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Are commercial antibody assays substantially underestimating SARS-CoV-2 ever infection? An analysis on a population-based sample in a high exposure setting [article]

Gheyath K. Nasrallah, Soha R. Dargham, Farah Shurrab, Duaa W. Al-Sadeq, Hadeel Al-Jighefee, Hiam Chemaitelly, Zaina Al Kanaani, Abdullatif Al Khal, Einas Al Kuwari, Peter Coyle, Andrew Jeremijenko, Anvar Hassan Kaleeckal (+12 others)
2020 biorxiv/medrxiv   pre-print

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AbstractBackgroundPerformance of three automated commercial serological IgG-based assays was investigated for assessing SARS-CoV-2 ever (past or current) infection in a population-based sample in a high exposure setting.MethodsPCR and serological testing was performed on 394 individuals.ResultsSARS-CoV-2-IgG seroprevalence was 42.9% (95% CI 38.1%-47.8%), 40.6% (95% CI 35.9%-45.5%), and 42.4% (95% CI 37.6%-47.3%) using the CL-900i, VidasIII, and Elecsys assays, respectively. Between the three
more » ... ays, overall, positive, and negative percent agreements ranged between 93.2%-95.7%, 89.3%-92.8%, and 93.8%-97.8%, respectively; Cohen kappa statistic ranged from 0.86-0.91; and 35 specimens (8.9%) showed discordant results. Among all individuals, 12.5% (95% CI 9.6%-16.1%) had current infection, as assessed by PCR. Of these, only 34.7% (95% CI 22.9%-48.7%) were seropositive by at least one assay. A total of 216 individuals (54.8%; 95% CI 49.9%-59.7%) had evidence of ever infection using antibody testing and/or PCR during or prior to this study. Of these, only 78.2%, 74.1%, and 77.3% were seropositive in the CL-900i, VidasIII, and Elecsys assays, respectively.ConclusionsAll three assays had comparable performance and excellent agreement, but missed at least 20% of individuals with past or current infection. Commercial antibody assays can substantially underestimate ever infection, more so when infection rates are high.
doi:10.1101/2020.12.14.20248163 fatcat:avn3zdljbzd2jm65gq4q36dft4
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Gheyath K. Nasrallah, Soha R. Dargham, Farah Shurrab, Duaa W. Al-Sadeq, Hadeel Al-Jighefee, Hiam Chemaitelly, Zaina Al Kanaani, Abdullatif Al Khal, Einas Al Kuwari, Peter Coyle, Andrew Jeremijenko, Anvar Hassan Kaleeckal, Ali Nizar Latif, Riyazuddin Mohammad Shaik, Hanan F. Abdul Rahim, Hadi M. Yassine, Mohamed G. Al Kuwari, Hamda Qotba, Hamad Eid Al Romaihi, Patrick Tang, Roberto Bertollini, Mohamed Al-Thani, Asmaa A. Althani, Laith J. Abu-Raddad. "Are commercial antibody assays substantially underestimating SARS-CoV-2 ever infection? An analysis on a population-based sample in a high exposure setting." biorxiv/medrxiv (2020)