![]() ![]() Q&A related to Apple hardware, software, and services. The ELISA kit can offer simplicity, speed, low cost and high throughput, making it a practical tool for monitoring the immune response following vaccination. The validation data characterize this ELISA as a suitable method for semi-quantitative measurement of VNA titers in human serum samples to assess vaccination status. The diagnostic specificity and sensitivity were 100% and 91.1%, respectively. The VNA titer cut-off value of ELISA was set at 1.5 IU/mL to ensure no false-positive. A total of 415 unknown positive human sera were double-blind tested by the RFFIT and ELISA. None of the 12 known negative human sera, tested positive by ELISA, highlighting the specificity. The inter-assay CVs were in the range of 6.60-10.79%, indicating the reproducibility. Using the HRIG reference, the LOD was found to be 0.02-0.06 IU/mL and the linear range was 0.2-10.0 IU/ mL. Multiple assays were carried out by different technicians at different laboratories for assay standardization. RABV GP for ELISA plate coating and optimal dilution of human serum sample was 1 µg/mL and 1:20, respectively. Specificity and sensitivity were established to assess the diagnostic accuracy. The limit of detection (LOD), linear range, reproducibility, and precision of the method were examined. Using a recombinant RABV GP expressed in mammalian cells as the capture antigen, the ELISA method was established using HuMAb NM57 reference initially and HRIG reference subsequently. Here, we report the development and validation of a RABV GP serology ELISA kit for semi-quantitative measurement of VNA titers in sera of vaccinated human subjects. A VNA titer of ≥ 0.5 IU/mL of sera indicates adequate response to vaccination. The measurement of VNAs to RABV is commonly used to assess the level of immunity in humans and animals after vaccination. Vaccination provides protection against infection by inducing VNAs mainly against RABV surface GP. AnyGo Technology, D1117 New China International Square, 89 Dayangfang Rd, Chaoyang District, Beijing, PR China AbMax Biotechnology Co., LTD, 99 Kechuang 14th Street, Building 18-2-201, Beijing, PR China.AnyGo Technology, D1117 New China International Square, 89 Dayangfang Rd, Chaoyang District, Beijing, PR China.New Drug R&D Center, State Key Laboratory of Antibody Research & Development, North China Pharmaceutical Corporation, 388 Heping East Road, Shijiazhuang, PR China.College of Veterinary Medicine, China Agricultural University, 2 Yuanmingyuan Xilu, Haidian District, Beijing, PR China.AbMax Biotechnology Co., LTD, 99 Kechuang 14th Street, Building 18-2-201, Beijing, PR China.Department of Emergency, The Sixth Medical Center of the General Hospital of the People's Liberation Army, Beijing 100048, PR China.National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention.155 Changbai Rd, Changping District,Beijing, PR China.MOE Key Laboratory of Protein Science, School of Life Sciences, Tsinghua University, Beijing 100084, PR China AnyGo Technology, D1117 New China International Square, 89 Dayangfang Rd, Chaoyang District, Beijing, PR China. ![]()
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