Evaluation of commercial SARS-CoV-2 serological assays in Canadian public health laboratories

Stein, Derek; Osiowy, Carla; Gretchen, Ainsley; Thorlacius, Laurel; Fudge, Denise; Lang, Amanda; Sekirov, Inna; Morshed, Muhammad; Levett, Paul N.; Tran, Vanessa; Kus, Julianne V.; Gubbay, Jonathan B.; Mohan, Vandana; Charlton, Carmen; Kanji, Jamil N; Serhir, Bouchra; Therrien, Christian; Roger, Michel; Jiao, Lei; Zahariadis, George; Needle, Robert; Gilbert, Laura; Desnoyers, Guillaume; Garceau, Richard; Bouhtiauy, Ihssan; Longtin, Jean; El-Gabalawy, Nadia; Dibernardo, Antonia; Lindsay, L. Robbin; Drebot, Michael A.

doi:10.1016/j.diagmicrobio.2021.115412

Cited by 12 publications

(13 citation statements)

References 19 publications

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“…This is supported by our earlier work describing this low level of seroprevalence ( 2 , 19 ). Given the absence of a gold standard ( 2 , 16 ), we used two approaches to estimate SARS-CoV-2 seropositivity, and results were consistent across methodologies. We also attempted to understand the impact of donor declared vaccine history on SARS-CoV-2 serological profiles.…”

Section: Discussionmentioning

confidence: 99%

“…During the SARS-CoV-2 pandemic, serological studies have provided a number of key insights into this newly emerged infection; they have affirmed that development of an antibody response correlates with clearance of viral shedding ( 11 ); they have helped delineate the fraction of infections that are identified as cases ( 12 ); have permitted estimation of infection fatality ratios and have facilitated identification of groups and regions with elevated infection risks and ongoing vulnerabilities to infection ( 13 – 16 ). However, seroprevalence studies rely on assays with imperfect sensitivity and specificity ( 16 ). Furthermore, estimation of sensitivity and specificity of these tests is made more challenging by the absence of a gold standard with which they can be compared ( 2 ).…”

Section: Introductionmentioning

confidence: 99%

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Estimating SARS-CoV-2 Seroprevalence in Canadian Blood Donors, April 2020 to March 2021: Improving Accuracy with Multiple Assays

et al. 2022

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Estimating SARS-CoV-2 Seroprevalence in Canadian Blood Donors, April 2020 to March 2021: Improving Accuracy with Multiple Assays

et al. 2022

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“…They found that Artron IgM cross-reacts with sera containing West Nile virus IgG, mumps IgM, and Chikungunya IgM [27]. Stein et al (2021) noticed that the sensitivity ranged from 74.2% for samples collected less than 7 days post-symptom onset to 95.3% in samples collected more than 14 days with 96.6% specificity [28]. On the contrary, Imai et al (2020) reported a comparable sensitivity to ours of (42.2%) but with higher specificity (97.9%) [29].…”

Section: Discussionmentioning

confidence: 99%

Comparative Evaluation of SARS-CoV-2 Rapid Immunochromatographic Test Assays with Chemiluminescent Immunoassay for the Diagnosis of COVID-19

Ismail

Halim

Mostafa

et al. 2021

Open Access Maced J Med Sci

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Background To date, the molecular assay is the gold-standard method for COVID-19 diagnosis. However, they are expensive and complex. There is a pressing necessity for developing other effective diagnostics for SARS‐CoV‐2 patients. Therefore, serological detection of antibodies against SARS‐CoV‐2 might provide a good alternative. Aim We aimed to compare and evaluate seven rapid diagnostic tests with Mindray chemiluminescent automated immunoassay as a reference method for SARS-CoV-2 antibodies detection. Methods: This study included the serum of a total of 49 attendees to the Reference Laboratory of Egyptian university hospitals during the period from April 2021 to May 2021. Anti-Covid-19 antibodies detection in serum samples was performed by Mindray fully automated system as our reference method and seven rapid antibody tests; Wondfo, Vazyme, Dynamiker, Panbio, Artron Maccura and Roche. Results: The chemiluminescent assay revealed 30 (61.2%) positive samples and 19 (38.8%) negative samples for COVID-19 IgG. For COVID-19 IgM, 11 (22.4%) samples were positive and 38 (77.6%) samples were negative. Anti-SARS-CoV-2 antibodies were not detected in any of the PCR negative individuals. The best diagnostic performance was demonstrated by Roche IgG and IgM, and Vazyme IgG and IgM antibody tests followed by Panbio. For Roche, the sensitivity and specificity for IgG and IgM were (83.3%, 89.5%) and (72.7%, 81.6%) respectively. Vazyme showed sensitivity and specificity for IgG and IgM were (77.8%, 85.7%) and (75%, 91.7%) respectively. Regards Panbio, the sensitivity and specificity for IgG and IgM were (63.6%, 87.5%) and (50%, 86.7%) respectively. Cohen’s Kappa values revealed a substantial agreement for Roche IgG, Vazyme IgG and IgM of (0.7076, 0.6250, 0.6667) respectively. The worst agreement was reported for Maccura IgG, Wondfo, and Dynamiker IgM with Cohen’s Kappa values of (0.2508, 0.1893, 0.0313) respectively. Conclusions: Rapid tests in our study exhibited heterogeneous diagnostic performances. Roche, Vazyme, and Panbio antibody tests showed promising results in concordance with our reference method with the best-reported results. On the other hand, the other tests were inferior and failed in providing valid and reliable results. Further studies are necessary to determine the practicality of these tests in different settings and communities.

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“…Given the absence of a gold standard ( 6 , 21 ), we previously characterized SARS-CoV-2 seropositivity, including latent class analysis ( 7 , 8 ) and composite reference standard approaches ( 6 ). We also attempted to understand the impact of donor-declared vaccine history on SARS-CoV-2 serological profiles ( 1 , 2 , 9 , 10 ).…”

Section: Introductionmentioning

confidence: 99%

“…The development of new anti-SARS-CoV-2 commercial assays allows for the operationalization of seroprevalence studies by non-research-focused laboratories, including clinical and public health laboratories as well as blood operators ( 7 , 21 , 25 , 26 ). The Abbott SARS-CoV-2 Quant assay (Abbott, Chicago, IL) was developed for the qualitative and quantitative determination of IgG against SARS-CoV-2 S. The qualitative cutoff for this assay has been described as 50 AU/mL ( 27 ).…”

Section: Introductionmentioning

confidence: 99%

A Qualitative Comparison of the Abbott SARS-CoV-2 IgG II Quant Assay against Commonly Used Canadian SARS-CoV-2 Enzyme Immunoassays in Blood Donor Retention Specimens, April 2020 to March 2021

et al. 2022

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Evaluation of commercial SARS-CoV-2 serological assays in Canadian public health laboratories

Cited by 12 publications

References 19 publications

Estimating SARS-CoV-2 Seroprevalence in Canadian Blood Donors, April 2020 to March 2021: Improving Accuracy with Multiple Assays

Estimating SARS-CoV-2 Seroprevalence in Canadian Blood Donors, April 2020 to March 2021: Improving Accuracy with Multiple Assays

Comparative Evaluation of SARS-CoV-2 Rapid Immunochromatographic Test Assays with Chemiluminescent Immunoassay for the Diagnosis of COVID-19

A Qualitative Comparison of the Abbott SARS-CoV-2 IgG II Quant Assay against Commonly Used Canadian SARS-CoV-2 Enzyme Immunoassays in Blood Donor Retention Specimens, April 2020 to March 2021

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