Analysis of latex agglutination test for Clostridium difficile toxin A (D-1) and differentiation between C difficile toxins A and B and latex reactive protein.

Borriello, S. P.; Barclay, Fiona; Reed, P. J.; Welch, A. R.; Brown, Joel D.; Burdon, D. W.

doi:10.1136/jcp.40.5.573

Cited by 33 publications

(19 citation statements)

References 17 publications

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“…The purported detection of C. difficile toxin A in fecal specimens by a commercial latex agglutination test has been the subject of much controversy (14,15,144 (37,143,209,247,288,294,295). However, the published positive and negative predictive values have varied considerably, ranging from 63 to 98%.…”

Section: Latex Agglutination Testsmentioning

confidence: 99%

Clostridium difficile: clinical disease and diagnosis

1993

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Clostridium difficile is an opportunistic pathogen that causes a spectrum of disease ranging from antibiotic-associated diarrhea to pseudomembranous colitis. Although the disease was first described in 1893, the etiologic agent was not isolated and identified until 1978. Since clinical and pathological features of C. difficile-associated disease are not easily distinguished from those of other gastrointestinal diseases, including ulcerative colitis, chronic inflammatory bowel disease, and Crohn's disease, diagnostic methods have relied on either isolation and identification of the microorganism or direct detection of bacterial antigens or toxins in stool specimens. The current review focuses on the sensitivity, specificity, and practical use of several diagnostic tests, including methods for culture of the etiologic agent, cellular cytotoxicity assays, latex agglutination tests, enzyme immunoassay systems, counterimmunoelectrophoresis, fluorescent-antibody assays, and polymerase chain reactions.

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Section: Latex Agglutination Testsmentioning

confidence: 99%

Clostridium difficile: clinical disease and diagnosis

1993

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“…The latex reactive protein was demonstrated to be glutamate dehydrogenase by Lyerly et al (16). Many investigators (1,5,20) suggested that the latex agglutination test should only be used in the laboratory as an alternative to culturing for C. difficile and not Table I Our results, also, demonstrated that this kit is very useful for the detection of C. difficile but correlation as to the presence of toxigenic strains is not good. In the United States, Marion Scientific has elected to delete reference to "toxin A" from the CDT kit label and package insert (5).…”

Section: Discussionmentioning

confidence: 67%

“…As reported by others (5,8,14), the C.D. CHECK D-1 kit agglutinated with toxigenic and nontoxigenic strains of C. difficile.…”

Section: Discussionmentioning

confidence: 90%

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Detection of Clostridium difficile Toxin A by Reversed Passive Latex Agglutination

Toma

Nakamura

Kamiya

et al. 1999

Microbiology and Immunology

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A reversed passive latex agglutination (RPLA) assay for detecting Clostridium difficile toxin A is presented. Purified monoclonal antibody (mAb 37B5) was used for latex sensitization. The culture supernatants of 93 strains of C. difficile were tested by RPLA assay and the results compared with those of a commercially available latex agglutination test, PCR and cytotoxin assay with Vero cells. There was agreement between RPLA, cytotoxicity and PCR assays, but 29 strains were positive in the RPLA assay while 35 were positive in the cytotoxicity test and PCR using primer pair NK3-NK2 directed to the nonrepeating portion of the C. difficile toxin A gene. The 6 cytotoxic but RPLA-negative strains were demonstrated to be toxin A-negative/toxin B-positive strains in the PCR assay by using primer pair NK11-NK9 directed to the repeating portion of the C. difficile toxin A gene. There were no cross-reactions with culture supernatants of the other clostridial strains except for two strains of C. sordelli that produced hemorrhagic toxin (which is immunologically related to C. difficile toxin A).

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“…Two currently popular diagnostic systems for detecting C. difficile are based on detecting the GDH common antigen (2) or toxin A and/or toxin B. Generally, diagnosis based on detecting toxins is superior, since GDH cannot distinguish toxigenic strains from nontoxigenic strains.…”

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confidence: 99%

Comparison of the Premier Toxin A and B Assay and the TOX A/B II Assay for Diagnosis of Clostridium difficile Infection

Novak-Weekley

Hollingsworth

2008

Clin Vaccine Immunol

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Clostridium difficile causes nosocomial diarrhea and is responsible for complications such as pseudomembranous colitis, megacolon, and perforation. Using 442 stool specimens, we compared the sensitivities and specificities of the Premier toxin A and B (Meridian Bioscience, Inc.) and C. difficile TOX A/B II (TechLab, Inc., Blacksburg, VA) immunoassays in the Virology Department of the Kaiser Permanente Regional Reference Laboratories. The Premier toxin A and B assay demonstrated a higher sensitivity (97.44%) and a higher positive predictive value (79.17%) than the C. difficile TOX A/B II assay (87.18% and 75.56%, respectively), while assay specificities and negative predictive values were similar. We also performed experiments using serially diluted, purified toxin A and B antigens to understand the basis for assay differences. The two assays' toxin A antibodies detected toxin A at comparable levels. Preliminary results indicated that the toxin B antibody in the Premier toxin A and B assay could detect toxin B at a concentration of 125 pg/100 l, while the toxin B antibody in the C. difficile TOX A/B II assay could not detect toxin B below a concentration of 250 pg/100 l. Therefore, the Premier toxin A and B assay provides greater sensitivity than the C. difficile TOX A/B II assay, perhaps due to a superior detection ability of its toxin B antibody.Clostridium difficile, the primary agent causing nosocomial diarrhea, affects 300,000 to 3,000,000 hospital patients in the United States each year at a cost of 1.1 billion dollars (6,8,13). An estimated 20% of all hospital inpatients and 25 to 80% of all healthy newborns and infants test positive for C. difficile. Virtually all (95 to 100%) cases of pseudomembranous colitis are attributed to C. difficile infection (6, 9). Many infected individuals remain asymptomatic, but symptomatic individuals may present with mild diarrhea, high fever, severe abdominal pain, colitis, prolonged ileus, or perforation (6, 13).At greatest risk for C. difficile-associated diarrhea (CDAD) are hospitalized adults older than 65 years and patients with certain underlying conditions (6, 15). Most CDAD cases resolve within several days if diagnosed promptly and treated appropriately (14). However, relapse occurs in 20% of patients, and those individuals are still at risk for subsequent relapses and development of severe complications (13).All toxigenic and nontoxigenic C. difficile strains synthesize glutamate dehydrogenase (GDH), but only toxigenic strains produce toxin A and toxin B, virulence factors thought to function synergistically (10,11,16). Aberrant strains may express additional virulence factors, such as binary toxin, which is similar to the iota toxin of Clostridium perfringens and Clostridium spiroforme. Binary toxin has been identified among a low percentage of clinical isolates. However, the role of this toxin in CDAD is not clear at the present time (18).Once it became clear that C. difficile can cause disease, numerous diagnostic techniques were developed, but the cytotoxin B...

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Analysis of latex agglutination test for Clostridium difficile toxin A (D-1) and differentiation between C difficile toxins A and B and latex reactive protein.

Cited by 33 publications

References 17 publications

Clostridium difficile: clinical disease and diagnosis

Clostridium difficile: clinical disease and diagnosis

Detection of Clostridium difficile Toxin A by Reversed Passive Latex Agglutination

Comparison of the Premier Toxin A and B Assay and the TOX A/B II Assay for Diagnosis of Clostridium difficile Infection

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