Screening test for Open Spina Bifida/ONTD, Trisomy 21/Down syndrome and Trisomy 18/Edward's syndrome

Integrated screening requires two specimens: one collected in the first trimester and one in the second trimester.

Gold serum separator (SST) tube

• Maternal serum specimens must be drawn prior to amniocentesis to avoid contamination with fetal blood
• Collect between 10.0 and 13.9 weeks gestation
• Immediatley following collection, mix sample by gently inverting 5 times

1. Allow sample to clot for a minimum of 30 minutes
2. Spin within two (2) hours of sample collection

Pour off/aliquoting is not advised

Gold serum separator (SST) tube

• Fetal nuchal translucency (NT) measurement
  • The NT measurement must be performed by a sonographer credentialed by the Fetal Medicine Foundation or other equivalent entity. The sonographer's credential/certification number must be provided.
• Crown rump length measurement
• Patient's race
• Patient's weight
• Patient's date of birth
• Patient's insulin dependent diabetic status
• Number of fetuses
• Patient history (ie, prior Down syndrome pregnancy, ultrasound anomalies).

Complete information is necessary to interpret the test

Maternal testing clinical information form

Gestational age conversions:

Ambient (preferred) - 7 days

Refrigerated - 14 days

Frozen - 14 days

Freeze/thaw cycles - stable x 3

• Gross hemolysis
• Gross lipemia
• Quantity not sufficient for analysis (QNS) 
• Improper specimen type

Chemiluminescent immunoassay

An interpretive report will be provided

There is no risk assessment after the first draw. A specimen for the Integrated 2 must be collected and the overall risk for Down syndrome, trisomy 18 and open spina bifida is provided after the testing of the second blood sample, using information from the part 1 and part 2. 

Serum testing is provided from 10.0 to 13.9 weeks of gestation. NT can be assessed when the CRL is 45 to 84 mm.