J Clin Pathol Qual Control.  2001 Dec;23(2):253-258.

Laboratory Evaluation of Automated Coagulation Analyzers Sysmex CA-1500(TM) and CA-7000(TM)

• Lee YW
• Chang CW
• Lim MS
• Lim BJ
• Lee YK

Abstract

BACKGROUND: Currently, many types of coagulation analyzers and reagents for measurement of prothrombin time (PT) and activated partial thromboplastin time (aPTT) have been developed and used. Remarkable differences of laboratory results in different analyzers can be diminished by continuous management of quality assurance based on optimal application of analyzer in clinical setting. CA-1500(TM) (Sysmex Corporation, Japan) and CA-7000(TM) (Sysmex Corporation, Japan) are newly developed, fully automated coagulation analyzers enabling simultaneously multi-parameter random assay for coagulation, chromogenic substrate method, and turbidimetric immunoassay. We evaluated the analytical performances and usefulness of these analyzers.
METHODS
Thromborel(R) S (Lot No. 505538, ISI 0.99, Dade Behring Corporation GmbH, Germany) and Actin(R) FS (Lot No. 527224, Dade Behring Corporation GmbH, Germany) were used for measurement of PT and aPTT, respectively. We evaluated the precisions of PT and aPTT using pooled normal plasma, Ci-Trol(R) Level 1 (Lot No. 528146, Dade Behring Corporation GmbH, Germany) and Ci-Trol(R) Level 2 (Lot No. 528222, Dade Behring Corporation GmbH, Germany). Comparison study was performed by comparing the results of CA-1500(TM) with those of CA-7000(TM). Detection limits of PT and aPTT for various coagulation factor deficiencies and heparin sensitivities of aPTT were investigated.
RESULTS
The coefficients of variation of both within-run and total precision for CA-1500(TM) and CA-7000(TM) were below 5% except for total precision of PT using Ci-Trol(R) Level 2. The comparison study indicated good correlation between results of CA-1500(TM) and those of CA-7000(TM). With CA-1500(TM), the detection limit of PT for factor VII deficiency was 38% and those of aPTT for factor VIII, factor IX deficiency were 32% and 42%, respectively. The sensitivity of aPTT for heparin showed similar results in both analyzers.
CONCLUSIONS
We concluded that CA-1500(TM) and CA-7000(TM) offered excellent performances and provided high throughput for routine coagulation tests. Therefore, both analyzers are expected to contribute significantly to increasing efficiency in clinical laboratories.

MeSH Terms

Blood Coagulation Factors
Factor VII Deficiency
Factor VIII
Hemophilia B
Heparin
Immunoassay
Indicators and Reagents
Limit of Detection
Partial Thromboplastin Time
Plasma
Prothrombin Time
Blood Coagulation Factors
Factor VIII
Heparin
Indicators and Reagents