[Comparison of homemade and imported HbsAg ELISA kits on screening blood samples].
BACKGROUND
To evaluate homemade and imported HbsAg ELISA kits on screening blood donors.


METHODS
Samples for evaluation included 120 HbsAg serum plates for the golden criteria and 400 sets of serum from blood donors in Dongguan. The samples underwent blind screening with homemade and imported ELISA kits respectively.


RESULTS
The sensitivity of homemade (Xinchuang) and imported (Diasorin) HbsAg ELISA kit were 85.71% (72/84) and 100% (84/84), respectively. Their specificity was 100% (436/436) and 96.55% (421/436) respectively. The consistency of two ELISA kits was 100%.


CONCLUSIONS
The imported ELISA kit had the highest sensitivity, but its specificity was not as good as that of homemade ELISA kit. The two kinds of ELISA kits had good repetition. The combination of the two reagents may ensure the safety of blood transfusion.
Liu
Fu-ping
FP
Dongguan Blood Center, Dongguan 523930, China.
Liu
Jing-chun
JC
Wang
De-wen
DW
D001782:Blood Donors; D002681:China; D004797:Enzyme-Linked Immunosorbent Assay / Q000295:instrumentation / Q000379:methods / Q000592:standards; D006509:Hepatitis B / Q000097:blood / Q000175:diagnosis / Q000517:prevention & control; D006514:Hepatitis B Surface Antigens / Q000097:blood*; D006801:Humans; D008403:Mass Screening / Q000379:methods / Q000592:standards; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D006514:Hepatitis B Surface Antigens; D011933:Reagent Kits, Diagnostic