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First Trimester Screen, hCG

Test Summary

To screen for Down Syndrome and Trisomy 18 at 10.0-13.9 weeks gestation.

Aliases

  • N/A

Specimen Collection

Special Instructions

N/A

Preferred Specimen

1.5 mL serum

Minimum Volume

0.8 mL

Instructions

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 the requisition form must be complete to permit accurate interpretation of results.

Patient Preparation

N/A

Storage

Plastic screw-cap vial

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

Gross hemolysis

Order Code

FTHCG

EPIC (Premier) Code

LAB5176

Includes

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

CPT Code

  • 84163
  • 84702 OR 81508* *The 2017 AMA CPT codebook contains the component CPT codes and the new MAAA codeset. Please direct any questions regarding coding to the payor being billed.

Billing Code

  • 670406
  • 670407
  • 670408

CPT Statement

Methodology

Calculation (CALC) • 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.

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 Trisomy 18 Risk: <1:100

Setup Schedule / Expected Turnaround Time

Monday - Saturday; Report available: 4 - 6 days

Specimen Collection

Special Instructions

N/A

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 the requisition form must be complete to permit accurate interpretation of results.

Patient Preparation

N/A

Storage

Plastic screw-cap vial

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

Gross hemolysis

Billing

CPT Code

  • 84163
  • 84702 OR 81508* *The 2017 AMA CPT codebook contains the component CPT codes and the new MAAA codeset. Please direct any questions regarding coding to the payor being billed.

Billing Code

  • 670406
  • 670407
  • 670408

CPT Statement

Result Information

Methodology

Calculation (CALC) • Chemiluminescence (CL) • Immunoassay (IA)

Testing Laboratory

N/A

Reference Range

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

Setup Schedule / Expected Turnaround Time

Monday - Saturday; Report available: 4 - 6 days