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The evolution of complete blood count (CBC) methodology from manual calculations to sophisticated high throughput hematology analyzers is the focus of this article. In recent years, hematology testing has greatly benefitted from the combination of various technologies with automated neural networks. In addition to an increasing complexity of the laboratory instrumentation, there is a demand on point of care CBC testing with its benefits and drawbacks. This article highlights exciting advancements of hematology testing from the past to the present and into the future., (Copyright © 2024 Elsevier Inc. All rights reserved.)

It is increasingly clear that an extraordinarily diverse range of clinically important conditions-including infections, vaccinations, autoimmune diseases, transplants, transfusion reactions, aging, and cancers-leave telltale signatures in the millions of V(D)J-rearranged antibody and T cell receptor [TR per the Human Genome Organization (HUGO) nomenclature but more commonly known as TCR] genes collectively expressed by a person's B cells (antibodies) and T cells. We refer to these as the immunome . Because of its diversity and complexity, the immunome provides singular opportunities for advancing personalized medicine by serving as the substrate for a highly multiplexed, near-universal blood test. Here we discuss some of these opportunities, the current state of immunome-based diagnostics, and highlight some of the challenges involved. We conclude with a call to clinicians, researchers, and others to join efforts with the Adaptive Immune Receptor Repertoire Community (AIRR-C) to realize the diagnostic potential of the immunome., Competing Interests: Author FR was employed by Roche Sequencing Solutions. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Arnaout, Prak, Schwab, Rubelt and the Adaptive Immune Receptor Repertoire Community.)

Background: The need for rapid point-of-care (POC) diagnostics is now becoming more evident due to the increasing need for timely results and improvement in healthcare service. With the recent COVID-19 pandemic outbreak, POC has become critical in managing the spread of disease. Applicable diagnostics should be readily deployable, easy to use, portable, and accurate so that they fit mobile laboratories, pop-up treatment centers, field hospitals, secluded wards within hospitals, or remote regions, and can be operated by staff with minimal training. Complete blood count (CBC), however, has not been available at the POC in a simple-to-use device until recently. The HemoScreen, which was recently cleared by the FDA for POC use, is a miniature, easy-to-use instrument that uses disposable cartridges and may fill this gap., Content: The HemoScreen's analysis method, in contrast to standard laboratory analyzers, is based on machine vision (image-based analysis) and artificial intelligence (AI). We discuss the different methods currently used and compare their results to the vision-based one. The HemoScreen is found to correlate well to laser and impedance-based methods while emphasis is given to mean cell volume (MCV), mean cell hemoglobin (MCH), and platelets (PLT) that demonstrate better correlation when the vision-based method is compared to itself due to the essential differences between the underlying technologies., Summary: The HemoScreen analyzer demonstrates lab equivalent performance, tested at different clinical settings and sample characteristics, and might outperform standard techniques in the presence of certain interferences. This new approach to hematology testing has great potential to improve quality of care in a variety of settings., (© American Association for Clinical Chemistry 2020. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Digital morphology hematology analyzers are becoming more prevalent in laboratories Aims: investigate practices and assess the benefits and limits of digital automated microscopy in hematology., Methods: questionnaire sent by e-mail in 2018 to French public and private laboratories., Results: out of 118 responses (56 private, 62 public), 117 participants had a CellaVision® microscope, 1 had a West Medica®. Practices were sometimes different, especially in the choice of smears to be digitized or for quality controls (16.1% had internal quality controls, 48.3% external quality controls); 62.1% never used the red blood cell (RBC) characterization tool; the number of cells counted varied from 100 to 400. The study reported a high rate of agreement for these benefits: traceability (95.7%), staff training (94.1%), eye strain (91.4%), risk of error (87.2%), time saving (83.6%). Among the disadvantages, apart from the inadequate search for platelets clumps (93.2%), the agreement rates were often lower: adaptation to digital images (61.2%), difficult assessment of atypical morphologies (49.6%) or RBC morphology (49.6%)., Conclusion: despite well-established benefits, standardization of practices and technical improvement are still needed.

There is increasing interest in the identification of biomarkers that could predict neurological outcome following a spinal cord injury (SCI). Although initial American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade is a good indicator of neurological outcome, for the patient and clinicians, an element of uncertainty remains. This preliminary study aimed to assess the additive potential of routine blood analytes following principal component analysis (PCA) to develop prognostic models for neurological outcome following SCI. Routine blood and clinical data were collected from SCI patients ( n  = 82) and PCA used to reduce the number of blood analytes into related factors. Outcome neurology was obtained from AIS scores at 3 and 12 months post-injury, with motor (AIS and total including all myotomes) and sensory (AIS, touch and pain) abilities being assessed individually. Multiple regression models were created for all outcome measures. Blood analytes relating to "liver function" and "acute inflammation and liver function" factors were found to significantly increase prediction of neurological outcome at both 3 months (touch, pain, and AIS sensory) and at 1 year (pain, R 2 increased by 0.025 and total motor, R 2 increased by 0.016). For some models "liver function" and "acute inflammation and liver function" factors were both significantly predictive, with the greatest combined R 2 improvement of 0.043 occurring for 3 month pain prediction. These preliminary findings support ongoing research into the use of routine blood analytes in the prediction of neurological outcome in SCI patients.

Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose.

Objective: Cardiovascular disease (CVD) risks in systemic lupus erythematosus (SLE) are similar to those in diabetes mellitus (DM). We investigated whether the numbers of lipid tests and statin prescriptions in patients with SLE are comparable with those in patients with DM and those in individuals without either disease., Methods: Using Analytic eXtract files from 29 states for 2007-2010, we identified a cohort of US Medicaid beneficiaries, ages 18-65 years, with prevalent SLE. Each SLE patient was matched for age and sex with 2 patients with DM and 4 individuals in the general Medicaid population who did not have either SLE or DM. We compared the proportions of patients in each cohort who received ≥1 lipid test and ≥1 statin prescription during 1-year follow-up. We used multivariable logistic regression to calculate the odds of lipid testing and receiving prescriptions for statins and conditional logistic regression to compare the matched cohorts., Results: We identified 3 Medicaid cohorts: 25,950 patients with SLE, 51,900 patients with DM, and 103,800 Medicaid recipients without either condition. In these cohorts, lipid testing was performed in 24% of patients in the SLE group, 43% of patients in the DM group, and 16% of individuals in the group with neither condition, and statin prescriptions were dispensed in 11%, 33%, and 7% of these groups, respectively. SLE patients were 66% less likely (odds ratio [OR] 0.34, 95% confidence interval [95% CI] 0.34-0.35) to have lipid tests and 82% less likely (OR 0.18, 95% CI 0.18-0.18) to fill a statin prescription compared with DM patients. SLE patients were also less likely (OR 0.89, 95% CI 0.84-0.94) to fill a statin prescription compared with individuals in the general Medicaid population., Conclusion: Despite having an elevated risk of CVD, SLE patients received less lipid testing and received fewer statin prescriptions compared with age- and sex-matched DM patients and individuals in the general Medicaid population; this gap should be a target for improvement., (© 2018, American College of Rheumatology.)

Background: Routine preoperative testing is discouraged before low-risk surgery because testing does not provide any beneficial effect in terms of patient outcome. However, few studies have assessed the utilization of hospital health care resources in terms of preoperative tests in a real-world setting. Here, we aimed to assess the prevalence and factors associated with preoperative blood tests before low-risk surgery in Japan., Methods: In this retrospective observational study, we used the nationwide insurance claims data of Japan. Patients who underwent low-risk surgeries between April 1, 2012 and March 31, 2016, were included. Our primary outcome was the receipt of any preoperative tests within 60 days before an index procedure: complete blood count, basic metabolic panel, coagulation tests, and liver function tests. We performed a descriptive analysis to estimate the proportions of preoperative blood tests, and examined the associations between patient-level and institutional-level factors and preoperative blood tests, using multilevel logistic regression analysis. Interinstitutional variation in the utilization of preoperative tests was summarized using the median odds ratio (OR)., Results: The study sample included 59,818 patients (mean [standard deviation] age, 44.0 [11.3] years; 33,574 [56.1%] women) from 9746 institutions. The overall proportion of each test was: complete blood count, 58.7%; metabolic panel, 47.8%; coagulation tests, 36.6%; and liver function tests, 48.5%. The proportion receiving any preoperative tests in the overall sample was 59.5%. Multilevel logistic regression analysis indicated that preoperative blood tests were associated with the Charlson comorbidity index score (score ≥3: adjusted OR, 4.21; 95% confidence interval [CI], 3.69-4.80), anticoagulant use (adjusted OR, 4.12; 95% CI, 2.35-7.22), type of anesthesia (general anesthesia: adjusted OR, 5.69; 95% CI, 4.85-6.68; regional anesthesia: adjusted OR, 3.76; 95% CI, 3.28-4.30), surgical setting (inpatient procedure: adjusted OR, 3.64; 95% CI, 3.30-4.00), and number of beds (≥100 beds: adjusted OR, 3.61; 95% CI, 3.19-4.08). The median institutional-specific proportion of preoperative tests was 40.0% (interquartile range, 0%-100%). The median OR for interinstitutional variation in ordering preoperative tests was 4.34. These findings were consistent across a sensitivity analysis., Conclusions: Preoperative blood tests were performed before 59.5% of low-risk surgeries. Preoperative tests were associated with the type of anesthesia, patient characteristics, and medical facility status. There was a substantial interinstitutional variation in the utilization of preoperative tests.

Goats in the tropics are often reared under the traditional extensive and semi-intensive management systems. These and other factors influence the pattern of pneumonia complex in goats. We investigated the bronchoalveolar lavage fluid (BALf) cellular changes and haematological response in different types of caprine pneumonia in Nigeria. Haematological indices and BALf cells were analysed from 300 goats randomly selected from 700 goats comprising different breed, age and body scores. The pneumonia status was well characterised using standard pathological tools. Data is summarized as Mean ± SEM and compared using non-parametric statistics at 5% significance. There was leukocytosis in the pneumonic animals. The overall lavage recovery rate was 55.5%. The differences in Haemoglobin concentration, and Lymphocyte-Neutrophil ratio were significant (p<0.05). BALf changes in the neutrophil, macrophage and eosinophil counts were significantly different (p<0.05). The diagnostic features including increased percentage neutrophils, Macrophage-Neutrophil ratio and eosinophils observed in BAL were reliable and also correlated positively to the pathological findings. BAL should be considered a component of the diagnostic approach to caprine pneumonia complex, as it may accurately aid diagnosis and identification of the causal organisms.

Internal quality control (IQC) is a critical component of laboratory quality management, and IQC products can determine the reliability of testing results. In China, given the fact that most blood transfusion compatibility laboratories do not employ IQC products or do so minimally, there is a lack of uniform and standardized IQC methods. To explore the reliability of IQC products and methods, we studied 697 results from IQC samples in our laboratory from 2012 to 2014. The results showed that the sensitivity and specificity of the IQCs in anti-B testing were 100% and 99.7%, respectively. The sensitivity and specificity of the IQCs in forward blood typing, anti-A testing, irregular antibody screening, and cross-matching were all 100%. The reliability analysis indicated that 97% of anti-B testing results were at a 99% confidence level, and 99.9% of forward blood typing, anti-A testing, irregular antibody screening, and cross-matching results were at a 99% confidence level. Therefore, our IQC products and methods are highly sensitive, specific, and reliable. Our study paves the way for the establishment of a uniform and standardized IQC method for pre-transfusion compatibility testing in China and other parts of the world.

Hamsters, gerbils, rats, and mice are presented to veterinary clinics and hospitals for prophylactic care and treatment of clinical signs of disease. Physical examination, history, and husbandry practice information can be supplemented greatly by assessment of hematologic parameters. As a resource for veterinarians and their technicians, this article describes the methods for collection of blood, identification of blood cells, and interpretation of the hemogram in mice, rats, gerbils, and hamsters., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Fish health is a growing concern as pets, education, and aquaculture evolves. For the veterinary staff, fish handling, diagnostics, medicine, and surgery may require specialized training and equipment in comparison with terrestrial and arboreal animals, simply because of their aquatic nature and diversity. Fish hematology is one diagnostic tool that may not require additional equipment, may be inexpensive, and provide useful information in guiding treatment options. Challenges involving hematology may include handling and restraint, venipuncture, evaluation, and interpretation. In this article, strategies for these challenges are discussed for teleost (bony fish) and elasmobranch (cartilaginous fish) fish types., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Pet ferrets are presented to veterinary clinics for routine care and treatment of clinical diseases and female reproductive problems. In addition to obtaining clinical history, additional diagnostic testing may be required, including hematological assessments. This article describes common blood collection methods, including venipuncture sites, volume of blood that can be safely collected, and handling of the blood. Hematological parameters for normal ferrets are provided along with a description of the morphology of ferret leukocytes to assist in performing a differential count., (Copyright © 2015 Elsevier Inc. All rights reserved.)

The basic principles of hematology used in mammalian medicine can be applied to reptiles. The appearances of the blood cells are significantly different from those seen in most mammals, and vary with taxa and staining method used. Many causes for abnormalities of the reptilian hemogram are similar to those for mammals, although additional factors such as venipuncture site, season, hibernation status, captivity status, and environmental factors can also affect values, making interpretation of hematologic results challenging. Values in an individual should be compared with reference ranges specific to that species, gender, and environmental conditions when available., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Iron is an essential element and is used by every cell in the body. This article summarizes iron metabolism and disorders associated with iron metabolism in dogs and cats. The diagnostic tests currently in use for assessing iron status are discussed., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Pet rabbits are presented to veterinary clinics for routine care and treatment of clinical diseases. In addition to obtaining clinical history, additional diagnostic testing may be required, including hematological assessments. This article describes common blood collection methods, including venipuncture sites, volume of blood that can be safely collected, and handling of the blood. Hematological parameters for normal rabbits are provided for comparison with in-house or commercial test results. A description of the morphology of rabbit leukocytes is provided to assist in performing a differential count. Differential diagnoses are provided for abnormal values identified in the hemogram., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Pet guinea pigs are presented to veterinary clinics for routine care and treatment of clinical diseases. In addition to obtaining clinical history and exam findings, diagnostic testing may be required, including hematological assessments. This article describes common blood collection methods, including venipuncture sites, the volume of blood that can be safely collected, and handling of the blood. Hematological parameters for normal guinea pigs are provided for comparison with in-house or commercial test results. A description of the morphology of guinea pig leukocytes is provided to assist in performing a differential count., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Avian veterinarians often rely heavily on the results of various diagnostic tests, including hematology results. As such, cellular identification and evaluation of the cellular response are invaluable tools that help veterinarians understand the health or condition of their patient, as well as to monitor severity and clinical progression of disease and response to treatment. Therefore, it is important to thoroughly understand how to identify and evaluate changes in the avian erythron and leukon, as well as to interpret normal and abnormal results., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Development of hematology analyzers has been predicated on the use of adult blood specimens without consideration for the unique morphologic and cellular content seen in pediatric patient populations. Because both dramatic qualitative and quantitative cellular changes occur in red and white blood cells and platelets from birth to early adulthood, development of pediatric reference intervals is necessary. Because testing is often performed on a small volume of blood, laboratories are required to develop unique approaches in specimen handling and analysis. Many newer instruments offer alternative cellular analysis allowing for unique insights into the hematopoietic response in disease and nondisease states., (Copyright © 2015 Elsevier Inc. All rights reserved.)

The combination of requirements for decreased turnaround time for hematology laboratory results and advances in technology have driven testing closer to the point of patient contact. This article provides an overview of the technologies available to measure hemoglobin, white blood cell counts, differentials, and CD4+ T cells at the patient's bedside and in satellite laboratories. Comparison with traditional laboratory testing, regulatory requirements, and operational considerations are also discussed, where appropriate., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Usually, the blood cell counting activity in haematology laboratory uses the comparison of IQC values to the target values proposed by the manufacturer. We intended to improve the monitoring of the proper functioning of our analytical measure system for 17 main haematologic parameters. To set the allowable critical limits of IQC, we propose our reflection based on several elements: benchmark and expert recommendation, clinical requirements, statistical indicators of the laboratory calculated using IQC values (3 levels, 2 different lots, 2 haematology analysers and 2 passage modes) and the EEQ values, during four months. We exploited the reports obtained from the middleware (our own IQC values), and the interlaboratory comparison reports (obtained from SNCS and EuroCell websites) and we compared our performances to the Ricos objectives, to set clearly argued allowable limits for IQC values. Finally, the allowable limits correspond to the imprecision limits stated by Ricos for 14 parameters (desirable for 11 parametres and minimal for 3 parameters) and personalized limits (more exigent than desirable Ricos limits) for 3 parameters of blood cell counting.

For years, the ability to study immune responses in patients with active visceral leishmaniasis (VL) has been hampered by the absence of detectable antigen-specific Th1 responses using cells from peripheral blood mononuclear cells (PBMCs). Employing whole blood assay (WBA), we recently reported that whole blood cells of active VL patients maintain the capacity to secrete significant levels of antigen driven IFN-γ and IL-10. Furthermore, WBA that uses soluble leishmania antigen (SLA) have advantages over the leishmanin skin test (LST), in terms of higher specificity and better correlation with surrogate markers of exposures to Leishmania donovani. These findings open the door to a series of immunological and epidemiological studies not previously possible for VL. In the present review, we discuss current status, future perspectives as well as obstacles in the research on WBA. Research in this area is essential for development of potential immunological and epidemiological tools for VL., (Copyright © 2014 Elsevier GmbH. All rights reserved.)

Importance: Our study indicates a prototype blood-based variant Creutzfeldt-Jakob disease (vCJD) assay has sufficient sensitivity and specificity to justify a large study comparing vCJD prevalence in the United Kingdom with a bovine spongiform encephalopathy-unexposed population. In a clinical diagnostic capacity, the assay's likelihood ratios dramatically change an individual's pretest disease odds to posttest probabilities and can confirm vCJD infection., Objectives: To determine the diagnostic accuracy of a prototype blood test for vCJD and hence its suitability for clinical use and for screening prion-exposed populations., Design, Setting, and Participants: Retrospective, cross-sectional diagnostic study of blood samples from national blood collection and prion disease centers in the United States and United Kingdom. Anonymized samples were representative of the US blood donor population (n = 5000), healthy UK donors (n = 200), patients with nonprion neurodegenerative diseases (n = 352), patients in whom a prion disease diagnosis was likely (n = 105), and patients with confirmed vCJD (n = 10)., Main Outcome and Measure: Presence of vCJD infection determined by a prototype test (now in clinical diagnostic use) that captures, enriches, and detects disease-associated prion protein from whole blood using stainless steel powder., Results: The assay's specificity among the presumed negative American donor samples was 100% (95% CI, 99.93%-100%) and was confirmed in a healthy UK cohort (100% specificity; 95% CI, 98.2%-100%). Of potentially cross-reactive blood samples from patients with nonprion neurodegenerative diseases, no samples tested positive (100% specificity; 95% CI, 98.9%-100%). Among National Prion Clinic referrals in whom a prion disease diagnosis was likely, 2 patients with sporadic CJD tested positive (98.1% specificity; 95% CI, 93.3%-99.8%). Finally, we reconfirmed but could not refine our previous sensitivity estimate in a small blind panel of samples from unaffected individuals and patients with vCJD (70% sensitivity; 95% CI, 34.8%-93.3%)., Conclusions and Relevance: In conjunction with the assay's established high sensitivity (71.4%; 95% CI, 47.8%-88.7%), the extremely high specificity supports using the assay to screen for vCJD infection in prion-exposed populations. Additionally, the lack of cross-reactivity and false positives in a range of nonprion neurodegenerative diseases supports the use of the assay in patient diagnosis.

Background: Preoperative laboratory testing is commonplace in the clinical setting and is often utilized at surgeon discretion. We searched the American College of Surgeons-National Surgical Quality Improvement Program (ACS-NSQIP) data set to determine the impact of preoperative laboratory testing in ambulatory plastic surgery patients., Objective: The authors assess the utilization and predictive value of preoperative laboratory testing in outpatient plastic surgery procedures., Methods: Patients undergoing ambulatory plastic surgery were identified from the 2005 to 2010 NSQIP databases. Laboratory tests were categorized by group: hematologic, chemistry, coagulation, and liver function tests (LFT). We defined complications in 2 groups: major postoperative and wound complications. Multivariate analyses were used to identify patient characteristics associated with testing and to assess the ability of laboratory testing to predict postoperative complications., Results: A total of 5359 (62.0%) patients underwent testing; 881 (16.4%) tests were performed on the day of surgery. In patients with no defined NSQIP comorbidities, 59.4% underwent preoperative testing and had a significantly lower rate of abnormal findings (33.4% vs 25.3%, P < .0001). In multivariate analyses, testing was associated with older age, American Society of Anesthesiologists class >2, Hispanic or African American race, body contouring procedures, epidural or spinal procedures, and with diabetes, hypertension, and cancer. Major complications occurred in 0.34% of patients. Our analysis demonstrated that neither testing nor abnormal results were associated with postoperative complications, either major (P = .178) or wound (P = .150)., Conclusions: We found no association between abnormal laboratory testing and postoperative morbidity. Preoperative testing in low-risk ambulatory plastic surgery patients may be costly and has limited direct clinical benefit.

In the last few decades we have seen a significant decrease in the rates of analytical errors in clinical laboratories. The test performances have improved, new parameters have been introduced, as well as internal and external quality controls have been used for the monitoring of accuracy. Currently available evidence demonstrates that the pre- and post-analytical steps show higher error rates (up to 70 % of all errors) than the analytical phase. Recognition of the weak points of the preanalytical phase and search for appropriate solutions in case of discrepancies will finally help to lead to the correct therapeutic strategy. In order to avoid problems in the preanaytical phase in hematology it is very important to consider some essential issues. The patients must be identified in appropriate form, the blood collection for the requested tests must be made using the appropriate tubes in the specified sequence and the samples must be transported to the lab at the right temperature and on time to be analysed. In case of special tests additional information for the lab is very important for the interpretation of the results. In case of unexpected results the lab should contact the responsible physician in order to look for an adequate explanation for the abnormal findings. With help of several cases of the daily haematology routine we want to point out some preanalytical problems.

Background: Laboratory tests are extensively used for diagnosis and monitoring in UK primary care. Test usage by GPs, and associated costs, have grown substantially in recent years., Aim: This study aimed to quantify temporal growth and geographic variation in utilisation of laboratory tests., Design and Setting: Retrospective cohort study using data from general practices in the UK., Method: Data from the General Practice Research Database, including patient demographics, clinical details, and laboratory test results, were used to estimate rates of change in utilisation between 2005 and 2009, and identify tests with greatest inter-regional variation, by fitting random-effects Poisson regression models. The study also investigated indications for test requests, using diagnoses and symptoms recorded in the 2 weeks before each test., Results: Around 660 000 tests were recorded in 230 000 person-years of follow-up. Test use increased by 24.2%, from 23 872 to 29 644 tests per 10 000 person-years, between 2005 and 2009. Tests with the largest increases were faecal occult blood (121%) and C-reactive protein (86%). There was substantial geographic variation in test utilisation; GPs in some regions requested tests such as plasma viscosity and cardiac enzymes at a rate more than three times the national average., Conclusion: Increases in the use of laboratory tests have substantial resource implications. Rapid increases in particular tests may be supported by evidence-based guidelines, but these are often vague about who should be tested, how often, and for how long. Substantial regional variation in test use may reflect uncertainty about diagnostic accuracy and appropriate indications for the laboratory test. There is a need for further research on the diagnostic accuracy, therapeutic impact, and effect on patient health outcomes of the most rapidly increasing and geographically variable tests.

Point-of-care testing (POCT) in haematology has continued to grow in popularity and uptake throughout the world. The increasing demand to reduce the turnaround time of test results, coupled with rapid improvements in technology, have led to the development of several devices that are designed for use in different clinical settings, with the hope of improving patient care. The most used POCT in haematology is measurement of haemoglobin concentration. Other POCT devices (used primarily in developing countries) for malaria screening and CD4+ T-lymphocytes for quantification of human-immunodeficiency-virus are becoming the cornerstone for the diagnosis and management of these disorders. New devices are also available for red cell indices, white blood cell count and platelets. In this review clinical studies that validate the use of such devices will be discussed, as well as the advantages and disadvantages of POCT in haematology. A disadvantage of POCT is a lack of training, poor standardization in obtaining blood samples and insufficient internal/external quality assessment. As there is every reason to expect that POCT use will increase in all pathology disciplines, including haematology, it is imperative that systems are put in place to oversee these issues., (© 2012 Blackwell Publishing Ltd.)

This article provides an overview of animal model systems to include their strengths and limitations in the study of hemostasis. Specific examples of spontaneous and engineered animal models are described in the context of cell-based hemostasis. The article concludes with a review of the comparative aspects of 3 laboratory assays of cell-based hemostasis: thromboelastography, thrombin generation, and flow cytometric assessment of platelet activation., (Copyright © 2011 Elsevier Inc. All rights reserved.)

There is a significant need for reliable molecular biomarkers to aid in Alzheimer's disease (AD) clinical diagnosis. RNA transcriptional profiling, although extensively applied for biomarker development in other diseases, is first defining its role in AD. Application of this technology has the sensitivity and power to provide sufficient information for the development of tests to determine disease severity, progression, heterogeneity, and potential for therapeutic response in the AD population. In order to bring forth the potential of this technology, however, the community needs to make a concerted effort to begin sample collection as soon as patients/subjects are identified. Only then can these powerful technologies be applied in a well controlled study for the development of novel diagnostics., (2010 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.)

In recent years, the engineering of blood viscometers for the diagnosis, prognosis, and prevention of cardiovascular and other diseases has been the subject of significant research interest. Conventional blood viscometers such as rotational viscometers and capillary viscometers typically rely on mechanical techniques in quantifying whole-blood viscosity, a process in which resistance to blood flow is measured in response to an applied force. The direct applicability of conventional viscometers as point-of-care diagnostic and clinical tools is subject to several limitations mainly related to their macro-structural features that augment the sampling size and reduce portability. The development of new fabrication technologies to scale down experimental processes has opened up the reality of miniaturizing existing concepts of blood viscometers into microchips, and paves the road for future development of blood viscometers. These micro-blood viscometers are advantageous because they use very small sample volumes for quick, routine clinical purposes. The easy fabrication of microsystems and large-scale production not only result in a lower cost, but also render these devices portable and disposable, both of which are highly desirable for clinical applications. The underlying challenges of these devices are associated with red blood cell clogging, measurement stability, reliability, and reproducibility. The present review discusses the state-of-the-art and emerging trends in the field of microfluidics to provide elegant solutions for quantifying blood viscosity with vastly improved efficacy and with the potential for use at the patient's bedside.

Blood donation screening represents rather a unique set of blood grouping-related and pathogen detection assays. We are confronted with continuously growing numbers of testing targets. Ideally, the spectrum of clinically significant blood group antigens and alloantibodies would be wider than allowed by current routine tests. At the same time, we are witnessing an increase in emerging and re-emerging human pathogens due to urbanisation, increased international travel and trade, climate change and other factors. The spectrum of blood-borne infectious agents requiring donation screening is expected to grow correspondingly. Dengue and chikungunya viruses, variant CJD and hepatitis E virus represent just some of the candidate infectious agents for future donation screening. Multiplexing techniques, such as microarrays are well suited to address the growing number of targets, pending the increase in sensitivity of some of the microarrays assays. There are several possible scenarios for future testing algorithms, combining new multiplexing techniques with the existing blood testing assays. New generation testing platforms capable of microbiology screening, blood grouping and potential additional types of targets, are also being developed., (Copyright 2009 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.)

Newborn screening is evolving very rapidly. Geographical coverage is expanding, particularly for common disorders such as congenital hypothyroidism. New technologies, particularly tandem mass spectrometry and high throughput mutation analysis, have increased greatly the range of disorders which could be covered. However, these new possibilities are being exploiting at very different rates in different countries. This is due in part to the different ways in which generally-accepted screening criteria, based on the ten principles of Wilson and Jungner, are being interpreted and applied to policy. The appropriate management of some of the conditions newly-detectable by screening also remains controversial and there is a pressing need to align screening policy and clinical practice. Critical analysis and careful collection of data on an international basis are required to resolve these issues.

Advances in safety of blood transfusion in clinical practice principally relate to preventing transfusion-transmitted infections (TTI). Epidemiological studies of TTI have resulted in the development, standardization, and implementation of an expanding array of immunoassays employed worldwide in routine screening of blood donated by voluntary blood donors. Exclusion of infected blood and their donors has remarkably reduced the risk of transmitting HBV, HCV, HIV-1/2, and HTLV-I/II infections. Nucleic acid tests (NAT) using enzymatic amplification of viral gene sequences have augmented the risk reduction in "window period" infections that are undetectable by the serological tests. Improved viral safety of transfusion therapy has led us to recognize the risk of bacterial contamination, especially in platelet concentrates stored optimally at room temperature. Besides the current effort devoted to microbial risk reduction, pathogen inactivation technologies promise reduction of the residual risk of known and emerging infectious agents. The clinical effectiveness of the foregoing measures, international harmonization/standardization of practices and procedures, and continued hemovigilance portend safest possible safety in the clinical practice of blood transfusion.

The pathogenic role of antiphospholipid antibodies (aPL) has been widely established over past years in several experimental models and clinical studies. Accordingly, the detection of aPL by immunoassays (anticardiolipin antibodies; anti-beta2 glycoprotein I antibodies) has become a routine practice in the clinical workup of patients with systemic autoimmune diseases. aPL are mostly assayed using commercial ELISA kits, whose performance has not been found to be sufficiently concordant among the different manufacturers. In the past years, collaborative groups have spent considerable effort to reach some form of standardization but this process is still ongoing. Such lack of standardization has recently become even more crucial, as manufacturers have had to face an increasing demand for fully automated tests for aPL, like those test systems that have been developed for other autoantibodies (e.g., antinuclear antibodies, anti-ENA antibodies). We therefore report our recent experience with two newly developed automated methods for anticardiolipin antibodies testing. In particular, we discuss the results obtained using routine samples, as we believe that these better reflect the "real-life" situation in which those automated methods will operate. We also mention other emerging technologies in the field of aPL detection.

Background: Availability of point-of-care testing (POCT) technology may lead to unnecessary testing and expense without improving outcomes. We tested the hypothesis that frequency of intraoperative blood testing (IBT) would increase in association with installation of POCT devices in our surgical suites., Methods: We performed a retrospective analysis of 38,115 electronic anesthesia records for cases performed in the 1 yr before and 1 yr after POCT installation. For each case, the frequency of IBT was tabulated and the change in frequency of IBT between the study periods was calculated for individual anesthesiologists, for the department as a whole, and for clusters of anesthetizing locations., Results: For the department as a whole, there was no significant change between the before and after study periods in the 13% proportion of cases in which IBT was obtained. For cases in which IBT was used, there was no significant increase in the number of IBTs per case., Conclusions: We found no significant increase in the overall utilization of IBT associated with POCT presence in noncardiothoracic operating rooms.

Study Objective: We describe emergency department (ED) visits in which patients had blood cultured and examine changes in blood culture use., Methods: Data from the 2001 to 2004 National Hospital Ambulatory Medical Care Survey, an annual sample survey of visits to US hospital EDs, were analyzed. About 400 EDs reported data for approximately 37,000 visits each year. Trends in blood culture use were examined among persons 3 months of age and older. Visits by admitted/transferred patients were compared to those released., Results: About 3.1 million blood cultures were ordered annually in US EDs; blood cultures were ordered at 2.8% of all visits. From 2001 through 2004, the proportion of visits where a blood culture was ordered increased by 33%, particularly in adults. The proportion of visits with a pneumonia diagnosis where a blood culture was ordered rose by 23% during the study period; these visits accounted for 22% of the increase in blood culture use among admitted patients. Almost half of blood cultures were ordered at visits in which the patient was released from the ED. For visits by released patients 3 years of age and older who had blood cultured, 43% had neither fever nor antibiotic prescriptions., Conclusion: There is an increasing national trend in the use of blood cultures at adult patient ED visits; a large proportion of these cultures were for released patients without apparent indicators for bacteremia, such as fever or antibiotic prescriptions. Factors and impact associated with this dynamically changing practice need further evaluation.

The century-old tuberculin skin test (TST) was until recently the only means of diagnosing latent tuberculosis infection (LTBI). Recent advances in mycobacterial genomics and human cellular immunology have resulted in two new blood tests that detect tuberculosis infection by measuring in vitro T-cell interferon (IFN)-gamma release in response to two unique antigens that are highly specific for Mycobacterium tuberculosis but absent from bacille Calmette-Guérin (BCG) vaccine and most nontuberculous mycobacteria. One assay, the enzyme-linked immunospot (ELISpot) [T-SPOT.TB; Oxford Immunotec; Oxford, UK] enumerates IFN-gamma-secreting T cells, while the other assay measures IFN-gamma concentration in supernatant by enzyme-linked immunosorbent assay (ELISA) [QuantiFERON-TB Gold; Cellestis; Carnegie, Australia]. A large and growing clinical evidence base indicates that both tests are more specific than the skin test because they are not confounded by prior BCG vaccination. In active tuberculosis, ELISA has similar sensitivity to the skin test, while ELISpot is significantly more sensitive. Current cross-sectional evidence suggests that for diagnosis of LTBI, sensitivity of ELISA is similar to TST, while ELISpot appears more sensitive. High specificity will enable clinicians to avoid unnecessary preventive treatment in BCG-vaccinated persons without infection who commonly have false-positive TST results. High sensitivity could enable accurate targeting of preventive treatment to patients with infection at the highest risk of progression to active tuberculosis who frequently have false-negative TST results due to impaired cellular immunity. However, longitudinal studies are needed to define the predictive value of positive blood test results for progression to tuberculosis.