LAMP testing (Loop-mediated isothermal amplification)

Procurement of LAMP (Loop-mediated isothermal amplification) assay for DPYD, CYP2C19 and HFE testing.

Additional information: The bidder must be able to provide an assay which detects the variants for DPYD, CYP2C19 and HFE as stated on the national genomics test directory. Please note: due to the laboratory's UKAS 15189; 2022 accreditation we require any kits to be CE marked. The assay must be ready for clinical use.

The bidder must provide full details of the validation of this solution used to determine the values provided for analytical sensitivity and specificity for detection of nucleotide changes included in each assay. Analytical sensitivity and specificity should be 100%. The assay should produce results that are repeatable, with concordant results for samples replicated within runs. The assay should demonstrate reproducibility, where typical test-to-test variability does not impact the result. Concordant results should be achieved for samples replicated across runs.

The assay must be validated to detect variants, with a need to differentiate between wild type and mutant alleles, and can therefore detect homozygous wildtype, heterozygous mutant and homozygous mutant genotypes.

The technical failure rate should be <5%.

The kit should be possible to process a sample within 4 hours, end to end.

The Bidder must provide assurance they have capacity based on the following indicative sample numbers

DPYD- approx. 6000/year CYP2C19- approx. 400/ year HFE- approx. 7000/ year

To express interest and participate in the tender, please register and apply via Atamis e-sourcing portal https://health-family.force.com/s/Welcome

Should Tenderers have any queries, or having problems using the portal, they should contact Helpdesk at:

Phone: 0800 9956035

E-mail: [email protected]