Use: Two-step algorithm to aid in the determination of C. difficile infection versus C. difficile colonization.

Limitations: * This test does not distinguish between viable and nonviable organisms.

• Test results are to be used in conjunction with information available from the patient's clinical evaluation and other diagnostic procedures.
• This test is for use with unformed (i.e., soft, loose) stool samples only.
• This test detects/presumptively differentiates the BI/NAP1/027 strain from other toxigenic strains of C. difficile. Detection of BI/NAP1/027 strains of C. difficile is presumptive and is solely for epidemiological purposes; it is not intended to guide or monitor treatment for C. difficile infections.
• The detection of bacterial nucleic acid is dependent on proper specimen collection and handling (including transportation and storage).
• Performance characteristics have not been established for patients less than two years of age.

Methodology: Real-time polymerase chain reaction (PCR) with reflex to enzyme immunoassay (EIA)

* This test can reflex up to 5 times.