Chip-based Real Time PCR test for Mycobacterium tuberculosis in sputum sample

Intended Use:

Quantitative detection and diagnosis of Mycobacterium tuberculosis (MTB) in human pulmonary and EPTB specimens and aids in the diagnosis of infection with MTB

TARGET SELECTION: nrdB gene which codes for ribonucleoside-diphosphate reductase large subunit.

LIMIT OF DETECTION: 100 CFU/ml sputum sample

Key Features

• Assay based on Taqman chemistry
• High primer sensitivity and specificity
• Micro chip based real-time PCR assay
• Minimal sample requirement @ 6µL
• Smart chip with lot specific data for quantitation of results
• Chip re-use lock
• Reaction port with contamination/evaporation resistant design

Contents of the Kit

A. Individually sealed pouches, each containing

1. Truenat MTB micro PCR chip
2. Microtube with freeze dried PCR reagents
3. DNase & RNase free pipette tip
4. Desiccant pouch

B. Package Insert