Ordering Recommendation

First-trimester screening test for trisomy 21 (Down syndrome), trisomy 18, and open neural tube defects. Risks determined using a combination of first and second-trimester serum markers, with or without first-trimester nuchal translucency measurement. Risks provided after testing is completed for second-trimester specimen, Maternal Serum Screening, Integrated, Specimen #2, Alpha Fetoprotein, hCG, Estriol, and Inhibin A (3000149).

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation

Specimen must be drawn between 10 weeks, 0 days and 13 weeks, 6 days gestation. (If gestational age is based on Crown-Rump length (CRL), the specimen must be collected when the CRL is between 32.4-83.9 mm.)

Collect

Serum Separator Tube (SST) or Plain Red.

Specimen Preparation

Separate from cells ASAP or within 2 hours of collection. Transfer 0.5 mL serum to an ARUP Standard Transport Tube. (Min: 0.3 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Plasma. Hemolyzed specimens.

Remarks

Submit with Order: Patient's date of birth, current weight, number of fetuses present, patient's race, if the patient was diabetic at the time of conception, if there is a known family history of neural tube defects, if the patient has had a previous pregnancy with a trisomy, if the patient is currently smoking, if the patient is taking valproic acid or carbamazepine (Tegretol), if this is a repeat sample, and the age of the egg donor if in vitro fertilization.

In addition to the above:

If a NT measurement is performed: the date of ultrasound, the CRL measurement, the nuchal translucency (NT) measurement and the name and certification number of the sonographer is required.  NT must be measured when the CRL is between 38-83.9 mm.
or
If no NT measurement is performed: a due date or CRL measurement with the date of ultrasound is required.

The NT measurement must also be performed by an ultrasonographer that is certified by one of the following agencies: Fetal Medicine Foundation (FMF) or Nuchal Translucency Quality Review (NTQR). To avoid possible test delays for an ultrasonographer that is new to our database, please contact the genetic counselor at (800) 242-2787 extension 2141 prior to sending specimen.

Stability

After separation from cells: Ambient: 72 hours; Refrigerated: 2 weeks; Frozen: 1 year (Avoid repeated freeze/thaw cycles.)

Methodology

Quantitative Chemiluminescent Immunoassay (CLIA)

Performed

Sun-Sat

Reported

2-4 days

Reference Interval

By report

Interpretive Data

Refer to report.

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

Compliance Category

Laboratory Developed Test (LDT)

Note

The first specimen of an Integrated Maternal Serum Screening is used to measure PAPP-A. Final interpretative report will be available when the second specimen test results are complete.

Hotline History

N/A

CPT Codes

84163

Components

Component Test Code* Component Chart Name LOINC
0080241 Estimated Due Date 11778-8
0080920 Maternal Screen Interpretation 49586-1
0080922 Specimen 19151-0
0080923 Dating 21299-3
0080926 Maternal Race 21484-1
0080927 Number of Fetuses 11878-6
0080932 Maternal Age At Delivery 21612-7
0081065 Nuchal Translucency (NT) 12146-7
0081069 Sonographer Certification # 49089-6
0081070 Sonographer Name 49088-8
0081071 Ultrasound Date 34970-4
0081158 Family History of Aneuploidy 32435-0
0081331 Best date to draw sample #2 by 33882-2
3000163 PAPP-A Maternal 48407-1
3000165 Smoking 64234-8
3000166 Crown Rump Length 11957-8
3000168 Nuchal Translucency (NT), Twin B 12146-7
3000170 Crown Rump Length, Twin B 11957-8
3000175 EER Maternal Serum, Integrated, Spcm1 11526-1
3000263 Gestational Age Calculated at Collection 18185-9
3000264 Maternal Weight 29463-7
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • First trimester screen
Maternal Serum Screening, Integrated, Specimen #1, PAPP-A, NT