Experimental performance evaluation by CA-1500 blood coagulation analyzer for D-dimer by immune turbidimetry

Objective To evaluate the experimental performance of CA-1500 blood coagulation analyzer for D-dimer.Methods According to series of files issued by CLSI, CA-1500 blood coagulation analyzer was applied to D-dimer test and assessed for the within-assay precision, interassay precision, correlation analysis, analytical measurement range(AMR), clinical reportable range(CRR), maximal dilution rate and etc. Low- and high-value calibrators were used to detect the precision. Totally 50 sodium citrate anticoagulation blood samples were selected randomly from the outpatients and inpatients, and then the correlation with CS-1500 blood coagulation analyzer was analyzed. CRRs were measured for the samples at normal level(L1), intermediate level(L2) and high level(L3). Interference tests were carried out with four kinds of interference plasmas of hemoglobin, bilirubin, triglyceride and cholesterol. Results The within-assay precision and interassay precision of the high-value calibrators were both less than 15%. CA-1500 blood coagulation analyzer gained high correlation with CS-1500 analyzer, with P=0.1030.01 and r=0.935. The AMR of CA-1500 blood coagulation analyzer for D-dimer was between 0 and 5 mg/L. The optimal dilution rate for CRR was 1/8, and CRR was determined between 0.03 and 40 mg/L. Interference tests proved that the influence degrees were all less than ±10%. Conclusion CA-1500 blood coagulation analyzer has its experimental performance meet the requirements of the manufacturer and series files issued by CLSI, and can provide references at precision, correlation, AMR, CRR, anti interference and etc.