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RhD & SRY Genotyping the promise of noninvasive RHD genotyping is here... now!
A Positive Way To Avoid
a Negative Outcome©
The Problem:
In the United States, there are approximately 400,000 pregnancies in Rh negative women every year and almost all of these could benefit from assessment of the RhD type of the fetus. Until now, this could only be determined by an invasive procedure, such as amniocentesis or CVS, both of which involve risk. Therefore, most Rh negative moms are currently managed without knowing the fetal Rh status, and are routinely treated with RhD immunoglobulin during pregnancy. This is relevant because RhD immunoglobulin is becoming increasingly expensive, and many women today seek to avoid unnecessary injections of human blood products.
The Solution:
LENETIX® Medical Screening Laboratory, Inc. is proud to offer an alternative, noninvasive way to assess the fetal RhD status. Using the SEQureDxTM technology, we can now determine the fetal RHD genotype from the mom’s blood. LENETIX® is approved by the New York Department of Health to perform noninvasive RHD genotyping in pregnancies of 15 weeks gestational age or greater. Third trimester injections of RhD immunoglobulin are unnecessary in pregnancies in which the fetus is Rh negative. We estimate that approximately 38% of all Rh negative women may avoid third trimester RhD immunoglobulin treatment.
The Clinical Testing Protocol:
Using the SEQureDxTM technology, LENETIX® has developed a clinical testing protocol that greatly enhances the sensitivity of the assays used in RHD genotyping.
Cell free fetal DNA (cffDNA) is extracted from an aliquot of the patient’s blood and evaluated for RHD genotype, as well as for fetal Y chromosome sequences and PSI(Ψ) allele. Each assay is performed in triplicate.
To provide further confidence in the result, cell free fetal DNA (cffDNA) is again extracted from a second aliquot of the patient’s blood and the entire procedure is repeated.
The Sample Submission Requirements:
- To be eligible for testing gestational age must be greater than or equal to 15 weeks.
- Completed LENETIX® GENETIC Requisition must accompany the sample(s).
- Draw 3 PPT Tubes (White Top Tubes) and spin down, and draw 1 EDTA Tube (Lavender Top Tube).
- Call 516-320-6370 for pick-up and/or ship via FED-EX with LENETIX® mailing supplies.
- Store and/or ship at room temperature. DO NOT ALLOW SPECIMEN TO FREEZE AT ANY TIME.
- Collections of specimen and shipping MUST be done Monday through Thursday.
The Report :
The results will be faxed and mailed to your office within 3 to 5 business days of receipt of the sample. FINAL REPORTS ARE GENERATED, except in the case of the female fetus that is Rh negative. In this situation, a second maternal sample is requested (increasing gestational age correlates with increasing circulating cell free fetal nucleic acids), and the entire process is performed again to confirm the probable diagnosis of an Rh negative female fetus.**
SEQureDxTM is a trademark of Sequenom®, Inc., used under license from Sequenom®. Use of the technology, covered by US Patent 6,258,540, is sublicensed to LENETIX® by Sequenom® Inc., the exclusive licensee. “This service is performed pursuant to an agreement with Roche Molecular Systems, Inc.”
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