Diagnostic Accuracy of Rapid Antigen Testing (RAT) Compared to Polymerase Chain Reaction (PCR) for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)     Diagnosis: Laboratory Validation

Hammad Hussain; Muhammad Ali  Rathore; Eijaz  Ghani; Saifullah Khan  Niazi; Faraz  Ahmed; Tahir  Ghafoor

doi:10.51253/pafmj.v76iSUPPL-7.10524

Authors

Hammad Hussain Department of Virology, Armed Forces Institute of Pathology, Rawalpindi/National University of Medical Sciences (NUMS) Pakistan
Muhammad Ali Rathore Department of Virology, Armed Forces Institute of Pathology, Rawalpindi/National University of Medical Sciences (NUMS) Pakistan
Eijaz Ghani Department of Virology, Armed Forces Institute of Pathology, Rawalpindi/National University of Medical Sciences (NUMS) Pakistan
Saifullah Khan Niazi Department of Virology, Armed Forces Institute of Pathology, Rawalpindi/National University of Medical Sciences (NUMS) Pakistan
Faraz Ahmed Department of Virology, Armed Forces Institute of Pathology, Rawalpindi/National University of Medical Sciences (NUMS) Pakistan
Tahir Ghafoor Department of Microbiology, Armed Forces Institute of Pathology, Rawalpindi/National University of Medical Sciences (NUMS) Pakistan

DOI:

https://doi.org/10.51253/pafmj.v76iSUPPL-7.10524

Keywords:

Rapid Antigen Detection Test, SARS-CoV-2, RT-PCR.

Abstract

Objective: To evaluate the diagnostic accuracy of rapid antigen detection test for detection of SARS-CoV-2 infection using real-time polymerase chain reaction as a gold standard.

Study design: Cross-sectional validation study.

Place and Duration of Study: Department of Virology, Armed Forces Institute of Pathology (AFIP), Rawalpindi, Pakistan, from Jul to Dec 2021.

Methodology: A total of 330 individuals were enrolled in this study. The sample size was calculated using the WHO calculator. It represents the total number of patients presenting to the Hospital during study period. Paired nasopharyngeal swabs of patients fulfilling the inclusion criteria were collected. The samples were simultaneously tested by both a rapid antigen detection test by iChroma, Korea, based on immunochromatography (ICT) and polymerase chain reaction. For polymerase chain reaction, automated extraction was done on Genru, USA, and amplification was performed using Argene kit on Ampli lab thermal cycler, Italy.

Results: A total of 330 patients were tested by RAT and PCR for the detection of SARS-CoV-2. RAT was positive in 75(22.7%) patients and negative in 255(77.3%) patients, and PCR was positive in 52(15.8%) patients and negative in 278(84.2%) patients. RAT test had a sensitivity of 80.77% and specificity of 88.13%, positive predictive value 56%, negative predictive value 96.08%, and diagnostic accuracy 86.97% in comparison with PCR.

Conclusions: This study showed that RAT has good sensitivity and specificity but was much less as calculated by SARS-CoV-2 PCR. However, ....

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