Performance Assessment of First-Generation Anti-SARS-CoV-2 Serological Assays
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Abstract
The clinical and epidemiological use of SARS-CoV-2 antibody assays is under debate with urgent need to validate and verify the performance of SARS-CoV-2 serologic assays. We aim to assess the clinical and analytical performance of three commercial serological assays of SARS-CoV-2, comparing three anti-SARS-CoV-2-IgG ELISA and identifying the seroconversion and seroprevalence in our population.
A cross sectional study conducted from April 2020 to July 2020 at National Institute of Blood disease and Bone Marrow Transplantation Karachi, Pakistan with sample size of 404, enrolled consecutively. Participants were categorized into four groups’ namely convalescent plasmadonors (CPDs n=239), health care professionals (HCPs n=44), healthy blood donors (HBDs n=70) and from community (n=51).
We evaluated the performance of Elecsys anti-SARS-CoV-2 electrochemiluminescence (ECLIA) assay on Cobas-e411 by Roche, three qualitative anti-SARS-CoV-2-IgG enzyme linked imunosorbant assay (ELISA) by (Generic assays, Euroimmun & Omega diagnostics), one quantitative ELISA assay by AESKU Diagnostics and two immune chromatography(ICT) kits namely InstaTest™ by CORTEZ and TEST IT by TURKLAB.
From total 404 subjects, 322 (83.5%) were males. Mean age was 36.79±11.95 years. Among 239 in CPDs group, 202(84.5%) showed positive antibodies by ECLIA. The qualitative anti-SARS-CoV-2 IgG ELISA was positive in 174 (72.8%) and quantitative IgG in 180(75.3%) with mean titer of 56.7 ±39.7 U/ml. Sensitivity and specificity of ECLIA were 97.44& 99%, ELISA by Generic assays were 67.85% and 89.9%; Euroimmun had 90.38% and 94.9%; Omega Diagnostics 96.4% and 95% and the AESKULISA 93.75% and 100% respectively. Seroconversion was found to be 53.8% and 77.77% within 7 -8 days and 12 to 14 days post onset of symptoms respectively. ICT had more specificity but less sensitivity. Seroprevalence was found to be 84.5%, 40.9% and 21.4% in CPDs, HCPs and HBDs respectively.
The Roche ECLIA, qualitative ELISA by Omega Diagnostics & Euroimmun showed higher sensitivity as well as higher specificity. Quantitative ELISA has higher specificity and relatively high sensitivity. Significant numbers of COVID patients do not have detectable antibodies by all assays.
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SciScore for 10.1101/2020.09.22.20197046: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IACUC: Study Design: A cross sectional study conducted from April 2020 to June 2020 in Karachi, Pakistan after the approval from institution’s ethical review committee.
Consent: Informed written consent was taken from all study subjects.Non-probability consecutive sampling technique was used for sampling.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources The anti-SARS-CoV-2 antibodies were tested by ECLIA, ICT and by ELISA. anti-SARS-CoV-2suggested: NoneECLIA): Total antibody against SARS-CoV-2(including IgG, IgM and IgA) detected by using double-antigen … SciScore for 10.1101/2020.09.22.20197046: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IACUC: Study Design: A cross sectional study conducted from April 2020 to June 2020 in Karachi, Pakistan after the approval from institution’s ethical review committee.
Consent: Informed written consent was taken from all study subjects.Non-probability consecutive sampling technique was used for sampling.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources The anti-SARS-CoV-2 antibodies were tested by ECLIA, ICT and by ELISA. anti-SARS-CoV-2suggested: NoneECLIA): Total antibody against SARS-CoV-2(including IgG, IgM and IgA) detected by using double-antigen sandwich assay on Cobas 1Immunoassay analyzer(Roche diagnostics International Ltd atRotkreuz Switzerland). SARS-CoV-2 ( including IgGsuggested: NoneEnzyme linked immunosorbent assay (ELISA): This technique is used to detect anti-SARS-CoV-2IgG antibody in subject’s serum. anti-SARS-CoV-2IgGsuggested: NoneAll of these kits detected antibodies against Nucleocapsid protein. antibodies against Nucleocapsid protein.suggested: NoneSoftware and Algorithms Sentences Resources Analysis was done on statistical package for social science SPSS (Version 23). SPSSsuggested: (SPSS, RRID:SCR_002865)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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SciScore for 10.1101/2020.09.22.20197046: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement MATERIAL &METHOD: Study Design: A cross sectional study conducted from April 2020 to June 2020 in Karachi, Pakistan after the approval from institution’s ethical review committee. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable From total 404 subjects, 322 (83.5%) were males. Table 2: Resources
Antibodies Sentences Resources The anti-SARS-CoV-2 antibodies were tested by ECLIA, ICT and by ELISA. anti-SARS-CoV-2suggested: NoneECLIA): Total antibody against SARS-CoV2(including IgG, IgM and IgA) … SciScore for 10.1101/2020.09.22.20197046: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement MATERIAL &METHOD: Study Design: A cross sectional study conducted from April 2020 to June 2020 in Karachi, Pakistan after the approval from institution’s ethical review committee. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable From total 404 subjects, 322 (83.5%) were males. Table 2: Resources
Antibodies Sentences Resources The anti-SARS-CoV-2 antibodies were tested by ECLIA, ICT and by ELISA. anti-SARS-CoV-2suggested: NoneECLIA): Total antibody against SARS-CoV2(including IgG, IgM and IgA) detected by using double-antigen sandwich assay on Cobas e-411Immunoassay analyzer(Roche diagnostics International Ltd atRotkreuz Switzerland). SARS-CoV2 ( including IgGsuggested: NoneEnzyme linked immunosorbent assay (ELISA): This technique is used to detect anti-SARS-CoV2IgG antibody in subject’s serum. anti-SARS-CoV2IgGsuggested: NoneG ICT(Cortez)* IgM/IgG ICT (Turk Lab)* # € $ ECLIAantiSARS-CoV-2 antibodies (including IgG, IgM& IgA), ELISAantiSARS-CoV-2 IgG (Qualitative assay) ELISA antiSARS-CoV-2 IgG (Quantitative assay), *Sensitivity and specificity of only IgG was considered in ICT assay Sensitivity was calculated from234 samples with formula 229 True positive / 229 True positive + 10 False Negative, b Specificity was calculated by using 50 samples from pre-pandemic era (sep – Nov 2019) with formula 50 True negative/ 50 true negative + 0 false positive,cSensitivity, specificity, NPV & NPV were calculated in comparison with AESKULISA, d Sensitivity was calculated from192 samples with formula 180 True positive/180 True positive + 12 False Negative,ePPV is f calculatedwith formula 229 True Positive / 229 True positive + 0 False positive, NPV is calculatedwith formula 50 True a g negative / 50 True negative + 5 False negative, PPV is calculatedwith formula 180 True Positive / 180 True positive + 0 False h positive, NPV is calculatedwith formula 50 True negative / 50 True negative + 12 False negative DISCUSSON: We evaluated the performance of three different serological assays infourdifferentgroups. ECLIAantiSARS-CoV-2suggested: NoneELISAantiSARS-CoV-2 IgGsuggested: NoneantiSARS-CoV-2 IgGsuggested: NoneSoftware and Algorithms Sentences Resources Analysis was done on statistical package for social science SPSS (Version 23) SPSSsuggested: (SPSS, RRID:SCR_002865)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
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