Suggested reference ranges in clinical chemistry for apparently healthy males and females of Pakistan.

Abstract Seven hundred and eighty six apparently healthy males (418) and females (368) aged 0-69 years were randomly selected for estimation of reference ranges of 24 serum analytes at the clinical chemistry laboratory of The Ago Khon University Hospital (AKUH). Of the total study samples, 56% (439/786) were in the poediatric age group (0-14 years) and 44% (347/786) in the adult (1 5_60 years) group. Beckman Astra Ideal Autoanalyzer was used for all the estimations. Moon and standard deviations (SD) were calculated for each of the age groups. Reference ranges were calculated following standard methods of the International Federation of Clinical Chemistry (IFCC) and International Committee far Standardization in Haematology (ICSH) (JPMA 43:113, 1993)

Clinical significance of optimal red cell mass and plasma volume estimation methods

BACKGROUND: The aim of this study was to present and compare the results of proposed methods for optimal red cell mass and plasma volume (RCM&PV) estimation, and their influence on the interpretation of obtained results. MATERIAL AND METHODS: In 120/280 patients with polycythaemia rubra vera, subjected to RCM&PV determination with autologous erythrocytes in vitro labelled with 51Cr-sodium chromate, optimal volumes were determined using: 1. traditional ml/kg of: - the real body weight method (ml/kg RBW); - the optimal body weight method (ml/kg OBW). 2. the body weight, height, and sex based method (Retzlaff's tables), 3. the method recommended by the International Council for Standardization in Haematology (ICSH), based on body surface area. RESULTS: Different interpretation of the same results of 120 RCM&PV measurements was registered in 48/120 patients (40%). The greatest disagreement existed between ml/kg RBW and ml/kg OBW methods (in 39/120 subjects, 32.5%). In underweight patients the ml/kg RBW method, and in overweight patients the ml/kg OBW method, offered better agreement with ICSH&Retzlaff's methods. The ml/kg RBW method disagreed with ICSH&Retzlaff's methods and ml/kg OBW in 25% and 19.2% of patients respectively. ICSH and Retzlaff's methods disagreed in 10/120 patients (8.3%). The ICSH method yielded significantly lower optimal volumes than Retzlaff's. CONCLUSION: Three methods for optimal RCM&PV estimation lead to different interpretations of the same results of RCM&PV measurements with 51Cr-erythrocytes in 40% of patients. Two ml/kg body weight methods show greater disagreement in comparison with ICSH and Retzlaff's methods, which differ significantly. The ICSH method yields lower optimal values compared to Retzlaff's

International Council for Standardization in Haematology Recommendations for Hemostasis Critical Values, Tests, and Reporting

This guidance document was prepared on behalf of the International Council for Standardization in Haematology (ICSH), the aim of which is to provide hemostasis-related guidance documents for clinical laboratories. The current ICSH document was developed by an ad hoc committee, comprising an international collection of both clinical and laboratory experts. The purpose of this ICSH document is to provide laboratory guidance for (1) identifying hemostasis (coagulation) tests that have potential patient risk based on analysis, test result, and patient presentations, (2) critical result thresholds, (3) acceptable reporting and documenting mechanisms, and (4) developing laboratory policies. The basis for these recommendations was derived from published data, expert opinion, and good laboratory practice. The committee realizes that regional and local regulations, institutional stakeholders (e.g., physicians, laboratory personnel, hospital managers), and patient types (e.g., adults, pediatric, surgical) will be additional confounders for a given laboratory in generating a critical test list, critical value thresholds, and policy. Nevertheless, we expect this guidance document will be helpful as a framework for local practice. © 2020 BMJ Publishing Group. All rights reserved

Validation of Platelet Counting Accuracy With the Celltac F Automated Hematology Analyzer

Rapid and accurate analysis of platelet count plays an important role in evaluating hemorrhagic status. Therefore, we evaluated platelet counting performance of a hematology analyzer, Celltac F (MEK-8222, Nihon Kohden Corporation, Tokyo, Japan), that features easy use with low reagent consumption and high throughput while occupying minimal space in the clinical laboratory. All blood samples were anticoagulated with dipotassium ethylenediaminetetraacetic acid (EDTA-2K). The samples were stored at room temperature (18^C–22^C) and tested within 4 hours of phlebotomy. We evaluated the counting ability of the Celltac F hematology analyzer by comparing it with the platelet counts obtained by the flow cytometry method that ISLH and ICSH recommended, and also the manual visual method by Unopette (Becton Dickinson Vacutainer Systems). The ICSH/ISLH reference method is based on the fact that platelets can be stained with monoclonal antibodies to CD41 and/or CD61. The dilution ratio was optimized after the precision, coincidence events, and debris counts were confirmed by the reference method. Good correlation of platelet count between the Celltac F and the ICSH/ISLH reference method (r = 0.99, and the manual visual method (r= 0.93) were obtained. The regressions were y = 0.90 x+9.0 and y=1.11x+8.4, respectively. We conclude that the Celltac F hematology analyzer for platelet counting was well suited to the ICSH/ISLH reference method for rapidness and reliability

2021 Update of the International Council for Standardization in Haematology Recommendations for Laboratory Measurement of Direct Oral Anticoagulants

International audienceIn 2018, the International Council for Standardization in Haematology (ICSH) published a consensus document providing guidance for laboratories on measuring direct oral anticoagulants (DOACs). Since that publication, several significant changes related to DOACs have occurred, including the approval of a new DOAC by the Food and Drug Administration, betrixaban, and a specific DOAC reversal agent intended for use when the reversal of anticoagulation with apixaban or rivaroxaban is needed due to life-threatening or uncontrolled bleeding, andexanet alfa. In addition, this ICSH Working Party recognized areas where additional information was warranted, including patient population considerations and updates in point-of-care testing. The information in this manuscript supplements our previous ICSH DOAC laboratory guidance document. The recommendations provided are based on (1) information from peer-reviewed publications about laboratory measurement of DOACs, (2) contributing author's personal experience/expert opinion and (3) good laboratory practice

Survey material choices in haematology EQA: a confounding factor in automated counting performance assessment

The complete blood count (CBC) is one of the most frequently requested tests in laboratory medicine, performed in a range of healthcare situations. The provision of an ideal assay material for external quality assessment is confounded by the fragility of the cellular components of blood, the lack of commutability of stabilised whole blood material and the lack of certified reference materials and methods to which CBC results can be traced. The choice of assay material between fresh blood, extended life assay material and fully stabilised, commercially prepared, whole blood material depends upon the scope and objectives of the EQA scheme. The introduction of new technologies in blood counting and the wider clinical application of parameters from the extended CBC will bring additional challenges for the EQA provider

Point-of-care estimation of haemoglobin concentration in all age groups in clinical practice

Background: The measurement of haemoglobin (Hb) concentration provides a reliable, primary screening test for the presence and severity of anaemia. The HemoCue® is a point-of-care test for Hb measurement. The introduction of point-of-care testing in hospitals and general practice has improved patient care and accessibility. This study was performed to evaluate the utility of point-of-care Hb measurement with the HemoCue® device for the diagnosis of anaemia. Method: In this prospective study, we compared the analytical performance of the HemoCue® to the Coulter® LH 750 automated haematology analyser with regard to accuracy, precision and linearity in the measurement of Hb in adult and paediatric patient samples, referred for routine laboratory testing. Results: Samples from 100 patients were analysed with both instruments, and the results were compared using standard scatter and difference plots. The mean Hb value of the HemoCue® (11.3 g/dl; range 4.6-16.7) was comparable to the Coulter® LH 750 (11.3 g/dl; range 4.7-17.2). The Bland-Altman difference plot revealed good correlation. Bias between the two methods was small, and the imprecision was within acceptable limits. Hb measurement was linear in the range of 4.8-20 g/dl. Conclusion: In all age groups, the HemoCue® point-of-care device can be used to provide accurate and reliable Hb measurements with a smaller sample volume, improved turnaround time, and long-term cost saving.Keywords: haemoglobin, HemoCue®, point-of-care testing, anaemia screenin

ANALISIS PERBANDINGAN PEMERIKSAAN HEMOGLOBIN MENGGUNAKAN ALAT HB METER DENGAN ALAT SPEKTROFOTOMETER PADA IBU HAMIL

The prevalence of anemia in Indonesia according to the World Health Organization (WHO) in 2021 in pregnant women is 57.1%. Anemia in pregnant women can cause postpartum hemorrhage which is the cause of death in childbirth. International Committee for Standardization in Haematology (ICSH) recommends checking hemoglobin levels using the cyanmet-hemoglobin method. This method is easy to do because it has a standard and can measure all types of hemoglobin. The purpose of this study was to determine the comparison of hemoglobin levels using the Hb Meter and Spectrophotometer for pregnant women. The research design used was prospective with a descriptive analytic method with a Cross Sectional approach. Hemoglobin examination with a spectrophotometer has lower results than using a Hb Meter and is significantly significant. Conclusion: Examination of hemoglobin with a spectrophotometer has lower results than using an Hb meter and is significantly significant.Prevalensi anemia di Indonesia menurut World Health Organization (WHO) pada tahun 2021 pada wanita hamil adalah 57,1%.Anemia pada ibu hamil dapat menyebabkan terjadinya perdarahan post partum yang merupakan penyebab kematian pada ibu melahirkan.International Committee for Standardization in Haematology (ICSH) menganjurkan pemeriksaan kadar hemoglobin dengan menggunakan metode sianmethemoglobin. Cara ini mudah dilakukan karena mempunyai standar dan dapat mengukur semua jenis hemoglobin. Tujuan penelitian ini untuk mengetahui Perbandingan Kadar Hemoglobin dengan menggunakan alat Hb Meter dan Spektrofotometer pada Ibu hamil. Desain penelitian yang digunakan adalah prospektif dengan metode analitik deskriptif dengan pendekatan Cross Sectional. Pemeriksaan hemoglobin dengan spektrofotometer mempunyai hasil lebih rendah dibandingkan dengan menggunakan alat Hb meter dan bermakna secara signifikan. Kesimpulan: Pemeriksaan hemoglobin dengan spektrofotometer mempunyai hasil lebih rendah dibandingkan dengan menggunakan alat Hb meter dan bermakna secara signifikan

Evaluation of micro-ESR method with Westergren method for determination of erythrocyte sedimentation rate

Background: Erythrocyte sedimentation rate (ESR) test provides valuable information in screening, diagnosis, as well as monitoring disease activity and therapeutic response in numerous health conditions. The most commonly used method for determination of ESR is Westergren method, which is time-consuming and requires a large amount of blood sample. There are several other methods, like Micro-ESR method which overcome the limitations of conventional Westergren method, hence the present study was performed to compare results of Westergren method with Micro-ESR method for determination of ESR.Methods: In the present study, blood samples from 100 patients were processed for ESR determination by Westergren method and Micro-ESR method. The results obtained were compared using Pearson’s correlation test.Results: The Westergren method was the reference method and the Micro-ESR method was testing method. The comparison was done between Micro- ESR method results (X-axis) and results of Westergren method (Y-axis). The slope of the regression line using linear regression was 1.010 with a y-intercept of -0.788. Statistical analysis demonstrated significant correlation of results of Micro-ESR method with Westergren method (r = 0.9977).Conclusions: Micro-ESR is a reliable and precise method for ESR measurement. The Micro- ESR method is simple to perform and requires very small volume of blood (0.2ml) as compared to conventional Westergren method. It can be potential useful tool in performing ESR determination especially for the patients with limitation of blood availability as pediatric patients and very old patients.