Head-to-head performance comparison of self-collected nasal versus professional-collected nasopharyngeal swab for a WHO-listed SARS-CoV-2 antigen-detecting rapid diagnostic test

Klein, Jürgen; Krüger, Lisa J.; Tobian, Frank; Gaeddert, Mary; Lainati, Federica; Schnitzler, Paul; Lindner, Andreas; Nikolai, Olga; Knorr, Britta; Welker, Andreas; Vos, Margaretha de; Sacks, Jilian A.; Escadafal, Camille; Denkinger, Claudia M.

doi:10.1007/s00430-021-00710-9

Cited by 44 publications

(78 citation statements)

References 16 publications

(22 reference statements)

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“…Finally, the performances of supervised self-collected specimens for detection of SARS-CoV-2 using a WHO-listed SARS-CoV-2 Ag-RDT was evaluated in adult volunteers in Charité hospital, Universitätsmedizin Berlin, Germany [ 12 , 13 , 14 , 15 ]. Thus, nasal sampling (including self-sampling) assessed against nasopharyngeal sampling led to comparable performance using SARS-CoV-2 Ag-RDT [ 12 , 13 , 15 ].…”

Section: Discussionmentioning

confidence: 99%

“…Thus, nasal sampling (including self-sampling) assessed against nasopharyngeal sampling led to comparable performance using SARS-CoV-2 Ag-RDT [ 12 , 13 , 15 ]. Klein and colleagues extended these studies by evaluating the clinical performances of a supervised, self-collected NMT swab and a professional-collected naso-pharyngeal swab, using Panbio™ Ag-RDT (distributed by Abbott) by reference to molecular testing [ 14 ]. Participants were able to reliably carry out the NMT-self-sampling.…”

Section: Discussionmentioning

confidence: 99%

“…Alternative sampling methods, such as nasal mid-turbinate (NMT) sampling (swab inserted about 2–3 cm into nostril parallel to the palate until resistance is met at turbinates), is well tolerated and can be performed by the person himself either unsupervised at home or supervised on-site [ 10 , 11 , 12 , 13 ]. NMT sampling was equivalent to nasopharyngeal sampling for a WHO-listed SARS-CoV-2 Ag-RDT, which lays the foundation for its use as a self-sampling technique under supervision [ 12 , 13 , 14 , 15 ]. Widespread use of self-testing for SARS-CoV-2 infection could help improve the control of the spread of the SARS-CoV-2 epidemic [ 16 , 17 , 18 , 19 , 20 , 21 ].…”

Section: Introductionmentioning

confidence: 99%

“…Previous experience with HIV self-testing showed that a self-test can be performed perfectly well by a layperson and gives reliable and accurate results, and that HIV self-testing is considered as an acceptable and useful tool to improve HIV testing coverage worldwide to improve HIV epidemic control [ 22 , 23 ]. Lateral flow tests for the SARS-CoV-2 antigen are appropriate for use as an antigen-detecting rapid diagnosis self-test (Ag-RDST) because of their low cost, ease of use, and prompt result [ 12 , 14 , 24 ].…”

Section: Introductionmentioning

confidence: 99%

“…Recent reports have established the achievability of NMT self-sampling under supervision [ 12 , 14 ]. Data on the clinical performance of self-testing with Ag-RDT are, however, limited to comparisons with quantitative real-time RT-PCR (rtRT-PCR) detection of SARS-CoV-2 RNA [ 25 , 26 ].…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of the Practicability of Biosynex Antigen Self-Test COVID-19 AG+ for the Detection of SARS-CoV-2 Nucleocapsid Protein from Self-Collected Nasal Mid-Turbinate Secretions in the General Public in France

Tonen‐Wolyec

Dupont²,

Awaida³

et al. 2021

Diagnostics

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Due to their ease-of-use, lateral flow assay SARS-CoV-2 antigen-detecting rapid diagnostic tests could be suitable candidates for antigen-detecting rapid diagnostic self-test (Ag-RDST). We evaluated the practicability of the Ag-RDST BIOSYNEX Antigen Self-Test COVID-19 Ag+ (Biosynex Swiss SA, Freiburg, Switzerland), using self-collected nasal secretions from the turbinate medium (NMT), in 106 prospectively included adult volunteers living in Paris, France. The majority of the participants correctly understood the instructions for use (94.4%; 95% confidence interval (CI): 88.3–97.4), showing a great ability to perform the entire self-test procedure to obtain a valid and interpretable result (100%; 95% CI: 96.5–100), and demonstrated the ability to correctly interpret test results (96.2%; 95% CI: 94.2–97.5) with a high level of general satisfaction. About one in eight participants (# 15%) needed verbal help to perform or interpret the test, and only 3.8% of test results were misinterpreted. By reference to multiplex real-time RT-PCR, the Ag-RDST showed 90.9% and 100% sensitivity and specificity, respectively, and high agreement (98.1%), reliability (0.94), and accuracy (90.9%) to detect SARS-CoV-2 antigen. Taken together, our study demonstrates the high usability and accuracy of BIOSYNEX Antigen Self-Test COVID-19 Ag+ for supervised self-collected NMT sampling in an unselected adult population living in France.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Evaluation of the Practicability of Biosynex Antigen Self-Test COVID-19 AG+ for the Detection of SARS-CoV-2 Nucleocapsid Protein from Self-Collected Nasal Mid-Turbinate Secretions in the General Public in France

Tonen‐Wolyec

Dupont²,

Awaida³

et al. 2021

Diagnostics

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COVID-19 Rapid Antigen Tests With Self-Collected vs Health Care Worker–Collected Nasal and Throat Swab Specimens

Todsen,

Jakobsen,

Grønlund

et al. 2023

JAMA Netw Open

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ImportanceSelf- or health care worker (HCW)–collected nasal swab specimens are the preferred sampling method to perform rapid antigen testing for COVID-19, but it is debated whether throat specimens can improve test sensitivity.ObjectiveTo compare the diagnostic accuracy of self- and HCW-collected nasal vs throat swab specimens for COVID-19 rapid antigen testing.Design, Setting, and ParticipantsThis per-protocol multicenter randomized clinical trial was conducted from February 15 through March 25, 2022. The participants, individuals aged 16 years or older requesting a COVID-19 test for diagnostic or screening purposes, had 4 specimens collected for individual testing at 1 of 2 urban COVID-19 outpatient test centers in Copenhagen, Denmark.InterventionsParticipants were randomized 1:1 to self-collected or HCW-collected nasal and throat swab specimens for rapid antigen testing. Additional HCW-collected nasal and throat swab specimens for reverse transcriptase–polymerase chain reaction (RT-PCR) were used as the reference standard.Main Outcomes and MeasuresThe primary outcome was sensitivity to diagnose COVID-19 of a self- vs HCW-collected nasal and throat specimen for rapid antigen testing compared with RT-PCR.ResultsOf 2941 participants enrolled, 2674 (90.9%) had complete test results and were included in the final analysis (1535 [57.4%] women; median age, 40 years [IQR, 28-55 years]); 1074 (40.2%) had COVID-19 symptoms, and 827 (30.9%) were positive for SARS-CoV-2 by RT-PCR. Health care worker–collected throat specimens had higher mean sensitivity than HCW-collected nasal specimens for rapid antigen testing (69.4% [95% CI, 65.1%-73.6%] vs 60.0% [95% CI, 55.4%-64.5%]). However, a subgroup analysis of symptomatic participants found that self-collected nasal specimens were more sensitive than self-collected throat specimens for rapid antigen testing (mean sensitivity, 71.5% [95% CI, 65.3%-77.6%] vs 58.0% [95% CI, 51.2%-64.7%]; P &lt; .001). Combining nasal and throat specimens increased sensitivity for HCW- and self-collected specimens by 21.4 and 15.5 percentage points, respectively, compared with a single nasal specimen (both P &lt; .001).Conclusions and RelevanceThis randomized clinical trial found that a single HCW-collected throat specimen had higher sensitivity for rapid antigen testing for SARS-CoV-2 than a nasal specimen. In contrast, the self-collected nasal specimens had higher sensitivity than throat specimens for symptomatic participants. Adding a throat specimen to the standard practice of collecting a single nasal specimen could improve sensitivity for rapid antigen testing in health care and home-based settings.Trial RegistrationClinicalTrials.gov Identifier: NCT05209178

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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

142

133

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Head-to-head performance comparison of self-collected nasal versus professional-collected nasopharyngeal swab for a WHO-listed SARS-CoV-2 antigen-detecting rapid diagnostic test

Cited by 44 publications

References 16 publications

Evaluation of the Practicability of Biosynex Antigen Self-Test COVID-19 AG+ for the Detection of SARS-CoV-2 Nucleocapsid Protein from Self-Collected Nasal Mid-Turbinate Secretions in the General Public in France

Evaluation of the Practicability of Biosynex Antigen Self-Test COVID-19 AG+ for the Detection of SARS-CoV-2 Nucleocapsid Protein from Self-Collected Nasal Mid-Turbinate Secretions in the General Public in France

COVID-19 Rapid Antigen Tests With Self-Collected vs Health Care Worker–Collected Nasal and Throat Swab Specimens

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

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