The Performance Verification of vWF∶Ag Domestic Kit
Objective To evaluate the detection performance of domestic vWF∶Ag(latex immunoturbidimetry)kit on imported coagulation detection system.Methods From April to July,2023,serum samples of 157 inpatients and 40 apparently healthy individuals were collected from Beijing Friendship Hospital Xicheng Campus to evaluate the precision and correctness of the vWF∶Ag domestic reagent.The results between domestic reagents and imported reagents were compared,and the correlation and bias between them were calculated.The anti-interference performance of the domestic kit against interfering substances(direct bilirubin,indirect bilirubin,hemoglobin,and fat emulsion)was also verified.Results The intra-assay precision CV,inter-assay precision CV and total precision CV of the three quality control concentrations of high-,medium-and low-domestic vWF∶Ag reagents were below 10％.The bias of the two levels of correctness were-2.0％and 3.3％,and both were＜±10％.The correlation coefficient of the linear range was greater than 0.995,while the deviation was＜±15％,and the linear range of the validation was 10％-253％.The reference range for people with blood type O was 47.8％-138.5％,and the reference range for people with non-blood type O was 76.5％-163.0％,which passed the validation test.The interfering substance bilirubin was ≤40mg/dL,hemoglobin was≤150mg/dL,fat emulsion was ≤600mg/dL,while the recovery rate was between 90％and 110％,and the relative deviation was＜±10％,which all met reagent requirements.Conclusion On the detection system of Werfen automatic coagulation analyzer ACL TOP500,the domestic vWF∶Ag(latex immunoturbidimetry)kit shows a good performance,which can meet the quality requirements of both laboratory testing and clinical testing.
vWF∶AgDomestic in vitro diagnostic reagentsPerformance verification
NETL
NSTL
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