Sequential Integrated Screen, Part 1 (NY)

Test Code

16974

CPT Codes
81508<br /> **This code is for New York clients only. For non-New York patient testing, use code 16131.**

Preferred Specimen

1.5 mL serum

Minimum Volume

0.8 mL

Instructions

Collect between 10.0 weeks to 13.9 weeks. Must complete patient demographic information using the “Maternal Serum Screen Requisition.

Additional Information: NT measurement, when provided by the physician, will be used for additional interpretation.

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

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

Reference Range

See Laboratory Report

Clinical Significance

To assess maternal risk for carrying a fetus with Down Syndrome (Trisomy 21) or Trisomy 18 in the first or second trimester, or a neural tube defect, when used in conjunction with the Part 2 testing. 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.