The AmplideX PCR/CE FMR1 Kit is an in vitro diagnostic (IVD) device for use in clinical laboratories for detection of the CGG repeats in the FMR1 gene. This kit is intended to aid in the diagnosis of Fragile X Syndrome and Fragile X associated disorders, e.g. tremor and ataxia syndrome (FX-TAS) and primary ovarian insufficiency (FXPOI)
The unique Triplet Repeat Primed PCR (TP-PCR) design allows for sensitive detection of all alleles and simultaneous resolution of zygosity. Now with Class C IVDR certification, this assay is optimised for use on widely established laboratory equipment and delivers FMR1 results in under six hours
The kit reliably amplifies GC-rich regions and provides automated peak calling with included AmplideX PCR/CE FMR1 Analysis Module
