NEW: SAMBA II SARS-CoV-2/Flu Multiplex Test

The SAMBA II SARS-CoV-2/FluA/FluB Test (P/N 8600) is a nucleic-acid based amplification test for the qualitative detection of nucleic acids from SARS-CoV-2, Influenza A and/or Influenza B in human respiratory specimens (combined nasal 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 one region of the SARS-CoV-2 genome (ORF1ab), one region of Influenza A genome in the matrix protein and one region of Influenza B genome in the non-structural protein, 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/FluA/FluB 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 Respiratory Specimen buffer to inactivate the viruses
  • Isothermal amplification and patented lateral flow detection
  • Detects one specific region of SARS-CoV-2 (ORF1ab), one region of FluA genome in the matrix protein and one region of FluB genome in the non-structural protein
  • Analytical sensitivity of 200 cp/ml for SARS-CoV-2, 75 cp/ml for FluA H1N1, 1500 cp/ml for FluA H3N2 and 1.5 TCID50/ml for FluB
  • Specific against other Coronaviruses strains
  • Positive percent agreement of 98.05% (95%CI: 94.41 – 99.60%) for SARS-CoV-2, 96.40% (95%CI: 91.03-99.01%) for Flu A and 100% (95%CI: 98.85-100%) for Flu B compared to the TaqPath COVID-19, Flu A/B, RSV Test
  • Negative percent agreement of 99.28% (95%CI: 97.42-99.91%) for SARS-CoV-2, 100 % (95%CI: 98.85-100%) for Flu A and 100% (95%CI: 99.08-100%) for Flu B 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 (2-30 oC for 12 months)