Evaluation of rapid antigen detection kit from the WHO Emergency Use List for detecting SARS-CoV-2

• Published in: Journal of clinical virology 2021-01, Vol.134, p.104712-104712, Article 104712
• Main Authors: Mak, Gannon C.K., Lau, Stephen S.Y., Wong, Kitty K.Y., Chow, Nancy L.S., Lau, C.S., Lam, Edman T.K., Chan, Rickjason C.W., Tsang, Dominic N.C.
• Format: Article
• Language: English
• Subjects: 2019 novel coronavirus; Antigens, Viral - analysis; COVID-19; COVID-19 - diagnosis; COVID-19 - pathology; COVID-19 - virology; COVID-19 Testing - methods; Cross Reactions; Hong Kong; Humans; Limit of Detection; Nasopharynx - virology; Pharynx - virology; Rapid antigen detection; Reagent Kits, Diagnostic - standards; Reverse Transcriptase Polymerase Chain Reaction; RT-PCR; SARS-CoV-2; SARS-CoV-2 - immunology; SARS-CoV-2 - pathogenicity; World Health Organization
• ISSN: 1386-6532; 1873-5967
• DOI: 10.1016/j.jcv.2020.104712

Currently, there are two rapid antigen detection (RAD) kits from the WHO Emergency Use List for detecting SARS-CoV-2. The Panbio COVID-19 Ag Rapid Test Device was selected to evaluate the performance for detecting SARS-CoV-2. Analytical sensitivity for the detection of SARS-CoV-2 virus was determined by limit of detection (LOD) using RT-PCR as a reference method. Clinical sensitivity was evaluated by using respiratory specimens collected from confirmed COVID-19 patients. The LOD results showed that the RAD kit was 100 fold less sensitive than RT-PCR. Clinical sensitivity of the RAD kit was 68.6 % for detecting specimens from COVID-19 patients. The RAD kit evaluated in the present study shared similar performance with another kit from the WHO Emergency Use List, the Standard Q COVID-19 Ag. Understanding the clinical characteristics of RAD kits can guide us to decide different testing strategies in different settings.