Chromosomal Microarray, Postnatal Parental Follow-up, Clarisure®

Test Code
92210


CPT Codes
Not Applicable

Physician Attestation of Informed Consent
This germline genetic test requires physician attestation that patient consent has been received if ordering medical facility is located in AK, DE, FL, GA, IA, MA, MN, NV, NJ, NY, OR, SD or VT or test is performed in MA.


Preferred Specimen
5 mL whole blood collected in a sodium heparin (green-top) tube


Minimum Volume
3 mL whole blood • 2 mL saliva


Other Acceptable Specimens
Whole blood collected in: Sodium heparin (royal blue-top) tube, sodium heparin lead free (tan-top) tube, or EDTA (lavender-top) tube • Buccal swab collected in: ORAcollect-Dx OCD-100/OCD-100A • Saliva collected in: OGD-500 Oragene Dx collection kit up to the "fill to" line on the device


Instructions
Whole blood: Critical NICU/Neonates 0.5 mL. All others 3-5 mL. Sodium heparin (green-top) tube or EDTA (lavender-top) tube.
Ship at room temperature. Other vacutainer tubes containing sodium heparin are acceptable.

Buccal swab collected in ORAcollect-DX OCD-100/OCD-100A* (*Device contains insert) or saliva collected in OGD-500 Oragene Dx collection kit up to the "fill to" line on the device, do not count bubbles.


Transport Container
Sodium heparin (green-top) tube


Transport Temperature
Room temperature


Specimen Stability
⁠⁠⁠⁠⁠⁠⁠Whole Blood: Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. Do not reject.

Buccal Swab
Room temperature: 14 days
Refrigerated: Unacceptable
Frozen: Unacceptable

Saliva
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable


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


Methodology
Oligo-SNP Array

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Daily


Report Available
10 days


Reference Range
See Laboratory Report


Clinical Significance
When a microarray analysis performed at Quest Diagnostics yields a result that is suggestive of pathogenicity but does not have enough evidence to support a classification, a targeted parental follow-up microarray will be performed to assist in establishing the clinical significance of the proband result.


Performing Laboratory
Quest Diagnostics Nichols Institute-San Juan Capistrano, CA
33608 Ortega Highway
San Juan Capistrano, CA 92675-2042



Last Updated: November 6, 2024


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.