Check every patient with acute diarrhea for the presence of
Shiga toxins before beginning antibiotic therapy. BioStar OIA SHIGATOX delivers performance necessary to make rapid treatment decisions with confidence.

New FDA-Cleared Claims / October 2007

• Now approved for specimens in Cary-Blair transport media, GN broth culture, and colony sweep from SMAC culture method

Benefits of the BioStar OIA SHIGATOX Test

• 100% sensitivity,** 98.1% specificity** with fresh samples
• Results in 15 minutes, instead of hours
• Detects Stx 1 and Stx 2 toxins
• Effective for all toxin producing strains, not just E. coli O157:H7
• No mess, simple procedure - no filtration, mixing, or centrifugation required
• Reduce inappropriate treatment

The Importance of Appropriate Testing

• Testing for E. coli O157 only will miss a large number of patients with STEC: A study of food related illness and death in the United States estimated that a third of all STEC infections were caused by non-O157 E. coli.¹ In a study in Germany and Austria, non-O157 E. coli accounted for almost half of all STEC isolates.²
• Treating a patient with STEC with antibiotics might cause progression to HUS: Research indicates use of antibiotics in STEC infections could result in an emergency response, thereby increasing the output of toxin.³ Use of antibiotics in children with STEC could increase the relative risk of developing Hemolytic-Uremic Syndrome (HUS) by 14.3.⁴
• Standards of Care urge determination of STEC presence prior to antibiotic treatment: The Infectious Disease Society of America recommends testing for Shiga toxin if the stool is bloody and recommends avoiding use of certain antimicrobial drugs if STEC is suspected.⁵
• Bloody diarrhea is not a foolproof method of rapidly determining the possibility of STEC: Bloody diarrhea was not observed in an average of 36% of the patients in a study of children with confirmed cases of HUS in which STEC O157 or non-O157 was identified.²
• Can be performed using liquid or semi-solid stool samples, colony sweep, or broth culture.
• Self contained kit with only three reagents.

Reduce the Risk of HUS

Physicians need to know if a patient with diarrhea has STEC before prescribing antibiotics or risk inducing HUS. Use the BioStar OIA SHIGATOX test to rapidly check every patient with diarrhea for the presence of Shiga toxins before beginning antibiotic therapy.

Bibliography & References

** Percent Positive Agreement = Relative Sensitivity; Percent Negative Agreement = Relative Specificity.

1. Food-Related Illness and Death in the United States, Mead P.S, Slutsker L., Dietz V., McCaig L. F., Bresee J. S., Shapiro C., Griffin P. M., Tauxe R. V., Emerging Infectious Diseases, Vol.5, No.5, Sep- Oct 1999, 607-25
2. Clinical Course and the Role of Shiga Toxin-Producing Escherichia coli Infection in the Hemolytic- Uremic Syndrome in Pediatric Patients, 1997- 2000, in Germany and Austria: A Prospective Study, Gerber A., Karch H., Allerberger F., Verweyen H. M., Zimmerhackl L. B., Journal of Infectious Diseases, 2002;186:493-500
3. Toxin Gene Expression by Shiga Toxin-Producing Escherichia coli: the Role of Antibiotics and the Bacterial SOS Response, Kimmitt P.T., Harwood C. R., Barer M. R., Emerging Infectious Diseases, Vol.6, No.5, Sept-Oct 2000, 458- 65
4. The Risk of the Hemolytic-Uremic Syndrome After Antibiotic Treatment of Escherichia coli O157:H7 Infections, Wong C.S., Jelacic S., Habeeb R.L., Watkins S.L., Tarr P. I., New England Journal of Medicine, June 29,2002, Vol 342, Num. 26:1930-36
5. Practice Guidelines for the Management of Infectious Diarrhea, Guerrant R. L., et. al., Clin. Infectious Diseases, 2001;32:331-50