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10.1371/journal.pone.0246346

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33529223!7853452!33529223
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suck abstract from ncbi


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pmid33529223      PLoS+One 2021 ; 16 (2): e0246346
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  • Development and performance evaluation of a rapid in-house ELISA for retrospective serosurveillance of SARS-CoV-2 #MMPMID33529223
  • Sil BK; Jahan N; Haq MA; Oishee MJ; Ali T; Khandker SS; Kobatake E; Mie M; Khondoker MU; Jamiruddin MR; Adnan N
  • PLoS One 2021[]; 16 (2): e0246346 PMID33529223show ga
  • BACKGROUND: In the ongoing pandemic situation of COVID-19, serological tests can complement the molecular diagnostic methods, and can be one of the important tools of sero-surveillance and vaccine evaluation. AIM: To develop and evaluate a rapid SARS-CoV-2 specific ELISA for detection of anti-SARS-CoV2 IgG from patients' biological samples. METHODS: In order to develop this ELISA, three panels of samples (n = 184) have been used: panel 1 (n = 19) and panel 2 (n = 60) were collected from RT-PCR positive patients within 14 and after 14 days of onset of clinical symptoms, respectively; whereas panel 3 consisted of negative samples (n = 105) collected either from healthy donors or pre-pandemic dengue patients. As a capturing agent full-length SARS-CoV2 specific recombinant nucleocapsid was immobilized. Commercial SARS-CoV2 IgG kit based on chemiluminescent assay was used for the selection of samples and optimization of the assay. The threshold cut-off point, inter-assay and intra-assay variations were determined. RESULTS: The incubation/reaction time was set at a total of 30 minutes with the sensitivity of 84% (95% confidence interval, CI, 60.4%, 96.6%) and 98% (95% CI, 91.1%, 100.0%), for panel 1 and 2, respectively; with overall 94.9% sensitivity (95% CI 87.5%, 98.6%). Moreover, the clinical specificity was 97.1% (95% CI, 91.9%, 99.4%) with no cross reaction with dengue samples. The overall positive and negative predictive values are 96.2% (95% CI 89.2%, 99.2%) and 96.2% (95% CI, 90.6% 99.0%), respectively. In-house ELISA demonstrated 100% positive and negative percent agreement with Elecsys Anti-SARS-CoV-2, with Cohen's kappa value of 1.00 (very strong agreement), while comparing 13 positive and 17 negative confirmed cases. CONCLUSION: The assay is rapid and can be applied as one of the early and retrospective sero-monitoring tools in all over the affected areas.
  • |Antibodies, Viral/*analysis[MESH]
  • |COVID-19/diagnosis/virology[MESH]
  • |Coronavirus Nucleocapsid Proteins/*analysis[MESH]
  • |Enzyme-Linked Immunosorbent Assay/instrumentation/*methods[MESH]
  • |Humans[MESH]
  • |Immunoglobulin G/analysis[MESH]
  • |Phosphoproteins/analysis[MESH]
  • |SARS-CoV-2/*isolation & purification[MESH]


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