Wang Zeng-qiang, Zhang Gui-yun, Jiang Yan, Zhang Hui, Jiang Hua-zhou, Shen Sheng, Pan Pin-liang, Liu Bo, Qiu Mao-feng
National AIDS Reference Laboratory, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing 102206, China.
Zhonghua Yu Fang Yi Xue Za Zhi. 2011 May;45(5):430-4.
This study was to compare the performance of three HIV antibody confirmatory assay kits in confirming early HIV infection.
Five HIV antibody-positive plasma specimens were ten-fold serially diluted and then detected by ELISA. The above diluted specimens were detected with the following three HIV antibody confirmatory assay kits to analyze their sensitivity, including Wantai-RIBA (Recombinant immunoblot assay, Beijing Wantai Biological Pharmacy, China), MP-WB (HIV Blot 2.2 WB, MP Biomedicals Asia Pacific Pte. Ltd., Singapore) and INNO-LIA (INNO-LIA(TM) HIV I/II Score, Innogenetics N.V., Belgium), respectively. These kits were further used to detect 48 ELISA-reactive specimens from 11 sets of HIV seroconversion specimens (a total of 48 samples) which were previously detected as HIV antibody-positive by ELISA.
When 5 samples were diluted to 100 fold, Wantai-RIBA still can detect them positive. Among the 48 HIV antibody-positive specimens detected with ELISA, the confirmation positive rate for Wantai-RIBA, MP-WB and INNO-LIA were 97.92% (47/48), 81.25% (39/48) and 91.67% (44/48), respectively. There was statistically significant difference between the confirmatory results of Wantai-RIBA and MP-WB (χ(2) = 6.13, P < 0.05), as well as between those of INNO-LIA and MP-WB (χ(2) = 5.48, P < 0.05); however, there was no statistically significant difference between those of Wantai-RIBA and INNO-LIA (χ(2) = 1.33, P > 0.05). For other six HIV seroconversion panels containing indeterminate specimens, the average seroconversion period of time for Wantai-RIBA, MP-WB and INNO-LIA were 0.7, 13.3 and 3.7 days, respectively.
Compared with MP-WB, Wantai-RIBA and INNO-LIA could reduce the window period to confirm early HIV infection.
本研究旨在比较三种HIV抗体确证检测试剂盒在确认早期HIV感染方面的性能。
将5份HIV抗体阳性血浆标本进行10倍系列稀释,然后用酶联免疫吸附测定(ELISA)法检测。用以下三种HIV抗体确证检测试剂盒对上述稀释标本进行检测,以分析其敏感性,这三种试剂盒分别为万泰重组免疫印迹法(Recombinant immunoblot assay,北京万泰生物药业股份有限公司,中国)、MP生物亚太私人有限公司的MP-WB(HIV Blot 2.2 WB)和比利时英诺基因公司的INNO-LIA(INNO-LIA™ HIV I/II Score)。这些试剂盒进一步用于检测11组HIV血清转化标本(共48份样本)中48份ELISA反应性标本,这些标本之前经ELISA检测为HIV抗体阳性。
当5份样本稀释至100倍时,万泰重组免疫印迹法仍能检测出它们呈阳性。在48份经ELISA检测为HIV抗体阳性的标本中,万泰重组免疫印迹法、MP-WB和INNO-LIA的确证阳性率分别为97.92%(47/48)、81.25%(39/48)和91.67%(44/48)。万泰重组免疫印迹法与MP-WB的确证结果之间存在统计学显著差异(χ(2)=6.13,P<0.05),INNO-LIA与MP-WB的确证结果之间也存在统计学显著差异(χ(2)=5.48,P<0.05);然而,万泰重组免疫印迹法与INNO-LIA的确证结果之间无统计学显著差异(χ(2)=1.33,P>0.05)。对于其他六组包含不确定标本的HIV血清转化样本,万泰重组免疫印迹法、MP-WB和INNO-LIA的平均血清转化时间分别为0.7天、13.3天和3.7天。
与MP-WB相比,万泰重组免疫印迹法和INNO-LIA可以缩短确认早期HIV感染的窗口期。