To be determined. Updates will be made when available.
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.
Specimen: Stool (unformed)
Volume: 5 g
Minimum Volume: 0.5 g or 0.5 mL liquid stool
Container: Sterile screw-cap container or stool transport without preservatives (Para-Pak® white clean vial). "Cool Whip" containers, denture cups or other similar containers often leak or even explode during transport and may be rejected by the laboratory.
Storage Instructions: Specimen should be kept at 2°C to 8°C and transported to the laboratory within 24 hours of collection. Do not freeze