Serum Integrated Screen, Part 2 (NY)

Test Code

16966

CPT Codes
81511<br /> <strong>**This test is not available for California patient testing.**<br /> **This code is for New York clients only. For non-New York patient testing, use code 16167**</strong>

Includes

AFP, Unconjugated Estriol, hCG, Dimeric Inhibin A, *PAPP-A from Maternal Serum, Serum Integrated Screen, Part 1 and Interpretation

Preferred Specimen

3 mL serum

Minimum Volume

1 mL

Instructions

Collect between 14.0 weeks to 22.9 weeks. Maternal date of birth (mm/dd/yy), Estimated Date of Delivery by US/LMP/PE, weight, race, insulin-dependent diabetes status, repeat sample (Y/N), number of fetuses, and neural tube defect history must be provided for interpretation of results. Must complete patient demographic information using the “Maternal Serum Screen Requisition.

Transport Container

Plastic screw-cap vial

Transport Temperature

Room temperature

Specimen Stability

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

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

Gross hemolysis • Gross lipemia

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

Maternal age confirmation and number of fetuses may alter result interpretation. Maternal screening tests 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 assess maternal risk for carrying a fetus with Down Syndrome (Trisomy 21), Trisomy 18, or a neural tube defect. These types of tests are standard-of-care in obstetrics.

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.