PaxGenBio Co., Ltd.

[Intended Use] PaxView® COVID-19 real-time RT-PCR Kit is an in vitro diagnostic kit designed for the qualitative detection of COVID-19 viral RNA in the oropharyngeal swab, nasopharyngeal swab, sputum, and bronchoalveolar lavage (BAL). [Principles of the Procedure] The PaxView® COVID-19 real-time RT-PCR Kit detects the novel coronavirus, COVID-19 using one-step real-time RT-PCR in a single tube. The target genes for the detection of the virus are Orf1ab and N gene. The sequence of primers and probes for the amplification were adapted from sources published by China CDC and WHO. The kit includes primers and a probe set targeting the human RNase P gene that serves as an internal positive control for the real-time RT-PCR.

[Intended Use]
PaxView® HPV 20 Genotyping MPCR-ULFA Kit is an in vitro diagnostic kit designed for the detection and genotyping of HPV in cervical swab specimens. The kit utilizes multiplex PCR and DNA hybridization to detect and identify 20 different HPV genotypes (6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 69, 70, 73).

[Principles of the Procedure]
PaxView® HPV 20 Genotyping MPCR-ULFA Kit uses MPCR-ULFA (Multiplex PCR - Universal Lateral Flow Assay) technology for the qualitative detection and identification of HPV genotypes.
The kit is comprises of MPCR kit for the multiplex PCR amplification of HPV DNA and ULFA kit for the detection of amplified PCR products.
MPCR kit includes PCR premix and primer mix for specific amplification of 20 HPV genotypes. Forward primers for the amplification include the nucleotide sequence complementary to the universal DNA probes immobilized on the nitrocellulose membrane of the cartridge. Reverse primers are biotinylated for the binding to streptavidin-conjugated gold nanoparticles for visualization. The PCR products move on the membrane along with running buffer and hybridize to the DNA probe on the membrane. When amplifying the DNA hybridizes to the probe, the red line will appears on the test line if HPV is present. If not, only Control lines appears.

[Intended Use] 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 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. [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.

PaxView SARS-CoV-2 MPCR-ULFA Kit  NEW!!

▪ 1. Analysis of the current situation
▪ - After the corona pandemic, real-time RT-PCR has been established as a diagnostic standard in developed countries and advanced countries familiar with molecular diagnosis.
▪ - However, the Arab world, South America, Southeast Asia, Africa, etc. still practically lack expensive real-time PCR equipment and laboratory experts.
▪ - As an alternative to this, antigen rapids are used, but the inherent limitation of antigen rapids is low sensitivity and
▪ It is also true that it is difficult to obtain accurate diagnosis results (especially false negative occurrences) due to large variations in the amount of antigen collected.

▪ 2. Product strengths and weaknesses:
▪ - Strengths: High cost-effectiveness, amplification using conventional PCR, which is already familiar in all laboratories, and quick result reading of the rapid kit principle
▪ It is easy to use, does not require expensive PCR equipment compared to real-time RT-PCR, has excellent cost-effectiveness, and has excellent LoD (10 copies/µl) that is comparable to LoD of real-time RT-PCR.
▪ - Disadvantages: The existing corona diagnosis standard, real-time RT-PCR is barrier and its low awareness.

▪ 3. Marketing point
▪ - Molecular diagnostic kit based on conventional PCR that enables fast and accurate confirmation with high cost-effectiveness.
▪ - Compared to the rapid test, which is mainly for screens, it is cost-effective and accurate molecular diagnosis confirmation method.
▪ - In Post corona pandemic, hopely, it is marked with a confirmatory method for cost-effective surveillance.