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Diagnostic accuracy of antibody-based rapid diagnostic tests in detecting coronavirus disease 2019: systematic review
Tiara Josephine Gracienta1, Ryan Herardi1, Frans Santosa1
1Faculty of Medicine, Universitas Pembangunan Nasional Veteran Jakarta, Indonesia.
Insights
Antibody rapid diagnostic tests (RDTs) for COVID-19 show limited accuracy. Combined IgM/IgG RDTs offer higher sensitivity, while IgG-only RDTs provide better specificity for screening purposes.
Area of Science:
- Medical Diagnostics
- Infectious Diseases
- Immunology
Background:
- The rapid spread of COVID-19 necessitates efficient detection methods.
- Antibody rapid diagnostic tests (RDTs) are widely used for COVID-19 detection due to their practicality, despite concerns about their accuracy.
Purpose of the Study:
- To systematically review and determine the diagnostic accuracy of antibody-based RDTs for COVID-19 detection.
Main Methods:
- A systematic literature search was conducted across five databases up to February 2021.
- Included studies were assessed for risk of bias using the Joanna Briggs Institute checklist.
- Pooled sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated.
Main Results:
- The combined IgM or IgG detection method demonstrated the highest sensitivity (73.41%) and negative predictive value (75.34%).
- The single IgG detection method exhibited the highest specificity (96.68%) and positive predictive value (95.97%).
Conclusions:
- Antibody-based RDTs are currently not ideal as primary diagnostic tools for COVID-19.
- These RDTs can serve as a valuable screening tool in specific contexts.
Introduction:
The rapid transmission of coronavirus disease 2019 (COVID-19) requires a fast, accurate, and affordable detection method. Despite doubts of their diagnostic accuracy, rapid diagnostic tests (RDTs) are used worldwide due to their practicality. This systematic review aims to determine the diagnostic accuracy of antibody-based RDTs in detecting COVID-19.
Material And Methods:
A literature search was carried out on five journal databases using the PRISMA-P 2015 method. We included all studies published up to February 2021. The risk of bias was evaluated using the Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Diagnostic Test Accuracy Studies. Data regarding peer-review status, study design, test kit information, immunoglobulin class, target antigen, and the number of samples were extracted and tabulated. We estimated the pooled sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) with a 95% confidence interval.
Results:
Thirty-three studies met the eligibility criteria. The pooled data results showed that the combined detection method of IgM or IgG had the highest sensitivity and NPV, which were 73.41% (95% CI: 72.22-74.57) and 75.34% (95% CI: 74.51-76.16), respectively. The single IgG detection method had the highest specificity and PPV of 96.68% (95% CI: 96.25-97.07) and 95.97% (95% CI: 95.47-96.42%), respectively.
Conclusions:
Antibody-based RDTs are not satisfactory as primary diagnostic tests but have utility as a screening tool.
