AIO-RHD Fetal DNA Kit
The AIO-RHD Fetal DNA Kit is a prenatal genetic diagnostic in vitro test using the multiplex polymerase chain reaction technique (PCR) and allow to detect the presence of specific exonic segment of the RHD gene. This test specifically detects the exon 5, 7 and 10 of the RHD gene.
The AIO-RHD Fetal DNA kit is intended to amplify trace of fetal DNA extracted from mother’s blood with at least 12thweek of pregnancy with any CE-IVD DNA extraction kit optimized for fetal DNA extraction.
The AIO-RHD Fetal DNA kit must be used by accredited laboratory with a valid Accreditation Agreement for prenatal test and follow the ISO 15189:2012 standard on Requirements for quality and competence applicable to medical laboratories.
A validation test must be performed according to the instruction specified in the chapter 7 in order to verify that the laboratory environment (technical platform, consumable and DNA extraction kit) will be compatible with the AIO-RHD Fetal DNA Kit.
At any change in a validated diagnosis process, a new kit qualification by the laboratory must be performed to assure the kit performance.