IVD Clinical Performance
The comparator or reference method should be scientifically justified for the intended diagnostic claim.
The comparator or reference method should be scientifically justified for the intended diagnostic claim.
Potential Reference Methods
Molecular
- PCR
- RT-PCR
- NAAT
- Sequencing where appropriate
Immunological
- ELISA
- Laboratory immunoassays
- Confirmatory serology
Microbiology
- Culture
- Microscopy
- Confirmatory microbiological methods
Toxicology
- LC-MS/MS
- GC-MS
Other
- Established laboratory analyzers
- Validated predicate methods
- Clinically accepted reference procedures
Can Bioexcel Arrange Comparator or Reference Testing?
Yes. Bioexcel can coordinate comparator and reference laboratory testing using scientifically justified methods appropriate to the intended diagnostic claim and study design.
