Evaluating the analytical performance of four new coagulation assays for the measurement of fibrinogen, D‐dimer and thrombin time

Kitchen, Steve; Geisen, Ulrich; Kappelmayer, János; Quehenberger, Peter; Lowe, Anna; Jones, Robert L.; Miles, Gabrielle; Boehm, Jana G.; Rozsnyai, Gergely

doi:10.1111/ijlh.12896

Cited by 9 publications

(10 citation statements)

References 33 publications

(54 reference statements)

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“…Performance of cobas t 711/t 511 analyzers Kitchen et al 465 compared with existing commercially available methods [26,27,29]. Our results complement and build on these previous data by further demonstrating consistency in analytical performance with the two analyzers and user satisfaction.…”

Section: Discussionsupporting

confidence: 80%

“…390 tests/h: all three centers) and cobas t 511 (mid-throughput; max. 195 tests/h: UK center only) analyzers, using a number of coagulation assays (aPTT, aPTT Lupus, aPTT Screen, AT, D-Dimer, Fibrinogen, PT-derived Fibrinogen, PT Owren, PT Rec and TT; Roche Diagnostics, Switzerland) described in detail previously [27,29]. All assays and analyzers were used according to manufacturers' instructions.…”

Section: Methodsmentioning

confidence: 99%

“…The potential advantages include increased precision and accuracy compared with pipetting when manually reconstituting reagents, increased walkaway time for operators and efficiencies in scheduling sample runs [26]. Assays used for routine coagulation testing with the cobas t 711 and 511 analyzers include three different aPTT reagents (aPTT, aPTT Lupus, aPTT Screen), AT, D-Dimer, Fibrinogen, PTderived Fibrinogen, PT Owren and PT Rec (recombinant human thromboplastin reagent); their analytical performance has been described in detail previously [26][27][28][29].…”

Section: Introductionmentioning

confidence: 99%

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System performance evaluation of the cobas t 711 and cobas t 511 coagulation analyzers in routine laboratory settings

Kitchen¹,

Maat

Nagler

et al. 2020

Blood Coagulation &Amp; Fibrinolysis

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Utility of coagulation analyzers in real-world settings depends on characteristics that are often not studied comprehensively. This study aimed to investigate the analytical performance, system functionality, practicability, consistency and throughput of two new automated coagulation analyzers in routine laboratory practice. Real-world settings were simulated in three major European hemostasis laboratories and multiple assays were performed in anonymized plasma samples in parallel with routine clinical practice on the cobas t 711 (high-throughput) and cobas t 511 (mid-throughput) analyzers using activated partial thromboplastin time (aPTT), aPTT Lupus, aPTT Screen, Antithrombin (AT), d -Dimer, Fibrinogen, Prothrombin Time (PT)-derived Fibrinogen, PT Owren, PT Rec (recombinant human thromboplastin reagent) and Thrombin Time assays. Precision was tested in a 21-day experiment and accuracy was compared with reference methods of the same laboratory. A number of experiments simulated challenging real-life situations. Pearson's correlation coefficient was more than 0.98 in all assays. Across assays, coefficients of variation ranged from 0.0 to 1.5% for intermediate precision; 0.2 to 3.0% for repeatability and 0.4 to 3.7% for total precision. Good between-run comparability was seen when testing samples under random conditions. Calculated maximum throughput was 197 and 387–402 tests/h for the cobas t 511 and 711 analyzers, respectively. Practicability met or exceeded user expectations in 98% of cases. In a simulated real-life setting of three major laboratories, the new cobas t 511 and cobas t 711 coagulation analyzers demonstrated a good functionality, practicability and performance and the throughput was high.

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Section: Discussionsupporting

confidence: 80%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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System performance evaluation of the cobas t 711 and cobas t 511 coagulation analyzers in routine laboratory settings

Kitchen¹,

Maat

Nagler

et al. 2020

Blood Coagulation &Amp; Fibrinolysis

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“…The aims of this study were first to reproduce previous results on imprecision and method comparison [[4], [5], [6], [7]], second to evaluate the performance of the anti-Xa assay (not previously published), third to determine whether the aPTT can be used to monitor UFH therapy, fourth to investigate a fast centrifugation protocol in order to shorten turn-around time, and finally to study sample stability over time, since this is known to be method and reagent dependent [8].…”

Section: Introductionmentioning

confidence: 99%

Performance of 6 routine coagulation assays on the new Roche Cobas t711 analyzer

Oostendorp

Noorman

Nijenhuis

et al. 2019

Practical Laboratory Medicine

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ObjectivesFor new analyzers or tests, analytical evaluation is required before implementation in the clinical laboratory. We evaluated the novel Roche Cobas t711 analyzer with six newly developed coagulation assays: the activated partial thromboplastin time (aPTT), prothrombin time (PT), international normalized ratio (INR), fibrinogen, d-dimer and anti-Xa. The evaluation included imprecision experiments, method comparison with the currently used Stago STA-R Evolution, monitoring of unfractionated heparin (UFH) with aPTT, a fast centrifugation protocol to improve turn-around time, and determination of sample stability in whole blood and plasma.Design and methodsImprecision and method comparison were assessed using commercial quality control samples and patient samples, respectively. For dose monitoring of UFH with the aPTT, samples from patients treated with UFH were used. Samples from healthy volunteers were collected for evaluation of the fast centrifugation protocol (5’ 2750×g) and for investigating sample stability over 6–8 h.ResultsResults for between-run precision were within the desirable specification. Method comparison showed an excellent agreement for fibrinogen, d-dimer and anti-Xa. For aPTT, PT and INR, a good correlation was found, but results were significantly lower on the t711 compared to the STA-R Evolution, which is caused by different coagulation activators. Results from the fast centrifugation protocol differed not significantly from the standard protocol (15’ 2500×g). Blood and plasma samples were stable at room temperature up to 6 and 8 h, respectively.ConclusionsThe t711 coagulation analyzer with 6 novel tests is suitable for routine use in clinical laboratories.

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“…In this study, we were able to confidently establish reference intervals based on the performance verification for the Cobas t 711. Some other reports have described the performance of the Cobas t 711 in detail [ [9] , [10] ] [ [9] , [10] ] [ [9] , [10] ]. We divided into groups based on the age of 50 and established a reference interval to reduce the impact of individual related variables on routine coagulation parameters in Chinese healthy population [ 11 ].…”

Section: Discussionmentioning

confidence: 99%

Assessment and establishment of a reference interval for Roche Cobas t 711 coagulation analyzer for a hospital in China

Zhu

Sun

et al. 2022

Practical Laboratory Medicine

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Evaluating the analytical performance of four new coagulation assays for the measurement of fibrinogen, D‐dimer and thrombin time

Abstract: This multicentre study demonstrates excellent analytical performance for four new coagulation assays on the cobas t 711 and cobas t 511 analysers.

Cited by 9 publications

References 33 publications

System performance evaluation of the cobas t 711 and cobas t 511 coagulation analyzers in routine laboratory settings

System performance evaluation of the cobas t 711 and cobas t 511 coagulation analyzers in routine laboratory settings

Performance of 6 routine coagulation assays on the new Roche Cobas t711 analyzer

Assessment and establishment of a reference interval for Roche Cobas t 711 coagulation analyzer for a hospital in China

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