SAMBA II SARS-CoV-2/FluA/FluB Test: technical validation report
Assay intended for use by professionals and trained operators on the SAMBA II instrument system in clinical and point-of-care settings.
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The SAMBA II SARS-CoV-2/FluA/FluB Test 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 SAMBA II SARS-CoV-2/FluA/FluB assay meets the diagnostic performance criteria for both sensitivity and specificity.
However, the sensitivity is achieved with a greater proportion of specimens with a ct<25 included in the application. If the number of specimens with a comparator ct<25 is reduced to bring the total proportion of specimen in that banding to 40%, then the sensitivity of the assay falls to 97.8 % and the lower 95% confidence limit to 93.7% which is still above the lower limit for an extracted PCR assay under the Coronavirus Test Device Authority (CTDA) regulations. In addition, the number of specimens with a ct>35 does not reach the requirement of the CTDA guidance; however, the Technical Virology Group allows approval of assays where the combined numbers of specimens above ct30 is at least 20% of the total number of specimens.
The evaluation was performed using a mixture of upper respiratory sample types including combined nose and throat swabs, nasal swabs and nasopharyngeal swabs. For CTDA approval, sufficient numbers of specimens of each sample type, across the dynamic range of the assay, would need to be supplied.