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IntegratedScreen

CPT:

84163


Synonyms

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


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.



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.


Storage Instructions

Refrigerate


Causes for Rejection

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


Test Details


Use

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


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.


Methodology

Enzyme immunoassay (EIA)


Pregnancy Week

0–13 Weeks
14–21 Weeks

References

Wald NJ, Watt HC, Hackshaw AK. Integrated screening for Down's syndrome based on tests performed during the first and second trimesters. N Engl J Med. 1999 Aug 12; 341(7):461-467.


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