Greencross Medical Science Corp. (Greencross MS) announced that it verified the validity of GENEDIA MTB Detection Kit, its diagnosis reagent of tuberculosis through clinical tests,
and it published the result on ‘Journal of Clinical Microbiology’, American Society for Microbiology’s official SCI journal.
GENEDIA MTB Detection Kit, Greencross MS (www.greencrossms.com) developed, can quickly detect Mycobacterium tuberculosis (MTB) by using Real-time PCR.
In the published article, the research team comprised of Lee Nam-yong, Ki Chang-seok and Huh Hee Jae at Samsunghospital's laboratory medicine compared GENEDIA MTB Detection Kit with Cobas TaqMan MTB assay of Roche in terms of the sensitivity, specificity and positive/negative predictability on tuberculosis.
The clinical test showed that GENEDIA MTB Detection Kit had the sensitivity and specificity at 81.8% and 99.8% respectively compared to 78.8% and 99.5% of comparison kit. In addition, its positive and negative predictability showed 96.4% and 99.0% compared to 89.7% and 98.8% of Cobas TaqMan MTB assay, although the performance difference between the two kits had no statistical significance.
“The clinical tests showed the result that Greencross MS’ GENEDIA MTB Detection Kit can stand comparison with Roche’s Cobas TaqMan MTB assay,, which was already internationally well recognized, “ said Ki Ching-seok, professor of Samsunghospital's laboratory medicine, “It had lower invalid results than Roche’s, and it can be applied to various medical devices as well as having other merits like quick Turn-around Time(TAT) and analysis cost saving.”
By Lee Kyung-ho