Related Experiment Video
Updated: Jun 2, 2026
Dried Blood Spots - Preparing and Processing for Use in Immunoassays and in Molecular Techniques
Published on: March 13, 2015
[Comparison of four domestic quantity assay reagents for detecting the weak-reactive results of HBsAg]
Ling-Li Jiang1, Hui-Ying Chen, Yan-Qun Xiao
1Shanghai Centre for Clinical Laboratory, Shanghai 200126, China.
Insights
This study compared four domestic hepatitis B surface antigen (HBsAg) assay reagents against the ARCHITECTi2000 immunoassay system. Domestic reagents showed lower sensitivity, particularly for weak-reactive samples, but higher agreement for samples with higher HBsAg concentrations.
Area of Science:
- Clinical Chemistry
- Immunoassay Technology
- Hepatitis B Diagnostics
Context:
- The ARCHITECTi2000 immunoassay system is a widely used platform for various diagnostic tests.
- Evaluating the performance of domestic diagnostic reagents is crucial for healthcare accessibility and cost-effectiveness.
- Hepatitis B surface antigen (HBsAg) testing is a primary method for diagnosing Hepatitis B virus infection.
Purpose:
- To assess the coincidence and correlation between four domestic HBsAg quantitative assay reagents and the ARCHITECTi2000 immunoassay system.
- To analyze the precision and agreement of these assays across different concentration levels of HBsAg.
- To compare the analytical sensitivity of domestic reagents with a commercial benchmark system.
Summary:
- 185 weak-reactive serum samples and standards were tested. Coincidence rates varied significantly, with domestic assays showing lower agreement (18.52%-51.85%) for low concentrations (0.05-1.00 IU/ml) compared to the ARCHITECTi2000.
- For higher concentrations (>1.00-10.00 IU/ml), coincidence rates improved for domestic assays (69.47%-95.42%).
- Domestic assays demonstrated lower analytical sensitivity than the ARCHITECTi2000, with notable discrepancies for samples below 0.80 IU/ml, while samples above 7.93 IU/ml showed high consistency.
Impact:
- Domestic HBsAg assay reagents exhibit performance limitations, especially in detecting low-level reactivity, compared to the ARCHITECTi2000 system.
- These findings highlight the need for further development of domestic reagents to enhance sensitivity and consistency across all clinically relevant concentration ranges.
- The study provides valuable data for laboratories considering the adoption of domestic HBsAg testing solutions, informing decisions based on performance characteristics and intended use.
Abstract:
To evalue the coincidence and correlation between the four domestic quantity assay reagents and with ARCHITECTi2000 immunoassay system. 185 weak-reactive serum samples and standard materials of different concentrations were tested by four domestic quantity assay reagents for HBsAg test and ARCHITECTi2000 immunoassay system. The coincidence, the precision and the correlations between different systems were analyzed. The coincidence rates of the results of 0.05-1.00 IU/ml samples between the four domestic quantity assay reagents and ARCHITECTi2000 immunoassay system were 25.93%, 35.19%, 51.85% and 18.52% respectively, and for those results of more than 1.00 to 10.00 IU/ml samples the coincidence rates were 71.76%, 87.79%, 95.42% and 69.47% respectively. The samples of 0.05 to 0.80 IU/ml weak-reactive serum samples detected by the i2000 system were all negative detected by the four domestic systems. The coincidence rates of more than 7.93 IU/ml serum samples detected by i2000 system were 100% detected by the four domestic systems. The correlations of the four domestic quantity assays were around 0.8629 to 0.9265. The analysis sensitivity of the four domestic quantity assay reagents were below the i2000 system. The results of under 0.80 IU/ml samples detected by i2000 system were disaccord with the results detected by the four domestic systems, whereas for the sapmples over 7.93 IU/ml the results were consistent.
