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Objective Some conventional laboratory tests are routinely used for the prediction of systemic autoimmune disease activity, such as the erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP); however, they can give false-negative results, pointing out the need to identify more specific markers. Methods We evaluated biomarkers in 21 Italian patients naïve to treatment with a diagnosis of autoimmune rheumatic disease according to the 2010 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Rheumatoid Arthritis during 6 months of therapeutic treatments. Results We found a significant difference in interleukin-6 (IL-6), CRP, ESR, platelet count, and fecal calprotectin in diagnosed patients compared with healthy participants and a significant decrease in these values during follow-up, except for IL-6 and platelet count. Conclusion We found that CRP, ESR, and fecal calprotectin seemed to be related to autoimmune rheumatic disorders and to be associated with therapy, whereas serum calprotectin and IL-6 did not seem to be associated with disease improvement after the start of treatment, along with leukocyte count and platelet count.

Background The ongoing SARS-CoV-2 pandemic requires the availability of accurate and rapid diagnostic tests, especially in such clinical settings as emergency and intensive care units. The objective of this study was to evaluate the diagnostic performance of the Vivalytic SARS-CoV-2 rapid PCR kit in lower respiratory tract (LRT) specimens. Methods Consecutive LRT specimens (bronchoalveolar lavage and bronchoaspirates) were collected from Intensive Care Units of San Martino Hospital (Genoa, Italy) between November 2020 and January 2021. All samples underwent RT-PCR testing by means of the Allplex™ SARS-CoV-2 assay (Seegene Inc., South Korea). On the basis of RT-PCR results, specimens were categorized as negative, positive with high viral load [cycle threshold (Ct) ≤ 30] and positive with low viral load (Ct of 31–35). A 1:1:1 ratio was used to achieve a sample size of 75. All specimens were subsequently tested by means of the Vivalytic SARS-CoV-2 rapid PCR assay (Bosch Healthcare Solutions GmbH, Germany). The diagnostic performance of this assay was assessed against RT-PCR through the calculation of accuracy, Cohen’s κ, sensitivity, specificity and expected positive (PPV) and negative (NPV) predictive values. Results The overall diagnostic accuracy of the Vivalytic SARS-CoV-2 was 97.3% (95% CI: 90.9–99.3%), with an excellent Cohen’s κ of 0.94 (95% CI: 0.72–1). Sensitivity and specificity were 96% (95% CI: 86.5–98.9%) and 100% (95% CI: 86.7–100%), respectively. In samples with high viral loads, sensitivity was 100% (Table 1). The distributions of E gene Ct values were similar (Wilcoxon’s test: p = 0.070), with medians of 35 (IQR: 25–36) and 35 (IQR: 25–35) on Vivalytic and RT-PCR, respectively (Fig. 1). NPV and PPV was 92.6% and 100%, respectively. Table 1 Demographic characteristics and data sample type of the study cases (N = 75) Male, N (%) 56 (74.6%) Age (yr), Median (IQR) 65 (31–81) BAS, N (%) 43 (57.3%) Negative 30.2% Positive—High viral load [Ct ≤ 30] 27.9% Positive—Low viral load [Ct 31–35] 41.9% BAL, N (%) 32 (42.7%) Negative 37.5% Positive—High viral load [Ct ≤ 30] 40.6% Positive—Low viral load [Ct 31–35] 21.9% Data were expressed as proportions for categorical variables. Specimens were categorized into negative, positive with high viral load [cycle threshold (Ct) ≤ 30] and positive with low viral load (Ct of 31–35). BAS bronchoaspirates, BAL bronchoalveolar lavage, Ct cycle threshold Fig. 1 Distribution of E gene cycle threshold values of the rapid PCR and RT-PCR Conclusions Vivalytic SARS-CoV-2 can be used effectively on LRT specimens following sample liquefaction. It is a feasible and highly accurate molecular procedure, especially in samples with high viral loads. This assay yields results in about 40 min, and may therefore accelerate clinical decision-making in urgent/emergency situations.

Bloodborne pathogens represent a major hazard for healthcare workers (HCWs) and exposure prevention still represents the primary strategy to reduce the risk of occupational bloodborne pathogen infections, such as hepatitis B (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV). Each healthcare organization should have simple and easy-to-apply operating procedures (OPs), quickly accessible to their personnel, including educational programmes, written protocols for prompt reporting and procedures for correct evaluation, counselling, treatment and follow-up of occupational exposure. From a careful review of literature data and international recommendations, in this study we summarize the recommendations to follow in the event of occupational exposure to HIV, HBV and HCV, also providing tables and a flowchart, that are simple to apply and could be a guide, especially in moments of apprehension caused by the occurrence of an occupational accident due to biohazard, in which important decisions must be taken and appropriate assessments carried out in the shortest possible time. Obviously, for this purpose, the people to be involved in the various processes must appear clearly in each OP, and the forms to be filled in must be easily and promptly accessible at all times.

Background: Increases in cardiac troponin (cTn) in coronavirus disease 2019 (COVID-19) have been associated with worse prognosis. Nonetheless, data about the significance of cTn in elderly subjects with COVID-19 are lacking.Methods: From a registry of consecutive patients with COVID-19 admitted to a hub hospital in Italy from 25/02/2020 to 03/07/2020, we selected those ≥60 year-old and with cTnI measured within 3 days from the molecular diagnosis of SARS-CoV-2 infection. When available, a second cTnI value within 48 hours was also extracted. The relationship between increased cTnI and all-cause in-hospital mortality was evaluated by a Cox regression model and restricted cubic spline functions with three knots.Results: Of 343 included patients (median age 75.0 (68.0-83.0) years, 34.7% men), 88 (25.7%) had cTnI above the upper-reference limit (0.046 µg/L). Patients with increased cTnI had more comorbidities, greater impaired respiratory exchange and higher inflammatory markers on admission than those with normal cTnI. Furthermore, they died more (73.9% vs. 37.3%, pConclusions: In elderly COVID-19 patients, an initial increase in cTn is common and predicts a higher risk of death. Serial cTn testing may not confer additional prognostic information.

The etiological cause of bacterial vaginosis (BV) is the change of the vaginal ecosystem characterized by a decrease of lactobacilli and an increase of other germs, such as Gardnerella vaginalis and Atopobium vaginae. Molecular tools have revolutionized the diagnosis of these conditions. The aim of this paper was to compare results obtained from 158 vaginal swabs collected from women aged between 18 and 59 years old and subjected to microscopic evaluation (Nugent Score), culture and to the multiparametric molecular assay Vaginitis and Vaginosis Multiplex-Tandem (MT) PCR (AU27117) - Nuclear Laser Medicine. In 50 samples we also used matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) for bacterial microbiome identification. Our results showed a moderate concordance between traditional and molecular methods for diagnosis of candidiasis and a lower concordance for BV and normal flora. MALDI TOF MS allowed us to discriminate more than 10 species of lactobacilli with a greater abundance of Lactobacillus gasseri, Lactobacillus paracasei spp. paracasei, Lactobacillus pentosus and Lactobacillus crispatus in BV and altered flora. This work underlined how the integration of different assays and metagenomics studies can greatly expand our current understanding of vaginal microbial diversity, providing more reliable diagnostic criteria for BV and its intermediate condition diagnosis.

IntroductionCoronavirus disease 2019 (COVID-19) can lead to respiratory failure due to severe immune response. Treatment targeting this immune response might be beneficial but there is limited evidence on its efficacy.The aim of this study was to determine if early treatment of patients with COVID-19 pneumonia with tocilizumab and/or steroids was associated with better outcome.MethodsThis observational single-center study included patients with COVID-19 pneumonia who were not intubated and received either standard of care (SOC, controls) or SOC plus early (within 3 days from hospital admission) anti-inflammatory treatment. SOC consisted of hydroxychloroquine 400mg bid plus, in those admitted before March 24th, also darunavir/ritonavir. Anti-inflammatory treatment consisted of either tocilizumab (8mg/kg intravenously or 162mg subcutaneously) or methylprednisolone 1 mg/kg for 5 days or both. Failure was defined as intubation or death, and the endpoints were failure-free survival (primary endpoint) and overall survival (secondary) at day 30. Difference between the groups was estimated as Hazard Ratio by a propensity score weighted Cox regression analysis (HROW).ResultsOverall, 196 adults were included in the analyses. They were mainly male (67.4%), with comorbidities (78.1%) and severe COVID-19 pneumonia (83.7%). Median age was 67.9 years (range, 30-100) and median PaO2/FiO2200 mmHg (IQR 133-289). Among them, 130 received early anti-inflammatory treatment with: tocilizumab (n=29, 22.3%), methylprednisolone (n=45, 34.6%), or both (n=56, 43.1%). The adjusted failure-free survival among tocilizumab/methylprednisolone/SOC treated patients vs. SOC was 80.8% (95%CI, 72.8-86.7) vs. 64.1% (95%CI, 51.3-74.0), HROW0.48, 95%CI, 0.23-0.99; p=0.049. The overall survival among tocilizumab/methylprednisolone/SOC patients vs. SOC was 85.9% (95%CI, 80.7-92.6) vs. 71.9% (95%CI, 46-73), HROW0.41, 95%CI: 0.19-0.89, p=0.025.ConclusionEarly adjunctive treatment with tocilizumab, methylprednisolone or both may improve outcomes in non-intubated patients with COVID-19 pneumonia.

AimsOptical microscopic (OM) evaluation of peripheral blood (PB) cells is still a crucial step of the laboratory haematological workflow. The morphological cell analysis is time-consuming and expensive and it requires skilled operator. To address these challenges, automated image-processing systems, as digital morphology (DM), were developed in the last few years. The aim of this multicentre study, performed according to international guidelines, is to verify the analytical performance of DM compared with manual OM, the reference method.MethodsFour hundred and ninety PB samples were evaluated. For each sample, two May Grunwald-stained and Giemsa-stained smears were performed and the morphological evaluation of cells was analysed with both DM and OM. In addition, the assessment times of both methods were recorded.ResultsComparison of DM versus OM methods was assessed with Passing-Bablok and Deming fit regression analysis: slopes ranged between 0.17 for atypical, reactive lymphocytes and plasma cells (LY(AT)) and 1.24 for basophils, and the intercepts ranged between −0.09 for blasts and 0.40 for LY(AT). The Bland-Altman bias ranged between −6.5% for eosinophils and 21.8% for meta-myemielocytes. The diagnostic agreement between the two methods was 0.98. The mean of assessment times were 150 s and 250 s for DM and OM, respectively.ConclusionDM shows excellent performance. Approximately only 1.6% of PB smears need the OM revision, giving advantages in terms of efficiency, standardisation and assessment time of morphological analysis of the cells. The findings of this study may provide useful information regarding the use of DM to improve the haematological workflow.

The goal of harmonizing laboratory testing is contributing to improving the quality of patient care and ultimately ameliorating patient outcome. The complete blood and leukocyte differential counts are among the most frequently requested clinical laboratory tests. The morphological assessment of peripheral blood cells (PB) through microscopic examination of properly stained blood smears is still considered a hallmark of laboratory hematology. Nevertheless, a variable inter-observer experience and the different terminology used for characterizing cellular abnormalities both contribute to the current lack of harmonization in blood smear revision. In 2014, the Working Group on Diagnostic Hematology of the Italian Society of Clinical Chemistry and Clinical Molecular Biology (WGDH-SIBioC) conducted a national survey, collecting responses from 78 different Italian laboratories. The results of this survey highlighted a lack of harmonization of interpretative comments in hematology, which prompted the WGDH-SIBioC to develop a project on “Harmonization of interpretative comments in the laboratory hematology report”, aimed at identifying appropriate comments and proposing a standardized reporting system. The comments were then revised and updated according to the 2016 revision of the World Health Organization classification of hematologic malignancies. In 2016, the Working Group on Diagnostic Hematology of the Italian Society of Clinical Chemistry and Clinical Molecular Biology (WGDH SIBioC) published its first consensus based recommendation for interpretative comments in laboratory hematology reporting whit the purpose of evaluating comments and the aim to (a) reducing their overall number, (b) standardizing the language, (c) providing information that could be easily comprehended by clinicians and patients, (d) increasing the quality of the clinical information, and (e) suggesting additional diagnostic tests when necessary. This paper represents a review of the recommendations of the former document.

Automation is considered one of the most important breakthroughs in the recent history of laboratory diagnostics. In a model of total laboratory automation (TLA), many analyzers performing different types of tests on different sample matrices are physically integrated as modular systems or physically connected by assembly lines. The opportunity to integrate multiple diagnostic specialties to one single track seems effective to improve efficiency, organization, standardization, quality and safety of laboratory testing, whilst also providing a significant return of investment on the long-term and enabling staff requalification. On the other hand, developing a model of TLA also presents some potential problems, mainly represented by higher initial costs, enhanced expenditure for supplies, space requirements and infrastructure constraints, staff overcrowding, increased generation of noise and heat, higher risk of downtime, psychological dependence, critical issues for biospecimen management, disruption of staff trained in specific technologies, along with the risk of transition toward a manufacturer’s-driven laboratory. As many ongoing technological innovations coupled with the current scenario, profoundly driven by cost-containment policies, will promote further diffusion of laboratory automation in the foreseeable future, here we provide a personal overview on some potential advantages and limitations of TLA.

SummaryBackground: The measurement of 25OH vitamin D continues to grow in clinical laboratories. The aim of this multicenter study was to compare the results of seven automated commercial immunoassays with a reference HPLC technique.Methods: One hundred and twenty consecutive outpatient serum samples were centrifuged, divided in aliquots, frozen and shipped to the participating laboratories. 25OH Vita - min D was measured with a reference HPLC system and with seven automated commercial immunoassays (Roche Cobas E601, Beckman Coulter Unicel DXI 800, Ortho Vitros ES, DiaSorin Liaison, Siemens Advia Centaur, Abbott Architect i System and IDS iSYS).Results: Compared to the reference method, the regression coefficients ranged from 0.923 to 0.961 (all pConclusions:The excellent correlation with the reference HPLC technique attests that all seven automated immuno - assays may be reliably used for routine assessment of 25OH-D in clinical laboratories. The significant bias among the different methods seems mostly attributable to the lack of standardization and calls for additional efforts for improving harmonization of 25OH-D immunoassays.

Background: The IFCC Task Force on Clinical Applications of Cardiac Biomarkers currently recommends evaluation of all troponin immunoassays within the same population to compare their performance. Hence, we planned a multicenter study to compare the four most widespread contemporary sensitive troponin I (TnI) methods. Methods: Seventy-six serum samples were centrifuged, separated and divided in 5 aliquots. The first aliquot was used for clinical measurement, whereas the rest were shipped to participating laboratories, where they were simultaneously thawed. High-sensitivity troponin T (HS-TnT) was measured on a Roche Cobas, whereas TnI was assessed with the Ortho Vitros cTnI, Beckman Coulter DXI 800 AccuTnI, Siemens Vista cTnI and Abbott Architect STAT cTnI. Results: A substantial bias was found between TnI and HSTnT values. Although the correlation was acceptable and comprised between 0.86-0.89, the agreement of diagnostic values was poor, with the kappa statistic always lower than 0.50. Although the direct comparison between the four contemporary sensitive TnI immunoassays generated more favourable results, with Pearson’s correlations greater than 0.970 and the kappa statistic equal to or higher than 0.59, we observed wide 95% confidence intervals, significant bias and large dispersion of values, with a single notable exception (i.e., Vitros cTnI versus DXI 800 AccuTnI). Conclusions: The results of this study attest that substantial discrepancies still exist among contemporary sensitive TnI immunoassays. The presence of random variation rather than constant bias appears to be the major contributor to this variance, thus precluding the interchangeability of methods and making the objective of harmonization a rather long and challenging enterprise.

Increasing evidence is emerging that the measurement of circulating biomarkers may be clinically useful for diagnosing and monitoring sepsis. Eight members of AcEMC (Academy of Emergency Medicine and Care) and eight members of SIBioC (Italian Society of Clinical Biochemistry and Laboratory Medicine) were identified by the two scientific societies for producing a consensus document aimed to define practical recommendations about the use of biomarkers for diagnosing of sepsis and managing antibiotic therapy in the emergency department (ED). The cumulative opinions allowed defining three grade A recommendations (i.e., highly recommended indications), entailing ordering modality (biomarkers always available on prescription), practical use (results should be interpreted according to clinical information) and test ordering defined according to biomarker kinetics. Additional grade B recommendations (i.e., potentially valuable indications) entailed general agreement that biomarkers assessment may be of clinical value in the diagnostic approach of ED patients with suspected sepsis, suggestion for combined assessment of procalcitonin (PCT) and Creactive protein (CRP), free availability of the selected biomarker(s) on prescription, adoption of diagnostic threshold prioritizing high negative predictive value, preference for more analytically sensitive techniques, along with potential clinical usefulness of measuring PCT for monitoring antibiotic treatment, with serial testing defined according to biomarker kinetics. PCT and CRP were the two biomarkers that received the largest consensus as sepsis biomarkers (grade B recommendation), and a grade B recommendation was also reached for routine assessment of blood lactate. The assessment of biomarkers other than PCT and CRP was discouraged, with exception of presepsin for which substantial uncertainty in favor or against remained.

article i nfo Article history: Laboratory testing, a highly complex process commonly called the total testing process (TTP), is usually subdivided into three traditional (pre-, intra-, and post-) analytical phases. The majority of errors in TTP originate in the pre-analytical phase, being due to individual or system design defects. In order to reduce errors in TTP, the pre-analytical phase should therefore be prioritized. In addition to developing procedures, providing training, improving interdepartmental cooperation, information technology and robotics may be a tool to reduce errors in specimen collection and pre-analytical sample handling. It has been estimated that N2000 clinical laboratories worldwide use total or subtotal automation supporting pre-analytic activities, with a high rate of increase compared to 2007; the need to reduce errors seems to be the catalyst for increasing the use of robotics. Automated systems to prevent medical personnel from drawing blood from the wrong patient were introduced commercially in the early 1990s. Correct patient identification and test tube labelling before phlebotomy are of extreme importance for patient safety in TTP, but currently few laboratories are interested in such products. At San Bassiano hospital, the implementation of advanced information technology and robotics in the pre-analytical phase (specimen collection and pre-analytical sample handling) have improved accuracy, and clinical efficiency of the laboratory process and created a TTP that minimizes errors.

Background: Although automation has become widely utilized in certain areas of diagnostic testing, its adoption in diagnostic microbiology has proceeded much more slowly. Objective: To describe our real-world experience of integrating an automated instrument for diagnostic microbiology (Walk-Away Specimen Processor, WASPLab) within a model of total laboratory automation (TLA). Methods: The implementation process was divided into 2 phases. The former period, lasting approximately 6 weeks, entailed the installation of the WASPLab processor to operate as a stand-alone instrumentation, whereas the latter, lasting approximately 2 weeks, involved physical connection of the WASPLab with the automation. Results: Using the WASPLab instrument in conjunction with the TLA model, we obtained a time savings equivalent to the work of 1.2 full-time laboratory technicians for diagnostic microbiology. The connection of WASPLab to TLA allowed its management by a generalist or clinical chemistry technician, with no need for microbiology skills on the part of either worker. Hence, diagnostic microbiology could be performed by the staff that is already using the TLA, extending their activities to include processing urgent clinical chemistry and hematology specimens. The time to result was also substantially improved. Conclusions: According to our experience, using the WASPLab instrument as part of a TLA in diagnostic microbiology holds great promise for optimizing laboratory workflow and improving the quality of testing. * Abbreviations : TLA : total laboratory automation MALDI-TOF : matrix-assisted laser desorption ionization-time of flight FTE : full-time equivalent TAT : turnaround time BIN : bulk input module HST : hematology system transport HPLC : high-performance liquid chromatography ESR : erythrocyte sedimentation rate HEPA : high-efficiency particulate arrestance LIS : laboratory information system EJI : economic justification index SJI : strategic justification index US$ : United States dollars

Objectives: A multicenter study to compare results of BRAHMS Kryptor PCT with those obtained using four BRAHMS-partnered procalcitonin (PCT) automated immunoassays (DiaSorin Liaison, BioMérieux Vidas, Roche Cobas E601 and Siemens Advia Centaur) and the Diazyme immunotubidimetric assay implemented on four clinical chemistry platforms (Abbott Architect c16000, Siemens Advia 2400, Roche Cobas C501 and Beckman Coulter AU5800). Design and methods: One hundred serum samples from in-patients with PCT values between 0.10 and 58.7 ng/mL were divided into aliquots and tested with the nine different reagents and analyzers. BRAHMS PCT Kryptor results were used as reference. Results: Compared to BRAHMS PCT Kryptor, significant differences in results were observed on Vidas, Advia Centaur, Architect, Cobas C501 and AU5800. However, the correlation coeffiecients (r) with BRAHMS PCT Kryptor were between 0.899 and 0.988. The mean bias was less than ±1.02 ng/mL, except for Vidas (2.70 ng/mL). The agreement at three clinically relevant cut-offs was optimal: between 83–98% at 0.50 ng/mL, 90–97% at 2.0 ng/mL, and 98% at 10 ng/mL. The comparison of Diazyme PCT across the four clinical chemistry analyzers yielded high correlation coefficients (r between 0.952 and 0.976), a mean bias less than ±0.9 ng/mL, acceptable agreement at 0.5 ng/mL (>82%), and high concordance at the 2.0 ng/mL (>97%) and 10 ng/mL (>98%) cut-offs. Conclusions: The methods and applications evaluated in this multicenter study are aligned with BRAHMS PCT Kryptor and can be used for predicting the risk of progression to systemic inflammation in patients with bacterial infections using the conventional PCT diagnostic thresholds. Keywords: Procalcitonin, Sepsis, Bacterial infections, Immunoassay, Multicenter study

The aim of this study was to establish that laboratory testing may be impaired by pouring and sorting of centrifuged tubes into a bulk input module. The values of 17 analytes, including albumin, aspartate aminotransferase (AST), bilirubin, urea nitrogen, C-reactive protein (CRP), calcium, chloride, cholesterol, creatine kinase (CK), creatinine, ferritin, glucose, lactate dehydrogenase (LDH), potassium, sodium, total protein, and thyroid-stimulating hormone (TSH), were measured in 29 centrifuged serum samples collected in tubes with gel separator and paired centrifuged lithium-heparin samples collected in tubes with gel separator, with (S-BIM) or without (S-NO-BIM) being poured and sorted by a bulk input module (Inpeco, Lugano, Switzerland). In serum tubes, significant differences were observed in S-BIM values of albumin, AST, cholesterol, ferritin, glucose, LDH, potassium, and sodium compared with S-NO-BIM, with bias of LDH exceeding the total allowable error. In lithium-heparin tubes, statistically significant differences were observed in S-BIM values of all parameters, except urea nitrogen, CRP, and sodium, compared with S-NO-BIM. The percentage bias of AST, LDH, glucose, and creatinine exceeded the total allowable error. These results demonstrate that check-in and sorting of centrifuged serum and lithium-heparin tubes may be unsuitable using a bulk input module.

Background. The achievement of dialysis adequacy targets in peritoneal dialysis (PD) is assessed by the calculation of the Kt/V and creatinine clearance (C Cr ) obtained by collecting dialysate and urine, usually two or three times a year. Prescription decisions are based on such adequacy assessments, regardless of any variability in the single measurements. The aim of our study was to assess the day-to-day variability of common dialysis adequacy parameters and to evaluate its impact on the adequacy indexes in PD. Methods. Twenty-four patients (14 CAPD, 10 APD) at two centres were studied by means of a triple dialysate and urine collection for a period of 1 week. Variability in the findings for a given patient was expressed by the coefficient of variation (CV%) calculated for peritoneal (p), renal, and total (tot) adequacy parameters. The target Kt/V and C Cr values were recalculated on the basis of variability. Results. Kt/V was less variable (CV 4.0 and 4.4% for peritoneal Kt/V (pKt/V) and total Kt/V (totKt/V) respectively) than C Cr (4.7 and 6.0% for peritoneal creatinine clearance (pC Cr ) and total creatinine clearance (totC Cr ) respectively) and proved to be a more reliable indicator of adequacy in terms of the CV. Both variability parameters became worse if renal clearance was added to peritoneal clearance. CV in APD proved to be no different from CAPD for all the parameters considered. In our centres dialysis adequacy target correction for variability provided safe values for weekly Kt/V (pKt/V = 1.78-2.10 and totKt/V = 1.82-2.15 target 1.7-2.0) and C Cr /1.73 (pC Cr = 53.7-64.4 1 and totC Cr =55.1-66.1 1; target 50-60 1). Conclusions. Evaluating the adequacy of PD by means of a single measurement should take into account the weekly variability as demonstrated by a triple dialysate and urine collection. Standard adequacy targets can be corrected to allow for variability. Thus one can obtain safe values for prescription decisions based on a single collection result.

Background: Provided that basic criteria are fulfilled, it is widely assumed that centrifuged gel tubes may be safely shipped from one center to another. The aim of this study was to evaluate sample stability after shipment of centri-fuged serum and lithium-heparin gel tubes from a periph-eral collection center to the core laboratory. Methods: The study population consisted in 30 unse-lected outpatients requiring collection of both serum and lithium-heparin gel tubes. The primary blood tubes were centrifuged, an aliquot was taken and tubes were recapped. All samples were then shipped by courier from the peripheral facility to the core laboratory, located 34 km away (52 min transportation). In the core laboratory the following parameters were assessed: albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, calcium, chloride, cholesterol, creatine kinase (CK), creatinine, C reactive protein (CRP), ferritin, glucose, lactate dehydrogenase (LDH), potassium, sodium, total protein, thyroid stimulating hormone (TSH) and urea nitrogen. Results: Compared with paired aliquots, significant dif-ferences were observed for ALT, AST, bilirubin calcium, chloride, CK, glucose, LDH, potassium and urea nitrogen in lithium-heparin gel tubes, and for calcium, chloride, CK, LDH, potassium and urea nitrogen in serum gel tubes. When percentage variations were compared with the desirable specifications, significant bias was found for AST ( + 7.8%), calcium ( + 1.2%), glucose ( – 3.3%) and LDH ( +3 5%) in lithium-heparin gel tubes. The bias in serum gel tubes was always lower than the desirable specifications. Conclusions: Serum gel tubes seem to have practi-cal advantages over lithium-heparin gel tubes during medium-term transportation, and hence should be pre-ferred for sample shipment. Keywords: gel; preanalytical variability; quality; speci-men; stability; transportation.

Standardization of cardiac troponin I (cTnI) immunoassays remains an unmet target and comparability of current commercial methods is modest. We hence planned a study to investigate whether realignment of cTnI data by means of reference samples may improve comparability among different cTnI methods. Seventy six routine serum samples were collected in one center, centrifuged, aliquoted and shipped to participant centers, along with four additional reference serum samples with defined cTnI concentrations. The centers performed blind measurement of thawed aliquots and reference samples using four widespread contemporary-sensitive immunoassays (Ortho-Clinical Diagnostics Vitros cTnI ES, Beckman Coulter DXI 800 AccuTnI, Siemens Healthcare Diagnostics Dimension Vista cTnI and Abbott Diagnostics Architect STAT cTnI). Test results were analyzed as provided by the centers, and also after data alignment by means of polynomial regression parameters obtained on reference sera. In five out of six circumstances the Deming fit improved after harmonization. The median inter-assay variability increased from 22% to 53% after alignment with polynomial regression parameters. A reduction of bias was observed in half of the circumstances, whereas in the remaining the bias increased. After harmonization, the agreement at diagnostic thresholds decreased in 4 out of 6 circumstances. These results show that calibration may only be a minor contributor of inter-assay variability of commercial cTnI immunoassays. Harmonization by means of reference sera was also counterproductive for improving methods agreement around a diagnostic threshold.

The aim of this study was to assess whether preanalytical management of coagulation samples through an open total laboratory automation system may impair the reliability of routine hemostasis tests as compared with loading of centrifuged plasma specimens directly into the coagulation analyzer for routine testing. Forty inpatient samples were divided into two aliquots. The former was centrifuged and directly loaded in a hemostasis analyzer, whereas the latter was entered into a 16.5 m long track-line system (FlexLab), where it was automatically centrifuged and conveyed to the same coagulation analyzer. An analytically significant difference was found between values of samples directly loaded in the coagulation analyzer and those entered in the track-line system for prothombin time (19.6 ± 1.7 versus 19.2 ± 1.6 s; p < 0.001) and activated partial thromboplastin time (38.0 ± 1.4 versus 37.5 ± 1.3 s; p = 0.021) but not for fibrinogen (305 ± 12 versus 304 ± 12 mg/dL; p = 0.97). Nevertheless, the mean percentage bias of prothombin time (-1.8%), activated partial thromboplastin time (-1.0%), and fibrinogen (0.4%) was modest and always lower than the total allowable error and was thereby considered not clinically significant. The results of this study confirm that connection of coagulation analyzers to track-line systems is a viable solution for modern clinical laboratories.

Despite manufacturers' claim that systematical assessment of serum indices does not impact on testing efficiency, there is widespread perception that this practice may increase the turnaround time (TAT). A multicenter investigation was planned to verify TAT and performance of serum indices on five different clinical chemistry analyzers.Twenty study samples prepared from pooled sera of outpatients, emergency department, intensive care unit and dialyzed patients were divided in aliquots and shipped to 5 different laboratories. According to local instrumentation (Beckman Coulter AU5800, Roche Cobas 6000, Siemens Dimension Vista 1500, Abbott Architect c 16000 and Ortho Vitros 5.1/FS) and reagents, 13 clinical chemistry parameters were assayed on all study samples, with or without contextual assessment of serum indices.The TAT with assessment of serum indices modestly or even negligibly increased, and varied from -0.2 to +5.0% (i.e., from -3 to +85 s). When using the lowest thresholds for sample acceptability, the agreement of hemolysis index (HI) among different instruments was comprised between 0.62 and 1.00 (all p0.01), but was higher than 0.80 in only 4/10 cases. The agreement of icteric and lipaemic indices could not be estimated due to the low number of samples exceeding acceptability criteria.The results of this study confirm that systematical measurement of serum indices does not impair instrument efficiency. The comparison of HI also suggests that major harmonization may be advisable for this measure among different manufacturers and instrumentations.

Laboratory testing, a highly complex process commonly called the total testing process (TTP), is usually subdivided into three traditional (pre-, intra-, and post-) analytical phases. The majority of errors in TTP originate in the pre-analytical phase, being due to individual or system design defects. In order to reduce errors in TTP, the pre-analytical phase should therefore be prioritized. In addition to developing procedures, providing training, improving interdepartmental cooperation, information technology and robotics may be a tool to reduce errors in specimen collection and pre-analytical sample handling. It has been estimated that >2000 clinical laboratories worldwide use total or subtotal automation supporting pre-analytic activities, with a high rate of increase compared to 2007; the need to reduce errors seems to be the catalyst for increasing the use of robotics. Automated systems to prevent medical personnel from drawing blood from the wrong patient were introduced commercially in the early 1990s. Correct patient identification and test tube labelling before phlebotomy are of extreme importance for patient safety in TTP, but currently few laboratories are interested in such products. At San Bassiano hospital, the implementation of advanced information technology and robotics in the pre-analytical phase (specimen collection and pre-analytical sample handling) have improved accuracy, and clinical efficiency of the laboratory process and created a TTP that minimizes errors.