Related Experiment Video
Updated: May 5, 2026
Development of a Lateral Flow Immunochromatographic Strip for Rapid and Quantitative Detection of Small Molecule Compounds
Published on: November 13, 2021
[Comparison of ELISA diagnostic kits used in China for hepatitis C virus IgG antibody detection]
Qing-Ling Meng1, Jian Lu, Feng Qiu
1Institute for Viral Disease Control and Prevention, China CDC, Beijing 102206, China.
Insights
Commercial diagnostic reagents for hepatitis C virus (HCV) IgG antibody detection in China show high conformity rates, with reagent D demonstrating the best performance. This evaluation aids in HCV prevention strategies.
Area of Science:
- Medical Diagnostics
- Virology
- Public Health
Background:
- Hepatitis C virus (HCV) infection is a significant global health concern.
- Accurate and reliable diagnostic tools are crucial for effective HCV prevention and control programs.
- Commercial diagnostic reagents play a vital role in widespread HCV screening.
Purpose of the Study:
- To evaluate and compare the performance of commercially available hepatitis C virus (HCV) IgG antibody detection reagents in China.
- To provide data to inform the selection of reliable diagnostic tools for HCV prevention efforts.
- To assess the conformity and accuracy of different commercial kits against a gold standard.
Main Methods:
- Six commercial HCV-IgG antibody detection reagents (Enterprises A-F) were selected for evaluation.
- A total of 160 serum samples, including 88 positive and 72 negative for HCV, were tested.
- ABBOTT's HCV-IgG reagent was used as the gold standard, with RIBA method for gray zone samples.
Main Results:
- Total conformity rates across the six reagents ranged from 88.13% to 98.13% when compared to the gold standard.
- Youden indexes varied from 0.74 to 0.96, indicating good diagnostic accuracy for most reagents.
- Reagent D exhibited the highest conformity (98.13%) and the highest Youden index (0.96).
Conclusions:
- Commercial HCV-IgG antibody detection reagents available in China demonstrate high overall conformity, exceeding 88% compared to the ABBOTT gold standard.
- While generally reliable, variations in performance were noted, particularly concerning the detection of negative samples for some reagents.
- The findings support the use of these reagents for HCV screening but highlight the need for careful selection based on performance data for optimal HCV prevention.
Objective:
To compare the commercial diagnostic reagent available in China for hepatitis C virus ( HCV) IgG antibody detection in order to provide some useful information for HCV prevention.
Methods:
The HCV-IgG detection reagents produced by six different Enterprises named A, B, C, D, E and F were chosen and applied to detect 160 HCV specious sera samples. HCV-IgG reagent from ABBOTT was adopted as gold-standard and the samples in gray zone were determined by RIBA method finally.
Results:
160 sera samples comprised 88 positive samples and 72 negative samples. The total conformity ranged from 88.13% to 98.13% and the Youden indexes ranged from 0.74 to 0.96 when the reagents from six different Enterprises were compared with gold-standard. The highest conformity was 98.13%, observed in D reagent with the highest Youden index of 0.96.
Conclusion:
The total conformity rates were more than 88% when the HCV-IgG antibody detection reagents from six different Enterprises were compared with ABBOTT reagent. It was highly conformable. However, some reagent proved to be less conformable in negative samples detection.
