Recent initiatives in harmonization of hemostasis practice

Favaloro, Emmanuel J.; Gosselin, Robert; Olson, John D.; Jennings, Ian; Lippi, Giuseppe

doi:10.1515/cclm-2018-0082

Cited by 12 publications

(6 citation statements)

References 23 publications

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“…95 There are several harmonization/standardization initiatives in play in the field of hemostasis, including laboratory testing. 96,97 We hope that this article spurs manufacturers of mainstream hemostasis analyzers to contribute to even greater initiatives in this area of need. Finally, we offer our own "checklist" of 10 bullet points (a kind of "wishlist") of some far-reaching innovations in the future in ►Table 6.…”

Section: Resultsmentioning

confidence: 98%

Recent Advances in Mainstream Hemostasis Diagnostics and Coagulation Testing

Favaloro

Lippi

2019

Semin Thromb Hemost

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The authors provide a narrative review of mainstream hemostasis analyzers. The review is presented in two parts. In the first part, the authors give voice to several internationally representative manufacturers of mainstream hemostasis analyzers. They ask these manufacturers to (1) answer a series of survey questions that may otherwise reflect common questions asked by users or potential users of their equipment, (2) provide a bullet list of their main focus areas, and (3) provide other information in regard to their instrumentation. The authors then offer their own personal perspective of the benefits of various aspects of such equipment, as well as a sampling of some hemostasis tests as currently available, or potentially in progress. It is hoped that this snapshot of mainstream hemostasis diagnostics and coagulation testing drives positive future changes that will ultimately provide the best outcomes for laboratories performing hemostasis assays and the patients they help diagnose and manage.

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Section: Resultsmentioning

confidence: 98%

Recent Advances in Mainstream Hemostasis Diagnostics and Coagulation Testing

Favaloro

Lippi

2019

Semin Thromb Hemost

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“…These findings are not really surprising, as the APTT reagents of the three manufacturers are based on different contact activators (i. e., ellagic acid for Roche, colloidal silica for IL, and polyphenols for Stago; ►Table 1), thus mirroring recent evidence showing that harmonization in hemostasis testing is still an unmet target, even for longstanding and widely used tests such as the APTT. [15][16][17] The bias may also be explained by differences in the phospholipid sources and/or concentration of different APTT reagents, the use of different mathematical algorithms for detection of clot endpoint, the use of different detection methods between Stago (mechanical endpoint) and IL ACL TOP and cobas t 711 (both optical endpoints), as well as by the possibility that some specimens might have had lupus anticoagulant activity, with different potential sensitivity among the three APTT reagents. Further study could hence be conducted to assess other aspects of this new analyzer, including normal reference ranges and heparin therapeutic range, sensitivity to factor deficiencies and lupus anticoagulants, responsiveness to nonheparin anticoagulants, along with instruments comparability for APTT values greater than 60 seconds.…”

Section: Discussionmentioning

confidence: 99%

Analytical Assessment of the New Roche Cobas t 711 Fully Automated Coagulation Analyzer

Lippi

Salvagno

Gelati

et al. 2019

Semin Thromb Hemost

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This study aimed to provide a preliminary evaluation of the analytical performance of the new Roche cobas t 711 fully automated coagulation analyzer, which uses both liquid and lyophilized reagent cassettes. The analytical assessment included analysis of imprecision and linearity of prothrombin time (PT), activated partial thromboplastin time (APTT), and fibrinogen on cobas t 711 analyzer. Test results of 120 routine plasma samples were also compared with those obtained using two other coagulation analyzers (Instrumentation Laboratory ACL TOP 700 and Stago STA-R MAX). The accuracy, imprecision, and comparability of manual and automatic lyophilized material resuspension were also evaluated using 200 routine plasma samples. Overall, automatic resuspension was found to be more precise than, and equally accurate as, manual reconstitution, with coefficient of variations (CV%) three- to sixfold lower compared with manual reconstitution. The analytical imprecision was found to be excellent, as attested by total CV% of 0.7% for PT, 1.7 to 1.8% for APTT, and 1.9 to 3.2% for fibrinogen. Linearity was excellent over a clinically significant range of PT, APTT, and fibrinogen values, displaying correlation coefficients comprised between 0.994 and 0.999. Methods comparison studies revealed that results of PT, APTT, and fibrinogen on cobas t 711 are globally aligned with those obtained using identical plasma samples on IL ACL TOP 700 and Stago STA-R MAX, displaying correlation coefficients of 0.97 for PT, 0.81 and 0.88 for APTT, 0.90 and 0.94 for fibrinogen, respectively. In conclusion, the results of this preliminary evaluation demonstrate that PT, APTT, and fibrinogen on cobas t 711 coagulation analyzer displays excellent performance for routine use in clinical laboratories.

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“…We essentially harmonized NRRs and interpreted comments for PFA testing in our large pathology network, NSWHP, representing the largest public pathology organization in Australia. Harmonization has a number of advantages, as partly explored elsewhere 55 . We propose our evaluation will be useful for other organizations wishing to harmonize PFA testing in their networks.…”

Section: Discussionmentioning

confidence: 99%

Harmonizing platelet function analyzer testing and reporting in a large laboratory network

Favaloro

Mohammed

Vong

et al. 2022

Int J Lab Hematology

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Introduction: The platelet function analyzer (PFA) is a popular platelet function screening instrument, highly sensitive to von Willebrand disease (VWD) and to aspirin therapy, with moderate sensitivity to defects in platelet function and/or deficiencies in platelet number. There are two models, the original PFA-100 and the contemporary PFA-200. Normal reference ranges (NRRs) provided by the manufacturer are the same for both models, instead being based on the type of test cartridge, for which there are two main ones: collagen/epinephrine (C/Epi) and collagen/ adenosine diphosphate (C/ADP). Methods: Comparative evaluations of PFA testing and reporting in six different sites of a large pathology network, aiming to harmonize NRRs and test reporting across all network sites. A separate comparative study of testing a range of samples (n > 150) on a PFA-100 versus that on a PFA-200. Review of contemporary literature. Results: Each site was identified to have a different reporting NRR, which after consolidating data permitted establishment of an agreed harmonized NRR for use across the network (C/Epi: 90-160; C/ADP: 70-124; based on n > 180). Similarly, each site reported and interpreted results in different ways, and after discussion and consolidation, a harmonized approach to interpretation and reporting was achieved. The separate comparative study of PFA-100 versus PFA-200 testing confirmed instrument equivalence. Conclusion:We achieved harmonized NRRs and reporting for PFA testing across a large pathology network. Our approach may be useful for other laboratory networks wishing to harmonize PFA testing.

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Recent initiatives in harmonization of hemostasis practice

Cited by 12 publications

References 23 publications

Recent Advances in Mainstream Hemostasis Diagnostics and Coagulation Testing

Recent Advances in Mainstream Hemostasis Diagnostics and Coagulation Testing

Analytical Assessment of the New Roche Cobas t 711 Fully Automated Coagulation Analyzer

Harmonizing platelet function analyzer testing and reporting in a large laboratory network

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