‘QSTR*R-PL: Development and Validation of a QF-PCR based IVD for Rapid Aneuploidy Screening in the Event of Pregnancy Loss’

Elucigene are presenting a scientific poster at ESHG 2015 in Glasgow from the 6th to 9th of June. The poster is entitled ‘QSTR*R-PL: Development and Validation of a QF-PCR based IVD for Rapid Aneuploidy Screening in the Event of Pregnancy Loss.’

The incidence of miscarriage in couples trying to conceive is 15%-20% and that of recurrent miscarriage is 1%. Recurrent miscarriage is classified as the loss of three or more consecutive pregnancies. A woman may suffer from pregnancy loss even after giving birth to a healthy baby previously. Once a couple has been diagnosed with having recurrent miscarriages they should be offered a test to try and identify the cause. As 50% of first trimester miscarriages can be attributed to a chromosome abnormality, particularly aneuploidy, it is these that are commonly tested for.

QST*R-PL is a simple to use assay for the rapid and accurate diagnosis of the six most common autosomal trisomies associated with recurrent miscarriage; 13, 15, 16, 18, 21 and 22.  The kit also contains X and Y specific markers and has fast 1 day sample to diagnosis.

A QST*R-PL performance evaluation assay was evaluated using protocols developed by Elucigene Diagnostics. Testing involved 125 anonymised DNA samples extracted from fetally derived tissues/product of conception, whose aneuploidy status was previously determined using alternative testing methods including Karyotyping, FISH and Microarray. QST*R-PL test accuracy was assessed through concordance with the previous diagnosis.

The QST*R-PL data demonstrated high quality results across all testing sites. Comparison of the QST*R-PL diagnostic results with that of the previous diagnostic data showed 100% concordance with no failed results.

QST*R-PL determines the aneuploidy status of the fetus and can not only be helpful in the planning of future pregnancies but may influence the way recurrent pregnancy loss is managed clinically in the future.

The research was conducted by Gavin Batman and Greg Fitzgibbon and was supported and paid for by Elucigene Diagnostics.

Recurrent Pregnancy Loss Kit Poster