Establishment of neutralizing antibody detection method for SARS-CoV-2 Omicron XBB.1.5
10.13200/j.cnki.cjb.004322
- VernacularTitle:新型冠状病毒Omicron XBB.1.5中和抗体检测方法的建立
- Author:
DAI Hang
- Publication Type:Journal Article
- Keywords:
SARS-CoV-2;
Omicron variant;
Neutralizing antibody;
Analysis Quality by Design(AQbD);
Whole life cycle
- From:
Chinese Journal of Biologicals
2024;37(10):1225-1229+1238
- CountryChina
- Language:Chinese
-
Abstract:
Objective According to the latest global Analysis Quality by Design(AQbD) and whole life cycle concept, a neutralizing antibody detection method for clinical and epidemiological investigations of the SARS-CoV-2 Omicron XBB.1.5.Methods Based on the established neutralizing antibody detection method(CPE method) of SARS-CoV-2 prototype strain, a risk assessment was conducted for the potential impact factors introduced by changes in the XBB.1.5 on the neutralizing antibody detection method. The main risk factors were conditionally optimized to obtain the detection method adapted to the XBB.1.5. The method was validated for the various performance indicators and demonstrated to meet the pre-set Analysis Target Profile(ATP)by method validation.Results The main risk factors introduced by the XBB.1.5 change were the cells,culture media, and the time for result determination. Through optimization of the experimental conditions, the best detection conditions for XBB.1.5 were ultimately determined to be observation on the 5th day, using Vero-E6 cells in DMEM culture medium. It was verified that the method had a relative accuracy and intermediate precision of average relative bias of-9. 2%to 2. 9%, and a GCV of 33. 2% to 47. 1%, which met the requirements of ATP. Meanwhile the misjudgment rate of the method was less than 1. 6%.Conclusion Based on the AQbD and whole life cycle research concept, a neutralizing antibody detection method for the SARS-CoV-2 XBB.1.5 variant has been established, which was verified to meet the original ATP,and can be used for neutralizing antibody detection in clinical and epidemiological investigations.
