J Clin Pathol Qual Control.  2001 Dec;23(2):247-252.

Measurement of PT, APTT, and Fibrinogen by Automatic Coagulation Analyzer, Sysmex CA-540

  • 1Department of Clinical Pathology, Pundang Jesaeng General Hospital, Sungnam, Korea.


BACKGROUND: We evaluated the CA-540, an automatic coagulation analyzer, with respect to its precision, sensitivity and comparability with another coagulation analyzer, the MCA 210.
The precision of the CA-540 was evaluated with Ci-Trol 1, 2 (Dade Behring Marburg GmbH, Germany) and pooled normal plasma for 20 days. The normal reference ranges of PT, APTT, fibrinogen were obtained. The results of CA-540 were compared with those of MCA 210 (Bio/Data Co., USA). Sensitivity to factor VIII and VII deficiency and in vitro sensitivity to heparin were analyzed.
Within-run precision of PT, APTT, fibrinogen ranged from 0.39% to 3.34% by coefficients of variation (CV). Total precision (CV) was in the range of 1.50% to 5.79% for PT, APTT and 5.25% to 8.79% for fibrinogen. The normal reference ranges for PT, APTT and fibrinogen were 9.3-12.4 seconds, 23.9-38.0 seconds and 176.7-399.4 mg/dL respectively. INR results showed good correlation (y=1.05x-0.0042, R2=0.894) between the results from CA-540 and MCA 210. PT and APTT tests were able to detect plasmas that have less than 50% of factor VII activity and less than 40% of factor VIII activity, respectively. The therapeutic APTT range for heparin therapy was determined as 42.7 to 99.7 seconds.
The precision and sensitivity of CA-540 and correlation results of INR between CA-540 and MCA 210 were acceptable. We concluded that CA-540 would be a useful analyzer for routine coagulation test in a small to medium sized laboratory.

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