Cloned DNA, isolated from reference strains of TB (MTB H37Rv, ATCC 27294), RIF resistant strains, and INH resistant were diluted in five levels and repeatedly tested three times for each concentration to measure the detection limit. (cut-off concentration)
The test results showed 100% positive and resistant detection rates in MTB, RIF resistant strains, and INH resistant strains until 100 copies which thus confirmed the product's limit of detection as 100 copies.
The results of tests on genomic DNAs obtained from 12 kinds of nontuberculous mycobacteria that might work as a cross material during the use of this product and 14 kinds of other pathogenic microorganisms that might migrate into samples showed no cross-reaction.
The results of tests on three kinds of PCR inhibitors (urea, hemoglobin, and blood) and anti-TB drugs (Rifampicin, Isoniazid, Ethambutol, Pyrazinamide, Moxifloxacin, and Levofloxacin) that might hinder the response of this product showed no interfering reaction.