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IntegratedScreen

CPT:

84163

IntegratedScreenSM is a two-part test that screens for fetal Down syndrome, trisomy 18 and open neural tube defects. Between 10 weeks / 3 days (10.4 weeks, CRL = 39-84 mm) and 13 weeks / 6 days (10.4-13.9 weeks, CRL = 39-84 mm), pregnancy-associated plasma protein A (PAPP-A) is measured in a maternal blood sample and the nuchal translucency (NT) measurement is obtained. Then, patients are directed to come back between 15 weeks / 0 days and 21 weeks / 6 days (15.0-21.9 weeks) for a second blood draw. Alpha-fetoprotein (AFP), human chorionic gonadotropin (hCG), unconjugated estriol (uE3) and dimeric Inhibin-A are measured on the second sample. IntegratedScreen combines these measurements to provide risk assessments in the second trimester for fetal Down syndrome, trisomy 18 and open neural tube defects.

Test Details

Use

Screening test for open neural tube defects, Down syndrome, and trisomy 18

Synonyms

Down Syndrome; Nuchal Translucency (NT); PAPP-A;

Methodology

Enzyme immunoassay (EIA)

Pregnancy Week

0–13 Weeks
14–21 Weeks

Specimen Requirements

Specimen

Serum; whole blood; dried blood spot

Volume

Serum:​  2 mL serum, in SST for both first and second trimester specimens.

Whole Blood: 7 mL in SST or 10 mL in red-top tube in both first and second trimester specimens; allow to clot; centrifuge (15 minutes at 1,500 rpm) to prevent hemolysis.

Dried Blood Spot: Fill a minimum of three circles completely with blood. Please Note: If prenatal carrier screening for cystic fibrosis is ordered in conjunction with first trimester screening all six circles should be filled.  Please Note: Only the first trimester integrated sample (Part 1 of IntegratedScreen) can be collected on dried blood spot filter paper. For the second trimester sample of IntegratedScreen, please send whole blood or serum (see specimen requirements listed). Second trimester dried blood spot samples will be rejected and cancelled.

Container

Serum:  Serum separator tube (SST)

Whole blood:  Serum separator tube (SST) or red-top tube

Dried blood spots collection on laboratory provided blood spot card

Collection

Whole Blood:  allow to clot; centrifuge (15 minutes at 1,500 rpm) to prevent hemolysis.

Dried Blood Spot:  Fill a minimum of three circles completely with blood. Please Note: If prenatal carrier screening for cystic fibrosis is ordered in conjunction with first trimester screening all six circles should be filled.​ Please Note: Only the first trimester integrated sample (Part 1 of IntegratedScreen) can be collected on dried blood spot filter paper. For the second trimester sample of IntegratedScreen, please send whole blood or serum (see specimen requirements listed). Second trimester dried blood spot samples will be rejected and cancelled.  Please Note: Please do not send dried blood spot samples for second trimester samples of IntegratedScreen.

Special Instructions

Integrated Genetics will accept NT measurements only from appropriately certified sonographers {e.g., the Nuchal Translucency Quality Review Program (NTQR) and the Fetal Medicine Foundation (FMF)}. Please submit certification information before sending specimens for IntegratedScreen. Please contact our Client Services Department with any questions.

Causes for Rejection

Gross hemolysis; gross lipemia; quantity not sufficient for analysis; improper specimen type

Storage Instructions

Refrigerate

Additional Information

Limitations

IntegratedScreen requires two specimens: one collected in the first trimester and one in the second trimester. This test number is for the first trimester portion of the test. Result interpretation will be provided only when the second trimester specimen is received and tested. This is a screening test. A positive result means that diagnostic testing may be offered to the pregnant woman to determine if a neural tube defect or chromosome abnormality is present.

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Patient?

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