Evaluation of a New Immunochromatography Test for Rapid and Simultaneous Detection of Clostridium difficile Antigen and Toxins

作者：Samra Zmira^*; Madar Shapiro Liora; Aziz Mahanez; Bishara Jihad

来源：Israel Medical Association Journal, 2013, 15(7): 373-376.

• Clostridium difficile
• glutamate dehydrogenase (GDH)
• polymerase chain reaction (PCR)
• enzyme immunoassay (EIA)
• C. DIFF QUIK CHEK (R)

Background: Clostridium difficile infection is considered the most common cause of nosocomial infectious diarrhea among adults in the developed world. It is responsible for virtually all cases of pseudomembranous colitis. The Tox A/B enzyme immunoassay (EIA) is the most widely used test for the detection of C. difficile toxins A and B. However, it is associated with poor sensitivity and an unacceptable high rate of false-negative results.
Objectives: To evaluate the performance of the C. DIFF QUIK CHEK COMPLETE (R) assay, designed to simultaneously detect C. difficile-produced glutamate dehydrogenase (GHD) and toxins A and B.
Methods: Using the C. DIFF QUIK CHEK COMPLETE (R) assay, the Tox A/B EIA, and polymerase chain reaction (PCR), we tested 223 stool specimens from hospitalized patients with antibiotics-associated diarrhea. Sensitivity and specificity, and positive and negative predictive values (PPV, NPV) were calculated for the C. DIFF QUIK CHEK COMPLETE test and the Tox A/B EIA against PCR
Results: The C. DIFF QUIK CHEK COMPLETE test had a sensitivity of 83.5% and specificity of 94.3% compared to PCR for Tox A/B, with 93.7% correlation (PPV 98.5%, NPV 91.7%). The Tox A/B EIA yielded corresponding values of 72.1% and 93.1%, with 85.6% correlation (PPV 85.1%, NPV 85.8%).
Conclusions: Given the importance of an early and appropriate diagnosis of Clostridium difficile-associated infection, the C. DIFF QUIK CHEK COMPLETE test may be of huge benefit to practitioners.

• 出版日期2013-7