Xpert c difficile

Manufactured by Cepheid

Sourced in United States

The Xpert C. difficile is a rapid, automated molecular diagnostic test that detects the presence of the toxin B gene of Clostridium difficile in patient samples. The test provides results in approximately 45 minutes, enabling healthcare professionals to quickly identify and manage patients with suspected Clostridium difficile infection.

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Lab products found in correlation

Geneohm c diff assay, by BD (4 mentions) Filmarray respiratory panel, by Cepheid (1 mentions) Vidas c difficile toxin a b, by bioMérieux (1 mentions) Vidas c difficile gdh, by bioMérieux (1 mentions) Max cdiff, by BD (1 mentions) Maldi tof ms, by Bruker (1 mentions) Etest, by bioMérieux (1 mentions) Xpert norovirus, by Cepheid (1 mentions)

Close spelling variants of this product

Xpert C. difficile assay Xpert C. difficile/Epi assay Xpert C. difficile/Epi test Xpert® C. difficile/Epi PCR assay Xpert C. difficile/Epi Xpert C. difficile PCR Xpert C. difficile PCR assay Xpert C. difficile system

23 protocols using xpert c difficile

Screening and Diagnosis of Clostridium difficile Infection

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Screening for CD was based on a rectal swab (Stuarts Swab, Copan Diagnostics, Brescia, Italy), with a PCR assay that detects sequences in the genes for toxin B (tcdB) and binary Toxin (cdt) (Xpert C. difficile; Cepheid, Sunnyvale, CA, USA). This assay is validated and approved for testing the unformed stool for CDI diagnosis; its use for screening via rectal swabbing was off-label. Patients were offered screening for CD within 24 hr of admission. All submitted rectal swabs were tested immediately during working hours; late-submitted samples were tested the next morning.
CDI diagnosis was based on laboratory report of an unformed stool with positive PCR (Xpert C. difficile; Cepheid, Sunnyvale, CA, USA) together with an enzyme immunoassay (EIA) positive to either glutamate dehydrogenase (GDH) or CD toxin (CDT (, which were performed on all samples [6] . Indications for stool tests for CDI followed the CDC guidelines, which specify that only patients with three or more unformed stools within 24 hr (in the absence of laxative use) should be assessed.

Meltzer E., Smollan G., Huppert A., Fluss R., Tal I., Gilboa M., Zilberman-Daniels T., Keller N., Rahav G, & Regev-Yochay G. (2019). Universal screening for Clostridioides difficile in a tertiary hospital: risk factors for carriage and clinical disease. Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases, 25(9).

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Epidemiology of C. difficile Infections

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Overall, 29 patients with diarrhea, who were found positive for C. difficile from June 2014 to May 2015, were admitted at the Poria Medical Center located in northern Israel. Identification of C. difficile from patients’ stool specimens was carried out on a bio-molecular platform, which also enables identification of C. difficile ribotype 027 (Xpert® C. difficile, Cepheid, Sweden) [19 (link)]. The following demographic and clinical data concerning patients with CDI were collected from electronic files: age, sex, functional status, community versus nosocomial acquired CDI, and antibiotic susceptibility.
A clostridium severity score index was calculated. For each patient the score incorporated nine parameters, each variable added one point: altered mental status, abdominal pain or distention, 1500 > WBC > 20,000, ALB < 2.5, ascites or colitis (imaging), MAP < 65, pulse > 110, ICU transfer. A score of 0–3 criteria meant mild disease, 4–6: moderate disease, ≥7: severe disease [10 (link)].
The study protocol was reviewed and approved by the Poria-Baruch Padeh Medical Centre Institutional Review Board/Ethics Committee. A waiver was ushered for informed patient consent.

Peretz A., Tkhawkho L., Pastukh N., Brodsky D., Halevi C.N, & Nitzan O. (2016). Correlation between fecal calprotectin levels, disease severity and the hypervirulent ribotype 027 strain in patients with Clostridium difficile infection. BMC Infectious Diseases, 16, 309.

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Respiratory Illness Diagnosis and Characterization

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LRTI was defined by clinical signs or symptoms of respiratory tract infection and pulmonary infiltrate on radiographic imaging compatible with a bacterial or viral pneumonia (eg, consolidation, interstitial infiltrate, or ground-glass opacities). Healthcare visits and hospitalizations were classified as URI-related if URI symptoms were addressed in the encounter, regardless of the primary reason for the encounter. Peak flu season was defined as December through March [21 ]. Nasal swabs were submitted for respiratory viral testing at the clinicians’ discretion. Testing was generally performed using a laboratory-developed multiplex polymerase chain reaction (PCR) test that can detect 12 respiratory viruses [22–24 (link)]. Additional tests, including the Biofire FilmArray Respiratory Panel or Influenza-specific tests (Cepheid Xpert Flu), were also captured. Clostridioides difficile testing was performed using PCR (Xpert C. difficile; Cepheid).

Krantz E.M., Zier J., Stohs E., Ogimi C., Sweet A., Marquis S., Klaassen J., Pergam S.A, & Liu C. (2019). Antibiotic Prescribing and Respiratory Viral Testing for Acute Upper Respiratory Infections Among Adult Patients at an Ambulatory Cancer Center. Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America, 70(7), 1421-1428.

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Comparative Evaluation of C. difficile Diagnostic Tests

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This in vitro study was approved by the Institutional Review Board of the Konkuk University Medical Center, Seoul, Korea (a tertiary referral hospital with 900 beds). From January 2015 to April 2015, we collected 271 consecutive, remnant diarrheal stool samples submitted to the clinical microbiology laboratory from patients admitted to our hospital.They included 258 adults and 13 children (male 148, female 123). Since we used remnant samples after routine tests and the data were analyzed anonymously, informed consent was exempted. As a routine practice of C. difficile testing in our hospital, we performed toxigenic culture and VIDAS C. difficile toxin A&B (bioMérieux) simultaneously. The VIDAS C. difficile GDH (bioMérieux) and Xpert C. difficile (Cepheid) were additionally performed in the same samples. Duplicated samples from the same patients and from patients on treatment for CDI were excluded. The samples were tested within 2 hours of collection; otherwise, they were kept at 2–8°C for up to 2 days.

Moon H.W., Kim H.N., Hur M., Shim H.S., Kim H, & Yun Y.M. (2016). Comparison of Diagnostic Algorithms for Detecting Toxigenic Clostridium difficile in Routine Practice at a Tertiary Referral Hospital in Korea. PLoS ONE, 11(8), e0161139.

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C. difficile PCR Testing Protocol

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C.difficile PCR testing was done via PCR for the toxin B gene (Xpert C. difficile, Cepheid, Sunnyvale, CA). At our institution, this test is ordered separately from and/or in addition to the GI PCR test panel at the discretion of the ordering provider. There is an institutional electronic “hard stop” that prohibits stool PCR testing in patients who have received laxatives within the previous 24 h.

Laszkowska M., Kim J., Faye A.S., Joelson A.M., Ingram M., Truong H., Silver E.R., May B., Greendyke W.G., Zucker J., Lebwohl B., Hur C, & Freedberg D.E. (2021). Prevalence of Clostridioides difficile and Other Gastrointestinal Pathogens in Patients with COVID-19. Digestive Diseases and Sciences, 66(12), 4398-4405.

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Comparative Evaluation of C. difficile Diagnostics

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We reviewed data from three diagnostic methods commonly used in clinical laboratories: GDH EIAs, toxin AB EIAs, and NAATs. EIAs are available in a well-type format (results are displayed as a color change that can be detected visually or spectrophotometrically) or a membrane-type format (results can be visually read from a membrane). Some EIAs are performed through an automated process that minimizes the manual process during the test. Among NAATs, Xpert C. difficile (Cepheid, Sunnyvale, CA, USA), BD Max Cdiff (Becton Dickinson, Sparks, MD, USA), and AdvanSure CD (LG Chem., Seoul, Korea) have been used with a relatively high frequency in Korea [5 (link)]. The information for each diagnostic method is shown in Table 1.

Chung H.S., Park J.S, & Shin B.M. (2021). Laboratory Diagnostic Methods for Clostridioides difficile Infection: the First Systematic Review and Meta-analysis in Korea. Annals of Laboratory Medicine, 41(2), 171-180.

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Cohort Study of CDI Diagnosis

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Sequential in-patients from May 2010 to August 2011 with a clinical diagnosis of CDI and positive for tcdB according to PCR (BD GeneOhm C diff Assay, Becton Dickinson, Franklin Lakes, NJ, USA, or Xpert C. difficile, Cepheid, Sunnyvale, CA, USA) were identified according to the protocol (HSR-IRB #13630, NIH/NIAID 5K23A1074681). Patients were deemed eligible if hospitalized at the time of CDI diagnosis, ≥ 18 years old, no recent history of chronic diarrhea (≥ 4 weeks), and adequate volume of stool for subsequent testing. Enrolled subjects were followed for clinical outcome by review of medical records and telephone contact following diagnosis.

Boone J.H., Archbald-Pannone L.R., Wickham K.N., Carman R.J., Guerrant R.L., Franck C.T, & Lyerly D.M. (2014). Ribotype 027 Clostridium difficile infections with measurable stool toxin have increased lactoferrin and are associated with a higher mortality. European Journal of Clinical Microbiology & Infectious Diseases, 33(6), 1045-1051.

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C. difficile Biomarker Testing Protocol

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C. difficile testing was done at the hospital clinical microbiology laboratory using tcdB PCR (BD GeneOhm C diff Assay, Becton Dickinson, or Xpert C. difficile, Cepheid) according to the manufacturer’s instructions. A fecal specimen from eligible tcdB-positive subjects on the day of CDI diagnosis was frozen at −80 °C and shipped to TechLab, Blacksburg, VA, USA, for biomarker testing and toxigenic culture, as well as PCR ribotyping. Stool toxin B was detected by tissue culture using the C. DIFFICILE TOX-B Test (TechLab^® Inc., Blacksburg, VA) including a neutral goat serum control as described by Boone et al. [37 (link)]

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C. difficile Outbreak Investigation in Pediatric Oncology

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The Center for Cancer and Blood Disorders (CCBD) Program, which includes inpatient and outpatient services for oncology, hematology, and bone marrow transplant patients, is located on a single floor of the free-standing Children’s Hospital of Colorado (CHCO). As previously described, as part of a C. difficile outbreak investigation, stool samples were collected from all patients admitted to the pediatric CCBD floor from October through December 2012.[9 (link), 21 (link)] Stool samples were tested for the C. difficile toxin B gene by PCR (Xpert C. difficile, Cepheid, Sunnyvale CA). An aliquot of stool was stored at -70°C and later thawed for sequence analysis. Clinical histories were ascertained by retrospective chart review. Research and data collection protocols were approved by the Colorado Multiple Institutional Review Board. Waiver of informed consent was approved for retrospective chart review of study participants.

Nycz B.T., Dominguez S.R., Friedman D., Hilden J.M., Ir D., Robertson C.E, & Frank D.N. (2018). Evaluation of bloodstream infections, Clostridium difficile infections, and gut microbiota in pediatric oncology patients. PLoS ONE, 13(1), e0191232.

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C. difficile Toxin Detection Protocol

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Liquid stool samples were submitted for detection of toxigenic C. difficile by a two-step algorithm. The C. difficile algorithm began with the C. DIFF QUICK CHEK^® test (TechLab), a membrane-bound enzyme immunoassays (EIA) that detects the glutamate dehydrogenase (GDH) antigen of C. difficile. From January to Mars 2012, a positive GDH result triggered the second-step TOX A/B QUICK CHEK^® (TechLab) EIA for toxins A and B detection. For specimens with negative EIA results (GDH positive, Toxins A/B negative), a culture was performed and the TOX A/B QUICK CHEK^® test was renewed from colonies. Subsequently, from April 2012, the second step of algorithm consisted of a direct stool PCR to detect the tcdB gene (Xpert^®C. difficile, Cepheid).

Dos Santos-Schaller O., Boisset S., Seigneurin A, & Epaulard O. (2016). Recurrence and death after Clostridium difficile infection: gender-dependant influence of proton pump inhibitor therapy. SpringerPlus, 5, 430.

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