Alere has announced that the US Food and Drug Administration (FDA) has cleared the TechLab Shiga Toxin Quik Chek test for the US market. The text is the only rapid diagnostic available that can detect Shiga toxin-producing Escherichia coli (STEC) directly from a stool specimen. The test offers significant advantages over other rapid cassette assays in that it removes the need for overnight bacterial culture preparation.
The Shiga Toxin Quik Chek provides results up to 24 hours before other rapid tests, enabling clinicians to initiate patient care sooner and minimise the potential for broader bacterial outbreaks. The test’s considerably shorter sample preparation process also helps to dramatically streamline laboratory workflows.
The Shiga Toxin Quik Chek is the latest addition to the Alere Enterics suite of Quik Chek assays developed and manufactured by TechLab. It combines the precise accuracy of an enzyme immunoassay with the speed and ease of use of a cassette. The Shiga Toxin Quik Chek requires few processing steps and provides differentiated results for Shiga Toxin 1 and 2 within 30 minutes of sample receipt, permitting rapid diagnosis and prompt initiation of treatment.
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