Serum Integrated 1

Casandra

Casandra Test Code LC59435Version 1 (DRAFT)

Performing Lab

Lab LabcorpLab Test ID 017200CPT Code 84163

Also known as: Down Syndrome, PAPP-A

Clinical Use

Order Test

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.

Test Details

Methodology

Immunoassay (CLIA)

Biomarkers

PAPP-A

Analyte

PAPP-A Value • Concentration / Level • Quantitative (Continuous) (e.g., copies/mL, % expression)

LOINC Codes

Result 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

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.