Trikafta Levels

Test Code

13805

CPT Codes
80299<br>Restricted Client Code<br><strong>This test is not available for New York patient testing</strong>

Preferred Specimen

2 mL serum collected in a red-top tube (no gel)

Minimum Volume

0.25 mL

Other Acceptable Specimens

Plasma collected in a (green-top) tube

Instructions

Allow to clot for 30 minutes, separate serum from cells immediately by centrifugation and aliquot into a labeled polypropylene or similar plastic tube. Use a separate tube for each test ordered. Allow room for expansion of sample inside tube.

Transport Temperature

Frozen

Specimen Stability

Room temperature: 24 hours
Refrigerate: Unacceptable
Frozen -20° C: 7 days
Frozen -70° C: 1 year

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Serum separator tube (SST) • Severe hemolysis • Thawed samples for greater than 24 hours

Methodology
HPLC-UV

FDA Status
The performance characteristics for this test have been validated by Advanced Diagnostic Laboratories at National Jewish Health. It has not been cleared or approved by the US Food and Drug Administration. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) as qualified to perform high complexity clinical laboratory testing.

Setup Schedule

Set up: Varies; Report available:10 days

Reference Range

Tezacaftor: 6 - 9.4 mcg/mL
Ivacaftor: 0.9 - 1.5 mcg/mL
Elexacaftor: 7.1 - 11.3 mcg/mL

Clinical Significance

This test is a high performance liquid chromatography drug monitoring assay that detects levels of elexacaftor, tezacaftor, ivacaftor and two metabolites (M1-IVA, M6-IVA) from a clinical serum specimen. The test is intended to enhance the precision and effectiveness of Trikafta therapy by tailoring the treatment to individual patients, optimizing dosages, mitigating side effects, monitoring treatment response, and offering valuable data for clinical decision-making.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.