Validation of the Sysmex CS5100 coagulation analyzer and comparison to the Stago STA‐R analyzer for routine coagulation parameters

Abstract

In conclusion, the CS5100 instrument is suitable for the determination of the APTT, PT, FBG, DDi and AT in routine analysis.

Evaluating the analytical performance of five new coagulation assays for the measurement of prothrombin time and activated thromboplastin time

“…Furthermore, each of the five assays performed on the cobas t 711 analyser showed good agreement with the commercially available assays/platforms used as comparator methods, which have previously demonstrated favourable performance for the measurement of their respective analytes. [34][35][36] The reference range in apparently healthy volunteers measured with the aPTT assay was consistent with those previously reported for other assays/platforms, 20,34,35 and the reference ranges for the aPTT Lupus and aPTT Screen assays were in line with those of the aPTT assay. The reference range for the PT Rec assay (8.4-10.6 seconds) was slightly lower than that previously reported for similar assays.…”

“…The reference range in apparently healthy volunteers measured with the aPTT assay was consistent with those previously reported for other assays/platforms, and the reference ranges for the aPTT Lupus and aPTT Screen assays were in line with those of the aPTT assay. The reference range for the PT Rec assay (8.4‐10.6 seconds) was slightly lower than that previously reported for similar assays . Reference ranges for each assay were consistent whether fresh or frozen samples were used, and with two different types of sample tube.…”

“…Overall, CVs for within‐run precision were ≤1.3% and those for total reproducibility were ≤6.3%; lot‐to‐lot comparisons with each assay showed a high level of consistency across all sites. Furthermore, each of the five assays performed on the cobas t 711 analyser showed good agreement with the commercially available assays/platforms used as comparator methods, which have previously demonstrated favourable performance for the measurement of their respective analytes …”

“…The reference range for the PT Rec assay (8.4-10.6 seconds) was slightly lower than that previously reported for similar assays. 34,37 Reference ranges for each assay were consistent whether fresh or frozen samples were used, and with two different types of sample tube.…”

The analysis of false prolongation of the activated partial thromboplastin time (activator: silica): Interference of C‐reactive protein

“…Among them, APTT on CS‐2000i and STA‐R Evolution (activator: kaolin) and ACL Top 700 system prolonged by 5 second at most, 0.5 second, 1.0 second, respectively. Different detecting systems have different methodology, and the mixed plasma’s APTT without any purified CRP was 34.5 second, 30.7 second, 37.7 second, 30.6 second in STA‐R Evolution (activator: silica), STA‐R Evolution (activator: kaolin), ACL Top 700, and CS‐2000i, respectively.…”