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Order Code LAB1STTM First Trimester Maternal Screen, Serum

Important Note

Do not send specimen to Mayo Clinic Laboratories if the sonographer is not NT-certified or before completing the application process. See Maternal Screening: Sonographer Approval Process link or complete the NT/CRL Data for First Trimester/Sequential Maternal Screening.

Sonographer name and code are required when ordering.

Additional Codes

Mayo test Code: 1STT1


Ordering Guidance


This test does not screen for neural tube defects. If risk assessment for neural tube defects is desired, collect specimen between 15 weeks, 0 days and 22 weeks, 6 days of gestation for an alpha-fetoprotein single marker screen; order MAFP1 / Alpha-Fetoprotein (AFP), Single Marker Screen, Maternal, Serum.

 

QUAD screening (QUAD1 / Quad Screen [Second Trimester] Maternal, Serum) is not recommended following first-trimester screening.

 



Necessary Information


Approval to send specimen for first-trimester screening is required and may take up to 5 business days to complete. Nuchal translucency (NT) measurements are only accepted from NT-certified sonographers. Do not send specimen to Mayo Clinic Laboratories if the sonographer is not NT-certified or before completing the application process. See Maternal Screening: Sonographer Approval Process link or complete the NT/CRL Data for First Trimester/Sequential Maternal Screening.



Specimen Required


Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge and aliquot serum into plastic vial within 2 hours of collection

Additional Information:

1. Blood draw and ultrasound must be completed between 10 weeks, 0 days and 13 weeks, 6 days of gestation, which corresponds to a crown-rump length (CRL) range of 31 to 80 mm.

2. Initial or repeat testing is determined in the laboratory at the time of report and will be reported accordingly. To be considered a repeat test for the patient, the testing must be within the same pregnancy and trimester, with interpretable results for the same test and both tests are performed at Mayo Clinic.


Useful For

Prenatal screening for trisomy 21 (Down syndrome) and trisomy 18

Method Name

Immunoenzymatic Assay

Reporting Name

First Trimester Maternal Screen

Specimen Type

Serum

Specimen Minimum Volume

0.75 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 7 days
  Frozen  90 days
  Ambient  7 days

Reject Due To

Gross hemolysis Reject
Gross lipemia OK
Gross icterus OK

Reference Values

DOWN SYNDROME

Calculated screen risks <1/230 are reported as screen negative.

Risks ≥1/230 are reported as screen positive.

 

TRISOMY 18

Calculated screen risks <1/100 are reported as screen negative.

Risks ≥1/100 are reported as screen positive. A numeric risk for trisomy 18 risk is provided with positive results on non-diabetic, non-twin pregnancies.

An interpretive report will be provided.

Method Description

The first-trimester screen for Down syndrome and trisomy 18 includes pregnancy-associated plasma protein A (PAPP-A), total human chorionic gonadotropin (hCG), and nuchal translucency measurement.

 

The Beckman Access HCG5 assay is an automated 2-site, mouse monoclonal antibody-based immunoenzymatic sandwich assay with paramagnetic separation and chemiluminescent detection. Testing is performed using the Beckman Coulter DxI.(Package insert: Access HCG5. Beckman Coulter, Inc; 2018)

 

The Access PAPP-A assay is a 2-site immunoenzymatic sandwich assay. Testing is performed using the Beckman Coulter DxI.(Unpublished Mayo method)

Day(s) Performed

Monday through Friday

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

81508