Abstract
Targeting the IS6110 and mtp40 genes for the detection of Mycobacterium tuberculosis (MTB), the PaxView TB/NTM MPCR-ULFA Kit is a novel tool that replaces gel electrophoresis with universal lateral flow assays. The sensitivity and specificity of this method were compared to those of established methodologies using clinical isolates from Indonesia. In this study, 148 sputum specimens isolated from suspected tuberculosis (TB) carriers were examined to evaluate the performance of the PaxView TB/NTM MPCR-ULFA Kit compared to smear microscopy and the Xpert MTB/RIF assay.
Of 148 cases, the rate of positive samples for TB evaluated by different methods was 18.2% (27/148; 95% CI 11.9–24.4) for smear microscopy, 20.3% (30/148 95% CI 13.8–26.8) for the Xpert MTB/RIF and 34.5% (51/148; 95% CI 26.8–42.1) for the PaxView TB/NTM MPCR Kit- ULFA. Twenty sputum samples from healthy subjects were also tested, all of which returned negative results across the three diagnostic tools examined in this paper. Compared to Xpert MTB/RIF, the PaxView TB/NTM MPCR-ULFA Kit was found to have a sensitivity of 96.7% (29/30; 95% CI 90.3-100).
In addition, the PaxView TB/NTM MPCR-ULFA Kit detected 18.6% (22/118, 95% CI 11.6–25.6) of Xpert MTB/RIF MTB negative samples and 20.7% (25/121, 95% CI 13.5–27.9) of smear microscopy negative samples as positive for MTB. The PaxView TB/NTM MPCR-ULFA Kit could be a useful molecular diagnostic tool to identify MTB in clinical samples in resource-limited countries, as this procedure is more cost-effective and sensitive than Xpert MTB/RIF, and more convenient than Xpert MTB/RIF. conventional. PCR gel electrophoresis methods.
Product name: PaxView TB/NTM MPCR-ULFA Kit
Certification: CE
Category: Medical Test Kit
Ingredients: –
Keywords: ivd, PCR, TB, molecule diagnostics
Unit size: –
Brand: PaxView
Unit Weight: 320 g
Origin: South Korea
Stock: 100
Type of supply: Available
HS Code: 382200
Product Information
The PaxView TB/NTM MPCR-ULFA Kit adopts PaxGenBio’s proprietary technology that uses the patented universal probe linked to the PCR primer that amplifies a target gene from clinical samples and allows visual inspection of DNA-DNA hybridization between the universal probe at one end of the PCR products and their complementary sequence.
When loaded onto the sample pad in a ULFA cartridge, the PCR products move over the nitrocellulose membrane along with running buffer and hybridize with complementary DNA fragments immobilized on specific regions of the nitrocellulose membrane.
Finally, it is easy to visually verify the results within 10 to 15 minutes after adding the PCR products. PaxView TB / NTM MPCR-ULFA Kit is a new molecular diagnostic technology that uses PaxGenBio’s patented MPCR-ULFA (Multiplex Polymerase Chain Reaction – Universal Lateral Flow Assay) technology and has an economical and convenient cost consisting of MPCR Kit and ULFA kit.
- Simultaneous diagnosis of Mycobacterium tuberculosis complex (MTBC) and non-tuberculous mycobacteria (NTM) infection.
- Application of MPCR-ULFA (Multiplex PCR – Universal Lateral Flow Assay), the patented technology owned by PaxGenBio
- Amplify and detect specific genes, IS6110 or mtp40 for Mycobacterium tuberculosis and rpoB gene for NTM
- High sensitivity and specificity – Limit of detection (LoD); MTBC: 2 copies/μl, NTM: 10 copies/μl
- All PCR equipment can be used
- Simple and easy to use method
- Visual check of results in 10~15 minutes, easy to use
- Patent registered in the USA.
PaxView TB / NTM MPCR-ULFA Kit is an in vitro diagnostic kit designed to detect tuberculosis and non-tuberculosis by the PCR method. Amplifying and detecting specific genes, IS6110 and mtp40 from tuberculosis bacteria, and the rpoB gene in mycobacteria. This efficient diagnosis is possible for TB and non-tuberculous infections.