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For pregnancies at increased risk of fetal abnormalities, the MaterniT21 PLUS test delivers a comprehensive NIPT for the analysis of chromosomal regions including trisomies 21, 18, and 13, fetal sex, sex chromosome aneuploidies, and an enhanced sequencing series that examines seven clinically-relevant microdeletions and two additional chromosomal regions, trisomies 22 and 16.
While the results of these tests are highly accurate, discordant results, including inaccurate fetal sex prediction, may occur due to placental, maternal, or fetal mosaicism or neoplasm; vanishing twin; prior maternal organ transplant; or other causes. Cell-free DNA (cfDNA) testing does not replace the accuracy and precision of prenatal diagnosis with CVS or amniocentesis. A patient with a positive or high risk score test result should be referred for genetic counseling and tests are not intended to identify pregnancies at risk for neural tube defects or ventral wall defects. cfDNA testing for whole chromosome abnormalities (including sex chromosomes) and for subchromosomal abnormalities could lead to the potential discovery of both fetal and maternal genomic abnormalities that could have minor or no clinical significance.
Evaluating the significance of a positive or nonreportable test result may involve both invasive prenatal testing and additional studies on the mother. Such investigations may lead to a diagnosis of maternal chromosomal or subchromosomal abnormalities, which on occasion may be associated with benign or malignant maternal neoplasms. cfDNA testing may not accurately identify fetal triploidy, balanced rearrangements, or the precise locations of subchromosomal duplications or deletions; these may be detected by prenatal diagnosis with CVS or amniocentesis. The ability to report results may be impacted by maternal body mass index (BMI), maternal weight, and/or maternal systemic lupus erythematosus (SLE). The results of this testing, including the benefits and limitations, should be discussed with a qualified health care provider. Pregnancy management decisions, including termination of the pregnancy, should not be based on the results of this test alone.
This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA).
Cell-free DNA is isolated from the sample and analyzed using massively parallel sequencing technology.
(2) 10 mL
Black-and-tan-top (Streck) tube (whole blood). Sequenom collection kits are available (PeopleSoft #116373 379551G-CS-LCA.SEQUENOM-LCA.SEQUENOM-LCA ONLY KIT EA=1/KIT and PeopleSoft #116374 549403G-CS-LCA.SEQUENOM-LCA TEST REG STICKERS ST=3/SET).
Only the Sequenom collection kit PS#116373 can be used for collection.
Room temperature. Do not refrigerate or freeze. Keep out of direct sunlight. Samples must be shipped to LabCorp in a Sequenom collection kit.
Causes for Rejection
Gestational age less than nine weeks; expired or incorrect blood tubes (including nonglass tubes); quantity not sufficient for analysis; received more than seven days from collections; excessive hemolysis; frozen specimens
The following information must be provided with the test request form: patient's date of birth, gestational age, additional patient demographic information, pregnancy type (singleton or multiple), donor egg status and the clinical indications (including advanced maternal age, abnormal ultrasound, history suggestive of increased risk for aneuploidy, positive serum screen, or other indications).
|Order Code||Order Code Name||Order Loinc||Result Code||Result Code Name||UofM||Result LOINC|
|451937||MaterniT21 PLUS Core+ESS+SCA||821805||Chromosome 21||75983-7|
|451937||MaterniT21 PLUS Core+ESS+SCA||821806||Chromosome 18||75982-9|
|451937||MaterniT21 PLUS Core+ESS+SCA||821807||Chromosome 13||75981-1|
|451937||MaterniT21 PLUS Core+ESS+SCA||821808||Interpretation||75975-3|
|451937||MaterniT21 PLUS Core+ESS+SCA||821809||Y Chromosome||77021-4|
|451937||MaterniT21 PLUS Core+ESS+SCA||821810||Y Chromosome Interpretation||77020-6|
|451937||MaterniT21 PLUS Core+ESS+SCA||821811||Additional Findings||8251-1|
|451937||MaterniT21 PLUS Core+ESS+SCA||821812||Add'l Findings Interpretation||8262-8|
|451937||MaterniT21 PLUS Core+ESS+SCA||821813||Additional Findings Note||8264-4|
|451937||MaterniT21 PLUS Core+ESS+SCA||821814||Lab Director Comments||75605-6|
|451937||MaterniT21 PLUS Core+ESS+SCA||821815||Approved By||72486-4|
|451937||MaterniT21 PLUS Core+ESS+SCA||821816||Test Method||49549-9|
|451937||MaterniT21 PLUS Core+ESS+SCA||821817||About the Test||77202-0|
|451937||MaterniT21 PLUS Core+ESS+SCA||821818||Performance||62364-5|
|451937||MaterniT21 PLUS Core+ESS+SCA||821821||Performance Data||62364-5|
|451937||MaterniT21 PLUS Core+ESS+SCA||821822||Limitations of the Test||N/A|
|451937||MaterniT21 PLUS Core+ESS+SCA||821823||Note||N/A|
|451937||MaterniT21 PLUS Core+ESS+SCA||821824||References||75608-0|
|451937||MaterniT21 PLUS Core+ESS+SCA||821825||51969-4|