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An Evaluation of the Sensitivity and Specificity of Three COVID-19 Rapid Immunochromatographic Test Kits Compared to
S Bani1, Ebenezer K Amakye1, Shanti Akomea1
1Department of Biomedical Laboratory Sciences, School of Allied Health Sciences, University for Development Studies, Tamale, GHA.
Insights
The DG Rapid and SD Rapid COVID-19 antigen tests show high diagnostic accuracy, making them reliable alternatives to rRT-PCR, especially in resource-limited settings like Ghana.
Area of Science:
- Virology
- Diagnostic Testing
- Public Health
Background:
- The COVID-19 pandemic strains global healthcare systems.
- There is a critical need for accessible diagnostic alternatives to RT-PCR, particularly in resource-limited regions.
- Ghana faces challenges with current COVID-19 diagnostic methods.
Purpose of the Study:
- To evaluate the diagnostic performance of three rapid immunochromatographic antigen test kits for COVID-19.
- To compare the sensitivity and specificity of DG Rapid, SD Rapid, and SS Rapid kits against the gold standard rRT-PCR.
- To assess the utility of these rapid tests in resource-limited settings.
Main Methods:
- Assessed three COVID-19 rapid antigen test kits (DG Rapid, SD Rapid, SS Rapid).
- Compared test kit performance against real-time reverse transcriptase-polymerase chain reaction (rRT-PCR) using 75 archived nasopharyngeal samples.
- Calculated sensitivity, specificity, and Cohen's kappa for each kit.
Main Results:
- All tested kits demonstrated 100% specificity.
- DG Rapid showed 79% sensitivity and excellent agreement with rRT-PCR (kappa=0.79).
- SD Rapid showed 74% sensitivity and good agreement (kappa=0.73), while SS Rapid showed 50% sensitivity (kappa=0.50).
- Higher sensitivity was observed for samples with cycle threshold (Ct) values <29.99.
Conclusions:
- DG Rapid and SD Rapid kits are effective and reliable alternatives to rRT-PCR for SARS-CoV-2 detection.
- These rapid tests offer a viable solution for COVID-19 diagnosis in resource-limited settings like Ghana.
- The study supports the use of these antigen tests for accessible and rapid COVID-19 screening.
Abstract:
Background and objective The coronavirus disease 2019 (COVID-19) pandemic has imposed a significant burden on healthcare systems worldwide. This highlights the need for simple, rapid, and affordable diagnostic tests that can serve as alternatives to the existing costly and demanding polymerase chain reaction (PCR) assay, especially in resource-limited countries like Ghana. In light of this, we aimed to assess the diagnostic efficacy of three COVID-19 rapid immunochromatographic antigen test kits vs. real-time reverse transcriptase-PCR (rRT-PCR). Methods This study evaluated the sensitivity and specificity of three COVID-19 rapid immunochromatographic antigen test kits: DG Rapid, SD Rapid, and SS Rapid. They were compared with the gold standard RT-PCR for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleocapsid antigen in 75 randomly selected archived nasopharyngeal samples. Results Of the 75 samples tested, 38 (50.7%) were positive and 37 (49.3%) were negative for SARS-CoV-2 RNA by rRT-PCR assay. No false positives were recorded. On the other hand, the DG Rapid kit detected 30 (78.9%) true positives and eight (21.1%) false negatives. SD Rapid kit detected 28 (73.7%) true positives and 10 (26.3%) false negatives, while the SS Rapid kit detected 19 (50.0%) true positives and 19 (50.0%) false negatives. While the specificity of each test kit was 100% (95% CI), the sensitivity of the DG Rapid, SD Rapid, and SS Rapid kits was 79%, 74%, and 50% (95% CI), respectively. Higher sensitivities were recorded among samples with cycle threshold (Ct) values <29.99 for each kit. Also, the DG Rapid kit demonstrated 79% excellent agreement with rRT-PCR, while the SD Rapid and SS Rapid kits demonstrated good agreement with rRT-PCR with 73% and 50% Cohen's kappa values, respectively. Conclusions Based on our findings, DG Rapid and SD Rapid kits are reliable alternatives to rRT-PCR for the detection of SARS-CoV-2 infection, especially in resource-limited settings like Ghana.
