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Test Code:
090-70-1030-01

Order Name:
C. difficile Toxin B gene, PCR (Stool)

 
Useful For:
Use for the direct, qualitative detection of the Clostridium difficile toxin B gene (tcdB) in patients suspected of having Clostridium difficile infection (CDI).
 
Methodology:
Real Time Polymerase chain reaction (Real-Time PCR)
 
AliasesName:
C. difficile Toxin B
C. difficile, Stool
Clostridium difficile, Feces
PCR for C. diff 
Clostridioides
Clostridium difficile infection (CDI)
 
 
 
Test Code:
090-70-1030-01

Order Name:
C. difficile Toxin B gene, PCR (Stool)

 
Collection Specimen Or Container:
Stool/ Clean container
 
Specimen Testing Type:
Stool
 
Sub Mission Container:
Clean container
 
Rejection Criteria:
Stool is mixed with toilet paper, water, soap or urine will be reject.
 
Specimen Stabillity:
Specimen Type Temperature Time
Stool Room temperature, 18oC to 25oC 48 hours
Stool Refrigerated, 2oC to 8oC 5 days
 
 
 
Test Code:
090-70-1030-01

Order Name:
C. difficile Toxin B gene, PCR (Stool)

 
Method detail:
Real Time Polymerase chain reaction (Real-Time PCR)
 
Schedule:
Test daily, at 08:00 a.m.
 
Turnaround Time:
Received specimen to reported within 1 day.
 
Performing Location:
Molecular biology & Genetics, Laboratory Department Tel.14168
 
Specimen Retention Time:
7 days
 
 
 
Test Code:
090-70-1030-01

Order Name:
C. difficile Toxin B gene, PCR (Stool)

 
 
Clinical Information:
Clostridium difficile is an anaerobic, gram-positive bacillus that is the leading cause of antibiotic associated diarrhea and pseudomembranous colitis in health care facilities. Incidence of Clostridium difficile infection (CDI) has been increasing, and severe cases are becoming more common. CDI disease symptoms range from mild diarrhea to severe colitis, and even bowel perforation and death. The most common risk factor is exposure to antibiotics. The diagnosis of Clostridium difficile infection is based upon the clinical signs and symptoms, such as diarrhea, and laboratory or pathologic tests. Laboratory diagnosis of toxigenic Clostridium difficile includes anaerobic culture followed by detection of toxin or detection of toxin gene(s) or enzyme(s) found in the stool. It appears that toxin B is necessary for the development of CDI. Recently, PCR methods for the detection of toxin A and/or toxin B have been developed with high sensitivity and specificity as compared to the cell cytotoxicity and immunoassays. The combination of these characteristics may allow for prompt targeted treatment of CDI patients and thus potential improvement in patient outcome, reduced recovery time, and infection control practices.
 
Reference Value:
Negative
 
Interpretation:
  1. This product is intended for use only with unpreserved liquid or soft stools; performance characteristics of other clinical specimen types have not been established.
  2. Incorrect test results may occur from improper specimen collection, handling or storage, technical error, sample mix-up or because the number of organisms in the specimen is below the analytical sensitivity of the test.
  3. A positive assay result does not necessarily indicate the presence of viable organisms.  It does however indicate the presence of the tcdB gene and allows for presumptive detection of a Clostridium difficile toxigenic organism.
  4. As with all PCR-based in vitro diagnostic tests, extremely low levels of target below the limit of detection of the assay may be detected, but results may not be reproducible.
  5. False negative results may occur due to loss of nucleic acid from inadequate collection, transport or storage of specimens, or due to inadequate bacterial cell lysis.
  6. Mutations or polymorphisms in primer- or probe-binding regions may affect detection of Clostridium difficile tcdB gene variants, resulting in a false negative result.
  7. Variant toxigenic Clostridium difficile without the tcdB gene or with a non-functional Toxin B protein are very rare. This assay targets the tcdB gene and it is unknown whether it would detect Toxin A+/Toxin B- variant strains.
 
Clinical Reference:
Manufacturer’s package insert, BD MAX™ Cdiff Assay, January 2017, Becton Dicksinson and Company, Franklin Lakes, New Jersey, USA