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

Favresse, Julien; Gillot, Constant; Oliveira, M. A. C. de; Cadrobbi, Julie; Elsen, Marc; Eucher, Christine; Laffineur, Kim; Rosseels, Catherine; Eeckhoudt, Sandrine Van; Nicolas, Jean-Baptiste; Morimont, Laure; Dogné, Jean‐Michel; Douxfils, Jonathan

doi:10.3390/jcm10020265

Cited by 82 publications

(86 citation statements)

References 31 publications

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“…Some studies included only a very limited number of patients, 14 included control samples collected during the pandemic period, 5,15 defined different categories since symptom onset (i.e., < or > 7 days, 13 0-6, 7-13, 14-25 days, 12 or 5-9, 10-18 days 14 ), or different categories since RT-PCR positivity. 14 Moreover, as with other rapid LFA, 19 we showed that the result may depend on the reader and on the timing of reading (20 min better than 10 min).…”

Section: Discussionsupporting

confidence: 61%

Clinical performance of the Panbio assay for the detection of SARS‐CoV‐2 IgM and IgG in COVID‐19 patients

Haguet

Douxfils

Eucher

et al. 2021

Journal of Medical Virology

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Following the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, numerous serological tests have been developed, including rapid diagnostic tests. This study aims at assessing the clinical performance of the Panbio immunoglobulin G (IgG)/IgM coronavirus disease 2019 (COVID-19) test (Abbott), a rapid lateral flow assay for the qualitative detection of IgG and IgM against SARS-CoV-2. One hundred and thirty-eight samples from 95 COVID-19 patients with a positive SARS-CoV-2 reverse-transcriptase polymerase chain reaction were analyzed to assess the clinical sensitivity. Seventy-six pre-COVID-19 samples were used to evaluate the clinical specificity. Two independent and blinded raters determined visually the presence or absence of the IgG, IgM, and control lines for each test after 10 and 20 min. The sensitivity obtained from collected samples more than 14 days after the onset of symptoms was 95.2% for IgG. IgM was less frequently detected (highest sensitivity of 20.5%). The specificities obtained were 98.7% and 100% for IgG and IgM, respectively. In addition, the sensitivity of the assay was better when the reading was performed at 20 min than at 10 min, whereas the specificity was unchanged. The Panbio COVID-19 IgG/IgM rapid test detects IgG with high sensitivity 14 days since symptom onset but presents a low sensitivity for IgM. The specificity was excellent for both IgG and IgM.

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Section: Discussionsupporting

confidence: 61%

Clinical performance of the Panbio assay for the detection of SARS‐CoV‐2 IgM and IgG in COVID‐19 patients

Haguet

Douxfils

Eucher

et al. 2021

Journal of Medical Virology

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“…Analytical sensitivity was not determined. 10 , 11 The mariPOC SARS-CoV-2 Antigen Test (ArcDia International, Turku, Finland) gained a sensitivity of 100.0% when directly performed on clinical swab specimens (84.4% in undefined transport mediums) and a specificity 100.0%. The observed limit of detection was 2.7 TCID50/test.…”

Section: Discussionmentioning

confidence: 99%

Performance of the Diasorin SARS-CoV-2 antigen detection assay on the LIAISON XL

Moeren

Zwart

Goderski

et al. 2021

Journal of Clinical Virology

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Background The current reference standard to diagnose a SARS-CoV-2 infection is real-time reverse transcriptase polymerase chain reaction (RT-PCR). This test poses substantial challenges for large-scale community testing, especially with respect to the long turnaround times. SARS-CoV-2 antigen tests are an alternative, but typically use a lateral flow assay format rendering them less suitable for analysis of large numbers of samples. Methods We conducted an evaluation of the Diasorin SARS-CoV-2 antigen detection assay (DAA) compared to real-time RT-PCR (Abbott). The study was performed on 248 (74 qRT-PCR positive, 174 qRT-PCR negative) clinical combined oro-nasopharyngeal samples of individuals with COVID-19-like symptoms obtained at a Municipal Health Service test centre. In addition, we evaluated the analytical performance of DAA with a 10-fold dilution series of SARS-CoV-2 containing culture supernatant and compared it with the lateral flow assay SARS-CoV-2 Roche/SD Biosensor Rapid Antigen test (RRA). Results The DAA had an overall specificity of 100% (95%CI 97.9%-100%) and sensitivity of 73% (95%CI 61.3% -82.7%) for the clinical samples. Sensitivity was 86% (CI95% 74.6%-93.3%) for samples with Ct-value below 30. Both the DAA and RRA detected SARS-CoV-2 up to a dilution containing 5.2 × 10 2 fifty-percent-tissue-culture-infective-dose (TCID50)/ml. Discussion The DAA performed adequately for clinical samples with a Ct-value below 30. Test performance may be further optimised by lowering the relative light unit (RLU) threshold for positivity assuming the in this study used pre-analytical protocol . The test has potential for use as a diagnostic assay for symptomatic community-dwelling individuals early after disease onset in the context of disease control.

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“…These rapid tests, through a rapid chromatographic immunoassay technique, are used for the qualitative detection of SARS-CoV-2 antigens generally in nasopharyngeal swabs, they can be easily interpreted without specialized instrument and in less than 30 min. Most rapid antigen test have been designed and validated for the detection of SARS-CoV-2 in patients with COVID-19 symptoms in hospital settings, and there is currently little evidence on the accuracy of these tests in widespread testing of asymptomatic populations and in different settings [8] .…”

Section: Introductionmentioning

confidence: 99%

Validation of a rapid antigen test as a screening tool for SARS-CoV-2 infection in asymptomatic populations. Sensitivity, specificity and predictive values

et al. 2021

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Background Early diagnosis of SARS-CoV-2 infection is essential to reduce disease spread. Rapid antigen tests have not been sufficiently evaluated in asymptomatic patients to be used as massive population screening tools. Methods Head-to-head evaluation of Roche SARS-CoV-2 Rapid Antigen Test and real-time reverse transcription polymerase chain reaction (RT-PCR) as SARS-CoV-2 screening tools performed in asymptomatic adults from a semi-closed community in University of Navarra (Spain) from November 2020 to January 2021. Sensitivity, specificity and predictive values were calculated using RT-PCR as reference method. Findings Roche SARS-CoV-2 Rapid Antigen Test was performed on 2542 asymptomatic adults in a community with a SARS-CoV-2 incidence of 1·93%. It showed a sensitivity of 71·43% (CI 95%: 56·74 – 83·42) and a specificity of 99·68% (CI 95%: 99·37 - 99·86). Positive Predictive Value was 81·4 (CI 95% 66·6 – 91·61) and Negative Predictive Value was 99·44 (CI 95% 99·06 – 99·69). Test sensitivity was related to viral load, with higher sensitivity in RT-PCR cycle threshold (Ct) values under 25 (93·75%, CI 95%: 71·96 – 98·93), that dropped to 29·41% (CI 95%: 10·31- 55·96) in RT-PCR Ct values above 25. Interpretation This study suggests that rapid antigen tests are less effective in asymptomatic population, when compared with RT-PCR. Further studies are needed to evaluate different options to improve screenings based on rapid antigen test, such as the use of clinical questionnaires to select higher risk-participants, the confirmation of negative results with RT-PCR or the use of repetitive sequential testing. Funding This research received no external funding.

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

Cited by 82 publications

References 31 publications

Clinical performance of the Panbio assay for the detection of SARS‐CoV‐2 IgM and IgG in COVID‐19 patients

Clinical performance of the Panbio assay for the detection of SARS‐CoV‐2 IgM and IgG in COVID‐19 patients

Performance of the Diasorin SARS-CoV-2 antigen detection assay on the LIAISON XL

Validation of a rapid antigen test as a screening tool for SARS-CoV-2 infection in asymptomatic populations. Sensitivity, specificity and predictive values

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