Sequential Integrated Screen, Part 2

Test Code
16133

CPT Codes
81511<br /> This test is not available for California patient testing.<br /> This code is for non-New York State clients only. For New York State patient testing, use code 16975.

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

Preferred Specimen
3 mL serum

Minimum Volume
1 mL

Instructions
Collect between 14.0 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.

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 • Gross lipemia

Methodology
Chemiluminescence (CL) • Immunoassay (IA)

FDA Status
*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
Sequential Integrated Screen results consistent with an increased risk of trisomy should be confirmed with CVS or 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.

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.