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First Trimester Screen, Hyperglycosylated hCG (h-hCG)

Test Summary

To screen for Down syndrome and trisomy 18 at 9.0-13.9 weeks gestation.

Aliases

  • N/A

Specimen Collection

Special Instructions

N/A

Preferred Specimen

1.5 mL serum

Minimum Volume

0.8 mL

Instructions

N/A

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Room temperature

Specimen Stability

  • Room temperature: 14 days
  • Refrigerated: 14 days
  • Frozen: 28 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.

Other Acceptable Specimens

N/A

Unacceptable Specimens

Moderate and gross hemolysis • Lipemia

Order Code

HYPHCG

EPIC (Premier) Code

LAB3235

Includes

PAPP-A (Pregnancy-associated Plasma Protein), h-hCG (hyperglycosylated hCG), risk calculation which includes NT (Nuchal Translucency)

CPT Code

  • 81508 - Not for California Clients. For New York patient testing
  • use test 16969

Billing Code

  • 670079

CPT Statement

Methodology

Chemiluminescence (CL) • Immunoassay (IA)

FDA Status

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.

Physician Attestation of Informed Consent

N/A

Testing Laboratory

Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675

Department

Reference Testing

Reference Range

MSS Down Syndrome Risk <1:270
MSS Risk for Trisomy 18 Risk <1:100

Setup Schedule / Expected Turnaround Time

Mornings; 6 days a week.

Specimen Collection

Special Instructions

N/A

Preferred Specimen

1.5 mL serum

Minimum Volume

0.8 mL

Instructions

N/A

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Room temperature

Specimen Stability

  • Room temperature: 14 days
  • Refrigerated: 14 days
  • Frozen: 28 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.

Other Acceptable Specimens

N/A

Unacceptable Specimens

Moderate and gross hemolysis • Lipemia

Billing

CPT Code

  • 81508 - Not for California Clients. For New York patient testing
  • use test 16969

Billing Code

  • 670079

CPT Statement

Result Information

Methodology

Chemiluminescence (CL) • Immunoassay (IA)

Testing Laboratory

N/A

Reference Range

MSS Down Syndrome Risk <1:270
MSS Risk for Trisomy 18 Risk <1:100

Setup Schedule / Expected Turnaround Time

Mornings; 6 days a week.