“David vs. Goliath”: A simple antigen detection test with potential to change diagnostic strategy for SARS-CoV-2

Introduction: As regard to all pandemics, the current COVID-19 pandemic, could also have been better managed with prudent use of preventive measures coupled with rapid diagnostic tools such as rapid antigen tests, but their efficacy is under question because of projected lower sensitivity as compare...

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Published inJournal of infection in developing countries Vol. 15; no. 7; pp. 904 - 909
Main Authors Agarwal, Jyotsna, Das, Anupam, Pandey, Pranshu, Sen, Manodeep, Garg, Jaya
Format Journal Article
LanguageEnglish
Published Sassari Journal of Infection in Developing Countries 31.07.2021
The Journal of Infection in Developing Countries
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Abstract Introduction: As regard to all pandemics, the current COVID-19 pandemic, could also have been better managed with prudent use of preventive measures coupled with rapid diagnostic tools such as rapid antigen tests, but their efficacy is under question because of projected lower sensitivity as compared to Real Time Reverse Transcriptase Polymerase Chain Reaction, which although considered gold standard has its own limitations. Methodology: A prospective, single centre study was carried out to evaluate the performance of Standard Q COVID-19 Ag, a rapid immuno-chromatographic assay for antigen detection, against TrueNat, a chip-based, point-of-care, portable, Real-Time PCR analyzer for diagnosis of COVID-19; on 467 nasal swab samples from suspected subjects at a fever clinic in North India in month of July 2020. Results: Of the 467 specimens tested, TrueNat showed positive result in 29 (6.2%), majority of whom were asymptomatic (72.4%) while 4/29 (13.9%) had influenza like illness and 2/29 (6.8%) presented with severe acute respiratory illness. Compared to TrueNat, Rapid antigen test gave concordance for 26 samples, while for 2 samples the result was false positive; giving an overall sensitivity of 89.7% (95% CI = 72.6- 97.8) and a specificity of 99.5%, indicating strong agreement between two methods. Conclusion: Community prevalence plays an important role is choosing the laboratory test and result interpretation. Rapid antigen detection tests definitely have a big role to play, especially in resource limited setting, for early diagnosis as well as for source control to halt the spread.
AbstractList Introduction: As regard to all pandemics, the current COVID-19 pandemic, could also have been better managed with prudent use of preventive measures coupled with rapid diagnostic tools such as rapid antigen tests, but their efficacy is under question because of projected lower sensitivity as compared to Real Time Reverse Transcriptase Polymerase Chain Reaction, which although considered gold standard has its own limitations. Methodology: A prospective, single centre study was carried out to evaluate the performance of Standard Q COVID-19 Ag, a rapid immuno-chromatographic assay for antigen detection, against TrueNat, a chip-based, point-of-care, portable, Real-Time PCR analyzer for diagnosis of COVID-19; on 467 nasal swab samples from suspected subjects at a fever clinic in North India in month of July 2020. Results: Of the 467 specimens tested, TrueNat showed positive result in 29 (6.2%), majority of whom were asymptomatic (72.4%) while 4/29 (13.9%) had influenza like illness and 2/29 (6.8%) presented with severe acute respiratory illness. Compared to TrueNat, Rapid antigen test gave concordance for 26 samples, while for 2 samples the result was false positive; giving an overall sensitivity of 89.7% (95% CI = 72.6- 97.8) and a specificity of 99.5%, indicating strong agreement between two methods. Conclusion: Community prevalence plays an important role is choosing the laboratory test and result interpretation. Rapid antigen detection tests definitely have a big role to play, especially in resource limited setting, for early diagnosis as well as for source control to halt the spread.
As regard to all pandemics, the current COVID-19 pandemic, could also have been better managed with prudent use of preventive measures coupled with rapid diagnostic tools such as rapid antigen tests, but their efficacy is under question because of projected lower sensitivity as compared to Real Time Reverse Transcriptase Polymerase Chain Reaction, which although considered gold standard has its own limitations.INTRODUCTIONAs regard to all pandemics, the current COVID-19 pandemic, could also have been better managed with prudent use of preventive measures coupled with rapid diagnostic tools such as rapid antigen tests, but their efficacy is under question because of projected lower sensitivity as compared to Real Time Reverse Transcriptase Polymerase Chain Reaction, which although considered gold standard has its own limitations.A prospective, single centre study was carried out to evaluate the performance of Standard Q COVID-19 Ag, a rapid immuno-chromatographic assay for antigen detection, against TrueNat, a chip-based, point-of-care, portable, Real-Time PCR analyzer for diagnosis of COVID-19; on 467 nasal swab samples from suspected subjects at a fever clinic in North India in month of July 2020.METHODOLOGYA prospective, single centre study was carried out to evaluate the performance of Standard Q COVID-19 Ag, a rapid immuno-chromatographic assay for antigen detection, against TrueNat, a chip-based, point-of-care, portable, Real-Time PCR analyzer for diagnosis of COVID-19; on 467 nasal swab samples from suspected subjects at a fever clinic in North India in month of July 2020.Of the 467 specimens tested, TrueNat showed positive result in 29 (6.2%), majority of whom were asymptomatic (72.4%) while 4/29 (13.9%) had influenza like illness and 2/29 (6.8%) presented with severe acute respiratory illness. Compared to TrueNat, Rapid antigen test gave concordance for 26 samples, while for 2 samples the result was false positive; giving an overall sensitivity of 89.7% (95% CI = 72.6- 97.8) and a specificity of 99.5%, indicating strong agreement between two methods.RESULTSOf the 467 specimens tested, TrueNat showed positive result in 29 (6.2%), majority of whom were asymptomatic (72.4%) while 4/29 (13.9%) had influenza like illness and 2/29 (6.8%) presented with severe acute respiratory illness. Compared to TrueNat, Rapid antigen test gave concordance for 26 samples, while for 2 samples the result was false positive; giving an overall sensitivity of 89.7% (95% CI = 72.6- 97.8) and a specificity of 99.5%, indicating strong agreement between two methods.Community prevalence plays an important role is choosing the laboratory test and result interpretation. Rapid antigen detection tests definitely have a big role to play, especially in resource limited setting, for early diagnosis as well as for source control to halt the spread.CONCLUSIONCommunity prevalence plays an important role is choosing the laboratory test and result interpretation. Rapid antigen detection tests definitely have a big role to play, especially in resource limited setting, for early diagnosis as well as for source control to halt the spread.
Introduction: As regard to all pandemics, the current COVID-19 pandemic, could also have been better managed with prudent use of preventive measures coupled with rapid diagnostic tools such as rapid antigen tests, but their efficacy is under question because of projected lower sensitivity as compared to Real Time Reverse Transcriptase Polymerase Chain Reaction, which although considered gold standard has its own limitations. Methodology: A prospective, single centre study was carried out to evaluate the performance of Standard Q COVID-19 Ag, a rapid immuno-chromatographic assay for antigen detection, against TrueNat, a chip-based, point-of-care, portable, Real-Time PCR analyzer for diagnosis of COVID-19; on 467 nasal swab samples from suspected subjects at a fever clinic in North India in month of July 2020. Results: Of the 467 specimens tested, TrueNat showed positive result in 29 (6.2%), majority of whom were asymptomatic (72.4%) while 4/29 (13.9%) had influenza like illness and 2/29 (6.8%) presented with severe acute respiratory illness. Compared to TrueNat, Rapid antigen test gave concordance for 26 samples, while for 2 samples the result was false positive; giving an overall sensitivity of 89.7% (95% CI = 72.6- 97.8) and a specificity of 99.5%, indicating strong agreement between two methods. Conclusion: Community prevalence plays an important role is choosing the laboratory test and result interpretation. Rapid antigen detection tests definitely have a big role to play, especially in resource limited setting, for early diagnosis as well as for source control to halt the spread.
Author Pandey, Pranshu
Das, Anupam
Sen, Manodeep
Garg, Jaya
Agarwal, Jyotsna
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Copyright (c) 2021 Jyotsna Agarwal, Anupam Das, Pranshu Pandey, Manodeep Sen, Jaya Garg.
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SubjectTerms Antigens
Coronaviruses
COVID-19
Medical diagnosis
Pandemics
Rapid Antigen Test
RAT
RT-PCR
Severe acute respiratory syndrome coronavirus 2
TrueNat
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Title “David vs. Goliath”: A simple antigen detection test with potential to change diagnostic strategy for SARS-CoV-2
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