Analytical sensitivity and clinical sensitivity of the three rapid antigen detection kits for detection of SARS-CoV-2 virus

Mak, Gannon C.K.; Lau, Stephen S. Y.; Wong, Kitty K.Y.; Chow, Nancy L.S.; Lau, CS; Lam, Edmund Wing Wo; Chan, RW; Tsang, Dnc

doi:10.1016/j.jcv.2020.104684

Cited by 89 publications

(107 citation statements)

References 13 publications

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“…For Ct values <25, the sensitivity increased above 95% [ 8 ]. The same conclusion was found by Mak et al, using only 35 specimens [ 17 ]. The lower sensitivity observed with higher Ct values is in line with our evaluation ( Table 2 ).…”

Section: Discussionsupporting

confidence: 88%

“…In the literature, we identified at least four studies that evaluated the Panbio COVID-19 Ag rapid test [ 8 , 12 , 14 , 17 , 22 ]. In a population of 341 patients, Fenollar et al found a specificity of 94.9% and a good sensitivity but only for samples with Ct values <25 (i.e., 94.2 to 100%) [ 12 ].…”

Section: Discussionmentioning

confidence: 99%

“…Moreover, the use of RAD tests in mass screening programs could decrease the burden on laboratories that have been overwhelmed during the last COVID-19 pandemics [ 9 ]. Nevertheless, it is important to keep in mind that even with a high viral load (i.e., Ct values <25), a RAD test can result in false-negative estimates in both symptomatic patients and asymptomatic subjects [ 12 , 13 , 17 , 20 , 21 , 22 , 23 ]. Mass community screening would, therefore, require the use of more sensitive techniques.…”

Section: Discussionmentioning

confidence: 99%

“…Head-to-head comparisons of AD test performance for SARS-CoV-2 detection are scarce. The majority of the studies only included few patients, precluding a wide characterization of the “real-life” performance of these devices [ 3 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 ]. Recently, a Cochrane study found an average sensitivity of only 56.2% (95% confidence interval (CI): 29.5–79.8%) for rapid AD (RAD) tests [ 11 ].…”

Section: Introductionmentioning

confidence: 99%

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Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection

Favresse

Gillot

Oliveira

et al. 2021

JCM

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(1) Background: The detection of SARS-CoV-2 RNA in nasopharyngeal samples through real-time reverse transcription-polymerase chain reaction (RT-PCR) is considered the standard gold method for the diagnosis of SARS-CoV-2 infection. Antigen detection (AD) tests are more rapid, less laborious, and less expensive alternatives but still require clinical validation. (2) Methods: This study compared the clinical performance of five AD tests, including four rapid AD (RAD) tests (biotical, Panbio, Healgen, and Roche) and one automated AD test (VITROS). For that purpose, 118 (62.8%) symptomatic patients and 70 (37.2%) asymptomatic subjects were tested, and results were compared to RT-PCR. (3) Results: The performance of the RAD tests was modest and allowed us to identify RT-PCR positive patients with higher viral loads. For Ct values ≤25, the sensitivity ranged from 93.1% (95% CI: 83.3–98.1%) to 96.6% (95% CI: 88.1–99.6%), meaning that some samples with high viral loads were missed. Considering the Ct value proposed by the CDC for contagiousness (i.e., Ct values ≤33) sensitivities ranged from 76.2% (95% CI: 65.4–85.1%) to 88.8% (95% CI: 79.7–94.7%) while the specificity ranged from 96.3% (95% CI: 90.8–99.0%) to 99.1% (95% CI: 95.0–100%). The VITROS automated assay showed a 100% (95% CI: 95.5–100%) sensitivity for Ct values ≤33, and had a specificity of 100% (95% CI: 96.6–100%); (4) Conclusions: Compared to RAD tests, the VITROS assay fully aligned with RT-PCR for Ct values up to 33, which might allow a faster, easier and cheaper identification of SARS-CoV-2 contagious patients.

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Section: Discussionsupporting

confidence: 88%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection

Favresse

Gillot

Oliveira

et al. 2021

JCM

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“…Numerous commercial assays are now available [ 5 ], but there are limited data on their clinical performance. Based on previous studies, the sensitivity of SARS-CoV-2 Ag-RDTs range between 22.9% and 93.9% when compared to rRT-PCR [ 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 ]. Apart from sensitivity, it is important that such tests identify potentially contagious individuals to reduce SARS-CoV-2 transmission.…”

Section: Introductionmentioning

confidence: 99%

The Comparative Clinical Performance of Four SARS-CoV-2 Rapid Antigen Tests and Their Correlation to Infectivity In Vitro

Kohmer

Toptan

Pallas

et al. 2021

JCM

150

140

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Due to globally rising numbers of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections, resources for real-time reverse-transcription polymerase chain reaction (rRT-PCR)-based testing have been exhausted. In order to meet the demands of testing and reduce transmission, SARS-CoV-2 antigen-detecting rapid diagnostic tests (Ag-RDTs) are being considered. These tests are fast, inexpensive, and simple to use, but whether they detect potentially infectious cases has not been well studied. We evaluated three lateral flow assays (RIDA®QUICK SARS-CoV-2 Antigen (R-Biopharm), SARS-CoV-2 Rapid Antigen Test (Roche)), and NADAL® COVID-19 Ag Test (Nal von Minden GmbH, Regensburg, Germany) and one microfluidic immunofluorescence assay (SARS-CoV-2 Ag Test (LumiraDx GmbH, Cologne, Germany)) using 100 clinical samples. Diagnostic rRT-PCR and cell culture testing as a marker for infectivity were performed in parallel. The overall Ag-RDT sensitivity for rRT-PCR-positive samples ranged from 24.3% to 50%. However, for samples with a viral load of more than 6 log10 RNA copies/mL (22/100), typically seen in infectious individuals, Ag-RDT positivity was between 81.8% and 100%. Only 51.6% (33/64) of the rRT-PCR-positive samples were infectious in cell culture. In contrast, three Ag-RDTs demonstrated a more significant correlation with cell culture infectivity (61.8–82.4%). Our findings suggest that large-scale SARS-CoV-2 Ag-RDT-based testing can be considered for detecting potentially infective individuals and reducing the virus spread.

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Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection

Dinnes

Sharma

Berhane

et al. 2022

Cochrane Database of Systematic Reviews

143

133

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Analytical sensitivity and clinical sensitivity of the three rapid antigen detection kits for detection of SARS-CoV-2 virus

Cited by 89 publications

References 13 publications

Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection

Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection

The Comparative Clinical Performance of Four SARS-CoV-2 Rapid Antigen Tests and Their Correlation to Infectivity In Vitro

Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection

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