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Integrated Screen, Part 2 (NY)
Test Code16977
CPT Codes
81511*<br /> <strong>**This code is for New York patient testing. For non-New York patient testing, use 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.
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
Plastic screw-cap vial
Transport Temperature
Room temperature
Specimen Stability
Room temperature: 14 days
Refrigerated: 14 days
Frozen: 28 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
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
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.
