EuDx™-MDR TB Detection Kit
Description
EuDx™-MDR TB Detection Kit (Multidrug-resistant TB, MDR TB)
diagnosis reagent swiftly analyzes the presence or absence
of mutations of rpoB, katG, inhA genes, which are the causation
genes of drug-resistance, in the genes IS6110, rpoB, RIF,
and INH through PCR. EuDx™-MDR TB Detection Kit (Multidrug-resistant TB, MDR TB)
is an In Vitro Diagnostic medical device aimed to aid in the diagnosis of TB pathogen infections and the determination of the drug-resistance of such TB pathogens
in suspected patients.
Features
1) High Responsiveness and Specificity
- MTB and MDR TB → TB (IS6110) + 6 types of mutations
- Simultaneous gene testing (Multiplex PCR)
- Fusion of various PCR technology (Real-time PCR + MGB TaqMan Probe Assay)
2) Minimizes pollution and Provides credible data
- 3 step PCR One tube test (prevents cross-pollution)
- provides credible results through Internal control (IC)
3) Increased patient satisfaction through swift diagnosis (85 minutes required)
- reduction of inspection time through simultaneous detection of TB and multidrug-resistant bacteria and increased possibility of early diagnosis and treatment
Currently, products sold for the diagnosis of drug-resistant TB can be summarized into three types. The product developed by LG Life Sciences and Hain Lifescience in Germany, currently holding the largest domestic market share, first extracts the DNA from the sample and amplifies the mutations of rpoB, katG, inhA genes, which are the causation genes of drug-resistance in the pathogens, through PCR. The resulting product then goes through hybridization with a membrane combined with a probe in order to check for mutations, but this process has a disadvantage - diagnosis takes 3-4 hours to complete. The second utilizes melting analysis and PCR developed by Seegene, and this analysis takes around 3 hours, but its share in the domestic market is negligible. Lastly, there is the Xpert RIF product developed by Cepheid, and this is the most popular product internationally. This product prioritizes analyzing small numbers of samples instead of large amounts, and it has a disadvantage in that it only checks for resistance towards Rifampicin in addition to being expensive. The product developed at Eudipia has a short diagnosis time of 90 minutes and it tests for both Rifampicin and Isoniazid simultaneously. No other comparable product has been manufactured thus far.
Specification
Product Composition
- 2X qPCR Premix
- 4X Reaction Mixture
(Primer/Probe +
Internal Control)
- Positive Control DNA
- Nuclease Free Water
Others
Product Specification
-1box 48tests