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 Respiratory Syncytial Virus (RSV) in human respiratory specimens (combined nose and throat, nasal or 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 ORF8) and one region of 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 confirms the SAMBA II SARS-CoV-2/FluA/FluB Test meets the diagnostic performance criteria for both sensitivity and specificity. This is the classification with the highest level of performance, requiring no confirmatory testing.

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 Respiratory Specimen buffer to inactivate the viruses
  • Detects two specific regions of SARS-CoV-2 (ORF1ab and ORF8)
  • Analytical sensitivity of 150 cp/ml for SARS-CoV-2, 0.5 TCID50/ml for RSV-A and 0.2 TCID50/ml for RSV-B
  • Specific against other Coronaviruses and RSV strains
  • 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 (2-30oC for 12 months)

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