About one-third of the world's population is currently infected with Mycobacterium tuberculosis (MTB). It is estimated that approximately 3 million people die from tuberculosis each year and another 8 million new cases are reported. The most reliable diagnostic method for tuberculosis is to detect MTB in clinical samples. Both non-tubercular Mycobacteria (NTM) as well as tuberculosis bacteria can cause tuberculosis. In fact, NTM is detected in 30% to 50% of nontubercular bacteria positive samples in areas where NTM frequency is high. The diagnosis of tuberculosis has commonly been the use of TB acid-fast bacteria smear tests and culture. These tests have the advantage of being rapid, inexpensive, and simple to use, but have the disadvantage of being relatively low in sensitivity (between 22% and 78%) and unable to distinguish between MTB and NTM. The TB culture test, a standard method for tuberculosis diagnosis, is reported to have a sensitivity of 80% to 85%, which is higher than the TB acid-fast bacteria smear method alone. Specificity is close to 100% so it is widely used as a confirmation method but has the disadvantage of lengthy result turnaround times. Some culture methods performed by automatic incubation systems using liquid mediums are used to reduce bacterial incubation time, but this also takes more than two weeks, is costly and complicated to test, and requires additional identification processes to distinguish MTB and NTM.
Recently, with the development of molecular diagnostic technology, a number of tuberculosis molecular tests have been developed and are being increasingly utilized.
Intended Use
The NamuPlex™ MTBC/NTM Real-time PCR Kit is an in vitro diagnostic test using real-time PCR, designed for the qualitative detection of nucleic acid from Mycobacterium tuberculosis complex (MTBC) and 20 types of non-tuberculous mycobacteria (NTM) in sputum, bronchial fluid, and culture samples from patients with clinical suspicion of tuberculosis (TB).
Performed on a real-time PCR instrument, this assay enables early and accurate diagnosis of tuberculosis by detecting even a small number of bacteria in the sample and providing results quickly. It is also widely used for tuberculosis diagnosis due to its high sensitivity and specificity.
NamuPlex™
MTBC/NTM Real-time PCR Kit
Cat. GNT-2003-1
CE-IVD
Intended Use
The NamuPlex™ MTBC/NTM Real-time PCR Kit is an in vitro diagnostic test using real-time PCR, designed for the qualitative detection of nucleic acid from Mycobacterium tuberculosis complex (MTBC) and 20 types of non-tuberculous mycobacteria (NTM) in sputum, bronchial fluid, and culture samples from patients with clinical suspicion of tuberculosis (TB).
Performed on a real-time PCR instrument, this assay enables early and accurate diagnosis of tuberculosis by detecting even a small number of bacteria in the sample and providing results quickly. It is also widely used for tuberculosis diagnosis due to its high sensitivity and specificity.
Targets
Nontuberculous mycobacteria
Workflow
Results