The Performance of Antigen-detecting Rapid Diagnostic Test Among COVID-19 Outbreaks in North-Eastern Peninsular Malaysia
Background and aims: Accurate and timely diagnosis is crucial for coronavirus disease 2019 (COVID-19) outbreaks. Antigen-detecting rapid diagnostic tests (Ag-RDTs) are easily accessible and affordable, producing rapid results. They are an alternative to the limited gold-standard real-time reverse-tr...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Hazlienor Mohd Hatta [verfasserIn] Nik Mohd Hafiz Mohd Fuzi [verfasserIn] Suhaiza Sulaiman [verfasserIn] Abdul Haris Muhammad [verfasserIn] Zaini Hussin [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2022 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
In: International Journal of Epidemiologic Research - Shahrekord University of Medical Sciences, 2015, 9(2022), 4, Seite 164-170 |
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| Übergeordnetes Werk: |
volume:9 ; year:2022 ; number:4 ; pages:164-170 |
| Links: |
|---|
| DOI / URN: |
10.34172/EHSJ.2022.30 |
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| Katalog-ID: |
DOAJ02484733X |
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| 520 | |a Background and aims: Accurate and timely diagnosis is crucial for coronavirus disease 2019 (COVID-19) outbreaks. Antigen-detecting rapid diagnostic tests (Ag-RDTs) are easily accessible and affordable, producing rapid results. They are an alternative to the limited gold-standard real-time reverse-transcription polymerase chain reaction (rRT-PCR) tests. This study assessed the performance of Ag-RDTs for COVID-19 outbreaks in institutional settings with high disease prevalence in Kelantan State, Malaysia. Methods: This study analyzed a total of 303 individuals from five institutional outbreaks with paired nasopharyngeal specimens tested for COVID-19 by Ag-RDTs and rRT-PCR. The diagnostic performance of Ag-RDTs was evaluated through rRT-PCR as the gold standard based on cycle threshold (Ct) value, disease prevalence, and manufacturers. Results: There was a moderate agreement between Ag-RDTs and RT-PCR (κ = 0.603; 95% CI: 0.520- 0.686; P < 0.001). The overall specificity was 97.9% (95% CI: 94.1%-99.6%), sensitivity was 63.3% (95% CI: 55.3%-70.8%), accuracy Ag-RDTs was 81.2% (95% CI: 76.4%-85.5%), while positive and negative predictive value was 96.6% (95% CI: 90.2%-98.9%) and 74.1% (95% CI: 70.0%-77.9%), respectively. Further, lower median Ct was reported in 100 (33.0%) true-positive cases compared to 58 (19.1%) false-negative cases (20.3 vs 31.4, P < 0.001). The sensitivity was higher (P < 0.001) in those with high viral load (Ct value ≤ 25.0) with better performance and a prevalence < 10%. In addition, no significant difference was observed between the studied manufacturers. Conclusion: The Ag-RDTs performed well in diagnosing COVID-19 among outbreaks with higher viral load and disease prevalence. High-risk cases tested negative by Ag-RDTs may have low viral load and require confirmation by rRT-PCR. | ||
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10.34172/EHSJ.2022.30 doi (DE-627)DOAJ02484733X (DE-599)DOAJ4da219cc09794579903c2ca788a3fcf9 DE-627 ger DE-627 rakwb eng RM1-950 RC109-216 Hazlienor Mohd Hatta verfasserin aut The Performance of Antigen-detecting Rapid Diagnostic Test Among COVID-19 Outbreaks in North-Eastern Peninsular Malaysia 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background and aims: Accurate and timely diagnosis is crucial for coronavirus disease 2019 (COVID-19) outbreaks. Antigen-detecting rapid diagnostic tests (Ag-RDTs) are easily accessible and affordable, producing rapid results. They are an alternative to the limited gold-standard real-time reverse-transcription polymerase chain reaction (rRT-PCR) tests. This study assessed the performance of Ag-RDTs for COVID-19 outbreaks in institutional settings with high disease prevalence in Kelantan State, Malaysia. Methods: This study analyzed a total of 303 individuals from five institutional outbreaks with paired nasopharyngeal specimens tested for COVID-19 by Ag-RDTs and rRT-PCR. The diagnostic performance of Ag-RDTs was evaluated through rRT-PCR as the gold standard based on cycle threshold (Ct) value, disease prevalence, and manufacturers. Results: There was a moderate agreement between Ag-RDTs and RT-PCR (κ = 0.603; 95% CI: 0.520- 0.686; P < 0.001). The overall specificity was 97.9% (95% CI: 94.1%-99.6%), sensitivity was 63.3% (95% CI: 55.3%-70.8%), accuracy Ag-RDTs was 81.2% (95% CI: 76.4%-85.5%), while positive and negative predictive value was 96.6% (95% CI: 90.2%-98.9%) and 74.1% (95% CI: 70.0%-77.9%), respectively. Further, lower median Ct was reported in 100 (33.0%) true-positive cases compared to 58 (19.1%) false-negative cases (20.3 vs 31.4, P < 0.001). The sensitivity was higher (P < 0.001) in those with high viral load (Ct value ≤ 25.0) with better performance and a prevalence < 10%. In addition, no significant difference was observed between the studied manufacturers. Conclusion: The Ag-RDTs performed well in diagnosing COVID-19 among outbreaks with higher viral load and disease prevalence. High-risk cases tested negative by Ag-RDTs may have low viral load and require confirmation by rRT-PCR. accuracy covid-19 diagnostic performance rapid antigen test Therapeutics. Pharmacology Infectious and parasitic diseases Nik Mohd Hafiz Mohd Fuzi verfasserin aut Suhaiza Sulaiman verfasserin aut Abdul Haris Muhammad verfasserin aut Zaini Hussin verfasserin aut In International Journal of Epidemiologic Research Shahrekord University of Medical Sciences, 2015 9(2022), 4, Seite 164-170 (DE-627)1760632457 23834366 nnns volume:9 year:2022 number:4 pages:164-170 https://doi.org/10.34172/EHSJ.2022.30 kostenfrei https://doaj.org/article/4da219cc09794579903c2ca788a3fcf9 kostenfrei http://ijer.skums.ac.ir/article_252369_e45d5c8d2a44881e08a26e6f2c0f7598.pdf kostenfrei https://doaj.org/toc/2383-4366 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA AR 9 2022 4 164-170 |
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10.34172/EHSJ.2022.30 doi (DE-627)DOAJ02484733X (DE-599)DOAJ4da219cc09794579903c2ca788a3fcf9 DE-627 ger DE-627 rakwb eng RM1-950 RC109-216 Hazlienor Mohd Hatta verfasserin aut The Performance of Antigen-detecting Rapid Diagnostic Test Among COVID-19 Outbreaks in North-Eastern Peninsular Malaysia 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background and aims: Accurate and timely diagnosis is crucial for coronavirus disease 2019 (COVID-19) outbreaks. Antigen-detecting rapid diagnostic tests (Ag-RDTs) are easily accessible and affordable, producing rapid results. They are an alternative to the limited gold-standard real-time reverse-transcription polymerase chain reaction (rRT-PCR) tests. This study assessed the performance of Ag-RDTs for COVID-19 outbreaks in institutional settings with high disease prevalence in Kelantan State, Malaysia. Methods: This study analyzed a total of 303 individuals from five institutional outbreaks with paired nasopharyngeal specimens tested for COVID-19 by Ag-RDTs and rRT-PCR. The diagnostic performance of Ag-RDTs was evaluated through rRT-PCR as the gold standard based on cycle threshold (Ct) value, disease prevalence, and manufacturers. Results: There was a moderate agreement between Ag-RDTs and RT-PCR (κ = 0.603; 95% CI: 0.520- 0.686; P < 0.001). The overall specificity was 97.9% (95% CI: 94.1%-99.6%), sensitivity was 63.3% (95% CI: 55.3%-70.8%), accuracy Ag-RDTs was 81.2% (95% CI: 76.4%-85.5%), while positive and negative predictive value was 96.6% (95% CI: 90.2%-98.9%) and 74.1% (95% CI: 70.0%-77.9%), respectively. Further, lower median Ct was reported in 100 (33.0%) true-positive cases compared to 58 (19.1%) false-negative cases (20.3 vs 31.4, P < 0.001). The sensitivity was higher (P < 0.001) in those with high viral load (Ct value ≤ 25.0) with better performance and a prevalence < 10%. In addition, no significant difference was observed between the studied manufacturers. Conclusion: The Ag-RDTs performed well in diagnosing COVID-19 among outbreaks with higher viral load and disease prevalence. High-risk cases tested negative by Ag-RDTs may have low viral load and require confirmation by rRT-PCR. accuracy covid-19 diagnostic performance rapid antigen test Therapeutics. Pharmacology Infectious and parasitic diseases Nik Mohd Hafiz Mohd Fuzi verfasserin aut Suhaiza Sulaiman verfasserin aut Abdul Haris Muhammad verfasserin aut Zaini Hussin verfasserin aut In International Journal of Epidemiologic Research Shahrekord University of Medical Sciences, 2015 9(2022), 4, Seite 164-170 (DE-627)1760632457 23834366 nnns volume:9 year:2022 number:4 pages:164-170 https://doi.org/10.34172/EHSJ.2022.30 kostenfrei https://doaj.org/article/4da219cc09794579903c2ca788a3fcf9 kostenfrei http://ijer.skums.ac.ir/article_252369_e45d5c8d2a44881e08a26e6f2c0f7598.pdf kostenfrei https://doaj.org/toc/2383-4366 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA AR 9 2022 4 164-170 |
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10.34172/EHSJ.2022.30 doi (DE-627)DOAJ02484733X (DE-599)DOAJ4da219cc09794579903c2ca788a3fcf9 DE-627 ger DE-627 rakwb eng RM1-950 RC109-216 Hazlienor Mohd Hatta verfasserin aut The Performance of Antigen-detecting Rapid Diagnostic Test Among COVID-19 Outbreaks in North-Eastern Peninsular Malaysia 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background and aims: Accurate and timely diagnosis is crucial for coronavirus disease 2019 (COVID-19) outbreaks. Antigen-detecting rapid diagnostic tests (Ag-RDTs) are easily accessible and affordable, producing rapid results. They are an alternative to the limited gold-standard real-time reverse-transcription polymerase chain reaction (rRT-PCR) tests. This study assessed the performance of Ag-RDTs for COVID-19 outbreaks in institutional settings with high disease prevalence in Kelantan State, Malaysia. Methods: This study analyzed a total of 303 individuals from five institutional outbreaks with paired nasopharyngeal specimens tested for COVID-19 by Ag-RDTs and rRT-PCR. The diagnostic performance of Ag-RDTs was evaluated through rRT-PCR as the gold standard based on cycle threshold (Ct) value, disease prevalence, and manufacturers. Results: There was a moderate agreement between Ag-RDTs and RT-PCR (κ = 0.603; 95% CI: 0.520- 0.686; P < 0.001). The overall specificity was 97.9% (95% CI: 94.1%-99.6%), sensitivity was 63.3% (95% CI: 55.3%-70.8%), accuracy Ag-RDTs was 81.2% (95% CI: 76.4%-85.5%), while positive and negative predictive value was 96.6% (95% CI: 90.2%-98.9%) and 74.1% (95% CI: 70.0%-77.9%), respectively. Further, lower median Ct was reported in 100 (33.0%) true-positive cases compared to 58 (19.1%) false-negative cases (20.3 vs 31.4, P < 0.001). The sensitivity was higher (P < 0.001) in those with high viral load (Ct value ≤ 25.0) with better performance and a prevalence < 10%. In addition, no significant difference was observed between the studied manufacturers. Conclusion: The Ag-RDTs performed well in diagnosing COVID-19 among outbreaks with higher viral load and disease prevalence. High-risk cases tested negative by Ag-RDTs may have low viral load and require confirmation by rRT-PCR. accuracy covid-19 diagnostic performance rapid antigen test Therapeutics. Pharmacology Infectious and parasitic diseases Nik Mohd Hafiz Mohd Fuzi verfasserin aut Suhaiza Sulaiman verfasserin aut Abdul Haris Muhammad verfasserin aut Zaini Hussin verfasserin aut In International Journal of Epidemiologic Research Shahrekord University of Medical Sciences, 2015 9(2022), 4, Seite 164-170 (DE-627)1760632457 23834366 nnns volume:9 year:2022 number:4 pages:164-170 https://doi.org/10.34172/EHSJ.2022.30 kostenfrei https://doaj.org/article/4da219cc09794579903c2ca788a3fcf9 kostenfrei http://ijer.skums.ac.ir/article_252369_e45d5c8d2a44881e08a26e6f2c0f7598.pdf kostenfrei https://doaj.org/toc/2383-4366 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA AR 9 2022 4 164-170 |
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10.34172/EHSJ.2022.30 doi (DE-627)DOAJ02484733X (DE-599)DOAJ4da219cc09794579903c2ca788a3fcf9 DE-627 ger DE-627 rakwb eng RM1-950 RC109-216 Hazlienor Mohd Hatta verfasserin aut The Performance of Antigen-detecting Rapid Diagnostic Test Among COVID-19 Outbreaks in North-Eastern Peninsular Malaysia 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background and aims: Accurate and timely diagnosis is crucial for coronavirus disease 2019 (COVID-19) outbreaks. Antigen-detecting rapid diagnostic tests (Ag-RDTs) are easily accessible and affordable, producing rapid results. They are an alternative to the limited gold-standard real-time reverse-transcription polymerase chain reaction (rRT-PCR) tests. This study assessed the performance of Ag-RDTs for COVID-19 outbreaks in institutional settings with high disease prevalence in Kelantan State, Malaysia. Methods: This study analyzed a total of 303 individuals from five institutional outbreaks with paired nasopharyngeal specimens tested for COVID-19 by Ag-RDTs and rRT-PCR. The diagnostic performance of Ag-RDTs was evaluated through rRT-PCR as the gold standard based on cycle threshold (Ct) value, disease prevalence, and manufacturers. Results: There was a moderate agreement between Ag-RDTs and RT-PCR (κ = 0.603; 95% CI: 0.520- 0.686; P < 0.001). The overall specificity was 97.9% (95% CI: 94.1%-99.6%), sensitivity was 63.3% (95% CI: 55.3%-70.8%), accuracy Ag-RDTs was 81.2% (95% CI: 76.4%-85.5%), while positive and negative predictive value was 96.6% (95% CI: 90.2%-98.9%) and 74.1% (95% CI: 70.0%-77.9%), respectively. Further, lower median Ct was reported in 100 (33.0%) true-positive cases compared to 58 (19.1%) false-negative cases (20.3 vs 31.4, P < 0.001). The sensitivity was higher (P < 0.001) in those with high viral load (Ct value ≤ 25.0) with better performance and a prevalence < 10%. In addition, no significant difference was observed between the studied manufacturers. Conclusion: The Ag-RDTs performed well in diagnosing COVID-19 among outbreaks with higher viral load and disease prevalence. High-risk cases tested negative by Ag-RDTs may have low viral load and require confirmation by rRT-PCR. accuracy covid-19 diagnostic performance rapid antigen test Therapeutics. Pharmacology Infectious and parasitic diseases Nik Mohd Hafiz Mohd Fuzi verfasserin aut Suhaiza Sulaiman verfasserin aut Abdul Haris Muhammad verfasserin aut Zaini Hussin verfasserin aut In International Journal of Epidemiologic Research Shahrekord University of Medical Sciences, 2015 9(2022), 4, Seite 164-170 (DE-627)1760632457 23834366 nnns volume:9 year:2022 number:4 pages:164-170 https://doi.org/10.34172/EHSJ.2022.30 kostenfrei https://doaj.org/article/4da219cc09794579903c2ca788a3fcf9 kostenfrei http://ijer.skums.ac.ir/article_252369_e45d5c8d2a44881e08a26e6f2c0f7598.pdf kostenfrei https://doaj.org/toc/2383-4366 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA AR 9 2022 4 164-170 |
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10.34172/EHSJ.2022.30 doi (DE-627)DOAJ02484733X (DE-599)DOAJ4da219cc09794579903c2ca788a3fcf9 DE-627 ger DE-627 rakwb eng RM1-950 RC109-216 Hazlienor Mohd Hatta verfasserin aut The Performance of Antigen-detecting Rapid Diagnostic Test Among COVID-19 Outbreaks in North-Eastern Peninsular Malaysia 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background and aims: Accurate and timely diagnosis is crucial for coronavirus disease 2019 (COVID-19) outbreaks. Antigen-detecting rapid diagnostic tests (Ag-RDTs) are easily accessible and affordable, producing rapid results. They are an alternative to the limited gold-standard real-time reverse-transcription polymerase chain reaction (rRT-PCR) tests. This study assessed the performance of Ag-RDTs for COVID-19 outbreaks in institutional settings with high disease prevalence in Kelantan State, Malaysia. Methods: This study analyzed a total of 303 individuals from five institutional outbreaks with paired nasopharyngeal specimens tested for COVID-19 by Ag-RDTs and rRT-PCR. The diagnostic performance of Ag-RDTs was evaluated through rRT-PCR as the gold standard based on cycle threshold (Ct) value, disease prevalence, and manufacturers. Results: There was a moderate agreement between Ag-RDTs and RT-PCR (κ = 0.603; 95% CI: 0.520- 0.686; P < 0.001). The overall specificity was 97.9% (95% CI: 94.1%-99.6%), sensitivity was 63.3% (95% CI: 55.3%-70.8%), accuracy Ag-RDTs was 81.2% (95% CI: 76.4%-85.5%), while positive and negative predictive value was 96.6% (95% CI: 90.2%-98.9%) and 74.1% (95% CI: 70.0%-77.9%), respectively. Further, lower median Ct was reported in 100 (33.0%) true-positive cases compared to 58 (19.1%) false-negative cases (20.3 vs 31.4, P < 0.001). The sensitivity was higher (P < 0.001) in those with high viral load (Ct value ≤ 25.0) with better performance and a prevalence < 10%. In addition, no significant difference was observed between the studied manufacturers. Conclusion: The Ag-RDTs performed well in diagnosing COVID-19 among outbreaks with higher viral load and disease prevalence. High-risk cases tested negative by Ag-RDTs may have low viral load and require confirmation by rRT-PCR. accuracy covid-19 diagnostic performance rapid antigen test Therapeutics. Pharmacology Infectious and parasitic diseases Nik Mohd Hafiz Mohd Fuzi verfasserin aut Suhaiza Sulaiman verfasserin aut Abdul Haris Muhammad verfasserin aut Zaini Hussin verfasserin aut In International Journal of Epidemiologic Research Shahrekord University of Medical Sciences, 2015 9(2022), 4, Seite 164-170 (DE-627)1760632457 23834366 nnns volume:9 year:2022 number:4 pages:164-170 https://doi.org/10.34172/EHSJ.2022.30 kostenfrei https://doaj.org/article/4da219cc09794579903c2ca788a3fcf9 kostenfrei http://ijer.skums.ac.ir/article_252369_e45d5c8d2a44881e08a26e6f2c0f7598.pdf kostenfrei https://doaj.org/toc/2383-4366 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA AR 9 2022 4 164-170 |
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Antigen-detecting rapid diagnostic tests (Ag-RDTs) are easily accessible and affordable, producing rapid results. They are an alternative to the limited gold-standard real-time reverse-transcription polymerase chain reaction (rRT-PCR) tests. This study assessed the performance of Ag-RDTs for COVID-19 outbreaks in institutional settings with high disease prevalence in Kelantan State, Malaysia. Methods: This study analyzed a total of 303 individuals from five institutional outbreaks with paired nasopharyngeal specimens tested for COVID-19 by Ag-RDTs and rRT-PCR. The diagnostic performance of Ag-RDTs was evaluated through rRT-PCR as the gold standard based on cycle threshold (Ct) value, disease prevalence, and manufacturers. Results: There was a moderate agreement between Ag-RDTs and RT-PCR (κ = 0.603; 95% CI: 0.520- 0.686; P < 0.001). The overall specificity was 97.9% (95% CI: 94.1%-99.6%), sensitivity was 63.3% (95% CI: 55.3%-70.8%), accuracy Ag-RDTs was 81.2% (95% CI: 76.4%-85.5%), while positive and negative predictive value was 96.6% (95% CI: 90.2%-98.9%) and 74.1% (95% CI: 70.0%-77.9%), respectively. Further, lower median Ct was reported in 100 (33.0%) true-positive cases compared to 58 (19.1%) false-negative cases (20.3 vs 31.4, P < 0.001). The sensitivity was higher (P < 0.001) in those with high viral load (Ct value ≤ 25.0) with better performance and a prevalence < 10%. In addition, no significant difference was observed between the studied manufacturers. Conclusion: The Ag-RDTs performed well in diagnosing COVID-19 among outbreaks with higher viral load and disease prevalence. 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The Performance of Antigen-detecting Rapid Diagnostic Test Among COVID-19 Outbreaks in North-Eastern Peninsular Malaysia |
| abstract |
Background and aims: Accurate and timely diagnosis is crucial for coronavirus disease 2019 (COVID-19) outbreaks. Antigen-detecting rapid diagnostic tests (Ag-RDTs) are easily accessible and affordable, producing rapid results. They are an alternative to the limited gold-standard real-time reverse-transcription polymerase chain reaction (rRT-PCR) tests. This study assessed the performance of Ag-RDTs for COVID-19 outbreaks in institutional settings with high disease prevalence in Kelantan State, Malaysia. Methods: This study analyzed a total of 303 individuals from five institutional outbreaks with paired nasopharyngeal specimens tested for COVID-19 by Ag-RDTs and rRT-PCR. The diagnostic performance of Ag-RDTs was evaluated through rRT-PCR as the gold standard based on cycle threshold (Ct) value, disease prevalence, and manufacturers. Results: There was a moderate agreement between Ag-RDTs and RT-PCR (κ = 0.603; 95% CI: 0.520- 0.686; P < 0.001). The overall specificity was 97.9% (95% CI: 94.1%-99.6%), sensitivity was 63.3% (95% CI: 55.3%-70.8%), accuracy Ag-RDTs was 81.2% (95% CI: 76.4%-85.5%), while positive and negative predictive value was 96.6% (95% CI: 90.2%-98.9%) and 74.1% (95% CI: 70.0%-77.9%), respectively. Further, lower median Ct was reported in 100 (33.0%) true-positive cases compared to 58 (19.1%) false-negative cases (20.3 vs 31.4, P < 0.001). The sensitivity was higher (P < 0.001) in those with high viral load (Ct value ≤ 25.0) with better performance and a prevalence < 10%. In addition, no significant difference was observed between the studied manufacturers. Conclusion: The Ag-RDTs performed well in diagnosing COVID-19 among outbreaks with higher viral load and disease prevalence. High-risk cases tested negative by Ag-RDTs may have low viral load and require confirmation by rRT-PCR. |
| abstractGer |
Background and aims: Accurate and timely diagnosis is crucial for coronavirus disease 2019 (COVID-19) outbreaks. Antigen-detecting rapid diagnostic tests (Ag-RDTs) are easily accessible and affordable, producing rapid results. They are an alternative to the limited gold-standard real-time reverse-transcription polymerase chain reaction (rRT-PCR) tests. This study assessed the performance of Ag-RDTs for COVID-19 outbreaks in institutional settings with high disease prevalence in Kelantan State, Malaysia. Methods: This study analyzed a total of 303 individuals from five institutional outbreaks with paired nasopharyngeal specimens tested for COVID-19 by Ag-RDTs and rRT-PCR. The diagnostic performance of Ag-RDTs was evaluated through rRT-PCR as the gold standard based on cycle threshold (Ct) value, disease prevalence, and manufacturers. Results: There was a moderate agreement between Ag-RDTs and RT-PCR (κ = 0.603; 95% CI: 0.520- 0.686; P < 0.001). The overall specificity was 97.9% (95% CI: 94.1%-99.6%), sensitivity was 63.3% (95% CI: 55.3%-70.8%), accuracy Ag-RDTs was 81.2% (95% CI: 76.4%-85.5%), while positive and negative predictive value was 96.6% (95% CI: 90.2%-98.9%) and 74.1% (95% CI: 70.0%-77.9%), respectively. Further, lower median Ct was reported in 100 (33.0%) true-positive cases compared to 58 (19.1%) false-negative cases (20.3 vs 31.4, P < 0.001). The sensitivity was higher (P < 0.001) in those with high viral load (Ct value ≤ 25.0) with better performance and a prevalence < 10%. In addition, no significant difference was observed between the studied manufacturers. Conclusion: The Ag-RDTs performed well in diagnosing COVID-19 among outbreaks with higher viral load and disease prevalence. High-risk cases tested negative by Ag-RDTs may have low viral load and require confirmation by rRT-PCR. |
| abstract_unstemmed |
Background and aims: Accurate and timely diagnosis is crucial for coronavirus disease 2019 (COVID-19) outbreaks. Antigen-detecting rapid diagnostic tests (Ag-RDTs) are easily accessible and affordable, producing rapid results. They are an alternative to the limited gold-standard real-time reverse-transcription polymerase chain reaction (rRT-PCR) tests. This study assessed the performance of Ag-RDTs for COVID-19 outbreaks in institutional settings with high disease prevalence in Kelantan State, Malaysia. Methods: This study analyzed a total of 303 individuals from five institutional outbreaks with paired nasopharyngeal specimens tested for COVID-19 by Ag-RDTs and rRT-PCR. The diagnostic performance of Ag-RDTs was evaluated through rRT-PCR as the gold standard based on cycle threshold (Ct) value, disease prevalence, and manufacturers. Results: There was a moderate agreement between Ag-RDTs and RT-PCR (κ = 0.603; 95% CI: 0.520- 0.686; P < 0.001). The overall specificity was 97.9% (95% CI: 94.1%-99.6%), sensitivity was 63.3% (95% CI: 55.3%-70.8%), accuracy Ag-RDTs was 81.2% (95% CI: 76.4%-85.5%), while positive and negative predictive value was 96.6% (95% CI: 90.2%-98.9%) and 74.1% (95% CI: 70.0%-77.9%), respectively. Further, lower median Ct was reported in 100 (33.0%) true-positive cases compared to 58 (19.1%) false-negative cases (20.3 vs 31.4, P < 0.001). The sensitivity was higher (P < 0.001) in those with high viral load (Ct value ≤ 25.0) with better performance and a prevalence < 10%. In addition, no significant difference was observed between the studied manufacturers. Conclusion: The Ag-RDTs performed well in diagnosing COVID-19 among outbreaks with higher viral load and disease prevalence. High-risk cases tested negative by Ag-RDTs may have low viral load and require confirmation by rRT-PCR. |
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