Integrated Screening Test (IST)
— using first and second trimester markers —
for the most reliable prenatal Down syndrome (DS)
risk assessment available.

Screening Requirements

First serum sample

  • CRL between 39 and 84 mm
  • NT* (unless serum integrated only requested)
  • Draw serum sample between 10w 3d and 13w 6d gestation
  • Complete Part 1 of Integrated Screening Test requisition

Second serum sample

  • Serum sample drawn between 15 and 21 weeks gestation
  • Complete Part 2 of Integrated Screening Test requisition

*NT must be measured by sonographer certified by FMF, SMFM, MFMF, or NTQR

The Foundation for Blood Research's role as pioneer of improvements and refinements in prenatal screening for Down syndrome continues with the introduction of the Integrated Screening Test (IST). Demonstrated by several major studies to be the most reliable screening approach available,1,2 the IST takes advantage of informative first trimester markers and integrates them with relevant clinical information to provide the most accurate Down syndrome risk estimation. The full IST uses the nuchal translucency (NT) measurement along with PAPP-A in the first trimester. A second trimester serum sample is tested for AFP, uE3, hCG, and inhibin - the same components that constitute the AFP Profile Four. This combination of first and second trimester markers provides optimal screening for fetal Down syndrome, and maintains current detecton rates for trisomy 18 and open neural tube defects.


Integrated Screening Test*

With NT Without NT Either
Down syndrome Down syndrome T183 ONTD4
Detection 90% 85% 80% 83%
Screen Positive 3% 3% 0.5% 3%

*Actual DS Detection and Screen Positive Rates will depend on maternal and gestational age. DS rates adapted from Wald et al, SURUSS Report2


 

The Integrated Screening Test: What you need to know


What are the advantages of the Integrated Screening Test?

The IST utilizes the best of the first and second trimester markers resulting in unsurpassed prenatal screening performance for Down syndrome, trisomy 18, and open neural tube defects.

What are the limitations of the Integrated Screening Test?

The IST is dependant upon careful timing of both the first and second trimester serum samples. Both samples must be sent to and analyzed by the same laboratory. Interpretation is available only after the second trimester sample is analyzed. Women who have had CVS or amniocentesis in their current pregnancy are not eligible for the IST. To take full advantage of the IST, an NT-certified sonographer must provide a nuchal translucency (NT) measurement.

What if NT measurement is not available in my area?

An IST utilizing only biochemical markers (without NT) is always available in situations where NT measurement is not provided. The FBR has extensive experience with Serum Integrated Screening, the most effective method of screening using serum markers only5,6.

Is the IST reimbursed by insurance?

Most insurers should cover the IST to the extent that they cover prenatal ultrasound and serum screening procedures. Patients are encouraged to check with their insurance carriers if in doubt.

Integrated Test Technology under license from Intema Ltd., UK

1 Malone FD, Wald NJ, Canick JA, et al. First and second-trimester evaluation of risk (FASTER) trial: principal results of the NICHD multicenter Down syndrome screening study. Am J Obstet Gynecol 2003; 189(6):s56.

2 Wald NJ, Rodeck C, Hackshaw AK, et al. First and second trimester antenatal screening for Down's syndrome: the results of the Serum, Urine and Ultrasound Screening Study (SURUSS). J Med Screen 2003; 10:56 104.

3 Palomaki GE, Neveux LM, Knight GJ, Haddow JE: Maternal serum integrated screening for trisomy 18 using both first and second-trimester markers. Prenal Diagn. 2003 Mar;23(3):243-7.

4 Wald NJ, Cuckle H, Brock JH, et al. Maternal serum alpha-fetoprotein measurement in antenatal screening for anencephaly and spina bifida in early pregnancy: Report of U.K. collaborative study on alpha-fetoprotein in relation to neural tube defects. Lancet 1977;I:1323-32.

5 Knight GJ, Palomaki GE, Neveux LM, et al. Integrated serum screening for Down syndrome in primary obstetric practice. Prenat Diagn 2005; 25:1162.

6 Palomaki GE, Kloza EM, Haddow JE, Williams J, Knight GJ: Patient and health professional acceptance of integrated serum screening for Down syndrome. Semin Perinatal 2005; 29:247-251.


 

Screening requirements for health care professionals:

  • account established with FBR

First serum sample

  • Complete Part 1 of Integrated Screening Test requisition
  • CRL between 39 and 84 mm
  • NT measured by sonographer certified by FMF, SMFM, MFMF, or NTQR (unless serum integrated only requested)
  • Serum sample drawn between 10w 3d and 13w 6d gestation

Second serum sample

  • Complete Part 2 of Integrated Screening Test requisition
  • Serum sample drawn between 15 and 21 weeks gestation

 

For more information about FBR's Integrated Screening Test or to create an account, please contact Client Services.