Related Experiment Video
Updated: Aug 12, 2025
A Rapid, Multiplex Dual Reporter IgG and IgM SARS-CoV-2 Neutralization Assay for a Multiplexed Bead-Based Flow Analysis System
Published on: April 6, 2021
The sensitivity and specificity of COVID-19 rapid anti-gene test in comparison to RT-PCR test as a gold standard test
Oday Taher Mohammed Al-Hashimi1, Waleed Ibraheem Ali Al-Ansari1, Safia Abdullkareem Abbas1
1College of Medicine, University of Baghdad, Baghdad, Iraq.
Insights
Rapid antigen tests for COVID-19 (coronavirus disease 2019) show low sensitivity and specificity compared to RT-PCR. These rapid tests should not be used alone for COVID-19 diagnosis.
Area of Science:
- Infectious Diseases
- Virology
- Diagnostic Testing
Background:
- Coronavirus disease 2019 (COVID-19) is a global pandemic caused by SARS-CoV-2.
- Accurate and rapid diagnostic methods are crucial for disease control.
Purpose of the Study:
- To compare the diagnostic performance of rapid antigen tests versus RT-PCR for COVID-19.
- To evaluate the sensitivity and specificity of rapid antigen tests.
Main Methods:
- A cohort hospital-based study was conducted from July to September 2020.
- 148 suspected COVID-19 cases were tested using both rapid antigen tests and RT-qPCR.
- Rapid IgG and IgM antibody tests were also analyzed.
Main Results:
- RT-qPCR detected 19.6% positive cases, while rapid antigen tests identified 35.1% positive cases.
- The rapid antigen test demonstrated a sensitivity of 37.9% and specificity of 65.5%.
- Rapid IgG tests were more sensitive but less specific than rapid IgM tests.
Conclusions:
- Rapid antigen tests alone are insufficient for diagnosing COVID-19.
- RT-PCR and other investigations like CT scans are necessary for definitive diagnosis.
- Rapid antibody tests show varying performance, with IgG being more sensitive but less specific than IgM.
Background:
Coronavirus disease 2019 (COVID-19) is a modern infectious disease, first identified in December 2019 in Wuhan, China. The etiology is via severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), in a pandemic manner. The study aimed to compare between RT-PCR and rapid anti-gene tests for COVID-19 with regard to sensitivity and specificity.
Methods:
This is a cohort hospital-based study done during the period of July to September 2020. Both rapid anti-gene test kit (SARS-CoV-2) and RT-qPCR were used for the detection of COVID-19 in suspected cases.
Results:
A total of 148 cases were tested using both the RT-qPCR and rapid test. Twenty-nine (19.6%) of these cases had positive results for RT-qPCR and 119 (80.4%) were negative, whereas 52 (35.1%) patients were positive to rapid anti-gene test and 96 (64.9%) of them negative. The sensitivity of the rapid test was 37.9%, the specificity was 65.5% and the accuracy was 64.44%. Rapid IgG test was positive in 47 (31.8) of cases. Although, rapid IgM test was positive in 18 (12.2%). The rapid IgG test was more sensitive than rapid IgM (Sensitivity 34.48% vs. 3.45%), but it was less specific than rapid IgM test (Specificity 68.91% vs. 85.71%).
Conclusion:
We cannot consider rapid anti-gene test alone as a diagnostic method for COVID-19. We should also conduct RT-PCR test and other investigations like imaging CT scan of chest to confirm the diagnosis. The rapid IgG test is more sensitive than rapid IgM, but it was less specific.
Related Concept Videos
02:57Real Time RT-PCR
The real-time quantification of the number of amplified products is...
01:13Sensitivity, Specificity, and Predicted Value
Sensitivity is the...