Clinical Accuracy of Instrument-Read SARS-CoV-2 Antigen Rapid Diagnostic Tests (Ag-IRRDTs)

Keskïn, Ali

doi:10.1155/2022/9489067

Cited by 5 publications

(8 citation statements)

References 67 publications

(34 reference statements)

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“…The sensitivity estimate falls short of the WHO's minimal acceptable sensitivity requirement (≥ 80%), while the pooled speci city exceeded the acceptable speci city requirement (≥ 97%) (68). One test (LumiraDx) met the requirements for both sensitivity and speci city at 81.1% (95% CI 73.2 to 87.0%) and 97.3% (95% CI 95.7 to 98.3), respectively, aligning with earlier reports (11,17,18). However, when assessing symptomatic individuals within the rst week of symptom onset, the pooled performance estimates of all iAg tests satis ed the WHO requirements, indicating the high utility of these tests in this particular population.…”

Section: Discussionsupporting

confidence: 86%

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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Section: Discussionsupporting

confidence: 86%

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

Manten,

Katzenschlager,

Brümmer

et al. 2024

Preprint

View full text Add to dashboard Cite

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“…In a mixed population of symptomatic and asymptomatic individuals, the sensitivity estimate falls short of the WHO’s minimal acceptable sensitivity requirement (≥ 80%), while the pooled specificity exceeded the acceptable specificity requirement (≥ 97%) [ 4 ]. One test (LumiraDx) met the requirements for both sensitivity and specificity at 81.1% (95% CI 73.2 to 87.0%) and 97.3% (95% CI 95.7 to 98.3), respectively, aligning with earlier reports [ 11 , 17 , 18 ].…”

Section: Discussionsupporting

confidence: 86%

“…Overall, we found that the clinical accuracy of the POC and lab-based iAg tests included in the review was comparable. Of note, we estimated the pooled sensitivity of POC-applicable iAg tests to be 76.1% (95% CI 72.1 to 79.7), higher than the 67.1% sensitivity that was previously reported by Keskin et al [ 17 ]. Although there were notably more studies in our review, the overall sample size was smaller.…”

Section: Discussioncontrasting

confidence: 67%

“…Previous review articles combined data from instrument-free and instrument-based antigen tests regardless of their development stage [ 10 , 14 ]. Only digital and fluorescence immunoassays, which are often more appropriate for point-of-care (POC) use, were considered in the review by Keskin et al, specifically focused on iAg tests [ 17 ]. Here, we conducted a systematic review and meta-analysis to assess the clinical performance of commercially available iAg tests for detecting current SARS-CoV-2 infection compared to RT-qPCR and/or culture as the reference standard.…”

Section: Background and Rationalementioning

confidence: 99%

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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

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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“…Nevertheless, the observed sensitivity and specificity of the Ag-RDTs in relation to the RT-PCR appears to be in line with those reported for other studies involving the same Ag-RDTs as used in our pilot project [ 20 , 21 ]. It should be noted, however, that the performance of Ag-RDTs varies among brands [ 22 ]. Therefore, policymakers should pay careful attention when selecting suitable Ag-RDTs for testing programs.…”

Section: Discussionmentioning

confidence: 99%

Feasibility, Uptake, and Results of COVID-19 Antigen Rapid Diagnostic Tests among Refugees and Migrants in a Pilot Project in North-West Syria

Ghawji¹,

Alyousfi²,

Satyanarayana³

et al. 2023

TropicalMed

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North-west Syria (NWS) is a conflict-affected and unstable area. Due to its limited health infrastructure, accessing advanced COVID-19 testing services is challenging. COVID-19 antigen rapid diagnostic tests (Ag-RDTs) have the potential to overcome this barrier. A pilot project was implemented to introduce Ag-RDTs in NWS, aiming to determine the feasibility, uptake, and results of Ag-RDTs and identify facilitators and barriers to testing with Ag-RDTs. A cross-sectional study design involving secondary analysis of data collected during the project was employed. A local non-governmental organization implemented 25,000 Ag-RDTs that were conducted cross-border by trained community health workers. In total, 27,888 eligible individuals were enrolled, 24,956 (89.5%) consented to test, and 121 (0.5%) were COVID-19-positive. The highest positivity was observed among those with severe COVID-19 symptoms (12.7%), with respiratory illnesses (2.5%), enrolled at hospitals in Afrin (2.5%), and healthcare workers (1.9%). A non-random sample of 236 individuals underwent confirmatory RT-PCR testing. Observed sensitivity, specificity, and positive and negative predictive values were 80.0%, 96.1%, 91.4%, and 90.3%, respectively. Challenges included obtaining informed consent and conducting confirmatory testing. Ag-RDTs represent a feasible screening/diagnostic tool for COVID-19 infections in NWS, with nearly 90% uptake. Embedding Ag-RDTs into COVID-19 testing and screening strategies would be highly beneficial.

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Clinical Accuracy of Instrument-Read SARS-CoV-2 Antigen Rapid Diagnostic Tests (Ag-IRRDTs)

Cited by 5 publications

References 67 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

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

Feasibility, Uptake, and Results of COVID-19 Antigen Rapid Diagnostic Tests among Refugees and Migrants in a Pilot Project in North-West Syria

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