Performance evaluation of a new Stago<sup>®</sup> automated haemostasis analyser: The STA R Max<sup>®</sup> 2

Cupaiolo, Roberto; Govaerts, D.; Blauwaert, Marine; Cauchie, Philippe

doi:10.1111/ijlh.13100

Cited by 5 publications

(4 citation statements)

References 5 publications

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“…Within‐assay and between‐assay imprecision values were all ≤5.0% for TSVT ratio and ET ratio, which are within expected limits for clotting assays on automated and semiautomated analytical platforms 42–45 …”

Section: Discussionsupporting

confidence: 55%

International multicenter, multiplatform study to validate Taipan snake venom time as a lupus anticoagulant screening test with ecarin time as the confirmatory test: Communication from the ISTH SSC Subcommittee on Lupus Anticoagulant/Antiphospholipid Antibodies

Moore

Jones

Platton

et al. 2021

Journal of Thrombosis and Haemostasis

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Background Lupus anticoagulant (LA) assays are compromised in anticoagulated patients, and existing strategies to overcome the interferences have limitations. The prothrombin‐activating Taipan snake venom time (TSVT) screening test and ecarin time (ET) confirmatory test are innately insensitive to vitamin K antagonists (VKA) and direct factor Xa inhibitors (DFXaI). Objectives Validate standardized TSVT/ET reagents for LA detection, in a multicenter, multiplatform study. Patients/Methods Six centers from four countries analyzed samples with TSVT/ET from 81 nonanticoagulated patients with LA, patients with established antiphospholipid syndrome (APS), and proven persistent LA who were either not anticoagulated (n = 120) or were anticoagulated with VKAs (n = 180) or DFXaIs (n = 71). Additionally, 339 nonanticoagulated LA‐negative patients, and 575 anticoagulated non‐APS patients (172 VKA, 403 DFXaI) were tested. Anticoagulant spiking experiments were performed and 112 samples containing potential interferences (i.e., direct thrombin inhibitors) were tested. Results were evaluated against locally derived cutoffs. Imprecision was evaluated. Results Cutoffs were remarkably similar despite use of different analyzers and donor populations. Cutoffs for TSVT ratio, ET ratio, percent correction, and normalized TSVT ratio/ET ratio ranged between 1.08 and 1.10, 1.09 and 1.12, 9.3% and 14.8%, and 1.10 and 1.15, respectively. Coefficients of variation for TSVT and ET ratios were ≤5.0%. TSVT/ET exhibited sensitivity, specificity, and negative and positive predictive values of 78.2%/95.0%/86.3%/91.5%, respectively, with established APS as the LA‐positive population, and 86.9%/95.0%/76.8%/97.4%, respectively, with triple‐positive APS. Interference was seen with direct thrombin inhibitors, unfractionated heparin, and low molecular weight heparins, but not VKAs or DFXaIs. Conclusions TSVT/ET are validated for LA detection in nonanticoagulated patients and those on VKAs or DFXaIs.

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Section: Discussionsupporting

confidence: 55%

International multicenter, multiplatform study to validate Taipan snake venom time as a lupus anticoagulant screening test with ecarin time as the confirmatory test: Communication from the ISTH SSC Subcommittee on Lupus Anticoagulant/Antiphospholipid Antibodies

Moore

Jones

Platton

et al. 2021

Journal of Thrombosis and Haemostasis

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“…However, both D‐dimer and fibrinogen showed poor agreement despite being measured as concentration measures. Moreover, viscosity‐based activity measurements, such as the STA‐R analyzer used here, are considered the standard for VTE studies 18‐20 . Furthermore, the recommended the sample size for Bland‐Altman methods is usually N > 100 21 .…”

Section: Discussion and Resultsmentioning

confidence: 99%

“…Moreover, viscosity-based activity measurements, such as the STA-R analyzer used here, are considered the standard for VTE studies. [18][19][20] Furthermore, the recommended the sample size for Bland-Altman methods is usually N > 100. 21 Our small size may affect the accuracy of the width of the 95% agreement intervals.…”

Section: Two Previous Studies Assessed the Association Betweenmentioning

confidence: 99%

Agreement of aptamer proteomics with standard methods for measuring venous thrombosis biomarkers

Faquih

Mook‐Kanamori

Rosendaal

et al. 2021

Research and Practice in Thrombosis and Haemostasis

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“…Fibrinogen levels were measured in citrated plasma samples by the Clauss method, 21 using the STA Liquid FIB reagent on the STA-R Max (Diagnostica Stago, France) according to the manufacturers recommendations at the Department of Functional Coagulation, Synapse Research Institute, Maastricht, the Netherlands. 22 Both intra-and inter-assay coefficients of variation were 2.1% for samples within the normal range of fibrinogen specified to be 2-4 g/L in healthy subjects.…”

Section: Plasma Fibrinogen Measurementsmentioning

confidence: 89%

Plasma fibrinogen levels and all-cause and cause-specific mortality in an Italian adult population: results from the Moli-sani study

Parisi

Costanzo²,

Laat-Kremers³

et al. 2023

Bleed Thromb Vascul Biol

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Epidemiological data on the association between fibrinogen levels and mortality are scarse and controversial. Longitudinal analyses were performed, separately by sex, on 17,689 individuals from the Moli-sani study [53% women, ≥35 years, free from cardiovascular disease (CVD) or cancer at enrolment], to evaluate the association between plasma fibrinogen and all-cause and cause-specific mortality. Over a median follow-up of 11.2 years, 1,058 deaths (34.7% CVD, 36.3% cancer) were ascertained. Both in the lowest (1.12-2.64 g/L) and highest (≥3.62 g/L) fibrinogen quintiles, women had an increased all-cause mortality hazard, when compared with third quintile (2.97-3.23 g/L). Dose-response analyses showed a U-shaped relationship in women (P overall <0.0001; P non-linear association <0.0001), but a positive linear association for all-cause mortality in men (P overall 0.0038; P non-linear association 0.76). Similar trends for a U-shaped association were observed for CVD mortality, while no association was observed with cancer deaths. A U-shaped association of fibrinogen levels with other-cause mortality was also found in both sexes. This study shows that not only higher but also lower fibrinogen levels represent hazard for mortality when compared to normal levels; U-shaped curves being prevalently observed in women.

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Performance evaluation of a new Stago^® automated haemostasis analyser: The STA R Max^® 2

Cited by 5 publications

References 5 publications

International multicenter, multiplatform study to validate Taipan snake venom time as a lupus anticoagulant screening test with ecarin time as the confirmatory test: Communication from the ISTH SSC Subcommittee on Lupus Anticoagulant/Antiphospholipid Antibodies

International multicenter, multiplatform study to validate Taipan snake venom time as a lupus anticoagulant screening test with ecarin time as the confirmatory test: Communication from the ISTH SSC Subcommittee on Lupus Anticoagulant/Antiphospholipid Antibodies

Agreement of aptamer proteomics with standard methods for measuring venous thrombosis biomarkers

Plasma fibrinogen levels and all-cause and cause-specific mortality in an Italian adult population: results from the Moli-sani study

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Performance evaluation of a new Stago® automated haemostasis analyser: The STA R Max® 2

Cited by 5 publications

References 5 publications

International multicenter, multiplatform study to validate Taipan snake venom time as a lupus anticoagulant screening test with ecarin time as the confirmatory test: Communication from the ISTH SSC Subcommittee on Lupus Anticoagulant/Antiphospholipid Antibodies

International multicenter, multiplatform study to validate Taipan snake venom time as a lupus anticoagulant screening test with ecarin time as the confirmatory test: Communication from the ISTH SSC Subcommittee on Lupus Anticoagulant/Antiphospholipid Antibodies

Agreement of aptamer proteomics with standard methods for measuring venous thrombosis biomarkers

Plasma fibrinogen levels and all-cause and cause-specific mortality in an Italian adult population: results from the Moli-sani study

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Product

Resources

About

Performance evaluation of a new Stago^® automated haemostasis analyser: The STA R Max^® 2