Abstract
BackgroundThe Coronavirus disease 2019 (COVID-19) pandemic continues to spread across the world. Hence, there is an urgent need for rapid, simple, and accurate tests to diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Performance characteristics of the rapid SARS-CoV-2 antigen detection test should be evaluated and compared with the gold standard real-time reverse transcription-polymerase chain reaction (RT-PCR) test for diagnosis of COVID-19 cases.MethodsThe rapid SARS-CoV-2 antigen detection test, Standard™ Q COVID-19 Ag kit (SD Biosensor®, Republic of Korea), was compared with the real-time RT-PCR test, Allplex™ 2019-nCoV Assay (Seegene®, Korea) for detection of SARS-CoV-2 in respiratory specimens. Four hundred fifty-four respiratory samples (mainly nasopharyngeal and throat swabs) were obtained from COVID-19 suspected cases and contact individuals, including pre-operative patients at Siriraj Hospital, Bangkok, Thailand during March–May 2020.ResultsOf 454 respiratory samples, 60 (13.2%) were positive, and 394 (86.8%) were negative for SARS-CoV-2 RNA by real-time RT-PCR assay. The duration from onset to laboratory test in COVID-19 suspected cases and contact individuals ranged from 0 to 14 days with a median of 3 days. The rapid SARS-CoV-2 antigen detection test’s sensitivity and specificity were 98.33% (95% CI, 91.06–99.96%) and 98.73% (95% CI, 97.06–99.59%), respectively. One false negative test result was from a sample with a high real-time RT-PCR cycle threshold (Ct), while five false positive test results were from specimens of pre-operative patients.ConclusionsThe rapid assay for SARS-CoV-2 antigen detection showed comparable sensitivity and specificity with the real-time RT-PCR assay. Thus, there is a potential use of this rapid and simple SARS-CoV-2 antigen detection test as a screening assay.
Highlights
The Coronavirus disease 2019 (COVID-19) pandemic continues to spread across the world
Characteristics of Thai COVID‐19 cases Suspected COVID-19 cases and contact individuals were laboratory-confirmed by the gold-standard RTPCR assay as a national guideline for laboratory diagnosis of COVID-19 [15]
A total of 454 respiratory samples, including 447 nasopharyngeal (NP) and throat swabs, four endotracheal aspirates, and three sputum samples, were collected from suspected COVID-19 cases and pre-operative patients at Siriraj Hospital from March to May 2020. These respiratory samples were collected from subjects with the following conditions: (1) asymptomatic and upper respiratory tract infection individuals who had contacted with confirmed cases or were from COVID-19 risk areas, (2) clusters with acute respiratory infections, (3) unknown causative agents of pneumonia, (4) travelers screened at a port of entry and in quarantine places, and (5) pre-operative patients
Summary
The Coronavirus disease 2019 (COVID-19) pandemic continues to spread across the world. There is an urgent need for rapid, simple, and accurate tests to diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Performance characteristics of the rapid SARS-CoV-2 antigen detection test should be evaluated and compared with the gold standard real-time reverse transcription-polymerase chain reaction (RT-PCR) test for diagnosis of COVID-19 cases. The Coronavirus disease 2019 (COVID-19) pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread worldwide since its first recorded case in the city of Wuhan, China in December 2019. As of August 31st, 2020, there have been 3,412 confirmed COVID19 cases with 58 deaths; 2,444 cases were from local transmission [4, 5]. Since May 26th, 2020, no new local transmission cases were documented; new confirmed COVID-19 cases were people who have tested positive while in State Quarantine after returning from abroad [5]. Severe cases may develop acute respiratory distress syndrome (ARDS) and death with an average mortality rate of 6% (range 1–14.4%) [1, 3, 6]
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