텍스트
텍스트
텍스트
텍스트
텍스트
Diagnostics for Eutopia
Genomic DNA isolated from clinical specimens of influenza virus 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 detection rates in virus until 100 copies which thus confirmed the product's limit of detection as 100 copies.
Specificity tests were performed against of human genomic DNA, 2 kinds of PCR (Urea and Hemoglobin) and 6 kinds of antibiotics (Mucin, Mupirocin, Tobramycin, Phenylephrine, Zanamivir and Dexamethasone) were tested.
Interference reaction was not occurred.
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.
Genomic DNA isolated from reference strains of MP, LP, CP 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 detection rates until 100 copies which thus confirmed the product's limit of detection as 100 copies.
Specificity tests were performed against potential cross-reactants, Genomic DNAs from 13 kinds of the respiratory bacteria and 15 kinds of different pathogens. Cross reaction was not occurred.
As testing against potential inhibitors of human genomic DNA, 2 kinds of PCR (Urea and Hemoglobin) and 7 kinds of antibiotics (Clarithromycin, Rifampicin, Isoniazid, Ethambutol, Pyrazinamide, Moxifloxacin and Levofloxacin) were tested. Interference reaction was not occurred.
Genomic DNA isolated from clinical specimens of Bordetella pertussis (DSMZ 5571) , Bordetella parapertussis (DSMZ 13415) 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 detection rates in DNA until 100 copies which thus confirmed the product's limit of detection as 100 copies.
Specificity tests were performed against potential cross-reactants, Genomic DNAs from 35 kinds of different pathogens. Cross reaction was not occurred.
As testing against potential inhibitors of human genomic DNA, 2 kinds of PCR (Urea and Hemoglobin) and 5 kinds of antibiotics (Cotrimoxazole, Azithromycin, Clarithromycin , Moxifloxacin and Levofloxacin) were tested. Interference reaction was not occurred.
