First Trimester Screen, hCG (NY)

Test Code

16968

CPT Codes
81508<br /> This test is for New York clients. For non-New York patients use test code 16145

Includes

PAPP-A (Pregnancy-associated Plasma Protein-A), hCG, Maternal Risk calculation which includes NT (Nuchal Translucency)

Preferred Specimen

1.5 mL serum

Minimum Volume

0.8 mL

Instructions

Collect between 10.0 weeks to 13.9 (13 6/7) weeks. Perform between 10.0 to 13.9 (13 6/7) weeks gestational age. A special Maternal Serum Screen requisition designed to obtain patient data and the patient's informed consent must be used when ordering this test, because these results are influenced by certain patient characteristics. All data requested on therequisition form must be complete to permit accurate interpretation of results.

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
Calculation (CALC) • 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

First Trimester Screen results 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

Age Risk Down Syndrome	See Laboratory Report
MSS Down Syndrome Risk	<1:270
MSS Trisomy 18 Risk	<1:100
Calc'd Gestational Age	See Laboratory Report
PAPP-A	See Laboratory Report
PAPP-A MoM	See Laboratory Report
hCG, Serum	See Laboratory Report
hCG MoM	See Laboratory Report

NT MoM: First Trimester Screening screens for Down syndrome and Trisomy 18 only. Neural tube defect screening needs to be performed in the second trimester using Maternal Serum AFP (test code 5059), ideally. This is best performed at 16-18 weeks gestation. This is a screening test, not a diagnostic test. This risk assessment report is based on demographic data and test data (e.g., nuchal translucency [NT] measurement) provided by the ordering physician. Please notify the laboratory promptly if any data (especially NT data) are incorrect.

Clinical Significance

To screen for down syndrome and trisomy 18 at 10.0 to 13.9 weeks gestation.

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.