Can the Wondfo® SARS-CoV-2 IgM/IgG antibodies be used as a rapid diagnostic test?

Point-of-care serological tests for SARS-CoV-2 have been used for COVID-19 diagnosis. However, their accuracy over time regarding the onset of symptoms is not fully understood. We aimed to assess the accuracy of a point-of-care lateral flow immunoassay (LFI). Subjects, aged over 18 years, presenting clinical symptoms suggestive of acute SARS-CoV-2 infection were tested once by both nasopharyngeal and oropharyngeal RT-PCR and LFI. The accuracy of LFI was assessed in periodic intervals of three days in relation to the onset of symptoms. The optimal cut-off point was defined as the number of days required to achieve the best sensitivity and specificity. This cut-off point was also used to compare LFI accuracy according to participants’ status: outpatient or hospitalized. In total, 959 patients were included, 379 (39.52%) tested positive for SARS-CoV-2 with RT-PCR, and 272 (28.36%) tested positive with LFI. LFI best performance was achieved after 10 days of the onset of symptoms, with sensitivity and specificity of 84.9% (95%CI: 79.8-89.1) and 94.4% (95%CI: 91.0-96.8), respectively. Although the specificity was similar (94.6% vs. 88.9%, p = 0.051), the sensitivity was higher in hospitalized patients than in outpatients (91.7% vs. 82.1%, p = 0.032) after 10 days of the onset of symptoms. Best sensitivity of point-of-care LFI was found 10 days after the onset of symptoms which may limit its use in acute care. Specificity remained high regardless of the number of days since the onset of symptoms.

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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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Can the Wondfo® SARS-CoV-2 IgM/IgG antibodies be used as a rapid diagnostic test?

Cited by 3 publications

References 16 publications

Point-of-Care Testing of COVID-19: Current Status, Clinical Impact, and Future Therapeutic Perspectives

Point-of-Care Testing of COVID-19: Current Status, Clinical Impact, and Future Therapeutic Perspectives

Diagnostic accuracy of a SARS-CoV-2 rapid test and optimal time for seropositivity according to the onset of symptoms

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

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