Development and evaluation of a differential diagnostic test strip for antibodies induced by HIV-1 vaccine and natural infections

Zuowei YUAN; Yonghong WANG; Jun HUANG; Yangmin YE

doi:10.16016/j.1000-5404.201811017

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Development and evaluation of a differential diagnostic test strip for antibodies induced by HIV-1 vaccine and natural infections

Basic Medicine | 更新时间：2026-01-09

- Development and evaluation of a differential diagnostic test strip for antibodies induced by HIV-1 vaccine and natural infections
- Journal of Third Military Medical University Vol. 41, Issue 7, Pages: 678-683(2019)
- 作者机构：
  
  1.409099 重庆，重庆市黔江中心医院：检验科
  2.409099 重庆，重庆市黔江中心医院：输血科
- 作者简介：
- 基金信息：
  
  the Joint Medical Research Project of Science and Technology Committee and Health and Family Planning Commission of Chongqing(2018QNXM002);the Science and Technology Committee of Qanjiang District of Chongqing(黔科计2018004)
- DOI：10.16016/j.1000-5404.201811017
  CLC： R446.11;R447;R512.91
- Received：04 November 2018，
  
  Revised：2019-01-29，
  
  Published：15 April 2019
- 稿件说明：
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Zuowei YUAN, Yonghong WANG, Jun HUANG, et al. Development and evaluation of a differential diagnostic test strip for antibodies induced by HIV-1 vaccine and natural infections[J]. Journal of Third Military Medical University, 2019, 41(7): 678-683.
DOI：

Zuowei YUAN, Yonghong WANG, Jun HUANG, et al. Development and evaluation of a differential diagnostic test strip for antibodies induced by HIV-1 vaccine and natural infections[J]. Journal of Third Military Medical University, 2019, 41(7): 678-683. DOI： 10.16016/j.1000-5404.201811017.

摘要

目的

研制区分HIV-1自然感染与HIV-1疫苗诱导产生抗体的鉴别诊断试纸条，并对其诊断性能进行评价。

方法

将前期利用原核表达获取的HIV-1包膜蛋白gp41和鉴别融合肽段SK1-SK2-SK3分别包被NC膜，结合胶体金标记抗人蛋白A，研制新型HIV-1抗体鉴别诊断试纸条；采用新型试纸条检测评价HIV-1阳性血清、HIV阴性血清、HIV血清盘、HIV天坛疫苗血清及其他交叉反应血清，并与ELISA结果进行对比。

结果

成功研制了HIV-1疫苗诱导与自然感染产生抗体的鉴别诊断试纸条，SK1-SK2-SK3检测灵敏度为93.5%，检测特异性为100.0%，联合gp41后的HIV-1检出灵敏度可达100.0%；试纸条检测结果与ELISA检测结果一致(

0.05)；采用该试纸条检测天坛疫苗血清，SK1-SK2-SK3检测带均为阴性，避免了gp41条带检出的假阳性结果。

结论

该新型HIV-1抗体诊断试纸条能够有效区分HIV-1自然感染与HIV-1疫苗接种后产生的抗体，避免目前市售试剂盒的假阳性诊断。

Abstract

Objective

To develop a differential diagnostic kit for distinguishing antibodies induced by HIV-1 infection and HIV-1 vaccine and evaluate its diagnostic performance.

Methods

Nitrocellulose membrane was coated with HIV-1 envelope protein gp41 and HIV-1 recognition fusion peptide SK1-SK2-SK3 obtained using a prokaryotic expression system. The differential diagnostic test strip for HIV-1 antibodies was prepared by assembling the coated membrane with a non-woven fabric coated with protein A-coupled colloidal gold. The performance of the test strip was evaluated using samples of HIV-positive sera

HIV-negative sera

HIV serum panel

HIV Tiantan vaccine sera and other cross-reactive sera

and the test results using this strip were compared with those by ELISA.

Results

The sensitivity of SK1-SK2-SK3 coating on the novel differential diagnostic test strip for HIV-1 antibody detection was 93.5%

with a detection specificity of 100.0%. When combined with gp41 coating

the test strip showed a diagnostic sensitivity of 100.0%. The test results with the strip were consistent with those by ELISA (

0.05). For the Tiantan vaccine serum

the SK1-SK2-SK3 coating on the strip all yielded negative results without the false positive results of the gp41 coating.

Conclusion

This novel HIV-1 antibody diagnostic test strip can effectively distinguish the antibodies produced by HIV-1 infection from those generated by HIV-1 vaccination without false positive results as are common with the currently available commercial HIV test kits.

关键词

Keywords

references

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