzer were used as reference., Results: The difference between hematocrit measurements obtained with NIR spectroscopy and a hemocytometry analyzer was <15% for the 40 samples. The accuracy (≤9%) and precision (≤7%) for all the quality control samples were within the acceptance criteria of <15%. The intraassay and interassay coefficient of variability was ≤3% and ≤6%, respectively, for the different quality control levels. There were no deviations in the measurements for the samples with high HIL indices. The stability of hematocrit in DBS was up to 14 days for all levels., Conclusions: We developed and validated a hematocrit model using NIR spectroscopy. This nondestructive, accurate, and reproducible method has a short analysis time (51 seconds), and can be used to analyze DBS samples stored for up to 2 weeks in a desiccator cabinet., Competing Interests: The authors declare no conflict of interest., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Cerebrovascular reactivity (CVR) reflects the capacity of the brain to meet changing physiological demands and can predict the risk of cerebrovascular diseases. CVR can be obtained by measuring the change in cerebral blood flow (CBF) during a brain stress test where CBF is altered by a vasodilator such as acetazolamide. Although the gold standard to quantify CBF is PET imaging, the procedure is invasive and inaccessible to most patients. Arterial spin labeling (ASL) is a non-invasive and quantitative MRI method to measure CBF, and a consensus guideline has been published for the clinical application of ASL. Despite single post labeling delay (PLD) pseudo-continuous ASL (PCASL) being the recommended ASL technique for CBF quantification, it is sensitive to variations to the arterial transit time (ATT) and labeling efficiency induced by the vasodilator in CVR studies. Multi-PLD ASL controls for the changes in ATT, and velocity selective ASL is in theory insensitive to both ATT and labeling efficiency. Here we investigate CVR using simultaneous 15 O-water PET and ASL MRI data from 19 healthy subjects. CVR and CBF measured by the ASL techniques were compared using PET as the reference technique. The impacts of blood T1 and labeling efficiency on ASL were assessed using individual measurements of hematocrit and flow velocity data of the carotid and vertebral arteries measured using phase-contrast MRI. We found that multi-PLD PCASL is the ASL technique most consistent with PET for CVR quantification (group mean CVR of the whole brain = 42±19% and 40±18% respectively). Single-PLD ASL underestimated the CVR of the whole brain significantly by 15±10% compared with PET (p<0.01, paired t-test). Changes in ATT pre- and post-acetazolamide was the principal factor affecting ASL-based CVR quantification. Variations in labeling efficiency and blood T1 had negligible effects., (Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.)

Abstract: The patient's hematocrit (HCT) level can adversely affect the analysis results when dried blood spots (DBS) are used for sampling. Volumetric DBS sampling has been proposed to nullify the impact of HCT area bias (spreading area) on DBS by normalizing to a known sample volume. However, this strategy ignores DBS-related parameters such as analyte properties (red blood cell-to-plasma ratio) and HCT recovery bias. With the recent release of fully automated HCT measurement systems for DBS analysis, a broad range of end users are now able to measure and correct a sample's HCT level in a nondestructive manner. These systems permit correction for all known HCT-related impacts on DBS, such as analyte properties, HCT recovery bias, HCT area bias, and venous blood-to-DBS ratio, supporting and accelerating future quantitative DBS applications. However, with these novel tools, new questions arise concerning the normalization of analytical results, the choice of technique (single-wavelength reflectance vs near-infrared spectroscopy), and the DBS card-handling process post sampling. Herein, the necessary considerations for end users are addressed and examples are provided., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Animal blood is used in mock circulations or in forensic bloodstain pattern analysis. Blood viscosity is important in these settings as it determines the driving pressure through biomedical devices and the shape of the bloodstain. However, animal blood can never exactly mimic human blood due to erythrocyte properties differing among species. This results in the species-specific shear thinning behavior of blood suspensions, and it is therefore not enough to adjust the hematocrit of an animal blood sample to mimic the behavior of human blood over the entire range of shear rates that are present in the body. In order to optimize experiments that require animal blood, we need models to adapt the blood samples. We here offer mathematical models derived for each species using a multi linear regression approach to describe the influence of shear rate, hematocrit, and temperature on blood viscosity. Results show that pig blood cannot be recommended for experiments at low flow conditions (<200 s -1 ) even though erythrocyte properties are similar in pigs and humans. However, pig blood mimics human blood excellently at high flow condition. Horse blood is unsuitable as experimental model in this regard. For several studied conditions, sheep blood was the closest match to human blood viscosity among the tested species., (© 2021 The Authors. Physiological Reports published by Wiley Periodicals LLC on behalf of The Physiological Society and the American Physiological Society.)

Introduction: It is necessary to establish hematological reference intervals (RIs) in each population to improve disease management and healthcare quality. This study aimed to establish age- and sex-specific hematological RIs in a healthy adult Kurdish population and evaluate the influence of select lifestyle factors., Methods: Hematological parameters were studied in 6518 individuals (3006 females, 3512 males) from Ravansar Non-Communicable Disease (RaNCD) cohort study. Hematological parameters were measured by Beckman Coulter HmX Analyzer. After combined application of exclusion criteria and statistical outlier removal, RIs for all partitions were calculated using nonparametric methods., Results: The present study established hematological RIs for 14 parameters in a healthy adult Iranian population. Reference values for some analytes demonstrated significant age- and sex-specific differences and were slightly different when compared to RIs determined in other populations. Furthermore, the current smokers had higher levels of white blood cells (WBCs), red blood cells (RBCs), hemoglobin, hematocrit, mean corpuscular hemoglobin (MCH), and mean corpuscular volume than ex- and nonsmokers. Also, in the presence of high physical activity, elevated levels of RBC, hemoglobin, hematocrit, monocytes, and MCH were observed, as well as lower WBC levels. Further, a significant positive association was observed between body mass index (BMI) and WBC, red cell distribution width, and plateletcrit levels., Conclusion: Our study suggests hematological parameters are influenced by age, sex, and lifestyle factors such as physical activity and BMI. Additionally, discrepancies when compared to other population studies suggest that ethnic-specific differences need to be considered when establishing RIs for hematological parameters., (© 2020 John Wiley & Sons Ltd.)

There is an urgent need for reliable region-specific hematological reference values for clinical monitoring. Laboratory reference ranges are important for assessing study participant eligibility, toxicity grading and management of adverse events in clinical trials and clinical diagnosis. Most clinical laboratories in Kenya rely on hematological reference values provided by instrument manufacturers and/or textbooks, which are based on population from Europe or North America. The use of such values in medical practice could result in improper patient management, selection bias in selection of appropriate participants for clinical trials and flawed classification of the clinical adverse events when applied to African populations. The aim of this study was to establish local laboratory hematological reference values in infants aged 1 month to 17 months from Kombewa Sub-county that could be true representative of the existing rural population. The study participants in the current study were those who had previously been recruited from GSK-sponsored study. This study was a phase III, Double Blind, Randomized, GSK-sponsored, Malaria Vaccine Clinical Trial that was conducted in infants aged 1month to 17months. 1,509 participants were included in the study analysis. Data were partitioned into 3 different age groups (1-6 months[m], 6-12 m and 12-17 m) and differences between gender were compared within each group. Data were analyzed using Graphpad prism V5 to generate 95% reference ranges (2.5th-97.5th percentile). There was evidence of gender differences in hemoglobin values (p = 0.0189) and platelet counts (p = 0.0005) in the 1 to 6m group. For the 12-17m group, there were differences in MCV (p<0.0001) and MCH (p = 0.0003). Comparing gender differences for all age groups, differences were noted in percent lymphocytes (p = 0.0396), percent monocytes (p = 0.0479), percent granulocytes (p = 0.0044), hemoglobin (p = 0.0204), hematocrit (p = 0.0448), MCV (p = 0.0092), MCH (p = 0.0089), MCHC (p = 0.0336) and absolute granulocytes (p = 0.0237). In 1 to 6m age group and all age groups assessed, for WBCs, hemoglobin, hematocrit, MCV and lymphocytes absolute counts, both 2.5th and 97.5th percentiles for Kisumu infants were higher than those from Kilifi. Platelet ranges for Kisumu children were narrower compared to Kilifi ranges. Kisumu hematology reference ranges were observed to be higher than the ranges of Tanzanian children for the WBCs, absolute lymphocyte and monocyte counts, hemoglobin, hematocrit and MCV. Higher ranges of WBCs, absolute lymphocyte and monocyte counts were observed compared to the values in US/Europe. Wider ranges were observed in hemoglobin, hematocrit, and MCV. Wider ranges were observed in platelet counts in Kisumu infants compared to the US/Europe ranges. Compared to Harriet Lane Handbook reference values that are used in the area, higher counts were observed in WBC counts, both absolute and percent lymphocyte counts, as well as monocyte counts for current study. Wider ranges were observed in RBC, platelets and RDW, while lower ranges noted in the current study for hemoglobin, hematocrit and granulocyte counts. This study underscores the importance of using locally established hematology reference ranges of different age groups in support of proper patient management and for clinical trials., Competing Interests: Author VO is an employee of Africa Clinical Research Management but this company did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of this author are articulated in the ‘author contributions’ section. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Point-of-care C-reactive protein (POC CRP) testing is a potential tuberculosis (TB) screening tool for people living with HIV (PLHIV). Unlike lab-based assays, POC assays do not routinely adjust CRP levels for hematocrit, potentially resulting in TB screening status misclassification. We compared the diagnostic accuracy of unadjusted and hematocrit-adjusted POC CRP for culture-confirmed TB among PLHIV with CD4 cell-count ≤350 cells/uL initiating antiretroviral therapy (ART) in Uganda. We prospectively enrolled consecutive adults, measured POC CRP (Boditech; normal <8 mg/L), collected two spot sputum specimens for comprehensive TB testing, and extracted pre-ART hematocrit from clinic records. Of the 605 PLHIV included, hematocrit-adjusted POC CRP had similar sensitivity (80% vs 81%, difference +1% [95% CI -3 to +5], P= 0.56) and specificity (71% vs 71%, difference 0% [95% CI -1 to +1], P= 0.56) for culture-confirmed TB, relative to unadjusted POC CRP. When used for TB screening, POC CRP may not require adjustment for hematocrit. However, larger studies may be required if differences close to the clinically meaningful threshold are to be detected., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Tramadol is a synthetic opioid drug used in the treatment of chronic and acute pain. An abnormal prevalence of its misuse in elite sport to overcome pain resulting from prolonged physical effort was recently reported. However, besides its antinociceptive effects, tramadol consumption is associated with negative effects such as numbness, confusion, and reduced alertness. This fact prompted the Union Cycliste Internationale to ban the use of tramadol in cycling competitions. Herein, we present the development of a dried blood spot (DBS) sample collection and preparation method followed by a liquid-chromatography mass spectrometry (LC-MS) analysis to rapidly determine the presence of tramadol and its two main metabolites in blood samples. The detection window of each analyte was evaluated and the analysis of performance on various MS platforms (HRMS and MS/MS) was assessed. Tramadol and its two main metabolites were detected up to 12 h after the intake of a single dose of 50 mg of tramadol in positive controls. In professional cycling competitions, 711 DBS samples collected from 361 different riders were analysed using the developed methodology, but all returned negative results (absence of parent and both metabolite compounds). In the context of professional cycling, we illustrate a valid method bringing together the easiness of collection and minimal sample preparation required by DBS, yet affording the performance standards of MS determination. The proposed method to detect tramadol and its metabolites was successfully implemented in cycling races with a probable strong deterrent effect., (© 2020 John Wiley & Sons, Ltd.)

The greater mouse-eared bat (Myotis myotis) is a flagship species for the protection of hibernation and summer maternity roosts in the Western Palearctic region. A range of pathogenic agents is known to put pressure on populations, including the white-nose syndrome fungus, for which the species shows the highest prevalence and infection intensity of all European bat species. Here, we perform analysis of blood parameters characteristic for the species during its natural annual life cycle in order to establish reference values. Despite sexual dimorphism and some univariate differences, the overall multivariate pattern suggests low seasonal variation with homeostatic mechanisms effectively regulating haematology and blood biochemistry ranges. Overall, the species displayed a high haematocrit and haemoglobin content and high concentration of urea, while blood glucose levels in swarming and hibernating bats ranged from hypo- to normoglycaemic. Unlike blood pH, concentrations of electrolytes were wide ranging. To conclude, baseline data for blood physiology are a useful tool for providing suitable medical care in rescue centres, for studying population health in bats adapting to environmental change, and for understanding bat responses to stressors of conservation and/or zoonotic importance., Competing Interests: The authors have declared that no competing interests exist.

The aim of this exploratory clinical study was to evaluate whether the preanalytical quality of blood samples subjected to delayed centrifugation and transport - as a result of home-sampling - is affected in a way it alters the clinical decision-making for patients under systemic cancer therapy. This evaluation is part of a comprehensive investigation of the opportunities for oncological home-hospitalization. Forty-nine patients with cancer donated two additional blood samples during their ambulatory hospital visit. Fifteen blood analytes were compared between routine blood samples and samples that were subjected to transport and delayed centrifugation in order to mimic a locally implemented model for oncological home-hospitalisation. Deviations were analysed by means of Deming regression. For those analytes showing statistically significant intercepts and/or slopes, the mean deviations were compared to the desirable analytical bias; and the intra-individual differences were compared with the limits for clinical decision-making. Statistically significant intercepts and/or slopes were observed for haematocrit (HCT), mean cellular volume (MCV), platelets count (PLT) and C-reactive protein (CRP). Differences exceeding the allowable margins of desirable analytical bias were observed for HCT and MCV. Risk of different clinical decision-making couldn't be observed for any of the analytes showing statistically significant differences. These results demonstrate that home-collection of blood samples, transported at room temperature and centrifuged within a mean time of five hours after sampling, has no effect on clinical decision-making with regards to systemic cancer therapy. However, attention should be paid to the potential occurrence of haemolysis during the preanalytical phase, which can negatively influence haemolysis-dependent variables.

Introduction: In many African countries, laboratory reference values are not established for the local healthy adult population. In Mozambique, reference values are known for young adults (18-24yo) but not yet established for a wider age range. Our study aimed to establish hematological, biochemical and immunological reference values for vaccine trials in Mozambican healthy adults with high-risk for HIV acquisition., Methods: A longitudinal cohort and site development study in Mozambique between November 2013 and 2014 enrolled 505 participants between 18 to 35 years old. Samples from these healthy participants, were analyzed to determine reference values. All volunteers included in the analysis were clinically healthy and human immunodeficiency virus (HIV), hepatitis B and C virus, and syphilis negative. Median and reference ranges were calculated for the hematological, biochemical and immunological parameters. Ranges were compared with other African countries, the USA and the US National Institute of Health (NIH) Division of AIDS (DAIDS) toxicity tables., Results: A total of 505 participant samples were analyzed. Of these, 419 participants were HIV, hepatitis B and C virus and syphilis negative including 203 (48.5%) females and 216 (51.5%) males, with a mean age of 21 years. In the hematological parameters, we found significant differences between sex for erythrocytes, hemoglobin, hematocrit, MCV, MCH and MCHC as well as white blood cells, neutrophils and platelets: males had higher values than females. There were also significant differences in CD4+T cell values, 803 cells/μL in men versus 926 cells/μL in women. In biochemical parameters, men presented higher values than women for the metabolic, enzymatic and renal parameters: total and direct bilirubin, ALT and creatinine., Conclusion: This study has established reference values for healthy adults with high-risk for HIV acquisition in Mozambique. These data are helpful in the context of future clinical research and patient care and treatment for the general adult population in the Mozambique and underline the importance of region-specific clinical reference ranges., Competing Interests: The authors have declared that no competing interests exist.

Background External quality assessment programs are one of the currently available tools to evaluate the analytical performance of clinical laboratories, where the measurement error (ME) obtained can be compared with quality specifications to evaluate possible deviations. The objective of this work was to analyze the ME behavior over the analytical range to assess the need to establish concentration-dependent specifications. Methods A total of 389,000 results from 585 laboratories and 2628 analyzers were collected from the Spanish external quality assessment schemes (EQAS) in hematology during the years 2015-2016. The parameters evaluated included white blood cells, red blood cells, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelets, prothrombin time, activated partial thromboplastin time, neutrophils, lymphocytes, monocytes, eosinophils, basophils, reticulocytes, hemoglobin A2, antithrombin, factor VIII, protein C and von Willebrand factor. The 90th percentile of ME was calculated for every concentration evaluated of each parameter. Results We found a significant variation in the analytical performance of leukocytes, platelets, neutrophils, lymphocytes, monocytes, eosinophils, basophils, prothrombin time, reticulocytes, hemoglobin A2, antithrombin and protein C. Furthermore, this ME variation may not allow complying with the same biological variability requirements within the whole analytical range studied. Conclusions Our work shows the importance of implementing concentration-dependent specifications which can help laboratories to use proper criteria for quality specifications selection and for a better external quality control results evaluation.

Background Interpreting hematology analytes in children is challenging due to the extensive changes in hematopoiesis that accompany physiological development and lead to pronounced sex- and age-specific dynamics. Continuous percentile charts from birth to adulthood allow accurate consideration of these dynamics. However, the ethical and practical challenges unique to pediatric reference intervals have restricted the creation of such percentile charts, and limitations in current approaches to laboratory test result displays restrict their use when guiding clinical decisions. Methods We employed an improved data-driven approach to create percentile charts from laboratory data collected during patient care in 10 German centers (9,576,910 samples from 358,292 patients, 412,905-1,278,987 samples per analyte). We demonstrate visualization of hematology test results using percentile charts and z-scores (www.pedref.org/hematology) and assess the potential of percentiles and z-scores to support diagnosis of different hematological diseases. Results We created percentile charts for hemoglobin, hematocrit, red cell indices, red cell count, red cell distribution width, white cell count and platelet count in girls and boys from birth to 18 years of age. Comparison of pediatricians evaluating complex clinical scenarios using percentile charts versus conventional/tabular representations shows that percentile charts can enhance physician assessment in selected example cases. Age-specific percentiles and z-scores, compared with absolute test results, improve the identification of children with blood count abnormalities and the discrimination between different hematological diseases. Conclusions The provided reference intervals enable precise assessment of pediatric hematology test results. Representation of test results using percentiles and z-scores facilitates their interpretation and demonstrates the potential of digital approaches to improve clinical decision-making.

Introduction Dried blood spot (DBS) sample applications now encompass analytes related to clinical diagnosis, epidemiological studies, therapeutic drug monitoring, pharmacokinetic and toxicokinetic studies. Haematocrit (Hct) and haemoglobin (Hb) at very high or low concentrations may influence the accuracy of measurement quantification of the DBS sample. In this study, we aimed to predict the Hct of the punched DBS through primary spectrophotometric estimation of its haemoglobin-derivative (Hb-drv) content. Methods Formic acid solution was used to elute Hb-drv content of 3.2 mm spotted blood from its dry matrix. Direct spectrometry measurement was utilised to scan the extracted Hb-drv in the visible spectrum range of 520-600 nm. The linear relationship between an individual's Hct percentage and Hb-drv concentration was applied to estimate the Hct level of the blood spot. De-identified whole blood samples were used for the method development and evaluation studies. Results The Hb-drv estimation is valid in samples >2 months old. Method validation experiments DBS demonstrate linearity between 82.5 and 207.5 g/L, average coefficient of variation of 3.6% (intra-assay) and 7.7% (inter-assay), analytical recovery of 84%, and a high positive correlation (r=0.88) between Hb-drv and the original whole blood Hct. The Bland-Altman difference plot demonstrates a mean difference of 2.4% between the calculated DBS Hct and the directly measured Hct from fresh whole bloods. Conclusions We have successfully developed a simple Hb-drv method to estimate Hct in aged DBS samples. This method can be incorporated into DBS analytical work-flow for the in-situ estimation of Hct and subsequent correction of the analyte of interest as required.

Background: The hantavirus infection is an emerging zoonotic disease, endemic in Chile, generating the hantavirus cardiopulmonary syndrome (HCPS), characterized by cardiopulmonary dysfunction with rapidly progressive respiratory failure and high lethality. For an early clinical orientation of HCPS, due to its non-specificity in symptoms and to help the differential diagnosis, some laboratory parameter that may be useful have been studied., Aim: To identify laboratory criteria as predictive factors of HCPS in patients with suspected hantavirus infection., Methodology: Retrospective cohort study of 71 patients admitted to the Hospital Guillermo Grant Benavente Emergency. We determined discriminative capacity of laboratory's parameters at the time of admission: platelets recount, hematocrit, inmunoblasts, activated partial thromboplastin time (aPTT) and aspartate aminotransferase (AST/GOT)., Results: Were found significant differences in all parameters studied between confirmed patients (22) with respect to unconfirmed (49). Hematocrit, inmunoblasts, AST/GOT and aPTT had a OR > 1 and platelets count had a OR < 1. The best combination for predict HCPS was hematocrit, platelets count and AST/GOT with 90,01% sensibility and 81,63% specificity., Conclusion: The five parameters studied are good predictors of HCS in suspicious patients and they would may be useful in low complexity hospitals for quick transfer a center with critical care units.

Introduction: Blood gas analyzers can be alternatives to laboratory autoanalyzers for obtaining test results in just a few minutes. We aimed to find out whether the results from blood gas analyzers are reliable when compared to results of core laboratory autoanalyzers., Materials and Methods: This retrospective, single-centered study examined the electronic records of patients admitted to the emergency department of a tertiary care teaching hospital between May 2014 and December 2017. Excluded from the study were patients under 18 years old, those lacking data, those who had any treatment before the laboratory tests, those whose venous gas results were reported more than 30 minutes after the blood sample was taken and for whom any of the laboratory tests were performed at a different time, and recurrent laboratory results from a single patient., Results: Laboratory results were analyzed from a total of 31,060 patients. The correlation coefficients for sodium, potassium, hemoglobin, hematocrit, and glucose levels measured by a blood gas analyzer and a laboratory autoanalyzer were 0.725, 0.593, 0.982, 0.958, and 0.984, respectively; however, there were no good, acceptable agreement limits for any of the parameters. In addition, these results did not change according to the different pH stages (acidosis, normal pH and alkalosis)., Conclusion: The two types of measurements showed a moderate correlation for sodium and potassium levels and a strong correlation for glucose, hemoglobin, and hematocrit levels, but none of the levels had acceptable agreement limits. Clinicians should be aware of the limitations of blood gas analyzer results., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: In recent clinical trials, use of the MyGlucoHealth blood glucose meter (BGM) and electronic diary was associated with an unusual reporting pattern of glycemic data and hypoglycemic events. Therefore, the performance of representative BGMs used by the patients was investigated to assess repeatability, linearity, and hematocrit interference in accordance with regulatory guidelines., Method: Ten devices and 6 strip lots were selected using standard randomization and repeatability procedures. Venous heparinized blood was drawn from healthy subjects, immediately aliquoted and adjusted to 5 target blood glucose (BG) ranges for the repeatability and 11 BG concentrations for the linearity tests. For the hematocrit interference test, each sample within 5 target BG ranges was split into 5 aliquots and adjusted to hematocrit levels across the acceptance range. YSI 2300 STAT Plus was used as the laboratory reference method in all experiments., Results: Measurement repeatability or precision was acceptable across the target BG ranges for all devices and strip lots with coefficient of variation (CV) between 3.4-9.7% (mean: 5.7%). Linearity was shown by a correlation coefficient of .991; however, a positive bias was seen for BG <100 mg/dL (86% measurements did not meet ISO15197:2015 acceptance criteria). Significant hematocrit interference (up to 20%) was observed for BG >100 mg/dL (ISO15197:2015 acceptance criteria: ±10%), while the results were acceptable for BG <100 mg/dL., Conclusions: The BGM met repeatability requirements but demonstrated a significant measurement bias in the low BG range. In addition, it failed the ISO15197:2015 criteria for hematocrit interference.

Hematocrit is known to influence glucose values obtained on some blood glucose meters, with bias observed especially at low and high hematocrit levels. We evaluated the performance of a meter with hematocrit correction technology alongside 3 other commercially available meters. Capillary blood samples from 100 subjects were analyzed in duplicate and compared to the plasma values obtained by reference laboratory analyzer. Bias, error grid, and sensitivity to hematocrit analyses were performed for each meter. Average percentage bias was similar for all meters, however the evaluated meter performed best with respect to error grid analysis, with 100% of values falling within the "no effect on clinical action" and "no risk" categories and did not display any hematocrit associated bias.

Objective: To evaluate whether a standard operating procedure (SOP) for canine packed cell volume (PCV) measurement reduces operator-dependent variation and improves accuracy within a veterinary teaching hospital environment., Materials and Methods: Clinical staff and final-year undergraduate veterinary students were recruited to perform PCV measurements in blinded duplicate samples. Participants were randomly allocated to perform this with or without an SOP. Participants' results were compared against a reference, generated by the authors following the World Health Organization guidelines., Results: The study population comprised 18 clinical staff and 39 students. Three clinical staff and seven students displayed errors consistent with inaccurate reading, only one of whom had access to the SOP. Five students and two clinical staff had errors attributable to incorrect preparation, with only one having access to the SOP. Interoperator variation was significantly less using the SOP. Using the SOP, 95 per cent of the results were within 0.0125 l/l of the reference value, in comparison with within 0.09 l/l without SOP. Interoperator variation was significantly less in the SOP group (P=0.0025)., Clinical Significance: Using the SOP resulted in less variation and more accurate results. This confirms that PCV measurement with an SOP can truly be a 'waived' test., Competing Interests: Competing interests: None declared., (© British Veterinary Association 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Tacrolimus is an important immunosuppressive agent with high intra- and inter-individual pharmacokinetic variability and a narrow therapeutic index. As tacrolimus extensively accumulates in erythrocytes, hematocrit is a key factor in the interpretation of tacrolimus whole blood concentrations. However, as hematocrit values in pediatric kidney transplant patients are highly variable after kidney transplantation, translating whole blood concentration targets without taking hematocrit into consideration is theoretically incorrect. The aim of this study is to evaluate the potential impact of hematocrit correction on tacrolimus target exposure in pediatric kidney transplant patients., Methods: Data were obtained from 36 pediatric kidney transplant patients. Two hundred fifty-five tacrolimus whole blood samples were available, together responsible for 36 area under the concentration-time curves (AUCs) and trough concentrations. First, hematocrit corrected concentrations were derived using a formula describing the relationship between whole blood concentrations, hematocrit, and plasma concentrations. Subsequently, target exposure was evaluated using the converted plasma target concentrations. Ultimately, differences in interpretation of target exposure were identified and evaluated., Results: In total, 92% of our patients had lower hematocrit (median 0.29) than the reference value of adult kidney transplant patients. A different evaluation of target exposure for either trough level, AUC, or both was defined in 42% of our patients, when applying hematocrit corrected concentrations., Conclusion: A critical role for hematocrit in therapeutic drug monitoring of tacrolimus in pediatric kidney transplant patients is suggested in this study. Therefore, we believe that hematocrit correction could be a step towards improvement of tacrolimus dose individualization.

Background: The eastern quoll (Dasyurus viverrinus) is an endangered carnivorous marsupial that has recently suffered significant population declines. Several small captive breeding populations have been established, with plans to translocate wild and captive individuals to areas of their former distribution. Accordingly, hematologic and serum biochemical reference intervals (RIs) established from wild eastern quoll populations are essential for monitoring the health and disease status of both captive and wild populations, and to evaluate the health of individuals before, during, and after translocation., Objectives: We aimed to establish hematologic and serum biochemical RIs for wild eastern quolls, and examine the effects of age, sex, and season., Methods: We collected a total of 202 hematologic samples, 309 packed cell volume samples, and 335 serum biochemical samples from 168 individual quolls between May 2011 and November 2013. Species-level RIs were established, as well as RIs of groups separated by age (juvenile, adult) and sex (adult male, adult female) using nonparametric, robust, and parametric methods. Seasonal variation in age- and sex-specific reference values was also assessed., Results: Strong age and seasonal variation were evident in many hematologic and serum biochemical analytes, with significant variation observed in serum biochemical analytes between the sexes., Conclusions: The observed age, sex, and seasonal variation reflect differences in the timing of growth and reproductive stressors, which interact with seasonal energetic demands. Our findings highlight the importance of using age-, sex-, and season-specific RIs for clinical evaluation of eastern quolls, as species-level RIs will inadvertently smooth and mask important seasonal fluctuations that reflect reproductive status at different times., (© 2019 American Society for Veterinary Clinical Pathology.)

Laboratory results interpretation for diagnostic accuracy and clinical decision-making in this period of evidence-based medicine requires cut-off values or reference ranges that are reflective of the geographical area where the individual resides. Several studies have shown significant differences between and within populations, emphasizing the need for population-specific reference ranges. This cross-sectional experimental study sought to establish the haematological reference values in apparently healthy individuals in three regions in Ghana. Study sites included Nkenkaasu, Winneba, and Nadowli in the Ashanti, Central, and Upper West regions of Ghana, respectively. A total of 488 healthy participants were recruited using the Clinical and Laboratory Standards Institute (United States National Consensus Committee on Laboratory Standards, NCCLS) Guidance Document C28A2. Medians for haematological parameters were calculated and reference values determined at 2.5 th and 97.5 th percentiles and compared with Caucasian values adopted by our laboratory as reference ranges and values from other African and Western countries. RBC count, haemoglobin, and haematocrit (HCT) were significantly higher in males compared to females. There were significant intraregional and interregional as well as international variations of haematological reference ranges in the populations studied. We conclude that, for each geographical area, there is a need to establish geography-specific reference ranges if accurate diagnosis and concise clinical decisions are to be made.

Background: The effect of neither transfusion guidelines nor decision support tools on intraoperative transfusion has been previously evaluated. The University of Michigan introduced a transfusion guideline in 2009, and in 2011, the Department of Anesthesiology developed a transfusion decision support tool. The primary aim of this study was to assess the associations of the transfusion guideline and the optional use of the software transfusion tool with intraoperative behaviors; pretransfusion hematocrit assessment (whether or not a hematocrit was checked before each red cell unit) and restrictive red cell use (withholding transfusion unless the hematocrit was ≤21%)., Methods: This was a before-after retrospective study without a concurrent control group of patients transfused 1-3 units of red cells intraoperatively. Three phases were studied to provide data both before and after the implementation of the transfusion guideline and the intraoperative software tool. Within each phase, trends of checking hematocrits before transfusion and restrictive transfusion were charted against time. F tests were used to measure differences of slopes. The difference between means of each phase was measured using Mann-Whitney U tests. Independent associations were measured using mixed-effects multivariable logistic regression. A secondary outcome analysis was conducted for 30-day mortality, myocardial infarction, renal injury, and their combination., Results: The transfusion guideline was associated with increased pretransfusion hematocrit evaluation (67.4%, standard deviation [SD] 3.9 vs 76.5%, SD 2.7; P < .001) and restrictive transfusion practice (14.0%, SD 7.4 vs 33.3%, SD 4.4; P = .001). After adjustment for confounders, the guideline phase was independently associated with increased hematocrit checking (odds ratio, 1.72; 95% confidence interval, 1.46-2.03; P < .001) and restrictive red cell transfusion (odds ratio, 2.95; 95% confidence interval, 2.46-3.54; P < .001). The software tool was not associated with either transfusion behavior. There was no significant change in the rate of renal injury (16.06%), myocardial injury (4.93%), 30-day mortality (5.47%), or a composite (21.90%)., Conclusions: The introduction of a transfusion guideline was independently associated with increased intraoperative pretransfusion hematocrit assessment and restrictive transfusion. The use of a software tool did not further influence either behavior.

Regarding diagnosis of polycythemia vera (PV), discussion persists about hemoglobin (Hb) and/or hematocrit (Hct) threshold values as surrogate markers for red cell mass (RCM) and the diagnostic impact of bone marrow (BM) morphology. We performed a retrospective study on 290 patients with PV (151 males, 139 females; median age 65 years) presenting with characteristic BM features (initial biopsies, centralized evaluation) and endogenous erythroid colony (EEC) formations. This cohort included (1) a group of 229 patients when following the 2008 versus 256 patients diagnosed according to the 2016 World Health Organization (WHO) guidelines, all presented with increased RCM; (2) masked PV patients with low Hb (n = 143)/Hct (n = 45) recruited from the 2008 WHO cohort; (3) a cohort of 17 PV patients with elevated diagnostic Hb/Hct levels but low RCM; and (4) nine PV patients with increased RCM, opposing low Hb/Hct values. All patients were treated according to current PV guidelines (phlebotomies 87%, hydroxyurea 79%, and acetylsalicylic acid 87%). Applying the 2016 WHO criteria significantly increased concordance between RCM and Hb values compared with the 2008 WHO criteria (90 vs. 43% in males and 83 vs. 64% in females). Further analysis of the WHO 2016 PV cohort revealed that increased RCM is associated with increased Hb/Hct (93.8/94.6%). Our study supports and extends the diagnostic impact of the 2016 revised WHO classification for PV by highlighting the importance of characteristic BM findings and implies that Hb/Hct threshold values may be used as surrogate markers for RCM measurements.

Objective: Cleared blood glucose monitors (BGMs) for personal use may not always deliver levels of accuracy currently specified by international and U.S. regulatory bodies. This study's objective was to assess the accuracy of 18 such systems cleared by the U.S. Food and Drug Administration representing approximately 90% of commercially available systems used from 2013 to 2015., Research Design and Methods: A total of 1,035 subjects were recruited to have a capillary blood glucose (BG) level measured on six different systems and a reference capillary sample prepared for plasma testing at a reference laboratory. Products were obtained from consumer outlets and tested in three triple-blinded studies. Each of the three participating clinical sites tested a different set of six systems for each of the three studies in a round-robin. In each study, on average, a BGM was tested on 115 subjects. A compliant BG result was defined as within 15% of a reference plasma value (for BG ≥100 mg/dL [5.55 mmol/L]) or within 15 mg/dL (0.83 mmol/L) (for BG <100 mg/dL [5.55 mmol/L]). The proportion of compliant readings in each study was compared against a predetermined accuracy standard similar to, but more lenient than, current regulatory standards. Other metrics of accuracy included the overall compliance proportion; the proportion of extreme outlier readings differing from the reference value by >20%; modified Bland-Altman analysis including average bias, coefficient of variation, and 95% limits of agreement; and proportion of readings with no clinical risk as determined by the Surveillance Error Grid., Results: The different accuracy metrics produced almost identical BGM rankings. Six of the 18 systems met the predetermined accuracy standard in all three studies, 5 systems met it in two studies, and 3 met it in one study. Four BGMs did not meet the accuracy standard in any of the three studies., Conclusions: Cleared BGMs do not always meet the level of analytical accuracy currently required for regulatory clearance. This information could assist patients, professionals, and payers in choosing products and regulators in evaluating postclearance performance., (© 2018 by the American Diabetes Association.)

Objective: The primary objective was to compare I-Stat, HemoCue, and RapidLab in measurements of the hemoglobin concentration during cardiac surgeries using cardiopulmonary bypass., Design: Prospective analysis., Setting: Single-center, academic, tertiary care cardiovascular center., Participants: Thirty-four consecutive patients undergoing cardiac surgery requiring cardiopulmonary bypass., Interventions: Blood samples have been collected intraoperatively, and the hemoglobin concentration in each sample was measured, or calculated, simultaneously by the 3 point-of-care devices, HemoCue, RapidLab, and I-Stat., Measurements and Main Results: Correlation coefficients from the regression analysis for HemoCue versus I-Stat, RapidLab versus HemoCue, and RapidLab versus I-Stat were 0.89, 0.96, and 0.88, respectively. Results of the Bland-Altman analysis of the hemoglobin concentration measurements for each device against one another (Fig 1) were as follows: RapidLab versus I-Stat (bias 0.42; 95% confidence interval [CI], -1.05 to 1.89), I-Stat versus HemoCue (bias 0.23; 95% CI, -1.14 to 1.59), and RapidLab versus HemoCue (bias 0.65; 95% CI, -0.17 to 1.47). It appears that I-Stat slightly underestimated the concentration of hemoglobin when compared with both RapidLab and HemoCue. The results of Bland-Altman analysis of each device to a mean Z value (Fig 2) were as follows: RapidLab versus Z (bias 0.36; 95% CI, -0.29 to 1.01), I-Stat versus Z (bias -0.07; CI -0.97 to 0.84), and HemoCue versus Z (bias -0.29; 95% CI, -0.86 to 0.28). Based on the 174 paired samples used for the Pearson moment analysis, the R 2 values for I-Stat versus HemoCue, I-Stat versus RapidLab, and RapidLab versus HemoCue were 0.79, 0.80, and 0.87, respectively CONCLUSIONS: These data support the interchangeability of these 3 devices for the intermittent intraoperative point-of-care assessment of hemoglobin concentrations in cardiac surgery patients. It is important, however, to consider the possible pitfalls associated with each device when making a clinical decision to transfuse., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Introduction: ISO 15197:2013 recommends testing procedures and acceptance criteria for the evaluation of influence quantities such as hematocrit on measurement results with systems for self-monitoring of blood glucose (SMBG). In this study, hematocrit influence was evaluated for a novel SMBG system (system A) and five other systems with different hematocrit ranges based on ISO 15197:2013., Methods: Test procedures were performed with one test strip lot for each system. Each system was tested within the hematocrit range indicated in the manufacturer's labeling (system A: 10-65%, B: 15-65%, C: 20-60%, D: 35-60%, E: 30-60%, F: 30-55%). According to ISO 15197:2013, clause 6.4.2, venous blood samples were used for the evaluation of hematocrit influence. The evaluation was performed for three glucose concentration categories (30-50 mg/dL, 96-144 mg/dL, and 280-420 mg/dL). For each glucose concentration category, at least five different hematocrit levels were investigated., Results: The novel system A and systems B, E, and F complied with the tested lot with the defined criteria and showed ≤10 mg/dL and ≤10% difference between the test sample and the respective control sample with a hematocrit value of 42% ± 2% for BG concentrations <100 mg/dL and ≥100 mg/dL, respectively. Two systems showed >10% difference at glucose concentrations ≥100 mg/dL., Conclusions: Remarkable hematocrit influence within the labeled hematocrit range was obtained in two systems with the tested reagent system lot. Adequate SMBG systems should be carefully chosen by patients and their health care professionals, particularly for patients with increased and decreased hematocrit values.

Background: Therapeutic plasma exchange (TPE) is increasingly used throughout the world. Although the procedure itself is fairly standardized, it is yet unknown how the underlying disease entities influence the key coordinates of the treatment., Methods: Retrospective chart review. The treatment indications were clustered into four categories. Data are presented as median and interquartile (25-75%) range [IQR]., Results: Within 1 year, 912 TPE treatments were performed in 185 patients (90 female, 48.6%). The distribution of the treatment numbers to the pre-specified disease categories were as follows: transplantation (35.7%), neurology (31.9%), vasculitis and immunological disease (17.3%), and others including thrombotic microangiopathy (8.1%), critical care related diseases (5.4%), hematology [multiple myeloma] (1.1%), and endocrine disorders (0.5%). The calculated plasma volume was significantly higher in patients with vasculitis and immunological diseases (3984 [3433-4439] ml) as compared to patients treated for transplant related indications (3194 [2545-3658] ml; p = 0.0003) and neurological diseases (3058 [2533-3359] ml; p < 0.0001). This was mainly due to the differences in the hematocrit which was 30.5 [27.0-33.6] % in the vasculitis/immunological disease patients and 40.2 [37.5-42.9] % in the neurological patients; p < 0.0001. Interestingly, treatment time using a membrane based technology was significantly longer than TPE using a centrifugal device 135.0 [125.0-140.0] min vs. 120.0 [112.5-135.0] min. Furthermore, the relative exchanged plasma volume was significantly lower in the treatment of vasculitis and immunological diseases as compared to treatments of transplant related indications and neurological diseases., Conclusion: Patients with low hematocrit and high body weight do not receive the minimum recommended dose of exchange volume. Centrifugal TPE allowed faster plasma exchange than membrane TPE.

Background: Although point-of-care (POC) analyzers are commonly used during liver transplantation (LT), the accuracy of hematocrit measurement using a POC analyzer has not been evaluated. In this retrospective observational study, we aimed to evaluate the accuracy of hematocrit measurement using a POC analyzer and identify potential contributors to the measurement error and their influence on mistransfusion during LT., Methods: We retrospectively collected 6461 pairs of simultaneous intraoperative hematocrit measurements using POC analyzers and laboratory devices during LTs in 901 patients. The agreement of hematocrit measurements was assessed using Bland-Altman analysis for repeated measurements, while the incidence and magnitude of hematocrit measurement error were compared among 16 different laboratory abnormality categories. A generalized estimating equation analysis was performed to identify potential contributors to falsely low-measured POC hematocrit. Additionally, we defined potential "overtransfusion" in the case when POC hematocrit was <20% and laboratory hematocrit was ≥20% and investigated its association with intraoperative transfusion., Results: The POC hematocrit measurements were falsely lower than the laboratory hematocrit measurements in 70.3% (4541/6461) of pairs. The median (interquartile range) of hematocrit measurement error was -1.20 (-2.60 to 0.20). Bland-Altman analysis showed that 24.5% (1583/6461) of the errors were outside our a priori defined clinically acceptable limits of ±3%. The incidence of falsely low-measured hematocrit was significantly higher with the presence of concomitant hypoalbuminemia and hypoproteinemia. Hypoalbuminemia combined with hyperglycemia showed significantly larger hematocrit measurement error. Hypoalbuminemia, hypoproteinemia, and hyperglycemia were predictors of falsely low-measured hematocrit. Furthermore, the overtransfusion group showed larger amount of transfusion than the adequately transfused group, with a median difference of 2 units (95% confidence interval [0-4], P = .039), despite similar amount of blood loss., Conclusions: Hematocrit measured using the POC device tends to be lower than the laboratory hematocrit measured during LT. Commonly encountered laboratory abnormalities during LT include hypoalbuminemia, hypoproteinemia, and hyperglycemia, which may contribute to falsely low-measured POC hematocrit. Careful consideration of these confounders may help reduce overtransfusion that occurs due to falsely low-measured POC hematocrit.

Objective: To determine whether judicious blood testing impacts timing or amount of packed RBC transfusions in infants after heart surgery., Design: A retrospective study comparing before and after initiation of a quality improvement process., Setting: A university-affiliated cardiac ICU at a tertiary care children's hospital., Patients: Infants less than 1 year old with Risk Adjustment for Congenital Heart Surgery category 4, 5, 6, or d-transposition of great arteries (Risk Adjustment for Congenital Heart Surgery 3) consecutively treated during 2010 through 2013., Intervention: A quality improvement process implemented in 2011 to decrease routine laboratory testing after surgery., Measurements and Main Results: Fifty-two infants preintervention and 214 postintervention had similar age, weight, proportion of cyanotic lesions, and surgical complexity. Infants with single versus biventricular physiology were compared separately. The number of laboratory tests per patient adjusted for cardiac ICU length of stay (laboratory tests/patient/day) was significantly lower in postintervention populations for single and biventricular groups (9 vs 15 and 10 vs 15, respectively; p < 0.001). The proportion of single ventricle patients transfused post- and preintervention was not statistically different (72% vs 90%; p = 0.130). Transfusion in the biventricular groups was the same over time (65% vs 65%). Time to first transfusion was significantly longer in the postintervention single ventricle group (4 vs 1 d; p < 0.001), and was not statistically different in the biventricular patients (4 vs 7 d; p = 0.058). The median hematocrit level at first transfusion was significantly lower (37% vs 40%; p = 0.004) postintervention in the cyanotic population, but did not differ in the biventricular group (31% vs 31%; p = 0.840)., Conclusion: In infants after heart surgery, blood testing targeted to individual needs significantly decreased the number of blood tests, but did not significantly decrease postoperative blood transfusion.

Background: There is considerable uncertainty regarding the optimal haemoglobin threshold for the use of red blood cell (RBC) transfusions in anaemic patients. Blood is a scarce resource, and in some countries, transfusions are less safe than others because of a lack of testing for viral pathogens. Therefore, reducing the number and volume of transfusions would benefit patients., Objectives: The aim of this review was to compare 30-day mortality and other clinical outcomes in participants randomized to restrictive versus liberal red blood cell (RBC) transfusion thresholds (triggers) for all conditions. The restrictive transfusion threshold uses a lower haemoglobin level to trigger transfusion (most commonly 7 g/dL or 8 g/dL), and the liberal transfusion threshold uses a higher haemoglobin level to trigger transfusion (most commonly 9 g/dL to 10 g/dL)., Search Methods: We identified trials by searching CENTRAL (2016, Issue 4), MEDLINE (1946 to May 2016), Embase (1974 to May 2016), the Transfusion Evidence Library (1950 to May 2016), the Web of Science Conference Proceedings Citation Index (1990 to May 2016), and ongoing trial registries (27 May 2016). We also checked reference lists of other published reviews and relevant papers to identify any additional trials., Selection Criteria: We included randomized trials where intervention groups were assigned on the basis of a clear transfusion 'trigger', described as a haemoglobin (Hb) or haematocrit (Hct) level below which a red blood cell (RBC) transfusion was to be administered., Data Collection and Analysis: We pooled risk ratios of clinical outcomes across trials using a random-effects model. Two people extracted the data and assessed the risk of bias. We conducted predefined analyses by clinical subgroups. We defined participants randomly allocated to the lower transfusion threshold as 'restrictive transfusion' and to the higher transfusion threshold as 'liberal transfusion'., Main Results: A total of 31 trials, involving 12,587 participants, across a range of clinical specialities (e.g. surgery, critical care) met the eligibility criteria. The trial interventions were split fairly equally with regard to the haemoglobin concentration used to define the restrictive transfusion group. About half of them used a 7 g/dL threshold, and the other half used a restrictive transfusion threshold of 8 g/dL to 9 g/dL. The trials were generally at low risk of bias .Some items of methodological quality were unclear, including definitions and blinding for secondary outcomes.Restrictive transfusion strategies reduced the risk of receiving a RBC transfusion by 43% across a broad range of clinical specialties (risk ratio (RR) 0.57, 95% confidence interval (CI) 0.49 to 0.65; 12,587 participants, 31 trials; high-quality evidence), with a large amount of heterogeneity between trials (I² = 97%). Overall, restrictive transfusion strategies did not increase or decrease the risk of 30-day mortality compared with liberal transfusion strategies (RR 0.97, 95% CI 0.81 to 1.16, I² = 37%; N = 10,537; 23 trials; moderate-quality evidence) or any of the other outcomes assessed (i.e. cardiac events (low-quality evidence), myocardial infarction, stroke, thromboembolism (high-quality evidence)). Liberal transfusion did not affect the risk of infection (pneumonia, wound, or bacteraemia)., Authors' Conclusions: Transfusing at a restrictive haemoglobin concentration of between 7 g/dL to 8 g/dL decreased the proportion of participants exposed to RBC transfusion by 43% across a broad range of clinical specialities. There was no evidence that a restrictive transfusion strategy impacts 30-day mortality or morbidity (i.e. mortality at other points, cardiac events, myocardial infarction, stroke, pneumonia, thromboembolism, infection) compared with a liberal transfusion strategy. There were insufficient data to inform the safety of transfusion policies in certain clinical subgroups, including acute coronary syndrome, myocardial infarction, neurological injury/traumatic brain injury, acute neurological disorders, stroke, thrombocytopenia, cancer, haematological malignancies, and bone marrow failure. The findings provide good evidence that transfusions with allogeneic RBCs can be avoided in most patients with haemoglobin thresholds above 7 g/dL to 8 g/dL.

Background and Objectives: Quality control (QC) data collected by blood services are used to monitor production and to ensure compliance with regulatory standards. We demonstrate how analysis of quality control data can be used to highlight the sources of variability within red cell concentrates (RCCs)., Materials and Methods: We merged Canadian Blood Services QC data with manufacturing and donor records for 28 227 RCC between June 2011 and October 2014. Units were categorized based on processing method, bag manufacturer, donor age and donor sex, then assessed based on product characteristics: haemolysis and haemoglobin levels, unit volume, leucocyte count and haematocrit., Results: Buffy-coat method (top/bottom)-processed units exhibited lower haemolysis than units processed using the whole-blood filtration method (top/top). Units from female donors exhibited lower haemolysis than male donations. Processing method influenced unit volume and the ratio of additive solution to residual plasma., Conclusions: Stored red blood cell characteristics are influenced by prestorage processing and donor factors. Understanding the relationship between processing, donors and RCC quality will help blood services to ensure the safety of transfused products., (© 2016 International Society of Blood Transfusion.)

We report the improvement of a method for the detection of ochratoxin A (OTA) and its thermal degradation product 2'R-ochratoxin A in dried blood spots (DBS) by high performance liquid chromatographic (HPLC) tandem mass spectrometry (MS/MS). The DBS technique was advanced for the analysis of these two compounds in DBS with unknown amounts of blood as well as varying hematocrit values. Furthermore the comparability of venous vs. capillary blood was investigated. Human whole blood samples were spotted, dried, and extracted with a solvent consisting of acetone, acetonitrile and water for analysis by HPLC-MS/MS. Quantification was carried out by stable isotope labelled internal standards. Blood samples of volunteers (n=50) were used to further optimize and simplify the procedure. Ochratoxin A and 2'R-ochratoxin A concentrations found in the entire spots (approx. 100 μL blood) were compared with punched DBS discs of 8.8mm size containing approximately 20 μL blood. As a result the amounts of both toxins in a punched 8.8mm disc correlate well with the entire DBS. Also the use of capillary blood from finger-pricks versus venous blood was evaluated. The analyte levels correlate as well indicating that the less invasive finger-prick sampling gives also reliable results. The influence of hematocrit was investigated in a range of 25-55% according to the hematocrit in the used real blood samples (34-46% hematocrit). However no significant hematocrit effect was observed for the utilized real blood samples. Moreover different blood volumes were spotted and punched as a minimal spot size is usually recommended for accurate analysis. In this experiment finger-prick samples typically consist of about 90 μL blood. Therefore spots of 75, 100 and 125 μL blood were prepared and analyzed. Similar to the hematocrit effect, no considerable influence was observed., (Copyright © 2016 Elsevier B.V. All rights reserved.)

Background: Blood cell parameters in a healthy population of different ages and genders from the Daxingan region of Inner Mongolia were evaluated to establish reference intervals (RIs) for venous blood parameters for healthy individuals from this region., Methods: Venous blood specimens were collected from 1757 healthy individuals aged 7-65 years and analyzed by an XE-5000 automated hematology analyzer. Results were statistically analyzed by gender and age group. RIs for venous blood parameters of children were compared to the National Clinical Laboratory Procedures and those of adults were compared to the Health Industry Standards of the People's Republic of China (WST405-2012)., Results: In the Daxingan region, WBC, RBC, MCV, and NEUT%, MONO%, and EO% of healthy children were significantly different between genders (p < 0.05). Other parameters were not significantly different (p > 0.05). All parameters of adults were significantly different between different genders (p < 0.05) except for LYMPH% and BASO%. Comparison of mean values between children and adults of the same gender revealed significant differences in each blood cell parameter (p < 0.05). RBC, MCV, MCH, MCHC, PLT, MONO%, and BASO% of adult men were significantly different between different age groups (p < 0.05), and HGB, HCT, and EO% of adult women were significantly different between different age groups (p < 0.05). For children, only the mean of MCHC and EO% were close to the National Clinical Laboratory Procedures. Mean of RBC, HGB, PLT, LYMPH%, and MONO% were higher and the remaining parameters were lower than the National Clinical Laboratory Procedures. Compared with WST405-2012 for adults, PLT of women aged 18-40 years and NEUT% of adults were higher, whereas the mean of EO% and BASO% were significantly lower., Conclusions: RIs for venous blood parameters change with age, geographic region, ethnic group, and gender. There is a great necessity to establish RIs for venous blood parameters among the healthy population in the Daxingan region.

Background: In a collaboration between the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) and the Canadian Health Measures Survey (CHMS), we determined reference value distributions using an a priori approach and created a comprehensive database of age- and sex-stratified reference intervals for clinically relevant hematologic parameters in a large household population of children and adults., Methods: The CHMS collected data and blood samples from 11 999 respondents aged 3-79 years. Hematology markers were measured with either the Beckman Coulter HmX or Siemens Sysmex CA-500 Series analyzers. After applying exclusion criteria and removing outliers, we determined statistically relevant age and sex partitions and calculated reference intervals, including 90% CIs, according to CSLI C28-A3 guidelines., Results: Hematology marker values showed dynamic changes from childhood into adulthood as well as between sexes, necessitating distinct partitions throughout life. Most age partitions were necessary during childhood, reflecting the hematologic changes that occur during growth and development. Hemoglobin, red blood cell count, hematocrit, and indices (mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration) increased with age, but females had lower hemoglobin and hematocrit starting at puberty. Platelet count gradually decreased with age and required multiple sex partitions during adolescence and adulthood. White blood cell count remained relatively constant over life, whereas fibrinogen increased slightly, requiring distinct age and sex partitions., Conclusions: The robust dataset generated in this study has allowed observation of dynamic biological profiles of several hematology markers and the establishment of comprehensive age- and sex-specific reference intervals that may contribute to accurate monitoring of pediatric, adult, and geriatric patients., (© 2015 American Association for Clinical Chemistry.)

Background: Conductivity based point-of-care hematocrit with calculated hemoglobin devices serves an important role in clinical scenarios where time sensitive transfusion decisions are necessary. However, questions about the appropriateness of conductivity based assays in certain patient populations (patients on cardiopulmonary bypass and those receiving high volumes of intravenous fluids or autologous blood transfusions) have been raised. The clinical suitability of POC devices for these applications necessitates that they be accurate and that the results are interchangeable with central laboratory methods., Methods: We performed hematocrit and hemoglobin analysis on 225 clinical samples using the i-STAT instrument, a standard reference method for hematocrit (manual spun) and other common methods on both cardiopulmonary bypass and non-cardiopulmonary bypass patients., Results: The i-STAT hematocrit and hemoglobin showed close agreement to comparison methods with minimal bias. Median test results were not clinically or statistically different between those measured on the i-STAT and those measured using the manual spun hematocrit reference method (p=0.4085, Wilcoxon signed rank test) or the Sysmex photometric hemoglobin method (p=0.2728, Wilcoxon signed rank test). The results on the i-STAT were statistically different from those obtained on the Sysmex for hematocrit (p<0.0001) and the Siemens RAPIDLab co-oximeter for hemoglobin (p<0.0001)., Conclusion: The i-STAT hematocrit and hemoglobin performs well when compared to the hematocrit reference method and other common methods for both hematocrit and hemoglobin. Some differences between non-reference methods may be observed, but these were not considered clinically significant., (Copyright © 2015 Elsevier B.V. All rights reserved.)

Background: Non-cellulose dried matrix spotting (DMS) cards are an alternative to filter paper (FP) for bloodspots. We compared the interpatient distributions of bloodspot areas between DMS and FP for a fixed volume of application of whole blood, and examined correlations of areas with hematocrit., Methods: EDTA-whole blood adult patient samples (n=49; 25 males, 24 females) were utilized after routine measurement of hemoglobin and hematocrit. Replicate (4×) bloodspots were produced by bolus drop application of 50μL whole blood via a fixed-volume pipettor to either FP or DMS. Dried bloodspot areas were determined by image analysis., Results: Hematocrits (HCT) were normally distributed (HCT=30.9±5.3%). For both FP and DMS, bloodspot areas (a, cm(2)) across patients were normally distributed: for FP, a=1.11±0.056cm(2) (±5.0%); for DMS, a=0.378±0.037cm(2) (±9.9%). Relative bloodspot area differences across the population range were >20% for both DMS and FP. Correlation of bloodspot areas to hematocrit was negative for FP (r=-0.80) but positive for DMS (r=+0.78)., Conclusions: Interpatient variation in blood volume per area is a preanalytical variable for both DMS and FP bloodspots. Hematocrit is but one interpatient variable, as correlations of fixed-volume bloodspot areas with hematocrit across patients were substantially inexact (r(2)<0.65)., (Copyright © 2014. Published by Elsevier B.V.)

Background: Plasma variables may be affected by breed or body weight (BW). Small-sized dogs are very common, but no specific reference intervals (RI) are used., Objectives: The primary objective of this prospective study was to assess the potential effect of breed, BW, age, and sex on routine plasma analytes and packed cell volume (PCV) in small-sized dogs. A secondary objective was to establish RI in this small-sized population., Methods: Blood was sampled under standardized conditions from healthy dogs. PCV and 15 routine plasma variables were measured at the same laboratory. Effects of breed, BW, age, and sex were tested using a general linear model. The procedure recommended by the Clinical and Laboratory Standards Institute was used to establish RI., Results: In this study, 154 healthy dogs from 7 breeds were prospectively included. Although a significant effect of breed, BW, sex, or age was evidenced for most variables (except plasma sodium, phosphates, and triglycerides), it was considered as clinically irrelevant. More strikingly, the percentage of values in the reference sample group under the lower limit of the laboratory's RI ranged from 3.8% to 76.6% for 9 variables, and those higher than the upper limit of the laboratory's RI ranged from 4.5% to 9.7% for 7 variables. For example, the RI for creatinine in small-sized dogs was 45-90 μmol/L (vs 54-144 μmol/L for the general dog population)., Conclusion: Specific RI should be considered for PCV and selected plasma variables in small-sized dogs., (© 2014 American Society for Veterinary Clinical Pathology and European Society for Veterinary Clinical Pathology.)

Background: Severe hemodilution and perioperative bleeding are determinants of hematocrit (HCT) variations in cardiac surgery patients. These variations may be direct determinants of bad outcomes, and may trigger allogeneic blood product transfusions, which are associated with morbidity and mortality. The present study introduces the Percentage HEmatocrit VARiation (PHEVAR) index as a tool to assess the quality of patient blood management (PBM) and to possibly guide specific interventions., Methods: Seven-hundred-thirteen adult cardiac surgery patients were included in a retrospective analysis. The PHEVAR index was assessed based on the HCT determination at six points in time, being represented by the area under the curve of the percentage HCT variation from baseline. The PHEVAR index was explored for association with operative mortality and other outcome measurements., Results: The PHEVAR index was an independent predictor of operative mortality (odds ratio 1.015, 95% confidence interval 1.005-1.026), postoperative bleeding, length of mechanical ventilation; significantly higher values of PHEVAR were detected in patients with acute kidney injury, low cardiac output, and ventricular arrhythmias. Acute kidney injury was associated with a larger HCT variation during surgery; low cardiac output with a larger postoperative HCT variation; and ventricular arrhythmias with a larger preoperative HCT variation., Conclusion: The PHEVAR index reflects HCT variations during 7 days of hospital stay in cardiac surgery patients, is associated with mortality and morbidity, and may be used as a quality index for PBM.

The present study aimed at comparing the trypanosome specific 18S-PCR-RFLP using samples stored either on Whatman filter papers (PCR-RFLP-fp) or in a commercial cell lysis and DNA protecting buffer (PCR-RFLP-pb) with the haematocrit centrifugation technique (HCT), a method widely used for the diagnosis of African Animal Trypanosomosis. Out of 411 head of cattle, 49 (11.92%) (CI=8.95-15.45) scored positive for the presence of trypanosomes by HCT whereas 75 (18.25%) (CI=14.63-22.33) and 124 (30.17%) (CI=25.77-34.86) scored positive using PCR-RFLP-fp and PCR-RFLP-pb, respectively. Out of the 49 positives by HCT, 14 (28.57%) (CI=16.58-43.26) and 28 (57.14%) (CI=42.21-71.18) were concordant by PCR-RFLP-fp and PCR-RFLP-pb, respectively. None of the PCR techniques detected parasites from the Trypanozoon group. Although HCT detected more cases of Trypanosoma vivax (33), species identification using PCR-RFLP-fp and PCR-RFLP-pb were significantly different (p<0.001) from the HCT technique. The use of DNA protective buffer is thus recommended as the output of the PCR-RFLP-pb is improved and the risk of contamination between samples is reduced., (Copyright © 2014 Elsevier B.V. All rights reserved.)

We investigated the accuracy of i-STAT(®) (Abbott Point of Care Inc., Princeton, NJ, USA) haemoglobin (Hb) measurement in surgical patients with an estimated blood loss of ≥25% of total blood volume. Blood tests for i-STAT(®) Hb, laboratory Hb (Sysmex XE-2100(™), Sysmex Corporation, Kobe, Japan) and total plasma proteins were obtained at the start of surgery (T=0) and when an estimated 25% total blood volume loss had occurred (T=1). Thirty-one patients were recruited. The coefficient of variation of the paired i-STAT(®) Hb estimates was 2.8% and 2.9% at T=0 and T=1, respectively. The mean difference between i-STAT(®) and laboratory Hb was -7.6 g/l (standard deviation 6.5) at T=0 and -5.1 g/l (standard deviation 12) at T=1. The mean total plasma protein difference (total plasma protein T=0 minus T=1) was 13.6 g/l (95% confidence interval 10.2 to 17.0). There was poor correlation between total plasma protein and bias in i-STAT(®) measurements. The i-STAT(®) Hb had an acceptable coefficient of variation, but the Hb levels were lower than those estimated by the laboratory. The standard deviation of i-STAT(®) Hb was greater after ≥25% estimated total blood volume loss. Clinicians should not use the i-STAT(®) Hb in isolation for clinical decision-making when considering blood transfusion in a situation of 25% or greater blood loss.

In theory, the power of a trans-cranial Doppler signal may be used to measure changes in blood flow and vessel diameter in addition to velocity. In this study, a flow index (FI) of relative changes in blood flow was derived from frequency-weighted Doppler power signals. The FI, plotted against velocity, was calibrated to the zero intercept with absent flow to reduce the effects of non-uniform vessel insonation. An area index was also calculated. FIs were compared with actual flow in four silicone tubes of different diameter at increasing flow rates and increasing hematocrit (Hct) in a closed-loop phantom model. FI values were strongly correlated with actual flow, at constant Hct, but varied substantially with changes in Hct. Percentage changes in area indexes, relative to the 4-mm tube, were strongly correlated with tube cross-sectional area. The implications of these results for in vivo use are discussed., (Copyright © 2014 World Federation for Ultrasound in Medicine & Biology. Published by Elsevier Inc. All rights reserved.)

Background: At the start of their work, the European Bioanalysis Forum dried blood spots microsampling consortium did not form a dedicated team to investigate the spot homogeneity. However, two teams performed experiments that produced results relating to sample homogeneity., Results: The data, which were produced via two different approaches (a radiolabeled and a nonradiolabeled approach), are highly complementary and demonstrate clear effects on sample inhomogeneity due to the substrate type, compound and hematocrit levels., Conclusion: The results demonstrate that sample inhomogeneity is a significant hurdle to the use of dried blood spots for regulated bioanalysis that should be investigated further in the method establishment phase if the whole spot is not sampled.

Background: The European Bioanalysis Forum dried blood spots (DBS)/microsampling consortium is reporting back from the experiments they performed on further documenting the potential hurdles of the DBS technology. This paper is focused on the impact of hematocrit changes on DBS analyses., Results: The hematocrit can have an effect on the size of the blood spot, on spot homogeneity and on extraction recovery in a compound-dependent manner. The extraction recovery can change upon aging in an hematocrit-dependent way. Different card materials can give different outcomes., Conclusions: The results from the conducted experiments show that the issues of DBS in regulated bioanalysis are real and that the technology will need improvements to be ready for use as a general tool for regulated bioanalysis.