Tag Archives: Clostridium difficile laboratory test

TechLab C. diff. Quik Chek Complete® Antigen and Toxins A&B On A Single Device

C. difficile diagnostics

Clostridium difficile is the major cause
of nosocomial diarrhea and pseudomembranous colitis

C. difficile infection usually occurs when the normal microflora of the intestinal tract is altered or killed by antibiotics. Once C. difficile growth begins, toxins A and B are produced, causing diarrhea and colitis.

The disease can be treated with metronidazole or vancomycin, but relapses occur in about 20% of patients who develop the infection.

TECHLAB produces a panel of in vitro diagnostics for detecting C. difficile and its toxins in fecal specimens from patients suspected of having the disease.

 

For more information about TechLab and their products/services

click on the following link:  http://www.techlab.com/

 

 

 

DISCLAIMER
“The C Diff Foundation’s mission is to educate and advocate for Clostridium difficile infection prevention, treatments, support, and environmental safety worldwide.
The C Diff Foundation’s organization is comprised of 100% volunteering members who are dedicated to our mission and adhere to the Foundation’s Code of Ethics
which prohibits  paid endorsements or paid promotion of products, services, medications, or clinical studies in progress.   All website entries, public presentations, and workshops are to raise C. diff. infection awareness in all areas of the C Diff Foundation’s mission statement, including infection prevention, treatments, environmental safety products, diagnostics, sepsis, healthcare-associated infections, antimicrobial resistance, antibiotic stewardship and provide education on all the above.”

 

PositiveID Corporation Expands Firefly Dx Testing Capabilities for Hospital Acquired Infection (HAI) Market

PositiveID Corporation (“PositiveID” or “Company”), a developer of biological detection and diagnostics solutions, announced today that it has successfully detected Clostridium difficile (“C. diff”) on its Firefly Dx polymerase chain reaction (“PCR”) breadboard prototype pathogen detection system (“prototype system”) in less than 20 minutes.

The C. diff assay, provided to the Company for testing by partner GenArraytion, Inc., is a more comprehensive and specific test than many other C. diff assays on the market as it tests for the C. diff chromosome as well as both Toxin A and Toxin B.

Clostridium difficile (C. diff.)  is a bacterium that most often affects older patients in hospitals or long-term care facilities after antibiotic use, and causes symptoms ranging from diarrhea to lethal inflammation of the colon.

In addition to C. diff, the Company recently announced its successful detection of

methicillin-resistant Staphylococcus aureus (“MRSA”), another common hospital-acquired infection, on its Firefly Dx prototype system. It has also successfully identified methicillin-susceptible Staphylococcus aureus (“MSSA”).

To read this news article in its entirety click on the following link

https://ca.finance.yahoo.com/news/positiveid-expands-firefly-dx-testing-123000203.html

C. difficile Laboratory Test Information For Patients and Healthcare Providers

Testing for Clostridium difficile toxin with real-time polymerase chain reaction (PCR) can improve the laboratory diagnoses of C difficile–associated diarrhea, compared with A/B enzyme immunoassay (EIA), according to results from a study presented at a Association for Molecular Pathology meeting.

In fact, real-time PCR demonstrated a sensitivity of 100% and a specificity of 96.9%, whereas the A/B EIA was found to generate both false-positive and false-negative results.

“Although C difficile–associated diarrhea has increased in prevalence and severity, the inaccuracy of conventional C difficile toxin EIA for diagnosis is well documented in the literature,” said lead investigator Cynthia Essmyer, MD, medical pathologist at Saint Luke’s Hospital in Kansas City, Missouri. (1)

The Microbiology Laboratory medical pathologist at a University Hospital located in NC shared the following information to answer one of the many questions:  “Why won’t the lab run a test on hard formed stool?”

The lab will not accept a stool specimen that is hard/formed stool due to the fact that the PCR test is regulated by the testing company and a hard/formed stool can produce a false positive result.  Soft, unformed or watery stools are all accepted for the PCR testing.

  • ACCEPTABLE SPECIMEN: FecesCollect specimen as follows:
    1. Collect feces in a clean, dry container or bedpan not contaminated with urine, residual soap, or disinfectants.
    2. Transfer appropriate volume of feces to a clean dry tightly capped specimen cup.
    3. Submit double-bagged specimen cup immediately to laboratory.
  • NOTES:
    1. Patients should be passing at least 3 unformed or watery stool specimens in a 24-hour period. Most patients have more than 3 episodes of watery unformed stools per day.
    2. Soft specimen is defined as specimen assuming the shape of its container (unformed).
    3. Formed or hard fecal specimens will not be tested.
    4. Repeat testing following a negative test during the same episode of diarrhea is NOT recommended for at least 7-days because of high sensitivity (between 98-99% and with a 99% negative predictive value).

* There may be an alternate send out micro. test for hard formed stool and this information can be obtained at the laboratory being utilized.  Have a healthcare provider contact the lab prior to delivering a specimen to the lab location.

When a PCR result is NEGATIVE: the Wait time between testing is 7 days to retest.

When a PCR result is POSITIVE: the Wait time between testing is 14 days to retest.

Q:  Is there a wait time after completing antibiotic treatment (greater than 14 days since first positive result) to retest?
A:  No, since the PCR is testing micro-organisms the antibiotic will not interfere with testing.

 

Q:  Can a stool specimen be kept in a refrigerator and if so for how long?

Storage
REFRIGERATE IF TRANSPORT IS DELAYED. Specimens can be stored at 2-8 degrees C for 24 hours before significant degredation of the toxin is noted. SUBMIT WITH COLD PACKS OR ON ICE IF TRANSPORT WILL TAKE > 1 HOUR.
Transport
DELIVER IMMEDIATELY TO MICROBIOLOGY IN A TIGHTLY SEALED CONTAINER WITH NO EXTERNAL SPILLAGE.
REFRIGERATE IF TRANSPORT IS DELAYED. SUBMIT WITH COLD PACKS OR ON ICE IF TRANSPORT WILL TAKE >1 HOUR.

A specimen can be rejected by the lab if Specimen is received > 2 hours after collection unless submitted on ice or cold pack or with note that specimen stored in refrigerator prior to transport.

Q:  How long does it take to receive lab results?

A:  Routine turn around time is one day.

 

 

Source: (1) Medscape

other:  University Hospital Microbiology Laboratory in NC

Clostridium difficile (C.diff.) Laboratory Test Collection,Storage,Transport

CLOSTRIDIUM DIFFICILE TOXIN, PCR
Label Name: C DIFF
Lab Discipline: Microbiology
Subdiscipline: Bacteriology
Feces (Stool)
Container & Volume
Age Group Container Volume
0  – 18 Years Sterile Specimen Cup 5  ML
Label Reminders
Must include patient name, MRN, date/time of collection and collector’s initials.

 

 

Collection Notes
All:
  • ACCEPTABLE SPECIMEN: Feces

    Collect specimen as follows:
    1. Collect feces in a clean, dry container or bedpan not contaminated with urine, residual soap, or disinfectants.
    2. Transfer appropriate volume of feces to a clean dry tightly capped specimen cup.
    3. Submit double-bagged specimen cup immediately to laboratory.

  • NOTES:
    1. Patients should be passing at least 3 unformed or watery stool specimens in a 24-hour period. Most patients have more than 3 episodes of watery, foul-smelling stools per day.
    2. Soft specimen is defined as specimen assuming the shape of its container (unformed).
    3. Formed or hard fecal specimens will not be tested.
    4. Repeat testing following a negative test during the same episode of diarrhea is NOT recommended for at least 7-days because of high sensitivity (between 98-99% and with a 99% negative predictive value).
Storage
REFRIGERATE IF TRANSPORT IS DELAYED. Specimens can be stored at 2-8 degrees C for 24 hours before significant degredation of the toxin is noted. SUBMIT WITH COLD PACKS OR ON ICE IF TRANSPORT WILL TAKE > 1 HOUR.
Transport
DELIVER IMMEDIATELY TO MICROBIOLOGY IN A TIGHTLY SEALED CONTAINER WITH NO EXTERNAL SPILLAGE.
REFRIGERATE IF TRANSPORT IS DELAYED. SUBMIT WITH COLD PACKS OR ON ICE IF TRANSPORT WILL TAKE >1 HOUR.
Causes for Rejection
All:
  • 1. Specimen not labeled with patient’s name, MRN #, date/time of collection, collector’s initials.
    2. Container leaking.
    3. Specimen received > 2 hours after collection unless submitted on ice or cold pack or with note that specimen stored in refrigerator prior to transport.
    4. Formed or hard specimen.
    5. Specimen in Cary-Blair transport, Para-Pak (formalin/PVA) or in diaper.
    6. Specimen on swab.
    7. Patient has negative test within last 7 days.
    8. Patient has positive test within last 14 days.
Turn Around Time –  Routine: 1 day