NEW: SAMBA II SARS-CoV-2/RSV Multiplex Test
The SAMBA II SARS-CoV-2/RSV Test (P/N 8800) is a nucleic-acid based amplification test for the qualitative detection of nucleic acids from SARS-CoV-2 and/or Respiratory Syncytial Virus (RSV) in human respiratory specimens (combined nasal and throat/nasal/nasopharyngeal swabs). The assay is intended for use by professionals and trained operators on the SAMBA II instrument system in clinical and point-of-care settings.
The test specifically amplifies and detects two regions of the SARS-CoV-2 genome (ORF1ab and nucleocapsid protein, N) and one region of respiratory syncytial virus (RSV) genome in the non-structural protein 1 specific for both RSV-A and RSV-B, reported as three distinct lines on the test strip. A fourth line on the test strip, the internal control, is present to control for false negatives caused by instrument/reagent problems or inhibition.
The UK Health Security Agency’s technical validation report for the multiplex test is available here, confirming that the SAMBA II SARS-CoV-2/RSV assay meets the diagnostic performance criteria for both sensitivity and specificity. This is the classification with the highest level of performance, requiring no confirmatory testing. Note on validation report: further data has since been submitted for the purpose of fulfilling the UK HSA’s new criteria through the Coronavirus Test Device Approvals desktop review.