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Performance evaluation of an automatic chemiluminescence immune platform for SARS-CoV-2 neutralizing antibody after vaccination in real world.
Li, Min; Jiang, Ruiwei; Wang, Enyun; Xiong, Dan; Ou, Tong; Zhang, Xiuming; Dou, Xiaowen.
  • Li M; Medical Laboratory of Shenzhen Luohu People's Hospital, Shenzhen, 518001, China.
  • Jiang R; Medical College, Anhui University of Science and Technology, Huainan, 232000, Anhui, China.
  • Wang E; Medical Laboratory of Shenzhen Luohu People's Hospital, Shenzhen, 518001, China.
  • Xiong D; Medical College, Anhui University of Science and Technology, Huainan, 232000, Anhui, China.
  • Ou T; Medical Laboratory of Shenzhen Luohu People's Hospital, Shenzhen, 518001, China.
  • Zhang X; Medical Laboratory of Shenzhen Luohu People's Hospital, Shenzhen, 518001, China.
  • Dou X; Medical Laboratory of Shenzhen Luohu People's Hospital, Shenzhen, 518001, China.
BMC Infect Dis ; 22(1): 157, 2022 Feb 15.
Article in English | MEDLINE | ID: covidwho-1745485
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adolescent / Humans Language: English Journal: BMC Infect Dis Journal subject: Communicable Diseases Year: 2022 Document Type: Article Affiliation country: S12879-022-07141-8

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adolescent / Humans Language: English Journal: BMC Infect Dis Journal subject: Communicable Diseases Year: 2022 Document Type: Article Affiliation country: S12879-022-07141-8