8 minutes to detect group A streptococcal infection Alere molecular diagnostic reagents approved by the FDA

8 minutes to detect group A streptococcal infection Alere molecular diagnostic reagents approved by the FDA

April 07, 2015 Source: Bio Valley

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“Alere i Strep A test makes clinical diagnosis fast, efficient, accurate, and gives appropriate treatments in a timely manner. Avoiding blind abuse of antibiotics and improving patient cure rates.” Avi Pelossof, Global Director, US Air Force Infectious Diseases Business Unit Said at the press conference.

US Airil also submitted a Clinical Laboratory Improvement Amendment (CLIA) exemption application, hoping to use the kit in places other than general laboratories, such as doctor's offices, hospital emergency departments, and health clinics.

This kit uses Meili's patented technology - nucleic acid isothermal rapid amplification technology, unlike the ordinary polymerase chain reaction (PCR), this new technology does not require repeated thermal cycling and complex DNA purification, Within a wide range of conditions, nucleic acid molecules can be rapidly amplified to give results.

Products that also use this technology are also influenza virus detection kits. In June 2014, US Airil received FDA approval for the detection and typing kits for influenza A and B viruses. In January 2015, the US Airline Influenza Test Kit was granted a CLIA exemption.

“Alere i Strep A test has increased the testing program of the Alere i platform and expanded the applicable population.” The head of the US Airil company said, “The lack of seasonal characteristics of group A streptococci may cause infection throughout the year. People should Timely testing with the Alere i Strep A test." (BioValley Bioon.com)

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