First Trimester Screen, Hyperglycosylated hCG (h-hCG)

Test Code

HHCG

CPT Codes
81508<br /> This test is not available for New York, or California patient testing.<br /> This test code is for non-New York State patient testing only. For New York State patient testing, use 16969.

Includes

PAPP-A (Pregnancy-associated Plasma Protein), h-hCG (hyperglycosylated hCG), risk calculation which includes NT (Nuchal Translucency)

Preferred Specimen

1.5 mL serum

Minimum Volume

0.8 mL

Instructions

This test cannot be performed unless all demographic data and test data (e.g., nuchal translucency [NT] measurement) are provided by the ordering physician.

Transport Container

Plastic screw-cap vial

Transport Temperature

Room temperature

Specimen Stability

Room temperature: 14 days
Refrigerated: 14 days
Frozen: 28 days

Methodology
Chemiluminescence (CL) • Immunoassay (IA)

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 FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

*PAPP-A Component only: This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Quest Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

Setup Schedule

Set up: Mon-Sat; Report available: 4-6 days

Limitations

First Trimester Screen results consistent with increased risk of trisomy should be confirmed with CVS or amniotic fluid specimen. Maternal serum screening yields a low percentage of false negatives. A wide range of other chromosomal abnormalities are not identified by maternal serum screening.

Reference Range

See Laboratory Report

Clinical Significance

To screen for Down syndrome and trisomy 18 at 9.0-13.9 weeks gestation.

Performing Laboratory

Quest Diagnostics Nichols Institute-San Juan Capistrano, CA

33608 Ortega Highway

San Juan Capistrano, CA 92675-2042

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.