Update of European Society of Clinical Microbiology and Infectious Diseases coronavirus disease 2019 guidelines: diagnostic testing for severe acute respiratory syndrome coronavirus 2

Fragkou, Paraskevi C.; Angelis, Giulia De; Menchinelli, Giulia; Can, Füsun; García, Féderico; Morfin-Sherpa, Florence; Dimopoulou, Dimitra; Dimopoulou, Konstantina; Zelli, Silvia; Salazar, Adolfo de; Reiter, Rieke; Janocha, Hannah; Grossi, Adriano; Omony, Jimmy; Skevaki, Chrysanthi

doi:10.1016/j.cmi.2023.04.019

Cited by 3 publications

(1 citation statement)

References 183 publications

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“…There have been a number of systematic evidence syntheses on the diagnostic performance of instrument-free antigen detection tests for SARS-CoV-2 [ 9 , 11 , 14 – 16 ]; however, the performance of iAg tests has received relatively little attention. Previous review articles combined data from instrument-free and instrument-based antigen tests regardless of their development stage [ 10 , 14 ].…”

Section: Background and Rationalementioning

confidence: 99%

Clinical accuracy of instrument-based SARS-CoV-2 antigen diagnostic tests: a systematic review and meta-analysis

Manten,

Katzenschlager,

Brümmer

et al. 2024

Virol J

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Background During the COVID-19 pandemic, antigen diagnostic tests were frequently used for screening, triage, and diagnosis. Novel instrument-based antigen tests (iAg tests) hold the promise of outperforming their instrument-free, visually-read counterparts. Here, we provide a systematic review and meta-analysis of the SARS-CoV-2 iAg tests’ clinical accuracy. Methods We systematically searched MEDLINE (via PubMed), Web of Science, medRxiv, and bioRxiv for articles published before November 7th, 2022, evaluating the accuracy of iAg tests for SARS-CoV-2 detection. We performed a random effects meta-analysis to estimate sensitivity and specificity and used the QUADAS-2 tool to assess study quality and risk of bias. Sub-group analysis was conducted based on Ct value range, IFU-conformity, age, symptom presence and duration, and the variant of concern. Results We screened the titles and abstracts of 20,431 articles and included 114 publications that fulfilled the inclusion criteria. Additionally, we incorporated three articles sourced from the FIND website, totaling 117 studies encompassing 95,181 individuals, which evaluated the clinical accuracy of 24 commercial COVID-19 iAg tests. The studies varied in risk of bias but showed high applicability. Of 24 iAg tests from 99 studies assessed in the meta-analysis, the pooled sensitivity and specificity compared to molecular testing of a paired NP swab sample were 76.7% (95% CI 73.5 to 79.7) and 98.4% (95% CI 98.0 to 98.7), respectively. Higher sensitivity was noted in individuals with high viral load (99.6% [95% CI 96.8 to 100] at Ct-level ≤ 20) and within the first week of symptom onset (84.6% [95% CI 78.2 to 89.3]), but did not differ between tests conducted as per manufacturer’s instructions and those conducted differently, or between point-of-care and lab-based testing. Conclusion Overall, iAg tests have a high pooled specificity but a moderate pooled sensitivity, according to our analysis. The pooled sensitivity increases with lower Ct-values (a proxy for viral load), or within the first week of symptom onset, enabling reliable identification of most COVID-19 cases and highlighting the importance of context in test selection. The study underscores the need for careful evaluation considering performance variations and operational features of iAg tests.

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Section: Background and Rationalementioning

confidence: 99%

Clinical accuracy of instrument-based SARS-CoV-2 antigen diagnostic tests: a systematic review and meta-analysis

Manten,

Katzenschlager,

Brümmer

et al. 2024

Virol J

View full text Add to dashboard Cite

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Current Perspectives on Antigen Testing in Respiratory Infections

Dimopoulou,

Skevaki

2024

Pediatric Infectious Disease Journal

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Clinical accuracy of instrument-based SARS-CoV-2 antigen diagnostic tests: A systematic review and meta-analysis

Manten,

Katzenschlager,

Brümmer

et al. 2024

Preprint

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Background During the COVID-19 pandemic, antigen diagnostic tests were frequently used for screening, triage, and diagnosis because they are faster and less expensive than molecular tests, despite being less sensitive terms of analytical and clinical performance. Novel instrument-based antigen tests (iAg tests) hold the promise of outperforming their instrument-free, visually-read counterparts. Here, we provide a systematic review and meta-analysis of the SARS-CoV-2 iAg tests’ clinical accuracy. Methods We systematically searched MEDLINE (via PubMed), Web of Science, medRxiv, and bioRxiv for articles published before November 7th, 2022, evaluating the accuracy of iAg tests for SARS-CoV-2 detection. We performed a random effects meta-analysis to estimate sensitivity and specificity and used the QUADAS-2 tool to assess study quality and risk of bias. Results We compiled the data from 117 studies involving 95,181 individuals and assessing the clinical accuracy of 24 commercial COVID-19 iAg tests. The studies varied in risk of bias but showed high applicability. Of 24 iAg tests from 99 studies assessed in the meta-analysis, the pooled sensitivity and specificity compared to molecular testing of a paired NP swab sample were 76.7% (95% CI 73.5 to 79.7) and 98.4% (95% CI 98.0 to 98.7), respectively. Out of the eight tests with sufficient data for test-specific meta-analysis, only LumiraDx satisfied the WHO's sensitivity and specificity standards. Higher sensitivity was noted in individuals with high viral load (99.6% [95% CI 96.8 to 100] at Ct-level ≤ 20) and within the first week of symptom onset (84.6% [95% CI 78.2 to 89.3]), but did not differ between tests conducted as per manufacturer’s instructions and those conducted differently, or between point-of-care and lab-based testing. Conclusion Our study reveals that iAg tests' pooled sensitivity increases with lower Ct-values, a proxy for viral load, or within the first week of symptom onset, enabling reliable identification of most COVID-19 cases. While these characteristics are similar to those of instrument-free antigen diagnostics, different types of iAg tests might allow standardized result interpretation to curb human error, automated reporting, upscaling test runs or additional test-specific functions, such as the indication of antigen levels. Depending on their setup, they can be used at the point of care or at a laboratory with high-throughput.

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Update of European Society of Clinical Microbiology and Infectious Diseases coronavirus disease 2019 guidelines: diagnostic testing for severe acute respiratory syndrome coronavirus 2

Cited by 3 publications

References 183 publications

Clinical accuracy of instrument-based SARS-CoV-2 antigen diagnostic tests: a systematic review and meta-analysis

Clinical accuracy of instrument-based SARS-CoV-2 antigen diagnostic tests: a systematic review and meta-analysis

Current Perspectives on Antigen Testing in Respiratory Infections

Clinical accuracy of instrument-based SARS-CoV-2 antigen diagnostic tests: A systematic review and meta-analysis

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