Chromosome Analysis,Amniotic Fluid Reflex to ClariSure®,Oligo-SNP,Prenatal

Test Code

CHFLA

Alias/See Also

92704

CPT Codes
88235, 88269, 88280, 81229

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.

Includes

If Chromosomes Analysis, Amniotic Fluid is normal, then the Chromosomal Microarray, Prenatal, ClariSure® Oligo-SNP will be performed at an additional charge. (CPT code(s): 81229).

Preferred Specimen

30 mL fresh amniotic fluid collected in a sterile tube

Minimum Volume

10 mL

Instructions

Patient's age, gestational age, and indication(s) for testing are necessary; please submit completed cytogenetics requisition form with information. Do not split even if AFP requested. Send all tubes to lab (supernatant for AFP will be split by cytogenetics lab).
**Signed informed consent is a requirement. Amniotic fluid kit and handling instruction available upon request.

This test may be replaced by other Bill Codes, if the complete study cannot be performed, or if the specimen does not yield mitotically active cells for analysis: Prenatal Specimen Culture; or Cytogenetics Communication (if a communication is required).

Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not reject.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: Preferred
Refrigerated: Acceptable
Frozen: Unacceptable

Methodology
Culture • Karyotype • Microscopy

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 the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Set up: Daily; Report available: 6-8 days after receipt at the performing laboratory, additional days for reflex if needed. Add two (2) additional days for transport.

Reference Range

See Laboratory Report

Clinical Significance

Testing determines chromosomal status of the fetus. Numerical and structural chromosomal abnormalities can be diagnosed. Sex and the presence of more than one cell line (mosaicism) can also be determined. Indications include diagnosis of chromosome abnormalities in fetuses of women who are of advanced maternal age; had a previous child with a chromosome abnormality; parental carrier of a balanced translocation, inversion or marker chromosome; parental mosaicism and follow-up for abnormal maternal serum alpha fetoprotein or maternal screening results.
Chromosomal Microarray, Prenatal, ClariSure® Oligo-SNP - This assay may be useful for:
• Further investigation on fetuses with abnormal ultrasound findings indicating congenital malformation.
• Further definition of an imbalanced cytogenetic abnormality.
• Further investigation on equivocal cytogenetic findings.
• Attempt at characterization of supernumerary marker chromosome.
• Follow-up to a documented chromosome abnormality or genomic alteration in a sibling or a parent.
• Family history of a previous child with mental retardation and/or phenotypic abnormalities.

Performing Laboratory

Quest Diagnostics Nichols Institute

14225 Newbrook Drive

Chantilly, VA 20153

Last Updated: May 5, 2023

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.