Diagnostic Performance Assessment of Saliva RT-PCR and Nasopharyngeal Antigen for the Detection of SARS-CoV-2 in Peru

Author:

Calderón Roger I.123ORCID,Jhaveri Tulip A.45ORCID,Tovar Marco A.16,Palomino J. Santiago1,Barreda Nadia N.1,Sanabria Oswaldo M.1,Peinado Jesús1,Ramirez Claudio7,Llanos Zavalaga L. Fernando7,Valderrama Gissela1,Franke Molly F.8,Mitnick Carole D.8910,Lecca Leonid18,Velásquez Gustavo E.91112ORCID

Affiliation:

1. Socios En Salud Sucursal Peru, Lima, Peru

2. Faculdade de Medicina, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil

3. Grupo de Investigación en Bioquímica y Biología Sintética, Universidad Nacional Federico Villarreal, Lima, Peru

4. Division of Infectious Diseases, Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi, USA

5. Division of Medical Microbiology, Department of Pathology, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, USA

6. Escuela de Medicina, Facultad de Ciencias de la Salud, Universidad Peruana de Ciencias Aplicadas, Lima, Peru

7. Dirección de Redes Integradas de Salud Lima Norte, Lima, Peru

8. Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, USA

9. Division of Global Health Equity, Brigham and Women’s Hospital, Boston, Massachusetts, USA

10. Partners In Health, Boston, Massachusetts, USA

11. UCSF Center for Tuberculosis, University of California, San Francisco, California, USA

12. Division of HIV, Infectious Diseases, and Global Medicine, University of California, San Francisco, California, USA

Abstract

In this diagnostic validation study of 896 participants in Peru, saliva reverse transcription PCR (RT-PCR) had >80% sensitivity for the detection of SARS-CoV-2 among all-comers and symptomatic individuals, while the SD Biosensor STANDARD Q antigen test performed on nasopharyngeal swab had <80% sensitivity, except for participants whose same-day nasopharyngeal RT-PCR results showed cycle threshold values of <30, consistent with a high viral load in the nasopharynx. The specificity was high for both tests.

Funder

Partners In Health

HHS | NIH | National Institute of Allergy and Infectious Diseases

Harvard Global Health Institute

Harvard Medical School

Harvard University Center for AIDS Research

United States Agency for International Development

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Cell Biology,Microbiology (medical),Genetics,General Immunology and Microbiology,Ecology,Physiology

Reference26 articles.

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4. WHO. 2021. Considerations for implementing and adjusting public health and social measures in the context of COVID-19. WHO, Geneva, Switzerland. https://www.who.int/publications/i/item/considerations-in-adjusting-public-health-and-social-measures-in-the-context-of-covid-19-interim-guidance. Accessed 26 August 2021.

5. In Vitro Diagnostic Assays for COVID-19: Recent Advances and Emerging Trends

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