Early detection of SARS-CoV-2 infection is crucial to prevent its spread. This study aimed to document test sensitivity/specificity, correlation with cycle threshold value from polymerase chain reaction (PCR), fitness-for-use in different populations and settings, and user perspectives that could inform large-scale implementation. In this study, we evaluated the performance of a rapid antigen detection test, BD Veritor, and compared this (and another rapid test, Standard Q) against reverse transcription PCR (RT-PCR) in terms of sensitivity and specificity in 130 symptomatic and 130 asymptomatic adults. In addition, we evaluated the suitability and ease of use of the BD Veritor test in a subsample of study participants (n = 42) and implementers (n = 5). At 95% confidence interval, the sensitivity of the BD Veritor and Standard Q test were 70% and 63% in symptomatic and 87% and 73% in asymptomatic individuals, respectively, regarding positive SARS-CoV-2 RT-PCR results. Overall, the BD Veritor test was 78% sensitive and 99.5% specific compared with RT-PCR irrespective of the cycle threshold. This warrants large field evaluation as well as use of the rapid antigen test for quick assessment of SARS-CoV-2 for containment of epidemics in the country.
Address correspondence to Zannat Kawser, Institute for Developing Science and Health Initiatives (ideSHi), 167/24 Matikata, Kalshi Dhaka 1212, Bangladesh. E-mail: firstname.lastname@example.org
Financial support: The study was supported by Mass General Brigham: The Brigham and Women’s Hospital, Inc. (Agmt Ref. # 124901).
Authors’ addresses: Zannat Kawser, Mohabbat Hossain, Redwan Rahmat, Imrul Hasan, and Abu Bakar Siddik, Institute for Developing Science and Health Initiatives (ideSHi), Dhaka, Bangladesh, E-mails: email@example.com, firstname.lastname@example.org, email@example.com, firstname.lastname@example.org, and email@example.com. Sara Suliman, Division of Experimental Medicine, Zuckerberg San Francisco General Hospital, San Francisco, CA, E-mail: firstname.lastname@example.org. Shahin Lockman, Division of Infectious Diseases, Brigham and Women’s Hospital, Boston, MA, and Harvard T.H. Chan School of Public Health, Boston, MA, E-mail: email@example.com. Jesse Gitaka, Directorate of Research and Innovation, Mount Kenya University, Thika, Kenya, and Centre for Malaria Elimination, Mount Kenya University, Thika, Kenya, E-mail: firstname.lastname@example.org. Gama Bandawe, Biological Sciences Department, Academy of Medical Sciences, Malawi University of Science and Technology, Thyolo, Malawi, E-mail: email@example.com. Mokibul Hassan Afrad, Mohammed Ziaur Rahman, and Firdausi Qadri, International Center for Diarrheal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh, E-mails: firstname.lastname@example.org, email@example.com, and firstname.lastname@example.org. Glenn Miller, Mass General Brigham Center for COVID Innovation, Boston, MA, E-mail: email@example.com. David R. Walt, Mass General Brigham Center for COVID Innovation, Boston, MA, Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA, and Department of Pathology, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, E-mail: firstname.lastname@example.org. Louise C. Ivers, Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, and MGH Center for Global Health, Massachusetts General Hospital, Boston, MA, E-mail: email@example.com. Regina C. LaRocque and Jason B. Harris, MGH Center for Global Health, Massachusetts General Hospital, Boston, MA, E-mails: firstname.lastname@example.org and email@example.com.