Medicare Medical Necessity Restrictions May Apply
Medical Necessity Documentation:
Client Notes:
Patient Preparation:
The Quad test in pregnant women should be performed between 14.0 and 22.9 weeks gestational age, although the optimal period is 15.0 - 16.9 weeks. this time frame allows sufficient opportunity for further diagnostic studies if the initial Quad Screen test results are abnormal. Specimens submitted before 14.0 weeks or after 22.9 weeks of gestation cannot be properly evaluated for open neural tube defects, Down Syndrome or Trisomy 16.
Specimen Requirements:
3.0 mL Serum from a Red Top Tube into a Plastic Vial
Collection Instructions:
Collect between 14.0 and 22.9 weeks gestational age
Please make sure completing AFP Form
Minimum Volume:
1.0 mL Serum
Transport & Storage: Temperature/Stability:
14 days Ambient
14 days Refrigerated
28 days Frozen
Rejection Criteria:
Gross hemolysis • Gross lipemia
Reference Range:
Refer to Interpretive Results
Critical Ranges:
Test Comments:
Methodology:
Immunoassay
Clinical Significance:
Maternal serum Quad Screen is used for prenatal screening of Down syndrome (Trisomy 21), Trisomy 18 (Edwards syndrome), and open neural tube defects (ONTD). This profile includes alpha-fetaprotein (AFP), unconjugated estriol (µE3), human chorionic gonadotropin (hCG), and inhibin A. Establishing risk for fetal Down syndrome, using the quad screen achieves a 70-75% detection rate with a 5% false positive rate. Screening for Trisomy 18 detects 60% of affected fetuses with a 0.2% false positive rate. MSAFP screening detects 88% of anencephaly and 79% of open spina bifida with a 3% false positive rate. Normal results do not ensure birth of a normal infant. In addition, 2-3% of newborns have some type of physical or mental defect, many of which may be undetectable with current prenatal diagnostic procedures.
Documentation:
Limitation:
Quad Screen results consistent with an increased risk of trisomy should be confirmed with amniotic fluid specimen. Results consistent with increased risk of NTD may be followed-up with appropriate diagnostic testing as detailed in the report. Maternal serum screening yields a low percentage of false negatives. A wide range of other chromosomal abnormalities are not identified by maternal serum screening.
Custom Panel:
No
PRODUCTION SCHEDULE
Turn Around Time:
2 to 3 days
Days Performed:
Monday, Tuesday, Wednesday, Thursday, Friday, Saturday
Sites Performed:
Quest - Chantilly to San Juan Capistrano
PHL Test Code:
QUADS
EPIC Test Code:
LAB2882
Send Out Test Code:
30294
Alternate Test Names:
AFP Quad Screen; Alpha-Fetoprotein (AFP); Maternal Quad Scr; Maternal Serum
Included Tests:
AFP, unconjugated Estriol, hCG, Dimeric Inhibin A and Maternal Risk Interpretation
CPT Coding:
82105, 82677, 84702, 86336