Provision of a Quantitative Fluorescence-Polymerase Chain Reaction (QF-PCR) Assay

Tender description

The All Wales Genomics Laboratory (AWGL) is seeking a Quantitative Fluorescence-Polymerase Chain Reaction (QF-PCR) Assay solution for a period of three (3) years with the option to extend for a further two (2) years at annual intervals. The laboratory require a QF-PCR assay(s) which is CE-IVD approved or will become CE-IVD approved should the approval become mandatory to be used in the All Wales Genomics Laboratory (AWGL) on Cardiff & Vale UHB premises for copy number analysis of chromosomes 13, 18, 21, X and Y using DNA extracted from a variety of sample types for various testing scenarios Lot 1: The All Wales Genomics Laboratory (AWGL) is seeking a Quantitative Fluorescence-Polymerase Chain Reaction (QF-PCR) Assay solution for a period of three (3) years with the option to extend for a further two (2) years at annual intervals. The laboratory require a QF-PCR assay(s) which is CE-IVD approved or will become CE-IVD approved should the approval become mandatory to be used in the All Wales Genomics Laboratory (AWGL) on Cardiff & Vale UHB premises for copy number analysis of chromosomes 13, 18, 21, X and Y using DNA extracted from a variety of sample types for the following testing scenarios: Rapid aneuploidy testing for trisomies 13, 18, 21 and triploidy as a front-line test for all prenatal and pregnancy loss samples and for neonatal samples referred due to a clinical suspicion of a common trisomy. Sex chromosome testing in prenatal, pregnancy loss and postnatal samples referred with evidence of suspected sex chromosome aneuploidy. Determination of genotypic sex for foetuses at risk of an X-linked condition or congenital adrenal hyperplasia (CAH) and for neonates with ambiguous genitalia. Maternal cell contamination (MCC) testing of prenatal and pregnancy loss samples prior to onward testing.