LAMP Human DPD Deficiency KIT (5 variants)

The LAMP Human DPD5var KIT is an in vitro diagnostic test intended for the qualitative detection of five different non-functional or less functional DPYD alleles (*2A, *13, c.2846A>T, c.1129-5923C>G, *6) by Loop-mediated isothermal amplification (LAMP) on EDTA whole blood and extracted DNA. This assay is dedicated to professional use in diagnostic laboratory. The device is not for self-testing.

Regulatory Status: CE-IVDR

Format: 24 reactions

Target gene: DPYD

Drug relevance: Fluoropyrimidines, including drugs like 5-fluorouracil (5-FU), capecitabine, and tegafur

Variants detected: DPYD*2A (rs3918290), DPYD*13 (rs55886062), DPYD rs67376798, DPYD rs75017182, DPYD*6 (rs1801160)

Method: LAMP + meting curve analysis

Sample: EDTA whole blood - no DNA extraction required - or extracted DNA

Compatible instruments: LightCycler 480 I&II / Cobas z 480 (Roche); CFX96 / CFX Opus 96 (Bio-Rad); QuantStudio 1/3/5 & 6/7 Flex (Applied Biosystems); MIC qPCR (Bio Molecular Systems); LC-Genie III & Genie HT (Optigene)

Software / result interpretation: Automated genotype calling via GeneFox software; mandatory visual confirmation of the melting curve

Turn around time: < 1h

General information

Advantages

Fast

No DNA extraction

Compatible with a variety of qPCR machines

Automatic interpretation of the results

Related kits

DPD4var

The LAMP Human DPD4var KIT is an in vitro diagnostic test intended for the qualitative detection of four different non-functional or less functional DPYD alleles by Loop-mediated isothermal amplification (LAMP) on EDTA whole blood and extracted DNA.

DPD6

The LAMP Human DPD6 KIT is an in vitro diagnostic test intended for the qualitative detection of the less functional DPYD allele *6 by Loop-mediated isothermal amplification (LAMP).

DPDrs11

The LAMP Human DPDrs11 KIT is an in vitro diagnostic test intended for the qualitative detection of the less functional DPYD allele c.557A>G (rs115232898) by Loop-mediated isothermal amplification (LAMP) on EDTA whole blood and extracted DNA.

DPD7

The LAMP Human DPD deficiency KIT is an in vitro diagnostic test intended for the qualitative detection of the less functional DPYD allele *7 by Loop-mediated isothermal amplification (LAMP). This assay is dedicated to professional use in diagnostic laboratories.

DPD9

The LAMP Human DPD9 KIT is an in vitro diagnostic test intended for the qualitative detection of the less functional DPYD allele *9A (c.85T>C) by Loop-mediated isothermal amplification (LAMP).

The LC-DPD5var-LP kit uses loop mediated isothermal amplification, a robust amplification method using four to six primers per target, that can be directly used on EDTA-whole blood, without DNA purification and on extracted DNA samples from whole blood samples.

The genotyping is performed by melting curve analysis after amplification, using a specific probe and quencher for each target SNP.

Test principle

Fluoropyrimidines, including drugs like 5-fluorouracil (5-FU), capecitabine, and tegafur, are commonly prescribed to treat solid tumors. Approximately 10–40% of patients treated with fluoropyrimidines develop severe and potentially life-threatening side effects.

The dihydropyrimidine dehydrogenase (DPD) enzyme catalyzes the first and the rate-limiting step of the catabolic pathway of these drugs. Decreased DPD activity results in a slower drug clearance and extended half-life of 5-FU, which significantly increases the risk of dose-related toxicities.

DPD levels vary considerably between individuals, mainly due to differences in the DPYD gene. Among the Caucasian population, approximately 3-8% experience a partial DPD deficiency, while 0.3% show complete DPD deficiency.

DPYD*6

Also referred to as rs1801160 is associated to a reduction in the DPD enzyme activity.
South Asian carrier frequency: 8.9%**
Latin American carrier frequency: 6.5%**
African carrier frequency: 2.8%**
Asian carrier frequency: 2.6%**