RE: Excelllent news !!31 Jul 2024 06:49
Laboratory testing usually requires a blood sample.
Genedrive CYP2C19 ID Kit
2.12 The Genedrive System is a point-of-care gene amplification device used for
qualitative in vitro molecular diagnostic tests. The company states that the test
can detect the *2, *3, *4, *8, *17 and *35 alleles. The technology consists of:
• Genedrive System analyser, which is a rapid thermocycler capable of
polymerase chain reaction (PCR) and isothermal-based amplification
techniques.
• Genedrive CYP2C19 ID Kit, which includes an assay cartridge containing
reagents, a sample collection cheek swab, a transfer capillary and a
collection buffer. The cartridges can be stored at room temperature. The
Genedrive CYP2C19 ID Kit costs £100 (excluding VAT).
2.13 The test uses a single cheek swab to collect the sample. The company states
that each cartridge takes less than 1 hour to run. The result of the test is
automated. The person's diplotype (their specific pair of CYP2C19 alleles) and
metaboliser status are displayed on the device. The company states that results
can be transferred electronically to patient records by internet or third-party
middleware, or printed with an optional label printer. External controls for all
targeted alleles are available in a separate kit to check proper performance of the
platform.
Implementing laboratory-based CYP2C19 genotype testing for everyone who has a
stroke or TIA would result in a large population being tested, which may require
testing capacity to be scaled up over time. When implementing testing,
commissioners may wish to consider:
• point-of-care testing as an alternative if laboratory-based testing is not feasible
at this scale, or while capacity for laboratory-based testing is increased.
There are likely to be considerable barriers to implementing laboratory-based testing for
everyone who has had an ischaemic stroke or a TIA. If laboratory-based testing is not
available, or it will take a long time to develop capacity to provide it, then point-of-care
tests could be used. So, the Genedrive CYP2C19 ID Kit should be used when laboratorybased testing is not available.
Evidence from studies provided by the company suggests that the Genedrive CYP2C19 ID
Kit works well. It can detect more CYP2C19 alleles than the Genomadix Cube point-of-care
test. It also:
• does not need a freezer to store reagents
• is cheaper per test than laboratory tests and the Genomadix Cube.
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