A reference system approach to future standardization of laboratory tests for hemostasis. A position paper of the Joint Committee of the IFCC Scientific Division and the ISTH Scientific and Standardization Committee (original) (raw)
Related papers
Coagulation update: what's new in hemostasis testing?
Thrombosis research, 2011
The current report provides a personal perspective summarising some interesting recent developments in hemostasis, as well as providing a brief glimpse into some possible imminent changes to come. We briefly review routine coagulation tests, and what changes may take place related to the new emerging anticoagulants. We also briefly review the old and new global tests of hemostasis, including thrombin generation and thromboelastography. Also briefly discussed within the diagnostics of bleeding and thrombotic disorders are the role of microparticles, the rise and fall of thrombophilia testing, the 'disappearance' of fibrinolysis pathway tests, and the absence of tests related to the endothelium, in part reflecting upon Virchow's triad.
Biochemia Medica, 2018
Introduction: Haemolysis is the leading cause of sample rejection in laboratory haemostasis. Most studies focused on artificially haemolysed samples. The aim of this study was a prospective assessment of spontaneous haemolysis on haemostasis tests, by comparing results of haemolysed (H) versus new, non-haemolysed (NH) specimens, collected within 4hrs. As new coagulometers can identify interfering substances, visual assessment of haemolysis was also compared with instrumental haemolysis index and stratified in subclasses. Materials and methods: Two hundred and sixty nine paired samples were collected and analysed using ACL TOP750-CTS (Instrumentation Laboratory, Bedford, USA), for prothrombin time (PT), activated partial thromboplastin time (aPTT), D-Dimer (DD), fibrinogen (Fib) and antithrombin (AT). Bias between H and NH was calculated and compared with the respective critical difference (CD). Results: Mean bias was-0.1 s for PT (P = 0.057),-1.1 s for aPTT (P < 0.001), 1025 ng/mL for DD (P < 0.001),-0.04 g/L for Fib (P = 0.258) and 1.4% for AT (P = 0.013). Bias exceeding the CD varied according to the method, with larger differences for aPTT (36.1%) and DD (17.1%) and < 8% for PT, Fib and AT. No correlation emerged between free haemoglobin values and difference in haemostasis tests in H and NH samples for any tests. Moderate/severe haemolysis involved > 95% of samples. The agreement between visual assessment and instrumental evaluation of haemolysis was 0.62. Conclusion: Spurious haemolysis deeply influences aPTT and DD, and to a lesser extent AT and Fib. Prothrombin time seems only slightly influenced, suggesting that PT can be accepted also in haemolysed samples. Although a good inter-observer correlation of haemolysis evaluation was found, the instrumental assessment of haemolysis seems recommendable.
Rivista Italiana della Medicina di Laboratorio
Despite introduction of some measures to achieve a more effective standardization in routine coagulation testing, there are evidences that harmonization among different clinical laboratories has not been fully achieved as yet. To evaluate whether differences in instruments and reagents between two separate laboratories might influence the clinical management of patients with hemostatic disturbances, we analyzed prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen and d-dimer in 84 consecutive outpatients on oral or heparin anticoagulant therapy. Despite statistically significant differences could be observed for all the parameters tested, Passing & Bablok analysis yielded acceptable results. The extent of measurement deviation always exceeded the current analytical quality specifications for desirable bias, when available. The percentage of patients in the therapeutic range or outside the respective reference range was significantly different between laboratories for APTT and fibrinogen, but not for PT and d-dimer. In conclusion, results of our investigation testify that some further efforts are needed to achieve harmonization of routine coagulation testing among laboratories.
Guidelines on the laboratory aspects of assays used in haemostasis and thrombosis
International Journal of Laboratory Hematology, 2013
The Official journal of the International Society for Laboratory Hematology of the Haemostasis and Thrombosis Task Force of the British Committee for Standards in Haematology (BCSH). The guideline was then reviewed by a sounding board of approximately 50 UK haematologists, BCSH and the British Society for Haematology committee and comments incorporated where appropriate. The 'GRADE' system does not apply (because clinical trials are not available to support the 'best practice' recommendations that have been generated) and was therefore not used.
The MDA-180 coagulation analyser: a laboratory evaluation
Pathology, 1997
We have evaluated the technical performance of the MDA-180 automated coagulation analyser in a working diagnostic hemostasis laboratory environment. The analyser has been on site now for over 18 months, and has undergone considerable testing. More than 22,000 samples have been processed, with over 90% of these via the MDA-180's cap-piercing facility. The instrument has been primarily assessed for its technical ease of use and continued reliability, as well as its analytical performance. The instrument has also been successfully interfaced to, and used with, our Laboratory Information (CERNER PATHNET) system. A major feature of our evaluation has been an assessment of the MDA-180's ability to perform assays currently performed using alternative methodology or instrumentation (eg; ELlSA methodology or the Coagamate-X2 and ACL-300R instruments), as well as its potential to streamline the technical performance of some of these assays. We have co-evaluated the following assays:
Comparison of various principles of coagulation tests in handling hemolysed blood samples
Tropical Journal of Pathology and Microbiology, 2021
Background: Rejection of hemolysed samples for coagulation test is the standard practice.However, when clinicians deal with extremely sick patients where repeat sampling is difficult toobtain, rejection of the sample is a lost opportunity for the lab physician to assist inpatient care.Proceeding with the test and providing a clinically helpful interpretation of the results will ensure theactive participation of the laboratory physician. Different principles of coagulation testing handle thehemolysed samples differently. It is essential to know the best principle to proceed with thehemolysed sample if need be. This study set out to estimate the predictive values of post-hemolyticsample coagulation test results with various coagulation test principles. Methods: This is aprospective experimental study where the non-hemolysed samples were processed for coagulationtests. Part of the sample was deliberately hemolysed, and the coagulation tests were repeated.Results: Two hundred and forty-...
American Journal of Clinical Pathology, 2021
Objectives To verify a single platform of hemostasis instrumentation, the ACL TOP 50 Family, comprising 350, 550, and 750 instruments, across a large network of 60 laboratories. Methods Comparative evaluations of instrument classes (350 vs 550 and 750) were performed using a large battery of test samples for routine coagulation tests, comprising prothrombin time/international normalized ratio, activated partial thromboplastin time (APTT), thrombin time, fibrinogen and D-dimer, and using HemosIL reagents. Comparisons were also made against existing equipment (Diagnostica Stago Satellite, Compact, and STA-R Evolution) and existing reagents to satisfy national accreditation standards. Verification of manufacturer normal reference ranges (NRRs) and generation of an APTT heparin therapeutic range were undertaken. Results The three instrument types were verified as a single instrument class, which will permit standardization of methods and NRRs across all instruments (n = 75) to be deploy...