PaxView^® TB/NTM MPCR-ULFA Kit

[Intended Use]

PaxView® TB/NTM MPCR-ULFA Kit is a vitro test for the detection of two specific genes of Mycobacterium tuberculosis -IS6110 and mtp40- and a specific gene of the genus Mycobacterium -rpoB- in sputum or Bronchoalveolar lavage(BAL) found in the human body by utilizing the multiplex polymerase chain reaction (MPCR) and universal lateral flow assay (ULFA).

This test is for professional use and is intended to aid in the diagnosis of MTB and/or NTM infection.

[Introduction]

Tuberculosis is still one of the most widespread and serious infectious diseases worldwide. In addition to the Mycobacterium tuberculosis (MTB) complex, non-tuberculous mycobacteria (NTM) play a significant role as the causative agents of opportunistic infections in immunocompromised patients. The prevalence of non-tuberculous mycobacterium infection has increased in developed countries. Therefore, early diagnosis and rapid identification of Mycobacteria species is the most important stage for effective treatment. Molecular diagnostic method using PCR is widely used for the routinal diagnostic test of pulmonary and extrapulmonary tuberculosis in clinical laboratories.

PaxView® TB/NTM MPCR-ULFA Kit is an in vitro diagnostic kit designed for the simultaneous detection of two specific genes of Mycobacterium tuberculosis -IS6110 and mtp40- and a specific gene of mycobacterium family -rpoB- with increased sensitivity and accuracy. PaxView® TB/NTM MPCR-ULFA Kit detects target genes using the multiplex polymerase chain reaction (MPCR) and the ensuing, proprietary universal lateral flow assay (ULFA) which is based on DNA-DNA hybridization on nitrocellulose membranes.

[Principles of the Procedure]

The PaxView® TB/NTM MPCR-ULFA Kit adopts PaxGenBio’s proprietary technology using the patented universal probe linked to the PCR primer that amplifies a target gene from clinical samples and enables the visual inspection of DNA-DNA hybridization between the universal probe on one end of PCR products and its complementary sequence. When loaded on to the sample pad in an ULFA cartridge, PCR products move on the nitrocellulose membrane along with the running buffer and hybridize with the complementary DNA fragments immobilized on specific regions of the nitrocellulose membrane. Finally, it is easy to visually check the results within 10 minutes after adding the PCR products.