Serum Integrated Screen, Part 2

Test Code

16167

CPT Codes
81511<br /> <strong>This test is not available for California patient testing.<br /> This code is for non-New York clients only. For New York patient testing, use code 16966.</strong>

Includes

AFP, Unconjugated Estriol, hCG, Dimeric Inhibin A, PAPP-A (Pregnancy-associated Plasma Protein-A) from Maternal Serum, Serum Integrated Screen, Part 1 and Interpretation

Preferred Specimen

3 mL serum

Minimum Volume

1 mL

Instructions

Serum: 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 • Grossly lipemic

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

Serum Integrated Screen results consistent with an increased risk of trisomy should be confirmed with amniotic fluid specimen. Results consistent with increased risk of NTD may be followed-up with appropriate diagnostic testing as detailed in the report. 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.

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.