Diagnostic accuracy of three prevailing rapid antigen tests for detection of SARS-CoV-2 infection in the general population: cross sectional study

Abstract

ObjectiveTo assess the diagnostic accuracy of three rapid antigen tests (Ag-RDTs) for detecting SARS-CoV-2 infection in the general population.DesignCross-sectional study with follow-up using pseudonymised record linkage.SettingThree Dutch public health service COVID-19 test sites.ParticipantsConsecutively included individuals aged 16 years and older presenting for SARS-CoV-2 testing.Main outcome measuresSensitivity, specificity, positive and negative predictive values of BD-VeritortmSystem (Becton Dickinson), PanBio (Abbott), and SD-Biosensor (Roche Diagnostics), applying routinely used sampling methods (combined oropharyngeal and nasal [OP-N] or nasopharyngeal [NP] swab), with molecular testing as reference standard. For SD-Biosensor, the diagnostic accuracy with OP-N sampling was also assessed. A viral load cut-off (≥5.2 log10 SARS-CoV-2 E-gene copies/mL) served as a proxy of infectiousness.ResultsSARS-CoV-2 prevalence and overall sensitivities with 95% confidence intervals were 188/1441 (13.0%) and 129/188 (68.6% [61.5%-75.2%]) for BD-Veritor, 173/2056 (8.4%) and 119/173 (68.8% [61.3%-75.6%]) for PanBio, and 215/1769 (12.2%) and 160/215 (74.4% [68.0%-80.1%]) for SD-Biosensor with routine sampling, and 164/1689 (9.7%) and 123/164 (75.0% [67.7%-81.4%]) for SD-Biosensor with OP-N sampling. In those symptomatic or asymptomatic at sampling, sensitivities were 72.2%-83.4% and 54.0%-55.9%, respectively. With a viral load cut-off, sensitivities were 125/146 (85.6% [78.9%-90.9%]) for BD-Veritor, 108/121 (89.3% [82.3%-94.2%]) for PanBio, 160/182 (87.9% [82.3%-92.3%]) for SD-Biosensor with routine sampling, and 118/141 (83.7% [76.5%-89.4%]) with OP-N sampling. Specificities were >99%, and positive and negative predictive values >95%, for all tests in most analyses. 61.3% of false negative Ag-RDT participants returned for testing within 14 days (median of 3 days, interquartile range 3) of whom 90.3% tested positive.ConclusionsThe overall sensitivities of the three Ag-RDTs were 68.6%-75.0%, increasing to at least 85.6% after the viral load cut-off was applied. For SD-Biosensor, the diagnostic accuracy with OP-N and NP sampling was comparable. Over 55% of false negative Ag-RDT participants tested positive during follow-up.

Accuracy of COVID-19 self-tests with unsupervised nasal or nasal plus oropharyngeal self-sampling in symptomatic individuals in the Omicron period

“…These effects might be test device-specific given the variability in the performance across the three AG-RDTs. 5 We also found trends towards slightly higher sensitivities in participants who never received a COVID-19 vaccination for the MPBio and Clinitest Ag-RDTs with nasal self-sampling, but all confidence intervals overlapped with those who were vaccinated 1, 2 or 3 times and no differential impact was observed when combined OP-N sampling was applied. A detailed discussion of other subgroup analysis results can be found in supplementary material 4.…”

“…However, we observed similar trends for the BD-Veritor and SD-Biosensor Ag-RDTs with either professional or self-sampling in two previous studies. 5,7 The lower sensitivities of Ag-RDTs in individuals with a prior infection may be explained by generally lower viral loads, with some individuals potentially carrying viral RNA in the absence of a productive infection (i.e. no viral antigen production).…”

“…Rapid antigen diagnostic tests (Ag-RDTs) show promising performance for SARS-CoV-2 infection detection. [1][2][3][4][5] Ag-RDTs require minimal equipment, provide a result within 15-30 minutes, and can be performed in a range of settings without laboratory facilities. While Ag-RDTs were initially introduced for use by trained professionals, they are currently widely available over the counter.…”

Performance of different rapid antigen testing strategies for SARS‐CoV‐2: A living rapid review

“…One pre-print was included. 23 Most reports were from US or Western Europe settings, with additional studies from Hong Kong, 24,25 Pakistan 26 and Japan. 27,28 Although the dominant strain in circulation was rarely reported, the original SARS-CoV-2 24,[29][30][31][32][33] and early variants (Alpha and Delta) were the most common strains based on the study setting.…”

“…26,28,36,37 Studies reported a range of days for the timing of the antigen tests in relation to participant symptom onset, with most studies noting an average/median duration of symptoms of fewer than 7 days on the testing day. Although only one study explicitly reported on vaccination details, 23 most studies were conducted prior to vaccine rollout or at the early stages of population-wide vaccination.…”