CONDOR workstream reports and outputs.
Analytical Performance
This workstream evaluates which tests should be trialled in the different clinical settings and putting the right ones forward into our clinical studies.
The technical validation includes, but is not limited to, a biosafety assessment, lower dynamic range analysis and an initial test accuracy assessment. The acceptance criteria set by the Technical Validation Group (DHSC) is based on the Target Product Profile. These tests have been classed as not meeting this criteria either as a result of not meeting biosafety requirements or because the test performance did not meet the minimum acceptance levels based on the Target Product Profile.
Tests which were successfully validated and reported
Product | Manufacture | Test type | Status | Report link |
Direct SARS-CoV-2 RT-LAMP on the Genieâ II | OptiGene | LAMP | Validated and reported | Technical Validation of OptiGene RT LAMP Assay (Direct and RNA Formats) |
RNA SARS-CoV-2 RT-LAMP on the Genieâ HT | OptiGene | LAMP | Validated and reported | Technical Validation of OptiGene RT LAMP Assay (Direct and RNA Formats)
|
LUMIRADX SARS-COV-2 AG TEST | LumiraDx | Antigen | Validated and reported | |
SARS-CoV-2 (orf 1ab) Premix Reagent | Horiba | POC PCR | Validated and reported | |
Abbott ID now COVID-19 assay | Abbott | Isothermal amplification | Validated and reported | |
Sofia 2 SARS Antigen FIA | Quidel | Antigen | Validated and report pending |
|
Ongoing evaluations
Product | Manufacture | Test type | Status |
iAMP COVID-19 | Biosana Health | LAMP | On-going |
Bosch Vivalytic SARS-CoV-2 test | Randox | POC PCR | On-going |
be.wellä COVID-19 test | Alveo | LAMP | On-going |
BD Veritorä System for Rapid Detection of SARS-CoV-2 | BD | Antigen | On-going |