[Evaluation on the analytical sensitivity of 31 HBsAg enzyme immunoassay kits].
OBJECTIVE
To study the analytical sensitivity on 31 HBsAg enzyme immunoassy (EIA) test kits.


METHODS
Thirty one HBsAg EIA kits produced by domestic or overseas manufactories and applied for approval during May 2007 to May 2008, were evaluated using the national reference panels. The hyperbolic curve of the log A value and log concentration for the national sensitivity standards was established. The cut-off value of each kit was substituted into the curvilinear equation to determine the analytical sensitivity which was compared between different HBsAg EIA kits.


RESULTS
Twenty seven (351 lots) domestic and 4 (27 lots) overseas kits were compared. Among 378 lots of the 31 HBsAg EIA kits, only 2 lots of the domestic kits had a lower sensitivity when tested with the national HBsAg reference panels, with an average approvalr ate of 99.43% (349/351). The mean analytical sensitivity of the domestic kits for adr, adw, ay serotypes were 0.307, 0.419, 0.513 ng/ml, respectively. There was a significant difference between serotypes (F = 97.30, P < 0.01). The mean analytical sensitivity of the overseas kits for adr, adw, ay serotypes were 0.054, 0.066, 0.050 ng/ml respectively, with no significant difference between serotypes (F = 0.65, P > 0.05). The analytical sensitivity of the overseas kits for all the three serotypes was higher than that of the domestic kits (P < 0.01). There was no significant difference found between the analytical sensitivities of the kits produced by the same manufactory using 30- or 60-minute incubation of detection (P > 0.05). In contrast, there was significant difference noticed between the analytical sensitivities of the kits produced by the same manufactory when tested for 10 or 15-minute coloration of the results (P < 0.01).


CONCLUSIONS
Analytical sensitivity of the HBsAg EIA domestic kits should be further improved, especially for detecting adw and ay serotypes.
Gu
Wen-Jie
WJ
National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China.
Huang
Wei-Jin
WJ
Zhou
Cheng
C
Wu
Xing
X
Lan
Hai-Yun
HY
Yao
Xin
X
Lin
Jing-Xiang
JX
Li
He-Min
HM
Liang
Zheng-Lun
ZL
Zhuang
Hui
H
D006514:Hepatitis B Surface Antigens / Q000145:classification / Q000302:isolation & purification*; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods*; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012016:Reference Values; D012680:Sensitivity and Specificity; D012703:Serotyping
D006514:Hepatitis B Surface Antigens; D011933:Reagent Kits, Diagnostic