[Results of the participation of 360 laboratories of Russia in the external quality assessment program for HBsAG tests].
During their first participation in the external quality assessment program (EQAP), 78-81% of the laboratories detect positive samples of control panels containing 0.125 IU/ml of HBsAg; 95-97% of them identify negative samples of the control panels. The high efficiency of EQAP was established when the results of the same laboratories that had participated in two cycles were compared. For correct detection of positive samples of the control panel, it is necessary to use disposable containers and tips for example for solutions of conjugate concentrate, tetramethylbenzidine, buffer for conjugate dilution, and citrate-phosphate solution. The ranges of 95% confidence interval were established for the individual values of CV values of the commercial preparation ILC-HBsAg in the laboratories: from 0 to 11.3% with estimated convergence and from 0 to 14.2% with estimated reproducibility. In making an intralaboratory control of the quality of HBsAg test using ILC-HBsAg, one should be guided by the test accuracy indices given in the application sheet.
Netesova
I G
IG
Iaroslavtseva
O A
OA
Tsoĭ
L V
LV
Zhukov
V A
VA
Netesov
S V
SV
D019411:Clinical Laboratory Techniques / Q000592:standards; D006505:Hepatitis / Q000097:blood* / Q000175:diagnosis; D018963:Hepatitis Antigens / Q000097:blood*; D006801:Humans; D009313:National Health Programs; D011785:Quality Assurance, Health Care; D015203:Reproducibility of Results
D018963:Hepatitis Antigens