TY - JOUR
T1 - Real-life validation of the Panbio (TM) COVID-19 antigen rapid test (Abbott) in community-dwelling subjects with symptoms of potential SARS-CoV-2 infection
AU - Gremmels, Hendrik
AU - Winkel, Beatrice M F
AU - Schuurman, Rob
AU - Rosingh, Andert
AU - Rigter, Nicolette A M
AU - Rodriguez, Olga
AU - Ubijaan, Johan
AU - Wensing, Annemarie M J
AU - Bonten, Marc J M
AU - Hofstra, L Marije
N1 - Funding Information:
Dr. Wensing reports grants from ViiV Healthcare, Gilead, grants from Janssen, Gilead, Merck, grants from Janssen, Gilead, Merck, ViiV Healthcare, grants from ARK diagnostics, outside the submitted work. All other authors report no conflict.
Funding Information:
The authors would like to thank all participating employees from the GGD Utrecht and the department of Public Health in Aruba and the participating students from the UMCU for their help with data collection, as well as all participating volunteers. This study was investigator initiated. No external funding was received. All de-identified participant available data can be made available upon request per email to the corresponding author.
Publisher Copyright:
© 2020
PY - 2021/1
Y1 - 2021/1
N2 - Background: RT-qPCR is the reference test for identification of active SARS-CoV-2 infection, but is associated with diagnostic delay. Antigen detection assays can generate results within 20 min and outside of laboratory settings. Yet, their diagnostic test performance in real life settings has not been determined. Methods: The diagnostic value of the Panbio™ COVID-19 Ag Rapid Test (Abbott), was determined in comparison to RT-qPCR (Seegene Allplex) in community-dwelling mildly symptomatic subjects in a medium (Utrecht, the Netherlands) and high endemic area (Aruba), using two concurrently obtained nasopharyngeal swabs. Findings: 1367 and 208 subjects were enrolled in Utrecht and Aruba, respectively. SARS-CoV-2 prevalence, based on RT-qPCR, was 10.2% (n = 139) and 30.3% (n = 63) in Utrecht and Aruba respectively. Specificity of the Panbio™ COVID-19 Ag Rapid Test was 100% (95%CI: 99.7–100%) in both settings. Test sensitivity was 72.6% (95%CI: 64.5–79.9%) in the Netherlands and 81.0% (95% CI: 69.0–89.8%) in Aruba. Probability of false negative results was associated with RT-qPCR Ct-values, but not with duration of symptoms. Restricting RT-qPCR test positivity to Ct-values <32 yielded test sensitivities of 95.2% (95%CI: 89.3–98.5%) in Utrecht and 98.0% (95%CI: 89.2–99.95%) in Aruba. Interpretation: In community-dwelling subjects with mild respiratory symptoms the Panbio™ COVID-19 Ag Rapid Test had 100% specificity, and a sensitivity above 95% for nasopharyngeal samples when using Ct-values <32 cycles as cut-off for RT-qPCR test positivity. Considering short turnaround times, user friendliness, low costs and opportunities for decentralized testing, this test can improve our efforts to control transmission of SARS-CoV-2.
AB - Background: RT-qPCR is the reference test for identification of active SARS-CoV-2 infection, but is associated with diagnostic delay. Antigen detection assays can generate results within 20 min and outside of laboratory settings. Yet, their diagnostic test performance in real life settings has not been determined. Methods: The diagnostic value of the Panbio™ COVID-19 Ag Rapid Test (Abbott), was determined in comparison to RT-qPCR (Seegene Allplex) in community-dwelling mildly symptomatic subjects in a medium (Utrecht, the Netherlands) and high endemic area (Aruba), using two concurrently obtained nasopharyngeal swabs. Findings: 1367 and 208 subjects were enrolled in Utrecht and Aruba, respectively. SARS-CoV-2 prevalence, based on RT-qPCR, was 10.2% (n = 139) and 30.3% (n = 63) in Utrecht and Aruba respectively. Specificity of the Panbio™ COVID-19 Ag Rapid Test was 100% (95%CI: 99.7–100%) in both settings. Test sensitivity was 72.6% (95%CI: 64.5–79.9%) in the Netherlands and 81.0% (95% CI: 69.0–89.8%) in Aruba. Probability of false negative results was associated with RT-qPCR Ct-values, but not with duration of symptoms. Restricting RT-qPCR test positivity to Ct-values <32 yielded test sensitivities of 95.2% (95%CI: 89.3–98.5%) in Utrecht and 98.0% (95%CI: 89.2–99.95%) in Aruba. Interpretation: In community-dwelling subjects with mild respiratory symptoms the Panbio™ COVID-19 Ag Rapid Test had 100% specificity, and a sensitivity above 95% for nasopharyngeal samples when using Ct-values <32 cycles as cut-off for RT-qPCR test positivity. Considering short turnaround times, user friendliness, low costs and opportunities for decentralized testing, this test can improve our efforts to control transmission of SARS-CoV-2.
UR - http://www.scopus.com/inward/record.url?scp=85097461354&partnerID=8YFLogxK
U2 - 10.1016/j.eclinm.2020.100677
DO - 10.1016/j.eclinm.2020.100677
M3 - Article
C2 - 33521610
SN - 2589-5370
VL - 31
SP - 1
EP - 6
JO - EClinicalMedicine
JF - EClinicalMedicine
M1 - 100677
ER -