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Objective: To Screen an EIA kit that fits best for using in serological detection of anti-HBs in the national investigation of hepatitis B virus infection., Methods: Top 5 kinds of kits on the best seller list of China-made anti-HBs EIA detection kits were selected and each was detected the anti-HBs panel(44 positive and 108 negative) 5 times. The s/n ratio of each test was recorded and transformed by log(s/n+1). ICC and CV, the reliability indices and AUC, pAUC and Se(FPR=e), the validity indices were calculated and compared between each kit., Results: The indices of ICC and CV of the 5 kinds of kits arranged in the same order of D, E, B, C and A, from the best to the worst and the differences between them were significantly important (Bootstrap method, P < 0.05), except for between E and B in the index of CV; the AUCs ranged from 0.980 to 0.993 and pAUCs did not differ with each other, except with kit A, the lowest one. Kit E had the highest sensitivity which was higher than kits B, C and D when the specificity was fixed at 0.97, and the later kits were higher than kit A(Bootstrap method, P < 0.05)., Conclusion: All the 5 kits are excellent and have synthetically considered the reliability and validity indicators and its function, kit D is the best.

Objective: To establish HBV marker panels., Methods: 155 blood plasma specimens were selected and each was detected twice for 5 HBV markers with MEIA kits made by Abbott. Any plasma that had 2 positive or negative results were enrolled in the HBV marker panels and others were excluded., Results: 153 plasma were enrolled in the HBsAg panel and 154 were enrolled in anti-HBs, anti-HBc and anti-HBe panels respectively. Panel of HBeAg was not established because that there were only 4 positives., Conclusion: HBV marker panels can be established by screening enough blood plasma specimens with high accurate kits for more than one time. The panels should be used in a limited extension to avoid unnecessary mistakes.

Objective: The aim of this study is to select a better one from five EIA kits made in China for the serological detection of anti-HBe in a national hepatitis B survey., Methods: Top 5 kinds of kits on the best seller list of China-made anti-HBe EIA detection were selected and each was detected the anti-HBe panel (66 positive and 88 negative) 5 times. The co/s ratio of each test was recorded and transformed by log(co/s+1). ICC and CV, the reliability indices and AUC, pAUC and Se(PR=e), the validity indices were calculated and compared between every two kits., Results: The indices of ICC and CV of the 5 kinds of kits arranged in the same order of A, E, C, D and B, from the best to the worst. For ICC, there were significantly different between every two of them (Bootstrap method, P < 0.05), except for between kit C and E. The magnitude ofAUCs were from 0.969 to 0.996; the orders of pAUC and Se(FPR=e) indices was C, E, D, A, B, and C, D, E, B, A respectively; both the indices of kit C were significantly higher than others (Bootstrap method, P < 0.05)., Conclusion: All the 5 kinds of kits are excellent and kit C is the best.

Unlabelled: OBJECTIVE To Screen best EIA kit that fits best for using in serological detection of HBsAg in the national investigation of hepatitis B virus infection., Methods: Top 5 kinds of kits on the best seller list of China-made HBsAg EIA detection reagents were selected and each was detected the HBsAg panel (63 positive and 90 negative) 5 times. The s/n ratio of each test was recorded and transformed by log (s/n+1). Reliability indices ICC and CV, and validity indices AUC, pAUC and Se(FPR-e) were calculated and compared between each of the kits., Results: The indices of ICC and CV of the 5 kits arranged in the same order of E, C, D, B and A, from the best to the worst, and the differences between them were significantly important (Bootstrap method, P < 0.05); The AUCs ranged from 0.965 to 0.987, and for kits E and B which had the biggest pAUCs, differs significantly from kits A and D (Bootstrap method, P < 0.05). Kit E had the highest Se(FPR-e) which was significantly bigger than kit B (Bootstrap method, P < 0.05)., Conclusion: The 5 kinds of kits are all excellent and kit E is the best.

Objective: To Screen an EIA kit that fits best for using in serological detection of anti-HBc in the national investigation of hepatitis B virus infection., Methods: Top 5 kinds of kits on the best seller list of China-made anti-HBc EIA kit were selected and each detect the anti-HBc panel (95 positive and 57 negative) 5 times. The co/s ratio of each test was recorded and transformed by Ig(co/s+1). Reliability indices ICC and CV, and validity indices AUC, pAUC and Se(FPR=e) were calculated and compared between each kit., Results: The indices of ICC and CV of the 5 kinds of kits arranged in the same order of A, B, D, C and E, from the best to the worst. And the differences between them were significantly important (Bootstrap method, P < 0.05), except for between kits B and D in CV index; The AUCs ranged from 0.991 to 0.997; For index pAUCs, differences were significant between kits B, D, C ,which had the biggest values, kits A and E which had the lowest ones. For index Se(FPR=e), significant differences were only seen between kits B and A, and B and E (Bootstrap method, P < 0.05)., Conclusion: The diagnostic ability of all the 5 kinds of kits arrange in an order of B, C, D, A and E, from the best to the worst.

Objective: To observe the immunological effects of three doses of H2 strain live attenuated hepatitis A vaccine 8 years after the administration and to compare with that of one dose of the vaccine., Methods: In a country area, 110 children of 1 to 7 years old susceptible to HAV were screened and administered with one dose of the vaccine, as group B; Group A were 42 children from one of the villages and administered with 3 doses of the vaccine according to 0, 2, 6 month schedule. Blood samples were taken for the children 1, 2, 6, 7, 8, 12, 24, 36 and 96 months after the administrations respectively and detected for anti-HAV antibody., Results: For group B, the sero conversion rate of anti-HAV and GMC reached peak at 92.2% and 126.2 mIU/ml respectively, and then, began to drop with time; For group A, after 2 dose of the vaccine, the sero-conversion rate reached 100%, and the GMC reached peak of 2 739 mIU/ml one month after the third dose at 7 months. So that, group A has a better short-term immunological effects than that of group B. During 36 through 96 months, the anti-HAV positive rate in group B was 75%-71% and 80-89 mIU/ml respectively, and comparatively in group A were 100% and 918.2-480.6 mIU/ml respectively. The differences between group A and B were significantly important., Conclusion: A 3-dose schedule administration of H2 strain live attenuated hepatitis A vaccine has better immunological effects than 1-dose schedule in 8years and further observations are needed.

Objective: To determine the "alpha"dominant mutation of hepatitis B virus (HBV) in community-based Zhengding. Analysis the role of the newborn hepatitis B vaccination on the mutation., Methods: Based on the national surveillance of hepatitis B, 11,478 people's sera were collected and tested by SPRIA with kits. Collect people's sera with positive HBsAg and amplify the S gene. Sequencing and clastwaling them with the standard sequences., Results: Overall, HBV DNA was successfully amplified and sequenced in 434 of 443 samples. 6.7% samples mutated in HBV "alpha" dominant region. The difference between the mutation ratio of the two loops of HBV "alpha" dominant between the people born before and after the year 1986 has no significance., Conclusion: There were HBV "alpha" dominant mutant virus in the local area with a low infection rate in the population born after the year 1986. It could not explain the newborn hepatitis B vaccination can induce the prevalence of the "alpha" dominant mutate HBV.

Objective: Study the risk factors that impact the effectiveness of mass hepatitis B vaccination, and try to amend them in the future., Method: Based on the national surveillance of hepatitis B, all the 1734 of 1-15 years old children from Hebei Province were enrolled in the present study and they were divided into case and control group according to their sera HBsAg were positive or not., Results: Mother sera HBsAg positive and the hospital the children were born and earlier year of birth were risk factors., Conclusion: The effectiveness of mass neonate hepatitis B vaccination has greatly improved and the future focus should be on finding pregnant HBsAg positive women, and encourage them to give birth in better hospitals, and at the mean time, try to make the neonate hepatitis B vaccination perfect, especially in country areas.

AIM:To understand the anti HBs persistence and the long-term preventive efficacy in rural newborns after vaccination with plasma-derived hepatitis B vaccine.METHODS:In the time of expanded program on immunization (EPI), the newborns were vaccinated with 10&mgr;gcenter dot3 doses of hepatitis B vaccine and 762 newborns who were HBsAg negative after primary immunization were selected for cohort observation from 1986 to 1998. Their serum samples were detected qualitatively and quantitatively for hepatitis B infecting markers, including HBsAg, anti-HBs and anti-HBc by SPRIA Kits. The annual HBsAg positive conversion rate was counted by life-table method.RESULTS:(1)The anti-HBs positive rate was 94.44% for the babies born to HBsAg negative mothers and 84.21% for those born to HBsAg positive mothers in the 1st year after immunization, and dropped to 51.31% and 52.50% in the 12th year respectively.GMT value was dropped from 31.62 to 3.13 and 23.99 to 3.65 in the 2nd to the 12th year respectively. There was a marked drop in GMT at the 3rd to the 5th year, and in anti HBs positive rate at the 9th to the 10th year. (2) In the period of 12 years observation, the person-year HBsAg positive conversion rates were 0.12% (5/4150.0) in newborns born to HBsAg negative mothers and 0.20% (1/508.0) in those born to HBsAg positive mothers, and none of the HBsAg positive converted children became HBsAg chronic carriers. Compared with the baseline before immunization, the protective rates were 97.19% and 95.32% respectively.CONCLUSION:The protective efficacy of plasma-derived hepatitis B vaccine persisted at least 12 years, and a booster dose seems not necessary within at least 12 years after the primary three-doses immunization to newborns born to HBsAg negative mothers.