AITbiotech abTES™ DEN 4 qPCR I Kit is CE-IVD certified
AITbiotech Pte Ltd, a leading manufacturer of molecular diagnostic (MDx) assays and provider of genomic services based in Singapore has announced that it has received a CE-IVD mark for its abTES™ DEN 4 qPCR I Kit, a multiplexed real-time PCR test for dengue infection in April 2015.
Multiplex real-time PCR technology is used to detect and differentiate Dengue virus serotype 1, serotype 2, serotype 3, and serotype 4 in a single reaction tube. This multiplex kit is designed for rapid diagnosis and differentiation of dengue virus serotypes in clinical samples. The kit is also a reliable tool to be used for surveillance of dengue virus in population.
The abTES™ DEN 4 qPCR assays are manufactured at AITbiotech’s ISO13485 certified facilities in Singapore.
In a recent study (J Clin Microbiol. 2014 October; 52(10): 3781–3783.) conducted by a customer, the abTES™ Dengue kit is said to be more sensitive and less time-consuming than other molecular methods in providing rapidly diagnosis of dengue infection that can be helpful in urgent clinical situations.
“Our abTES™ DEN 4 qPCR kit have already been clinically validated as the preferred molecular assay for dengue surveillance in several public health institutes in SEA. With this Dengue kit now been CE-IVD certified, we are very excited that we can now offer this kit to many more regions” said Alex Thian, AITbiotech’s CEO. “AITbiotech is also in the process of seeking certification for more of our range of multiplex diagnostic assays and thus expand our certified assay offerings to the diagnostic markets in Asia.”
Article in Genomeweb Regulatory NewsGo back