Celiac PLUS
Use
PROMETHEUS® Celiac PLUS is the only celiac test that combines serologic and genetic testing in one convenient test. It aids in diagnosing celiac disease by identifying both serologic markers and genetic risk factors. Genetic testing involved in this analysis can detect genes specific to celiac disease (DQ2/DQ8), which if absent, can rule out celiac disease with a high negative predictive value (NPV) of 95% to 100%. The genetic component also estimates patient risk from extremely low to extremely high according to individual genetic profiles.
Special Instructions
The test is a laboratory-developed test analytically and clinically validated by Prometheus Laboratories Inc. under CLIA guidelines and performed exclusively in a high complexity CLIA-certified and CAP-accredited laboratory.
Limitations
As a laboratory-developed test, Celiac PLUS has not been cleared or approved by the US FDA. The test's clinical and analytical performance was established by Prometheus Laboratories and not subject to US FDA regulatory review. It is only intended for use as per applicable regulations and may require informed consent for genetic testing.
Methodology
Other
Biomarkers
Result Turnaround Time
4 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
2.0 mL
Minimum Volume
Not provided
Container
Serum Separator Tube or Red-Top Tube
Storage Instructions
Ambient or cold pack, do not freeze
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 7 days |
| Refrigerated | 30 days |