Serum Integrated 1
Also known as: Down Syndrome, PAPP-A
Use
Screening test for open neural tube defects, Down syndrome, and trisomy 18
Special Instructions
For inquiries regarding this test, contact CMBP genetic services at 800-345-4363. Required information includes gestational age, method of gestational age determination (LMP, EDD, US), patient's race, weight, date of birth, insulin-dependent diabetic status, and the number of fetuses. Additionally, a history of prior pregnancies, especially those with Down syndrome or ultrasound anomalies, must be provided. Use the Maternal Prenatal Screening requisition 0900 for submission. Testing is available from 10.0 to 14.0 weeks of gestation.
Limitations
This test, only for the first trimester portion, necessitates two specimens collected across the first and second trimesters. Results are contingent on both samples being obtained and processed. As it's a screening test, a positive outcome is an indication that diagnostic testing may be needed to determine the presence of a neural tube defect or chromosomal anomaly. The performance characteristics were established by Labcorp and it is not FDA cleared or approved.
Methodology
Immunoassay (CLIA)
Biomarkers
LOINC Codes
- 49586-1
- 18185-9
- 21299-3
- 43993-5
- 21484-1
- 29463-7
- 11878-6
- 48407-1
- 77202-0
- 11502-2
Result Turnaround Time
2-5 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
3 mL
Minimum Volume
1 mL
Container
Gel-barrier tube
Collection Instructions
Collect in serum separator tube with gel barrier. Allow blood to clot, avoiding hemolysis. Separate serum from cells by centrifugation. Transport spun tube to testing laboratory. Pour-off is not advised. Maternal serum specimens should be drawn before amniocentesis to avoid contamination with fetal blood.
Storage Instructions
Room temperature
Causes for Rejection
Gross hemolysis; gross lipemia; quantity not sufficient for analysis; improper specimen type
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 7 days |
| Refrigerated | 14 days |
| Frozen | 14 days |