RE: Test kits27 Mar 2021 13:03
Target Product Profile: Laboratory-Based SARS-CoV-2 Viral Detection tests
Updated 23 March 2021
Intended use - Desired
Multiplex - Determining current infection by detecting SARS-CoV-2 virus in samples from people of all ages at any point during active infection and differentiating from other respiratory infections
Target population - Desired
People with or without clinical signs associated with SARS-CoV-2 infection.
Target use Setting - Desired
Healthcare and Medical Laboratories
Test format - Desired
A standardised kit that contains all materials required for the laboratory procedure that includes controls, reagents and Instruction for Use (IFU).
All accessories needed to perform the assay and sample processing included, with the exception of routine laboratory consumables such as pipettes, pipette tips, disinfectants, screw cap eppendorfs, heat blocks, fluorescent readers etc.
SARS-CoV-2 Target - Desired
Dual (or more) SARS-CoV-2 RNA
Analyte - Desired
Multiplex panel for a range of infectious respiratory viruses
Detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus, RSV A & B
Sample type - Desired
Oral Fluid
Compatible sample collection- Desired
Test is validated for use with saliva and/or non-propriety collection media
Result output- Desired
Semi quantitative
Size- Desired
Standard mains power supply with UPS and the capability for battery power.
Ease of use and result interpretation- Desired
Suitable for target user groups (i.e. trained healthcare professionals)