닫기

Diagnostics for Eutopia

Product

EuDx™ ufPCR Detection kit

HOME Product EuDx™ ufPCR Detection kit
Ultra Fast PCR

EuDx™ Flu/RSV
Detection Kit

Target
Flu A-1: lnfluenza A Virus
Flu A-2: lnfluenza A Virus subtype, (H1N1)pdm09
Flu A-3: lnfluenza A Virus subtype, H3
Flu A-4: lnfluenza A Virus subtype, H5
Influenza B Virus
RSV
Specimen
Nasopharyngeal (NP) swab specimens
Amplification Chip
8well, 1person - 1chip
Time of analysis
≤30minutes
Amplification chip (8well)
  • EuDx™ Flu/RSV Detection Kit
Target Dye
Flu A-1 Eva green
Flu A-2
Flu A-3
Flu A-4
Flu B
RSV
Analytical sensitivity

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.

Analytical specificity

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.

EuDx™ ufPCR system EuDx™ ufPCR system EuDx™ ufPCR system
Ultra Fast PCR

EuDx™ MDR TB
Detection Kit

Target
MTB, RIF(6), INH(2)
RIF: S531L, L511P ,H526Y, H526D, D516V, D516Y
INH: inhA -15->T, katG 315 AGC->ACC
Specimen
Sputum
Amplification Chip
8well, 1person - 1chip
Time of analysis
≤40minutes
Amplification chip (8well)
  • EuDx™ MDR TB Detection Kit
Target Dye
MTB FAM
RIF -1
RIF -2
RIF -3
RIF -4
RIF -5
Analytical sensitivity

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.

Analytical specificity

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.

EuDx™ ufPCR system EuDx™ ufPCR system EuDx™ ufPCR system
Ultra Fast PCR

EuDx™ PN
Detection Kit

Target
Mycoplasma pneumoniae (MP)
Legionella pneumophila (LP)
Chlamydia pneumoniae (CP)
Specimen
Sputum, Nasopharyngeal (NP) swab specimens
Amplification Chip
8well, 2person - 1chip
Time of analysis
≤30minutes
Amplification chip (8well)
  • EuDx™ PN Detection Kit
Target Dye
MP Eva green
LP
CP
Analytical sensitivity

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.

Analytical specificity

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.

EuDx™ ufPCR system EuDx™ ufPCR system EuDx™ ufPCR system
Ultra Fast PCR

EuDx™ Bordetella
Detection Kit

Target
Bordetella pertussis (DSMZ 5571),
Bordetella parapertussis (DSMZ 13415)
Specimen
Nasopharyngeal (NP) swab specimens
Amplification Chip
8well, 2person – 1chip
Time of analysis
≤30minutes
Amplification chip (8well)
  • EuDx™ Bordetella Detection Kit
Target Dye
BP Eva green
BP & BPP
BPP
Analytical sensitivity

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.

Analytical specificity

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.

EuDx™ ufPCR system EuDx™ ufPCR system EuDx™ ufPCR system
Ultra Fast PCR

EuDx™ ufPCR STI

Under development
Amplification chip (8well)
  • EuDx™ MDR TB Detection Kit
Ultra Fast PCR

EuDx™ ufPCR ZCD

Under development
Amplification chip (8well)
  • EuDx™ MDR TB Detection Kit
Ultra Fast PCR

EuDx™ ufPCR Dengue

Under development
Amplification chip (8well)
  • EuDx™ MDR TB Detection Kit