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

Abstract

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.

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

“…Providing patient-specific treatment monitoring will greatly aid in the development of individualized, precision medicine. The high reagent loading capacity coupled with the automatic reagent reconstitution of the Cobas t 711 analyzer will contribute to shorter turnaround times (TAT) and improve laboratory efficiency [ 6 ].…”

Monitoring of different factor VIII replacement products using a factor VIII one‐stage clotting assay on cobas t 511/711 analysers

“…All measurements were performed on the cobas t 511/711 analysers, which work in an equivalent manner (Figure S1). 16,17 Determination of FVIII activity using a FVIII one-stage clotting assay (OSA) FVIII was measured in the OSA using the Factor VIII ready-for-use cassette for cobas t analysers (Roche Diagnostics International Ltd); other individual reagents required were sourced from Roche Diagnostics International Ltd and the assay protocol was performed according to the manufacturer's instructions. 18 Sample plasma was diluted and added to human plasma with a FVIII level < 1% of the physiological value, whereas all other coagulation factors were present at levels typically > 50% of the physiological value.…”

“…All measurements were performed on the cobas t 511/711 analysers, which work in an equivalent manner (Figure S1 ). 16 , 17 …”

Multicenter performance evaluation and reference range determination of a new one‐stage factor VIII assay

“…Here, we present the results of a multicenter evaluation of a new one‐stage FVIII aPTT‐based assay (Roche Diagnostics International Ltd) 17 intended for the quantitative assessment of FVIII activity. Our aim was to evaluate the analytical performance of the new assay on the cobas t 711 analyzer (Roche Diagnostics), a fully automated, high‐throughput, discrete coagulation instrument for the in vitro qualitative and quantitative determination of coagulation analytes in human plasma 18,19 …”

“…Our aim was to evaluate the analytical performance of the new assay on the cobas t 711 analyzer (Roche Diagnostics), a fully automated, high‐throughput, discrete coagulation instrument for the in vitro qualitative and quantitative determination of coagulation analytes in human plasma. 18 , 19 …”