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 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.
Kit contains all the reagents and disposables required to perform a test
Site must provide just a swab to collect a throat/nose swab, which is placed in the SAMBA Sample buffer to inactivate the viruses
Detects two specific regions of SARS-CoV-2 (Orf1ab and N)
Analytical sensitivity of 250 cp/ml for SARS-CoV-2, 0.5 TCID50/ml for RSV-A and 1.5 TCID50/ml for RSV-B
Specific against other Coronaviruses and RSV strains
Positive percent agreement of 100% (95%CI: 97.57-100%) for SARS-CoV-2 and 96.08 % (95%CI: 86.54-99.52%) for RSV compared to the TaqPath COVID-19, flu A/B, RSV Test
Negative percent agreement of 100% (95%CI: 98.69-100%) for SARS-CoV-2 and 99.74% (95%CI: 98.54-99.99%) for RSV compared to the TaqPath COVID-19, Flu A/B, RSV Test
Test results automatically read and interpreted by the SAMBA II instrument
Results can be stored in the tablet, printed, sent via SMS or transferred electronically
Kit can be shipped and stored at room temperature (2-37 oC for 6 months)
