Performance evaluation of an automatic chemiluminescence immune platform for SARS-CoV-2 neutralizing antibody after vaccination in real world
Abstract Objective Reliable high-throughput serological assays for SARS-CoV-2 antibodies present an important role in the strength and duration of immunity after vaccination. The study investigated the analytical and clinical performances of neutralizing antibodies (NTAb) assay by chemiluminescent (...
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| Format: | Article |
| Language: | English |
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BMC
2022-02-01
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| Series: | BMC Infectious Diseases |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12879-022-07141-8 |
| _version_ | 1819277859643981824 |
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| author | Min Li Ruiwei Jiang Enyun Wang Dan Xiong Tong Ou Xiuming Zhang Xiaowen Dou |
| author_facet | Min Li Ruiwei Jiang Enyun Wang Dan Xiong Tong Ou Xiuming Zhang Xiaowen Dou |
| author_sort | Min Li |
| collection | DOAJ |
| description | Abstract Objective Reliable high-throughput serological assays for SARS-CoV-2 antibodies present an important role in the strength and duration of immunity after vaccination. The study investigated the analytical and clinical performances of neutralizing antibodies (NTAb) assay by chemiluminescent (CLIA), and SARS-CoV-2 neutralizing antibody after vaccination in real world. Methods The analytical performances of CLIA for SARS-CoV-2 NTAb were evaluated, followed by the sensitivity and specificity identified with a PRNT test from 50 volunteers. Then, a cohort of vaccine recipients (n = 37) were tracked with SARS-CoV-2 NTAb assay at prior to vaccination, one, three and six months post two doses. In real world, a total of 737 cases were recruited from physical examination center in Shenzhen Luohu People’s Hospital (from Jun to August 2021) to analyze vaccination status. Results Serological assays on the CLIA were found with excellent characteristics including imprecision, repeatability and linearity. Besides, it was robust to icterus, lipemia and hemolysis. The good sensitivity and specificity were obtained at 98% and 100%, respectively. NTAb results showed a high correlation with PRNT50 titers (r 0.61). Until July 2021, the BBIBP-CorV (76.3%) and Sinovac CoronaVac (20.5%) were the predominant vaccines injection in Shenzhen, China. Adolescent less than 18 years was the main unvaccinated group (52.1%). The seropositive rate of inactive SRAR-CoV-2 vaccines exceeded 97% after inoculation. The NTAb generated by Sinovac CoronaVac with the schedule of 0–56 days was found significantly lower than that by BBIBP-CorV (P < 0.001). The follow-up of NTAb changes in a cohort and the dynamic variation of NTAb in real world disclosed steep downward by almost three times for NTAb level occurred at three months post twice vaccinations. The seropositive ratio was at least 50% over 6 months. Conclusions SARS-CoV-2 neutralizing antibodies assay show excellent analytical and clinical performances, and a high correlation with neutralizing activity. Anti-epidemic measures and the urgent trial of SARS-CoV-2 vaccine was calling for adolescents. |
| first_indexed | 2024-12-24T00:02:49Z |
| format | Article |
| id | doaj.art-96ba38986b0244ee8453773f5c9dd229 |
| institution | Directory Open Access Journal |
| issn | 1471-2334 |
| language | English |
| last_indexed | 2024-12-24T00:02:49Z |
| publishDate | 2022-02-01 |
| publisher | BMC |
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| series | BMC Infectious Diseases |
| spelling | doaj.art-96ba38986b0244ee8453773f5c9dd2292022-12-21T17:25:05ZengBMCBMC Infectious Diseases1471-23342022-02-012211810.1186/s12879-022-07141-8Performance evaluation of an automatic chemiluminescence immune platform for SARS-CoV-2 neutralizing antibody after vaccination in real worldMin Li0Ruiwei Jiang1Enyun Wang2Dan Xiong3Tong Ou4Xiuming Zhang5Xiaowen Dou6Medical Laboratory of Shenzhen Luohu People’s HospitalMedical Laboratory of Shenzhen Luohu People’s HospitalMedical Laboratory of Shenzhen Luohu People’s HospitalMedical Laboratory of Shenzhen Luohu People’s HospitalMedical Laboratory of Shenzhen Luohu People’s HospitalMedical Laboratory of Shenzhen Luohu People’s HospitalMedical Laboratory of Shenzhen Luohu People’s HospitalAbstract Objective Reliable high-throughput serological assays for SARS-CoV-2 antibodies present an important role in the strength and duration of immunity after vaccination. The study investigated the analytical and clinical performances of neutralizing antibodies (NTAb) assay by chemiluminescent (CLIA), and SARS-CoV-2 neutralizing antibody after vaccination in real world. Methods The analytical performances of CLIA for SARS-CoV-2 NTAb were evaluated, followed by the sensitivity and specificity identified with a PRNT test from 50 volunteers. Then, a cohort of vaccine recipients (n = 37) were tracked with SARS-CoV-2 NTAb assay at prior to vaccination, one, three and six months post two doses. In real world, a total of 737 cases were recruited from physical examination center in Shenzhen Luohu People’s Hospital (from Jun to August 2021) to analyze vaccination status. Results Serological assays on the CLIA were found with excellent characteristics including imprecision, repeatability and linearity. Besides, it was robust to icterus, lipemia and hemolysis. The good sensitivity and specificity were obtained at 98% and 100%, respectively. NTAb results showed a high correlation with PRNT50 titers (r 0.61). Until July 2021, the BBIBP-CorV (76.3%) and Sinovac CoronaVac (20.5%) were the predominant vaccines injection in Shenzhen, China. Adolescent less than 18 years was the main unvaccinated group (52.1%). The seropositive rate of inactive SRAR-CoV-2 vaccines exceeded 97% after inoculation. The NTAb generated by Sinovac CoronaVac with the schedule of 0–56 days was found significantly lower than that by BBIBP-CorV (P < 0.001). The follow-up of NTAb changes in a cohort and the dynamic variation of NTAb in real world disclosed steep downward by almost three times for NTAb level occurred at three months post twice vaccinations. The seropositive ratio was at least 50% over 6 months. Conclusions SARS-CoV-2 neutralizing antibodies assay show excellent analytical and clinical performances, and a high correlation with neutralizing activity. Anti-epidemic measures and the urgent trial of SARS-CoV-2 vaccine was calling for adolescents.https://doi.org/10.1186/s12879-022-07141-8SARS-CoV-2 vaccineImmunoassaysNeutralizing antibodiesSerological assayPlaque reduction neutralization testReal world |
| spellingShingle | Min Li Ruiwei Jiang Enyun Wang Dan Xiong Tong Ou Xiuming Zhang Xiaowen Dou Performance evaluation of an automatic chemiluminescence immune platform for SARS-CoV-2 neutralizing antibody after vaccination in real world BMC Infectious Diseases SARS-CoV-2 vaccine Immunoassays Neutralizing antibodies Serological assay Plaque reduction neutralization test Real world |
| title | Performance evaluation of an automatic chemiluminescence immune platform for SARS-CoV-2 neutralizing antibody after vaccination in real world |
| title_full | Performance evaluation of an automatic chemiluminescence immune platform for SARS-CoV-2 neutralizing antibody after vaccination in real world |
| title_fullStr | Performance evaluation of an automatic chemiluminescence immune platform for SARS-CoV-2 neutralizing antibody after vaccination in real world |
| title_full_unstemmed | Performance evaluation of an automatic chemiluminescence immune platform for SARS-CoV-2 neutralizing antibody after vaccination in real world |
| title_short | Performance evaluation of an automatic chemiluminescence immune platform for SARS-CoV-2 neutralizing antibody after vaccination in real world |
| title_sort | performance evaluation of an automatic chemiluminescence immune platform for sars cov 2 neutralizing antibody after vaccination in real world |
| topic | SARS-CoV-2 vaccine Immunoassays Neutralizing antibodies Serological assay Plaque reduction neutralization test Real world |
| url | https://doi.org/10.1186/s12879-022-07141-8 |
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