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.

Key features and performance
  • 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)

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