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PaxView® TB/NTM MPCR-ULFA Kit

 

Overview

Tuberculosis is still one of the most wide-spread and serious infectious diseases worldwide. In addition to the Mycobacterium tuberculosis (MTB) complex, non-tuberculous mycobacteria (NTM) play a significant role as causative agents of opportunistic infections in immunocompromised patients. The prevalence of non-tuberculous mycobacterium infection has increased in the 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 routine diagnostic test for 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 genus—rpoB—with increased sensitivity and accuracy. PaxView® TB/NTM MPCR-ULFA Kit detects target genes using  multiplex polymerase chain reaction (MPCR) and the ensuing, proprietary universal lateral flow assay (ULFA) which is based on DNA-DNA hybridization on nitrocellulose membranes.

 

Targets

TB(IS6110, MTP40), NTM(rpoB)

 

Principles

PaxView® TB/NTM MPCR-ULFA Kit adopts PaxGenBio’s proprietary technology using the patented universal probe linked with 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 ULFA device, PCR products moves on the nitrocellulose membrane along with 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 20 min after adding PCR products.

 

Specimens

Sputum, Urine

 

Features and Benefits

Visually check the test result on the ULFA device

Simultaneously detect TB and NTM in one assay

Highly sensitive and fast detection (within 10 min)

 

Performances

DNA Extraction: 15 min

DNA Amplification: 2 hrs

ULFA Detection: 10 min

 

Product Storage  

PaxView® DNA Extraction Kit: storage at 2~8℃

PaxView® TB/NTM MPCR Kit: storage at -25~-15℃

PaxView® ULFA Kit: storage at 15~30℃

 

References

1. M. A. E. Demellawy, A. A. Wahab, E. M. Emad, K. M. Kandeel, A. A. Tabll, and M. K. E. Awady. Sensitivity of IS6110, mtp40 and 85B-RNA based amplification assays in the diagnosis and treatment follow up of pulmonary Mycobacterium tuberculosis. 2006. J Biol Sci. 6(1). 121-126.

2. E. T. Richardson, D. Samson, and N. Banaei. Rapid identification of Mycobacterium tuberculosis and nontuberculous mycobacteria by multiplex, real-time PCR. 2009. J Clin Microbial. 47. 1497-1502.