tetano
Editor, Senior Moderator
Virol J
. 2020 Nov 13;17(1):177.
doi: 10.1186/s12985-020-01452-5.
Rapid SARS-CoV-2 antigen detection assay in comparison with real-time RT-PCR assay for laboratory diagnosis of COVID-19 in Thailand
Chutikarn Chaimayo[SUP] 1 [/SUP], Bualan Kaewnaphan[SUP] 1 [/SUP], Nattaya Tanlieng[SUP] 1 [/SUP], Niracha Athipanyasilp[SUP] 1 [/SUP], Rujipas Sirijatuphat[SUP] 2 [/SUP], Methee Chayakulkeeree[SUP] 2 [/SUP], Nasikarn Angkasekwinai[SUP] 2 [/SUP], Ruengpung Sutthent[SUP] 1 [/SUP], Nattawut Puangpunngam[SUP] 3 [/SUP], Theerawoot Tharmviboonsri[SUP] 4 [/SUP], Orawan Pongraweewan[SUP] 5 [/SUP], Suebwong Chuthapisith[SUP] 3 [/SUP], Yongyut Sirivatanauksorn[SUP] 3 [/SUP], Wannee Kantakamalakul[SUP] 1 [/SUP], Navin Horthongkham[SUP] 6 [/SUP]
Affiliations
Abstract
Background: The 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.
Methods: The 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.
Results: Of 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.
Conclusions: The 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.
Keywords: COVID-19; RT-PCR; Rapid antigen; SARS-CoV-2; Thailand.
. 2020 Nov 13;17(1):177.
doi: 10.1186/s12985-020-01452-5.
Rapid SARS-CoV-2 antigen detection assay in comparison with real-time RT-PCR assay for laboratory diagnosis of COVID-19 in Thailand
Chutikarn Chaimayo[SUP] 1 [/SUP], Bualan Kaewnaphan[SUP] 1 [/SUP], Nattaya Tanlieng[SUP] 1 [/SUP], Niracha Athipanyasilp[SUP] 1 [/SUP], Rujipas Sirijatuphat[SUP] 2 [/SUP], Methee Chayakulkeeree[SUP] 2 [/SUP], Nasikarn Angkasekwinai[SUP] 2 [/SUP], Ruengpung Sutthent[SUP] 1 [/SUP], Nattawut Puangpunngam[SUP] 3 [/SUP], Theerawoot Tharmviboonsri[SUP] 4 [/SUP], Orawan Pongraweewan[SUP] 5 [/SUP], Suebwong Chuthapisith[SUP] 3 [/SUP], Yongyut Sirivatanauksorn[SUP] 3 [/SUP], Wannee Kantakamalakul[SUP] 1 [/SUP], Navin Horthongkham[SUP] 6 [/SUP]
Affiliations
- PMID: 33187528
- PMCID: PMC7665091
- DOI: 10.1186/s12985-020-01452-5
Abstract
Background: The 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.
Methods: The 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.
Results: Of 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.
Conclusions: The 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.
Keywords: COVID-19; RT-PCR; Rapid antigen; SARS-CoV-2; Thailand.