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Quad Screen

Test Summary

Maternal serum Quad Screen is used for prenatal screening of Down syndrome (Trisomy 21), Trisomy 18 (Edwards syndrome), and open neural tube defects (ONTD). This profile includes alpha-fetoprotein (AFP), unconjugated estriol (µE3), human chorionic gonadotropin (hCG), and inhibin A. Establishing risk for fetal Down syndrome, using the quad screen achieves a 70-75% detection rate with a 5% false positive rate. Screening for Trisomy 18 detects 60% of affected fetuses with a 0.2% false positive rate. MSAFP screening detects 88% of anencephaly and 79% of open spina bifida with a 3% false positive rate. Normal results do not ensure birth of a normal infant. In addition, 2-3% of newborns have some type of physical or mental defect, many of which may be undetectable with current prenatal diagnostic procedures.

Aliases

  • QUAD Marker, Maternal Serum Screen 4, TETRA Profile, AFP/4 Screebn, AFP TETRA, Quad Screen

Specimen Collection

Special Instructions

N/A

Preferred Specimen

3 mL serum

Minimum Volume

1 mL

Instructions

The Quad test in pregnant women should be performed between 14.0 and 22.9 weeks gestational age, although the optimal period is 15.0-16.9 weeks. This time frame allows sufficient opportunity for further diagnostic studies if the initial Quad Screen test results are abnormal. Specimens submitted before 14.0 weeks or after 22.9 weeks gestation cannot be properly evaluated for open neural tube defects, Down Syndrome or Trisomy 18.

Note: For manual orders use "Maternal Serum Screen Requisition"
The Maternal Serum Screen Requisition designed to obtain patient data and the patient's informed consent must be utilized when ordering the Quad Screen test. Because the Quad Screen test results are influenced by certain patient characteristics, the following data must be provided with the specimen in order to permit accurate interpretation of results: date of collection, patient's (maternal) date of birth, patient's estimated date of delivery, patient's weight, patient's race, patient's diabetic status (is patient insulin dependent prior to pregnancy), number of fetuses, and whether this is a repeat sample.

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Room temperature

Specimen Stability

  • Room temperature = 14 days
  • Refrigerated = 14 days
  • Frozen = 28 days

Limitations

Quad 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.

Other Acceptable Specimens

N/A

Unacceptable Specimens

Gross hemolysis • Gross lipemia

Order Code

MSQUAD

EPIC (Premier) Code

LAB024

Includes

AFP, unconjugated Estriol, hCG, Dimeric Inhibin A and Maternal Risk Interpretation

CPT Code

  • 81511 - **This test is not available for California and New York patient testing. For New York patient testing use test code 16333.**

Billing Code

  • 671154

CPT Statement

Methodology

Immunoassay (IA)

FDA Status

FDA Approved

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

See Laboratory Report

Setup Schedule / Expected Turnaround Time

Monday - Saturday; Report available: 3 - 4 days

Specimen Collection

Special Instructions

N/A

Preferred Specimen

3 mL serum

Minimum Volume

1 mL

Instructions

The Quad test in pregnant women should be performed between 14.0 and 22.9 weeks gestational age, although the optimal period is 15.0-16.9 weeks. This time frame allows sufficient opportunity for further diagnostic studies if the initial Quad Screen test results are abnormal. Specimens submitted before 14.0 weeks or after 22.9 weeks gestation cannot be properly evaluated for open neural tube defects, Down Syndrome or Trisomy 18.

Note: For manual orders use "Maternal Serum Screen Requisition"
The Maternal Serum Screen Requisition designed to obtain patient data and the patient's informed consent must be utilized when ordering the Quad Screen test. Because the Quad Screen test results are influenced by certain patient characteristics, the following data must be provided with the specimen in order to permit accurate interpretation of results: date of collection, patient's (maternal) date of birth, patient's estimated date of delivery, patient's weight, patient's race, patient's diabetic status (is patient insulin dependent prior to pregnancy), number of fetuses, and whether this is a repeat sample.

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Room temperature

Specimen Stability

  • Room temperature = 14 days
  • Refrigerated = 14 days
  • Frozen = 28 days

Limitations

Quad 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.

Other Acceptable Specimens

N/A

Unacceptable Specimens

Gross hemolysis • Gross lipemia

Billing

CPT Code

  • 81511 - **This test is not available for California and New York patient testing. For New York patient testing use test code 16333.**

Billing Code

  • 671154

CPT Statement

Result Information

Methodology

Immunoassay (IA)

Testing Laboratory

N/A

Reference Range

See Laboratory Report

Setup Schedule / Expected Turnaround Time

Monday - Saturday; Report available: 3 - 4 days