According to a 2015 CDC study(1), Clostridium difficile causes more than 500,000 infections per year in the United States alone. Approximately 29,000 patients die within 30 days of initial C. difficile diagnosis. Of those, an estimated 15,000 deaths were directly attributable to CDI, making it the most deadly hospital infection and topping the CDC’s “urgent” threat level category for microbial infection. The financial burden of CDI is enormous and estimated to cost in excess of $4.8 Billion of additional health care costs annually for acute care facilities alone.(1,2,3,4) C. difficile infection results in severe diarrhea and can lead to life-endangering conditions including pseudomembranous colitis and toxic megacolon. Patients taking antibiotics are at risk for C. difficile infection since this common commensal microbe can become virulent when other intestinal microbes are eliminated by antimicrobial agents. Virulent C. difficile excretes potent toxins which can critically damage intestinal tissue.
The current gap in C. difficile diagnostics.
Current available, rapid technologies have limitations when it comes to diagnosing C. difficile infection. One type of diagnostic test, rapid enzyme immunoassay (EIA) tests for the toxins are cost-effective but lack the sensitivity necessary. Another type of test, real-time Polymerase Chain Reaction (PCR) tests bring a high level of sensitivity but are often cost restrictive and can have a lack of specificity due to the inability to distinguish colonization from active infection.
The MultiPath™ C. difficile toxin test.*
First Light Diagnostics bridges this gap by providing a cost-effective, ultra-sensitive and specific toxin test for C. difficile diagnosis. Utilizing the patented MultiPath™ platform, our test is able to deliver the speed, sensitivity, and specificity required for directly detecting C. difficile toxin at levels more appropriate to aid in the determination of C. difficile infection in less than 30 minutes with minimal sample preparation steps.
By using the MultiPath™ Analyzer to test for C. difficile, hospitals will be able to quickly identify the infection and take specific steps to address it, avoiding overtreatment and overdiagnosis.
To learn more about the capabilities of the MultiPath™ Technology, visit www.firstlightdx.com
References:
[1] https://www.cdc.gov/media/releases/2015/p0225-clostridium-difficile.html
[2] Magill et al. (2012). Infect Control Hosp Epidemiol 33, 283-291.
[3] Shorr, A.F., et al., (2016). Infect Control Hosp Epidemiol 37, 1331-1336
[4] Lessa, et al. (2015). N Engl J Med 372, 825-834
*Currently Under Development, Not available for Sale
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