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Test Code C diff C. diff EIA with Reflex to PCR

Patient Preparation

No special patient preparation required

Special Collection Instructions

Collect directly into a clean dry container. Do not place in preservative.  Stool must be liquid.

Collection Method

Stool collection

Minimum Volume

1.0 mL

Container

Sterile Cup

Preferred Specimen

Raw liquid stool

Acceptable Specimens

Raw liquid stool

Reference or Target Ranges

Negative for C. difficile

Reportable Units

Positive/Negative

Critical Value

Positive

Reasons for Rejection

Hemolysis Threshold N/A
Icterus Threshold N/A
Lipemia Threshold N/A
Other QNS, contaminated, improperly labled, improper specimen type, formed stool, patient is <2 years old, patient has had a positive result in last 30 days, patient has had negative result in past 7 days.

Specimen Stability

Ambient N/A
Refrigerated (4°C to 8°C) 72 hours
Frozen(-40°C to 0°C) N/A

Performance Information

Days and Time Performed Daily
Expected Turn Around Time 4 hours
Stat Availabilty No
Performing Bench AP Green, Microbiology
Instrument Quik Chek Complete (Manual)/Reflex: Cepheid Infinity
Methodology/Method Description Enzyme Linked Immunoassay/Reflex PCR

Reflex Testing

An enzyme linked immunoassay for GDH and Toxin A&B antigen will be performed. In cases for which these two parameters are both positive or both negative, a positive or negative result will be reported respectively. In cases of discrepant results between the GDH and Toxin antigens, a PCR test (including NAP1 gene) will be performed and reported. In both cases, only an interpretation of the individual tests will be reported accompanied by a comment indicating the methodology used.

Algorithm

Additional Information/Important Notes

Do not order if patient has had a previous negative within one week or a previous positive within three weeks.

CPT Codes

87324,87449; 87493(reflex)