Alere Inc, Waltham, Mass, reports the FDA has cleared the Techlab Shiga Toxin Quik Chek test for the US market.

Shiga Toxin Quik Chek can detect Shiga toxin-producing E. coli (STEC), which can have fatal effects, directly from a stool specimen.

“By narrowing the diagnostic window from a day to 30 minutes, the Shiga Toxin Quik Chek promises to be a significant help to clinicians, facilitating more rapid patient care that leads to better outcomes, improving workflows, and reducing the potential for broader outbreaks," says Jim Post, president of Alere North America.
 


The test removes the need for overnight bacterial culture preparation.

Shiga toxin-producing E. coli are commonly associated with food- and water-borne outbreaks of diarrheal illness, and diagnostics for these bacteria account for approximately $16 million of the total enteric disease market. Shiga Toxin 1 and Shiga Toxin 2, produced singly or in combination by more than 200 different strains of STEC, are the enterohemorrhagic toxins that cause disease. O157 is the most well known strain and has been responsible for numerous outbreaks in the past. Several other strains, though, have led to severe outbreaks, and Shiga Toxin Quik Chek detects toxins from both O157 and non-O157 strains.

This test is the newest addition to the Alere Enterics suite of Quik Chek assays developed and manufactured by Techlab Inc. It combines the accuracy of an enzyme immunoassay with the speed and ease of use of a cassette. The test requires few processing steps and provides differentiated results for Shiga Toxin 1 and 2 within 30 minutes of sample receipt, allowing for rapid diagnosis and prompt initiation of patient treatment.

Alere holds a 49% interest in Techlab Inc and has exclusive global distribution rights to the company’s line of enteric diagnostics.

[Source: Alere]