Clostridioides difficile Toxin Gene, NAA, With Reflex to Clostridioides difficile Toxins A+B, EIA *

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Category:

CPT Code:

To be determined. Updates will be made when available.

Overview:

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.

Collection Details:

Collection Instructions:

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