Hangzhou Biotest Biotech Co., Ltd.

Product Details: Material Hips Usage/Application Clinical Country of Origin Made in India Sample Volume 2.5 microlitre Brand Abbott model number AFINION CRP Assay time 3 to 4 minutes Sample material Capillary blood,serum,plasma,or anticoagulated venous blood (EDTA or heparin) Measuring range 5-200 mg/L (whole blood),5-160 mg/L (serum and plasma Abbott AFINION CRP Rapid Vitro Diagnostic Test

Ezplex HLA-B NGS typing Kit is an in vitro diagnostic test that detects and distinguishes allelic genes of HLA-B in human leukocyte antigens at high resolution using next-generation sequencing. Ezplex's unique amplicon approach simplifies the traditional complex NGS Library construction process and provides dedicated software optimized for HLA typing for easy analysis. The Ezplex HLA-B NGS typing Kit accurately reads the HLA-type Acuracy (95 percent Confidence Interval) in DRB1 Locus within a total of 35 hours from DNA extraction to NGS results analysis to help with pre-transplant testing.

Helicobacter pylori is a parasitic bacterium in the stomach that lives between the gastric mucosa and mucus. According to the WHO, more than half of the world's population has H. pylori and is the third leading cause of cancer-related deaths. In 1994, the WHO's IARC classified H. Pylori as a Class 1 carcinogen. The incidence of H. pylori in developing countries is the highest worldwide, highlighting the need for highly accurate and manageable testing. By 2025, the H. pylori testing market is expected to be worth 6 billion. Accordingly, SML Genetree has developed a reagent that can diagnose Helico-bacter pylori and Clarithromycin-resistant mutants (A2142G, A2143G) through DNA extracted from human hygienic tissue using Real-time Polymerase Chain Reaction. Since it contains multiple gene regions, Helico-bacter pylori and Clarithromycin-resistant mutations can be detected sensitively, and high reproducibility has been demonstrated through repeated tests by serially diluting various positive samples and standards. In addition, as a result of clinical evaluation on human sanitary inspection tissue by commissioning a large domestic consignment inspection institution, high sensitivity and specificity were confirmed, proving its excellent clinical performance.

Ezplex MTBC/NTM Real-time PCR Kit is an in vitro diagnostic test that simultaneously detects Mycobacterium tuberculosis complex (MTBC) and 20 types of nontuberculous mycobacteria (NTM). Sensitivity : Multiple gene targets for MTBC and NTM. Clinical Performance: Validated clinical performance. Fast Results: Testing can be completed within 2 hours post extraction.

HPV NGS Kit is an in vitro diagnostic test that simultaneously detects the genotype of human papillomavirus (HPV) using Next-Generation Sequencing technology (NGS). Automated workflows allow for fewer human errors and less hands-on time from library construction to analysis of results. HPV types are quickly identified by simultaneously analyzing up to 480 samples. NGS time is reduced to approximately 24 hours.

HPV is a virus that causes papillomas (benign tumors), and about 200 types have been discovered so far. Some types of HPV are known to be the direct cause of cervical cancer, head and neck cancer, etc. In particular, in the case of cervical cancer, more than 99% of the causes are reported to be caused by HPV. If it is detected early, it is easy to treat, but if it is detected late, the 5-year survival rate is less than 15% even with treatment, so regular check-ups are very important. SML Genetree has developed the world's first Ezplex�® HPV NGS Kit to diagnose HPV using the NGS method. Unlike the existing methods that only detected up to 20 to 40 types and only positive-negative, NGS was introduced to provide positive results for 45 types of HPV (up to 100 types including for export) according to the amount of DNA detected in steps 1 to 3 Semi-quantitative inspection of the level is possible. It has a high level of automation that is close to full automatic. The time has been shortened so that up to 480 people can be analyzed within 16 hours with one analysis, and it is possible to distinguish HPV species that were difficult to distinguish precisely. Unlike the existing sequencing method, the NGS method has been highly evaluated for its potential as a precision medical technology that can dramatically reduce time and cost by analyzing numerous DNAs at high speed. As a result of clinical efficacy evaluation with more than 2500 clinical specimens in large domestic hospitals, it is a product with high sensitivity and specificity compared to existing tests.

Ezplex�® SARS-CoV-2 G Kit, developed by SML Genetree, is a product that has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). This is an in vitro diagnostic test that qualitatively detects the nucleic acids of SARS-CoV-2 (RdRp and N genes) in sputum to aid in emergency screening for COVID-19. This product can be used for a large amount of screening tests because it can perform a pooling test, unlike the products that the existing domestic companies have approved for emergency use by the FDA. For the combined test, samples are collected in units of 5 people and tested. If positive, individual tests are performed. In the case of a negative test, all tests are performed in a negative way. In particular, since a large number of samples are tested at once, the test is only possible with high sensitivity and specificity compared to existing diagnostic kits. According to the FDA, it was confirmed that 100% agreement was achieved in the result comparison test of individual and collective tests, and it was the 20th in the world and the first Korean company to pass the test. Excellent clinical performance was demonstrated by confirming high sensitivity and specificity through clinical evaluation, and stability was confirmed for 12 months through long-term storage tests. In January 2021, it was officially approved by the Korean Ministry of Food and Drug Safety (MFDS).

Ezplex Respiratory Pathogens Real-time PCR Kit is an in vitro diagnostic test for the qualitative detection of 19 respiratory viruses and 6 types of pneumonia-causing bacteria through nucleic acids isolated and extracted from human throat swabs using real-time polymerase chain reaction Comprehensive Panel- One test can identify 19 respiratory viruses and 6 bacterial species simultaneously. Sensitivity Detection of all targeted viruses and bacteria with high sensitivity. Convenience Genetree Viewer analysis software available for users to conveniently produce test results. Clinical Performance: Clinical testing confirmed the high sensitivity and specificity. Stability: Shelf life of up to 12 months. Analytical Specificity: Testing of 31 species of microorganisms showed no cross reactivity.

Ezple Respiratory Pathogens Real-time PCR Kit is an in vitro diagnostic test for the qualitative detection of 19 respiratory viruses and 6 types of pneumonia-causing bacteria through nucleic acids isolated and extracted from human throat swabs using real-time polymerase chain reaction.