Test ID AFPA Alpha-Fetoprotein, Amniotic Fluid
Reporting Name
Alpha Fetoprotein, AFUseful For
Screening for open neural tube defects or other fetal abnormalities
Follow-up testing for patients with elevated serum alpha-fetoprotein results or in conjunction with cytogenetic testing
Clinical Information
Alpha-fetoprotein (AFP) is a single polypeptide chain glycoprotein with a molecular weight of approximately 70,000 Da. Synthesis of AFP occurs primarily in the liver and yolk sac of the fetus. It is secreted in fetal serum, reaching a peak at approximately 13 weeks gestation, after which it rapidly declines until about 22 weeks gestation and then gradually declines until term. Transfer of AFP into maternal circulation is accomplished primarily through diffusion across the placenta. Maternal serum AFP levels rise from the normal non-pregnancy level of 0.20 ng/mL to about 250 ng/mL at 32 weeks gestation.
If the fetus has an open neural tube defect, AFP is thought to leak directly into the amniotic fluid, causing unexpectedly high concentrations of AFP. Other fetal abnormalities such as omphalocele, gastroschisis, congenital kidney disease, and esophageal atresia; and other fetal distress situations such as threatened abortion, prematurity, and fetal demise, may also show AFP elevations. Decreased amniotic fluid AFP values may be seen when gestational age has been overestimated.
Interpretation
A screening alpha-fetoprotein (AFP) cutoff level of 2.0 multiples of median (MoM), followed by acetylcholinesterase (AChE) confirmatory testing on positive results, is capable of detecting 96% of open spina bifida cases with a false-positive rate of only 0.06% in non-blood-stained specimens.
AChE analysis is an essential confirmatory test for all amniotic fluid specimens with positive AFP results. Normal amniotic fluid does not contain AChE, unless contributed by the fetus as a result of open communication between fetal central nervous system (eg, open neural tube defects) or, to a lesser degree, fetal circulation. All amniotic fluid specimens testing positive for AFP will have the AChE test performed. False-positive AChE may occur from a bloody tap, which may cause both elevated AFP and AChE levels.
Testing Algorithm
If alpha-fetoprotein is positive, then acetylcholinesterase will be performed at an additional charge.
Reflex Tests
Test ID | Reporting Name | Available Separately | Always Performed |
---|---|---|---|
ACHE_ | Acetylcholinesterase, AF | Yes | No |
Report Available
2 to 19 daysDay(s) Performed
Monday through Friday
Clinical Reference
1. Clinical Laboratory Standards Institute (CLSI): Maternal Serum Screening: Approved Standard. 2nd ed. I/LA25-A2 CLSI; 2011
2. Cuckle H. Prenatal screening using maternal markers. J Clin Med. 2014;3(2):504-520. doi:10.3390/jcm3020504
3. Bernard JP, Cuckle HS, Bernard MA, Brochet C, Salomon LJ, Ville Y. Combined screening for open spina bifida at 11-13 weeks using fetal biparietal diameter and maternal serum markers. Am J Obstet Gynecol. 2013;209(3):223.e1-5
Method Name
AFPA: Immunoenzymatic Assay
ACHE_: Polyacrylamide Electrophoresis
Specimen Type
Amniotic FldNecessary Information
The following information is required:
1. Estimated due date by ultrasound
2. Collection date
3. Gestational age must be between 13 and 24 weeks; 16 to 18 weeks preferred.
If not ordering electronically, provide information on Second Trimester Maternal Screening Alpha-Fetoprotein / Quad Screen Patient Information (T595) and send with specimen.
Specimen Required
Container/Tube: Amniotic fluid container
Specimen Volume: 0.75 mL
Collection Instructions: Do not centrifuge.
Specimen Minimum Volume
0.5 mL
Specimen Stability Information
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Amniotic Fld | Refrigerated (preferred) | 7 days | |
Ambient | 7 days |
Reference Values
< 2.0 multiples of median (MoM)
Special Instructions
Test Classification
This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.CPT Code Information
82106
82013 (if appropriate)
LOINC Code Information
Test ID | Test Order Name | Order LOINC Value |
---|---|---|
AFPA | Alpha Fetoprotein, AF | 58735-2 |
Result ID | Test Result Name | Result LOINC Value |
---|---|---|
6739 | Collection Date | 58734-5 |
DAT15 | EDD by US Scan | 11781-2 |
6740 | Last Menstrual Period (LMP) | 8665-2 |
24233 | EDD by LMP | 11779-6 |
24239 | GA at Collection by Scan | 11888-5 |
24240 | GA at Collection by Dates | 11885-1 |
24234 | GA Used | 21299-3 |
9950 | Alpha Fetoprotein, AF | 1832-5 |
24241 | Results | 29595-6 |
24235 | Interpretation | 59462-2 |
24236 | Additional Comments | 48767-8 |
24237 | Follow up | 80615-8 |
24238 | General Test Info | 48767-8 |
Forms
Second Trimester Maternal Screening Alpha-Fetoprotein / Quad Screen Patient Information (T595) is required.
Secondary ID
9950mml-analyte