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It has not been cleared or approved by the US Food and Drug Administration (FDA). Sequenom collection kits are available, (People Soft #116373 379551G-CS-LCA. SEQUENOM-LCA ONLY KIT EA=1/KIT and People Soft #116374 549403G-CS-LCA.
SEQUENOM-LCA TEST REG STICKERS ST=3/SET)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).
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 Lab Corp.
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Cell-free DNA (cf DNA) testing does not replace the accuracy and precision of prenatal diagnosis with CVS or amniocentesis.