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

Ghada  Ismail; Rania  Abdel Halim; Marwa Salah Mostafa; Dalia  H Abdelhamid; Hossam  Abdelghaffar; Nashwa Naguib Omar; Noha Alaa Eldin Fahim

doi:10.3889/oamjms.2021.7076

Authors

Ghada Ismail Department of Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt; Director of Reference Laboratory of the Egyptian University Hospitals, Egypt
Rania Abdel Halim Department of Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt
Marwa Salah Mostafa Department of Medical Microbiology and Immunology, Faculty of Medicine, Cairo University, Cairo, Egypt
Dalia H Abdelhamid Department of Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt
Hossam Abdelghaffar Department of ENT, Faculty of Medicine, Helwan University, Egypt; Secretary General of the Supreme Council for University Hospitals, Egypt
Nashwa Naguib Omar Department of Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt https://orcid.org/0000-0002-2607-2518
Noha Alaa Eldin Fahim Department of Clinical Pathology, Faculty of Medicine, Ain Shams University, Cairo, Egypt https://orcid.org/0000-0001-6388-3857

DOI:

https://doi.org/10.3889/oamjms.2021.7076

Keywords:

Coronavirus disease 2019, Severe acute respiratory syndrome coronavirus-2, Antibody, Chemiluminescence, Lateral flow immunochromatography

Abstract

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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