Performance of SARS-CoV-2 rapid antigen test compared with real-time RT-PCR in asymptomatic individuals

Peña, Mónica; Ampuero, Manuel; Garcés, Carlos; Gaggero, Aldo; García, Patricia; Velasquez, María Soledad; Luza, Ricardo; Alvarez, Pía; Paredes, Fabio; Acevedo, Johanna; Farfán, Mauricio J.; Solari, Sandra; Soto-Rifo, Ricardo; Valiente-Echeverría, y Fernando

doi:10.1016/j.ijid.2021.04.087

Cited by 58 publications

(43 citation statements)

References 15 publications

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“…At the end of the data extraction process, 37 studies were still in preprint form [4,171,173,174,177,180,190,192,201,204,205,207,211,[214][215][216]218,220,222,223,225,227,231,233,234,238,240,244,247,253,257,265,267,284,287,290,293]. All studies were written in English, except for 2 in Spanish [175,280].…”

Section: Summary Of Studiesmentioning

confidence: 99%

Accuracy of novel antigen rapid diagnostics for SARS-CoV-2: A living systematic review and meta-analysis

et al. 2021

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Background SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDTs) are increasingly being integrated in testing strategies around the world. Studies of the Ag-RDTs have shown variable performance. In this systematic review and meta-analysis, we assessed the clinical accuracy (sensitivity and specificity) of commercially available Ag-RDTs. Methods and findings We registered the review on PROSPERO (registration number: CRD42020225140). We systematically searched multiple databases (PubMed, Web of Science Core Collection, medRvix, bioRvix, and FIND) for publications evaluating the accuracy of Ag-RDTs for SARS-CoV-2 up until 30 April 2021. Descriptive analyses of all studies were performed, and when more than 4 studies were available, a random-effects meta-analysis was used to estimate pooled sensitivity and specificity in comparison to reverse transcription polymerase chain reaction (RT-PCR) testing. We assessed heterogeneity by subgroup analyses, and rated study quality and risk of bias using the QUADAS-2 assessment tool. From a total of 14,254 articles, we included 133 analytical and clinical studies resulting in 214 clinical accuracy datasets with 112,323 samples. Across all meta-analyzed samples, the pooled Ag-RDT sensitivity and specificity were 71.2% (95% CI 68.2% to 74.0%) and 98.9% (95% CI 98.6% to 99.1%), respectively. Sensitivity increased to 76.3% (95% CI 73.1% to 79.2%) if analysis was restricted to studies that followed the Ag-RDT manufacturers’ instructions. LumiraDx showed the highest sensitivity, with 88.2% (95% CI 59.0% to 97.5%). Of instrument-free Ag-RDTs, Standard Q nasal performed best, with 80.2% sensitivity (95% CI 70.3% to 87.4%). Across all Ag-RDTs, sensitivity was markedly better on samples with lower RT-PCR cycle threshold (Ct) values, i.e., <20 (96.5%, 95% CI 92.6% to 98.4%) and <25 (95.8%, 95% CI 92.3% to 97.8%), in comparison to those with Ct ≥ 25 (50.7%, 95% CI 35.6% to 65.8%) and ≥30 (20.9%, 95% CI 12.5% to 32.8%). Testing in the first week from symptom onset resulted in substantially higher sensitivity (83.8%, 95% CI 76.3% to 89.2%) compared to testing after 1 week (61.5%, 95% CI 52.2% to 70.0%). The best Ag-RDT sensitivity was found with anterior nasal sampling (75.5%, 95% CI 70.4% to 79.9%), in comparison to other sample types (e.g., nasopharyngeal, 71.6%, 95% CI 68.1% to 74.9%), although CIs were overlapping. Concerns of bias were raised across all datasets, and financial support from the manufacturer was reported in 24.1% of datasets. Our analysis was limited by the included studies’ heterogeneity in design and reporting. Conclusions In this study we found that Ag-RDTs detect the vast majority of SARS-CoV-2-infected persons within the first week of symptom onset and those with high viral load. Thus, they can have high utility for diagnostic purposes in the early phase of disease, making them a valuable tool to fight the spread of SARS-CoV-2. Standardization in conduct and reporting of clinical accuracy studies would improve comparability and use of data.

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Section: Summary Of Studiesmentioning

confidence: 99%

Accuracy of novel antigen rapid diagnostics for SARS-CoV-2: A living systematic review and meta-analysis

et al. 2021

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“…Eighteen studies with 34,865 participants were retrieved [16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33]. Figure 1 depicts the process of the literature search, and Table 1 presents detailed characteristics of the studies.…”

Section: Resultsmentioning

confidence: 99%

Diagnostic Accuracy of SARS-CoV-2 Antigen Tests for Community Transmission Screening: A Systematic Review and Meta-Analysis

Chen

Bai

et al. 2021

IJERPH

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Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) caused the global pandemic of coronavirus disease 2019 (COVID-19). Rapid identification and isolation of infectious patients are critical methods to block COVID-19 transmission. Antigen tests can contribute to prompt identification of infectious individuals. This meta-analysis aims to evaluate the diagnostic accuracy of antigen tests for SARS-CoV-2. We conducted a literature search in PubMed, Embase, the Cochrane Library, and Biomed Central databases. Studies evaluating the diagnostic accuracy of antigen tests for SARS-CoV-2 in community participants were included. Only English-language articles were reviewed. We included eligible studies that provided available data to construct a 2 × 2 table on a per-patient basis. Overall sensitivity and specificity for antigen tests were generated using a bivariate random-effects model. Eighteen studies with 34,865 participants were retrieved. The meta-analysis for SARS-CoV-2 antigen tests generated a pooled sensitivity of 0.82 and a pooled specificity of 1.00. A subgroup analysis of ten studies that reported outcomes for 5629 symptomatic participants generated a pooled sensitivity of 0.87 and a pooled specificity of 1.00. Antigen tests might have higher sensitivity in detecting SARS-CoV-2 in symptomatic patients in the community and may be an effective tool to identify patients to be quarantined to prevent further SARS-CoV-2 transmission.

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“…Though helpful, the limitations of these kits should be noted by the users. Some studies have suggested low sensitivity in screening asymptomatic patients ( Eshghifar et al, 2021 ; Peña et al, 2021 ; Torres et al, 2021 ). Various authors have cited lower sensitivity in patients with low viral load (high Ct values on RT-PCR); hence RT-PCR testing should continue to be offered where clinical suspicion is high( Ebrahimi et al, 2021 ; Nalumansi et al, 2021 ; Peeling et al, 2021 ).…”

Section: Discussionmentioning

confidence: 99%

Performance of a rapid antigen test for SARS-CoV-2 in Kenya

Onsongo

Otieno

Duijn

et al. 2022

Diagnostic Microbiology and Infectious Disease

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Performance of SARS-CoV-2 rapid antigen test compared with real-time RT-PCR in asymptomatic individuals

Cited by 58 publications

References 15 publications

Accuracy of novel antigen rapid diagnostics for SARS-CoV-2: A living systematic review and meta-analysis

Accuracy of novel antigen rapid diagnostics for SARS-CoV-2: A living systematic review and meta-analysis

Diagnostic Accuracy of SARS-CoV-2 Antigen Tests for Community Transmission Screening: A Systematic Review and Meta-Analysis

Performance of a rapid antigen test for SARS-CoV-2 in Kenya

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