Alpha-Fetoprotein (AFP), Single Marker Screen, Maternal, Serum
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Prenatal screening for open neural tube defect
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Two-Site Immunoenzymatic (Sandwich) Assay
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
AFP SINGLE MARKER SCRN, MATERNAL, S
AFP Maternal Screening
AFP Neural Tube Defects
Maternal Screening, AFP Single Marker
AFP Neural Tube Defects
Maternal Screening, AFP Single Marker
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Preferred: Red top
Acceptable: Serum gel
Specimen Volume: 1 mL
1. Do not draw specimen after amniocentesis, as this could affect results.
2. Immediately spin down.
1. Draw blood between 15 weeks, 0 days and 22 weeks, 6 days.
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.
Forms: Second Trimester Maternal Screening Alpha-Fetoprotein (AFP)/QUAD Screen Patient Information Sheet (Supply T595) is required in Special Instructions.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Mild OK; Gross reject
Mild OK; Gross OK
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Serum||Refrigerated (preferred)||7 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Alpha-fetoprotein (AFP) is a fetal protein that is initially produced in the fetal yolk sac and liver. A small amount also is produced by the gastrointestinal tract. By the end of the first trimester, nearly all of the AFP is produced by the fetal liver. The concentration of AFP peaks in fetal serum between 10 to 13 weeks. Fetal AFP diffuses across the placental barrier into the maternal circulation. A small amount also is transported from the amniotic cavity.
The AFP concentration in maternal serum rises throughout pregnancy, from the nonpregnancy level of 0.20 ng/mL to about 250 ng/mL at 32 weeks gestation. If the fetus has an open neural tube defect (NTD), AFP is thought to leak directly into the amniotic fluid causing unexpectedly high concentrations of AFP. Subsequently, the AFP reaches the maternal circulation; thus producing elevated serum levels. Other fetal abnormalities such as omphalocele, gastroschisis, congenital renal disease, esophageal atresia, and other fetal distress situations such as threatened abortion and fetal demise also may show AFP elevations. Increased maternal serum AFP values also may be seen in multiple pregnancies and in unaffected singleton pregnancies in which the gestational age has been underestimated.
Lower maternal serum AFP values have been associated with an increased risk for genetic conditions such as trisomy 21 (Down syndrome) and trisomy 18. Risks for these syndrome disorders are only provided with the use of multiple marker screening (QUAD/81149 Quad Screen [Second Trimester] Maternal, Serum).
Measurement of maternal serum AFP values is a standard tool used in obstetrical care to identify pregnancies that may have an increased risk for NTD. The screen is performed by measuring AFP in maternal serum and comparing this value to the median AFP value in an unaffected population to obtain a multiple of the median (MoM). The laboratory has established a MoM cutoff of 2.5 MoM, which classifies each screen as either screen-positive or screen-negative. A screen-positive result indicates that the value obtained exceeds the established cutoff. A positive screen does not provide a diagnosis, but indicates that further evaluation should be considered.
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
NEURAL TUBE DEFECTS
An AFP multiple of the median (MoM) <2.5 is reported as screen negative. AFP MoMs > or =2.5 (singleton and twin pregnancies) are reported as screen positive.
An interpretive report will be provided.
Neural tube defects (NTD):
A screen-negative result indicates that the calculated alpha-fetoprotein (AFP) multiple of the median (MoM) falls below the established cutoff of 2.50 MoM. A negative screen does not guarantee the absence of NTDs.
A screen-positive result indicates that the calculated AFP MoM is > or =2.50 MoM and may indicate an increased risk for open NTDs. The actual risk depends on the level of AFP and the individual's pre-test risk of having a child with NTD based on family history, geographical location, maternal conditions such as diabetes and epilepsy, and use of folate prior to conception. A screen-positive result does not infer a definitive diagnosis of a NTD, but indicates that further evaluation should be considered. Approximately 80% of pregnancies affected with an open NTD have elevated AFP MoM values >2.5.
Upon receiving maternal serum screening results, all information used in the risk calculation should be reviewed for accuracy (ie, weight, diabetic status, gestational dating, etc.). If any information is incorrect the laboratory should be contacted for a recalculation of the estimated risks.
Screen-negative results typically do not warrant further evaluation.
Ultrasound is recommended to confirm dates for NTD screen-positive results. If ultrasound yields new dates that differ by at least 7 days, a recalculation should be considered. If dates are confirmed, high-resolution ultrasound and amniocentesis (including amniotic fluid AFP and acetylcholinesterase measurements for NTDs) are typically offered.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Race, weight, multiple fetus pregnancy, and insulin-dependent diabetes (IDD) may affect marker concentrations. Black mothers tend to have higher alpha-fetoprotein (AFP) levels but lower risk of neural tube defects (NTDs) and are assigned to a separate AFP median set. Multiple of the medians (MoMs) are adjusted for maternal weight (to account for dilution effects in heavier mothers). The AFP is adjusted upward in IDD to account for lower values in diabetic pregnancies.
The screen results are dependent on accurate information for gestation, race, insulin dependent diabetes, and weight. Inaccurate information can lead to significant alterations in the estimated risk. In particular, erroneous assessment of gestational age can result in false-positive or false-negative screen results. Because of its increased accuracy, we therefore recommend determination of gestational age by ultrasound, rather than by maternal dates alone when possible.
A screen-negative result does not guarantee the absence of fetal defects. A screen-positive result does not provide a diagnosis, but indicates that further diagnostic testing should be considered (an unaffected fetus may have screen-positive result for unknown reasons).
Valid measurements of AFP in maternal serum cannot be made after amniocentesis.
Triplet and higher multiple pregnancies cannot be interpreted.
Each center offering maternal serum screening to patients should establish a standard screening protocol, which provides pre- and post-screening education and appropriate follow-up for screen-positive results.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
Christensen RL, Rea MR, Kessler G, et al: Implementation of a screening program for diagnosing open neural tube defects: selection, evaluation, and utilization of alpha-fetoprotein methodology. Clin Chem 1986;32:1812-1817
Method Description Describes how the test is performed and provides a method-specific reference
Alpha-fetoprotein (AFP) values are compared to the median value of the unaffected population at a given gestational age and the multiple of the median (MoM) is obtained and classified as either screen-positive or screen-negative. An interpretive report is provided.
The Access AFP assay is a two-site immunoenzymatic sandwich assay. A sample is added to a reaction vessel with mouse monoclonal anti-AFP alkaline phosphatase conjugate and paramagnetic particles coated with a second mouse monoclonal anti-AFP antibody. The AFP in the sample binds to the immobilized monoclonal anti-AFP on the solid phase while, at the same time, the monoclonal anti-AFP-alkaline phosphatase conjugate reacts with different antigenic sites on the sample AFP. After incubation in a reaction vessel, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then the chemiluminescent substrate Lumi-Phos*530 is added to the reaction vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the amount of AFP in the sample. The amount of analyte in the sample is determined by means of a stored multi-point calibration curve.(Beckman-Coulter Assay Manual Beckman Coulter, Inc., Fullerton CA 2010)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; 5 a.m.-7 p.m., Saturday; 6 a.m.-4 p.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test has been cleared or approved by the U.S. 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 Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|7058||Recalculated Maternal Serum Screen||43995-0|
|7834||Calculated age at EDD||43993-5|
|IDD||Insulin dependent diabetes||33248-6|
|MULTF||Number of Fetuses||55281-0|
|7816||Gestation (GA) by U/S||11888-5|
|7817||Date of U/S||34970-4|
|10054||EDD by U/S scan||In Process|
|2907||Last Menstrual Period (LMP)||8665-2|
|7753||EDD by LMP||11779-6|
|7206||Gestation (GA) by dates||11885-1|
|7200||Date of estimate||In Process|
|7201||Gestation (GA) by physical exam||11884-4|
|7202||Date of physical exam||N/A|
|7203||GA on collection by U/S scan||11888-5|
|7204||GA on collection by dates||11885-1|
|7205||GA on collection by physical exam||11884-4|
|7830||GA used in risk estimate||21299-3|
|10357||RECOMMENDED FOLLOW UP||N/A|
|10358||GENERAL TEST INFORMATION||In Process|
|32284||Other Information||In Process|