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Product Name Product Code
C. DIFF QUIK CHEK COMPLETE
®
25 Test Kit
T30525C
C. DIFF QUIK CHEK COMPLETE
®
50 Test Kit
T30550C
Clinical Performance Summary
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C. DIFF QUIK CHEK COMPLETE, QUIK CHEK, the TECHLAB Logo and TECHLAB are trademarks of TECHLAB, Inc. under license. 120002372E-01 07/16
1. Polage, C. et al. Overdiagnosis of Clostridium difcile Infection in the Molecular Test Era. JAMA Intern Med 2015; 175(11):1792-1801.
2. Dubberke, E.R. et al. Strategies to prevent Clostridium difcile infections in acute care hospitals. Infect. Control Hosp. Epidemiol 2008;29(S1): S81-S92
3. Cohen, S.H et al. Clinical Practice Guidelines for Clostridium difcile Infection in Adults: 2010 Update by the Society for Healthcare Epidemiology of America (SHEA)
and the Infectious Diseases Society of America (IDSA). Infect. Control Hosp. Epidemiol 2010;31(5)
4. Magill, S. et al. Multistate Point-Prevalence Survey of Health Care-Associated Infections. N Engl J Med 2014; 370(13):1198-1208.
5. ESCMID (2016), Update of the diagnostic guidance document for Clostridium difcile infection
6. Swindells, J., Brenwald, N., Reading, N. and Oppenheim, B. Evaluation of Diagnostic Tests for Clostridium difcile Infection. J Clin Mic 2010; 48(2):606-608.
7. C. DIFF QUIK CHEK COMPLETE Package Insert
Access to timely information enables
targeted treatment decisions. Discover
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Performance of GDH antigen portion vs. cytoxicity testing
7
n = 1126
Sensitivity 98.7%
Negative Predictive
Value (NPV)
99.8%
All data calculated from package insert.
Performance of a Toxin A & B portion vs. cytoxicity testing
7
n = 1126
Sensitivity 87.8%
Specificity 99.4%
Positive Predictive
Value (PPV)
95.8%
Negative Predictive
Value (NPV)
98.1%
Correlation 97.8%
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