Integrated Screen, Part 2 (NY)

Test Code
16977


CPT Codes
81511<br><strong>This test code is for New York patient testing. For non-New York patient testing, use test code 16150.</strong>

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


Preferred Specimen
3 mL serum


Minimum Volume
1 mL


Instructions
Perform test between 14.0 weeks and 22.9 weeks gestational age.
A special "Maternal Serum Screen requisition", designed to obtain patient data and the patient's informed consen, must be used when ordering this test, because these results are influenced by certain patient characteristics. All data requested on the requisition form must be completed. 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.


Transport Container
Transport tube


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: 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
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.


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.