Analysis of the results of hepatitis B enzyme immunoassay-positive and nucleic acid negative blood donors in Zhejiang province
10.3760/cma.j.cn112866-20221130-00244
- VernacularTitle:浙江省乙肝酶免阳性核酸阴性献血者结果分析
- Author:
Min WANG
1
;
Fangjun FENG
;
Yiqin HU
;
Jihong HUANG
;
Danxiao WU
Author Information
1. 浙江省血液中心，杭州 310052
- Keywords:
Unpaid blood donors;
HBsAg;
HBV DNA;
Blood donor screening
- From:
Chinese Journal of Experimental and Clinical Virology
2023;37(4):429-434
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the situation of hepatitis B enzyme immunoassay-positive but nucleic acid negative infection (HBsAg ELISA(+ )/HBV-DNA(-)) among unpaid blood donors in Zhejiang Blood Center, and to explore the causes of inconsistency between enzyme immunoassay and nucleic acid result.Methods:A single nucleic acid test was performed on blood donors whose routine blood screening result were HBsAg-ELISA(+ )/HBV-DNA(-), and the test result of such blood donors were analyzed.Results:A total of 205 HBsAg-ELISA(+ )/HBV-DNA(-) samples were screened from 114017 blood donors from May to November, 2022. The proportion of male blood donors (0.14%) were significantly lower than that of the female blood donors (0.24%)( χ2= 14.761, P<0.005); the proportion of the first blood donor (0.32%) was significantly higher than that of the second blood donor (0.09%) ( χ2 = 78.781, P<0.005); the difference between different education levels is statistically significant ( χ2 =47.753, P<0.005). After single-person nucleic acid re-detection, the re-detection rate of nucleic acid in ELISA double-reagent positive samples was higher than that in single-reagent positive samples ( χ2=94.378, P<0.005); there was no significant difference between ELISA reagent 1 and reagent 2 in the detection rate of nucleic acid ( χ2 =0.163, P>0.005). There was no significant difference in the positive rate of secondary nucleic acid detection between the two nucleic acid detection systems ( χ2=0.626, P>0.005). Serological supplementary test showed that 11 HBV-DNA(+ ) samples showed two serological combination patterns after chemiluminescence detection, namely HBsAg(+ )/HBeAb(+ ) and HBeAb(+ ), most of which were HBsAg(+ )/HBeAb (+ ), a total of 10 cases, accounting for 90.91%, and only one case was HBeAb (+ ), accounting for 9.09%. The quantitative result of HBsAg showed that most of them were at low HBsAg level. Conclusions:After re-detection by single nucleic acid detection method, HBsAg-ELISA(+ )/HBV-DNA(-) samples of blood donors do have a certain proportion of HBV-DNA(+ ), but most of the samples were still HBV-DNA (-), additional experiments on HBV serological markers and HBV-DNA are needed to determine their true infection status and clarify the reasons for the inconsistency between enzyme immunoassay and nucleic acid test result. In addition, nucleic acid and HBsAg detection reagents with high sensitivity and specificity should be selected as far as possible in blood donor screening to ensure the accuracy of result.
