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

Abstract

IntroductionDue to the use of different detection reagents and methods, coagulation analyzers can produce different results. Therefore, detection instruments, reagents and methods are important factors affecting the results of coagulation test. Therefore, this paper aims to establish reference intervals applicable to our laboratory for the Roche Cobas t 711 for routine coagulation assays.Methods:We completed a preliminary evaluation of the analytical performance of the cobas t 711 before any experiment. Healthy volunteer recruitment and ostensibly healthy patients via physical examination were performed to collect individual reference samples. Data were grouped and compared according to age, and the Z test was used to determine whether there was a statistically significant difference between the mean values after grouping. ResultsThe self-established PT, APTT and TT reference intervals were 8.4–10.2s, 26.8–42.3s and 14.5–17.1s, respectively. The reference ranges of FIB, AT and DD for people aged 50 years or below were 1.85–3.78 (g/l), 83.9–113.2 (%) and 0–0.45 (mg/l), respectively, and those for people older than 50 years were 2.22–3.86 (g/l), 76.0–112.0 (%) and 0–0.52 (mg/l), respectively. ConclusionThe self-built reference intervals for the Roche t 711 were basically consistent with those in the instructions, except the APTT ranges were slightly wider. Laboratories should establish applicable reference intervals according to their own conditions to provide guidance for the diagnosis, monitoring and prognosis of clinically related diseases.