TABLE 1.

Methodological assessment of new swab types and viral transport media for SARS-CoV-2 and other respiratory viral testing

Phase	Description	Protocol outline	Acceptance criterion(a)
1	Visual inspection	VTM: leakage, vol, discoloration, turbidity, or visible contamination	No significant leakage or visibly compromised VTM tubes
Swabs: size, flexibility, breakage	No breakage outside designated breakpoints, flexibility and size comparable with reference swab
2	Evaluation of swabs	Sterility	No bacterial or fungal growth; no contamination detectable by PCR
In vitro performance	Results comparable with reference swab (CT difference of <2)
3	Evaluation of UTM	Sterility	No bacterial or fungal growth; no contamination detectable by PCR
Recovery of viral nucleic acids	Results comparable with reference swab (categorical agreement)
Stability at different storage conditions	Results comparable with reference swab at different time points (CT difference of <2)
4	Clinical performance	Performance on patients or volunteers	Results between reference swab and test swab in categorical agreement; tolerable comfort reported by patients