SAMBA II SARS-CoV-2/RSV Test: technical validation protocol
The SAMBA II SARS-CoV-2/RSV test is for the qualitative detection of nucleic acids from SARS-CoV-2 and/or Respiratory Syncytial Virus in human respiratory specimens.
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The SAMBA II SARS-CoV-2/RSV test assay meets the diagnostic performance criteria for both sensitivity and specificity.
The sensitivity is achieved with a greater proportion of specimens with a ct<25 included in the application. However, if the number of specimens with a comparator ct<25 is reduced to bring the total proportion of specimen in that banding to 40% the lcl remains above 94% – above the requirement to reach category-1 status 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 nasal and throat swabs, nasal 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.