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PaxGenBio Co., Ltd. (Bio-company of Peaceful Gene), was established in 2015 as a molecular diagnostics company that develops, manufactures, and markets a portfolio of IVD products targeting infectious diseases and cancers. PaxGenBio applies its proprietary, chimeric technologies that combine techniques for molecular and immune diagnostics. One of its original technologies, MPCR-ULFA that combines multiplex PCR amplification and universal lateral flow assay (ULFA) enables sensitive, specific, fast, affordable, and easy nucleic acid tests that are especially appropriate for applications in low resource settings.
PaxView® TB/NTM MPCR-ULFA Kit is a qualitative in 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 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. 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. The PaxView® TB/NTM MPCR-ULFA Kit adopts PaxGenBio’s proprietary technology using 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.