Performance Evaluation of the SAMBA II SARS-CoV-2 Test for Point-of-Care Detection of SARS-CoV-2

Author:

Assennato Sonny M.1,Ritchie Allyson V.1ORCID,Nadala Cesar2,Goel Neha1,Tie Cuijuan2,Nadala Lourdes M.2,Zhang Hongyi3,Datir Rawlings4,Gupta Ravindra K.56ORCID,Curran Martin D.3,Lee Helen H.12ORCID

Affiliation:

1. Diagnostics for the Real World EU, Ltd., Chesterford Research Park, Great Chesterford, United Kingdom

2. Diagnostics for the Real World, Ltd., San Jose, California, USA

3. Clinical Microbiology and Public Health Laboratory, PHE Cambridge, Addenbrooke’s Hospital, Cambridge, United Kingdom

4. Division of Infection and Immunity, University College London, London, United Kingdom

5. Department of Medicine, University of Cambridge, Cambridge, United Kingdom

6. Africa Health Research Institute, Durban, South Africa

Abstract

Nucleic acid amplification for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA in respiratory samples is the standard method for diagnosis. The majority of this testing is centralized and therefore has turnaround times of several days. Point-of-care (POC) testing with rapid turnaround times would allow more effective triage in settings where patient management and infection control decisions need to be made rapidly. The inclusivity and specificity of the Simple AMplification-Based Assay (SAMBA) II SARS-CoV-2 test were determined by both in silico analyses of the primers and probes and wet testing.

Funder

Wellcome

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

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