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 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.
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
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 (2-37 oC for 6 months)
