Molecular Diagnostics Kits

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Products Spotlight

Bacterial Vaginosis Real Time PCR Kit (Multiplexing)

One of the molecular diagnostics kitsBacterial vaginosis (BV) is a type of vaginal inflammation that results from the overgrowth of one of several types of bacteria normally present in the vagina, upsetting the natural balance of vaginal bacteria. Bacterial vaginosis (BV) is considered to be the most common cause of vaginal inflammation among both pregnant and non-pregnant women and prevalences between 4.9% and 36.0% have been reported from European and American studies. Bacterial Vaginosis Real-TM Quant kit is for the quantitative detection of Gardnerella vaginalis, Atopobium vaginae, Lactobacillus spp. and total bacteriae quantity in the vaginal biotope. More details about Real Time PCR Kits.

EGRF Gene Mutation Detection Kit

Feature ProductThe AmoyDx EGFR Mutation Test Kit is a superior sensitive and selective assay for the detection of the most common somatic mutations in the Epidermal Growth Factor Receptor (EGFR) gene. EGFR gene mutation relates to the drug response of Iressa (Gefitinib) and Tarceva (Erlotinib). The cancer patients with mutant EGFR genes are sensitive to Iressa and Tarceva, whereas the patients without EGFR mutations cannot be benefit from the treatments. However, the EGFR T790M mutation causes drug resistance. More details about EGR Mutation Dectection Kits.

Aflatoxin B1 ( AFB1) ELISA Kit

Feature ProductAflatoxin-producing members of Aspergillus are common and widespread in nature. They can colonize and contaminate grain before harvest or during storage. Host crops are particularly susceptible to infection by Aspergillus following prolonged exposure to a high-humidity environment, or damage from stressful conditions such as drought, a condition that lowers the barrier to entry..The United States Food and Drug Administration (FDA) has established action levels for aflatoxin present in food or feed to protect human and animal health. More details about Elisa Kits.

IMPORTANT NOTE

All our Sacace Diagnostic Reagents are CE marked and are in compliance with Directive 98/79EC. Quality Management System is ISO 9001:2008 and ISO 13485:2004 certified.

These reagents are made and sold for Research and Development only.

However a laboratory can adopt these reagents to develop their own LDT s which can be used in a clinical setting after following proper regulatory protocols suitable for any state or federal regulatory agency. All such burden will lie on the users who want to go through that route.

Here is some useful literature links for such purposes.

  1. Association of Molecular Pathologists Document
  2. Regulation-of-laboratory-developed-tests-LDTs
  3. How to obtain CLIA certification
  4. Validation publication for Molecular Diagnostics
  5. FDA/CDRH Public Meeting: Oversight of Laboratory Developed Tests (LDTs), Date July 19-20, 2010

Human Health Diagnostics

Human Health Diagnostics (HuHD) is a US-based company engaged in marketing of key cutting edge technologies and development of innovative technical solutions to address diagnostic and biomedical needs. Read more about HUHD.