Detection of clostridium difficile antigen and toxin in stool specimens: Comparison of the C. difficile quik chek complete enzyme immunoassay and GeneXpert C. difficile polymerase chain reaction assay
Background/Aims: Accurate and rapid laboratory diagnosis of Clostridium difficile infections (CDI) remains a significant challenge. A two-step algorithm for detection of toxigenic C. difficile in stool based on initial screening for glutamate dehydrogenase assay followed by confirmation by toxin A+B...
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wolters Kluwer Medknow Publications
2017-01-01
|
| Series: | The Saudi Journal of Gastroenterology |
| Subjects: | |
| Online Access: | http://www.saudijgastro.com/article.asp?issn=1319-3767;year=2017;volume=23;issue=4;spage=259;epage=262;aulast=Senok |
| _version_ | 1818148137240363008 |
|---|---|
| author | Abiola C Senok Kamel M Aldosari Rayan A Alowaisheq Othman A Abid Khalid A Alsuhaibani Mohammad A Khan Ali M Somily |
| author_facet | Abiola C Senok Kamel M Aldosari Rayan A Alowaisheq Othman A Abid Khalid A Alsuhaibani Mohammad A Khan Ali M Somily |
| author_sort | Abiola C Senok |
| collection | DOAJ |
| description | Background/Aims: Accurate and rapid laboratory diagnosis of Clostridium difficile infections (CDI) remains a significant challenge. A two-step algorithm for detection of toxigenic C. difficile in stool based on initial screening for glutamate dehydrogenase assay followed by confirmation by toxin A+B detection using an enzyme immunoassay (EIA) or molecular assay has been proposed. We aimed to evaluate the C. difficile Quik Chek Complete® (QCC-EIA) versus the GeneXpert® C. difficile polymerase chain reaction (PCR) assay in this two-step algorithm.
Materials and Methods: Two hundred and ten liquid stool samples obtained between June 2014 and June 2015 from patients suspected of CDI were tested by the QCC-EIA and GeneXpert PCR assay. The GeneXpert assay was used as the reference standard to calculate the QCC-EIA sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Results: Of the 210 stool samples tested, 43 (20.5%) were positive by QCC-EIA, while 31 (14.8%) were positive by GeneXpert assay. The sensitivity and specificity of the QCC-EIA were found to be 100 and 93%, respectively; the PPV and NPV were 72 and 100%, respectively. The binary toxin was detected in 12 (38.7%) and tcdC gene deletion in 3 (9.6%).
Conclusions: The low specificity of QCC-EIA makes it less reliable as a confirmatory test for CDI diagnosis. This test may be used as a screening test in a two-step algorithm when combined with a molecular assay or another confirmatory test. |
| first_indexed | 2024-12-11T12:46:21Z |
| format | Article |
| id | doaj.art-1490dc24744847319277d8a92279394f |
| institution | Directory Open Access Journal |
| issn | 1319-3767 1998-4049 |
| language | English |
| last_indexed | 2024-12-11T12:46:21Z |
| publishDate | 2017-01-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | The Saudi Journal of Gastroenterology |
| spelling | doaj.art-1490dc24744847319277d8a92279394f2022-12-22T01:06:49ZengWolters Kluwer Medknow PublicationsThe Saudi Journal of Gastroenterology1319-37671998-40492017-01-0123425926210.4103/sjg.SJG_80_17Detection of clostridium difficile antigen and toxin in stool specimens: Comparison of the C. difficile quik chek complete enzyme immunoassay and GeneXpert C. difficile polymerase chain reaction assayAbiola C SenokKamel M AldosariRayan A AlowaisheqOthman A AbidKhalid A AlsuhaibaniMohammad A KhanAli M SomilyBackground/Aims: Accurate and rapid laboratory diagnosis of Clostridium difficile infections (CDI) remains a significant challenge. A two-step algorithm for detection of toxigenic C. difficile in stool based on initial screening for glutamate dehydrogenase assay followed by confirmation by toxin A+B detection using an enzyme immunoassay (EIA) or molecular assay has been proposed. We aimed to evaluate the C. difficile Quik Chek Complete® (QCC-EIA) versus the GeneXpert® C. difficile polymerase chain reaction (PCR) assay in this two-step algorithm. Materials and Methods: Two hundred and ten liquid stool samples obtained between June 2014 and June 2015 from patients suspected of CDI were tested by the QCC-EIA and GeneXpert PCR assay. The GeneXpert assay was used as the reference standard to calculate the QCC-EIA sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Results: Of the 210 stool samples tested, 43 (20.5%) were positive by QCC-EIA, while 31 (14.8%) were positive by GeneXpert assay. The sensitivity and specificity of the QCC-EIA were found to be 100 and 93%, respectively; the PPV and NPV were 72 and 100%, respectively. The binary toxin was detected in 12 (38.7%) and tcdC gene deletion in 3 (9.6%). Conclusions: The low specificity of QCC-EIA makes it less reliable as a confirmatory test for CDI diagnosis. This test may be used as a screening test in a two-step algorithm when combined with a molecular assay or another confirmatory test.http://www.saudijgastro.com/article.asp?issn=1319-3767;year=2017;volume=23;issue=4;spage=259;epage=262;aulast=SenokClostridium difficileenzyme immunoassayGeneXpert PCR assay |
| spellingShingle | Abiola C Senok Kamel M Aldosari Rayan A Alowaisheq Othman A Abid Khalid A Alsuhaibani Mohammad A Khan Ali M Somily Detection of clostridium difficile antigen and toxin in stool specimens: Comparison of the C. difficile quik chek complete enzyme immunoassay and GeneXpert C. difficile polymerase chain reaction assay The Saudi Journal of Gastroenterology Clostridium difficile enzyme immunoassay GeneXpert PCR assay |
| title | Detection of clostridium difficile antigen and toxin in stool specimens: Comparison of the C. difficile quik chek complete enzyme immunoassay and GeneXpert C. difficile polymerase chain reaction assay |
| title_full | Detection of clostridium difficile antigen and toxin in stool specimens: Comparison of the C. difficile quik chek complete enzyme immunoassay and GeneXpert C. difficile polymerase chain reaction assay |
| title_fullStr | Detection of clostridium difficile antigen and toxin in stool specimens: Comparison of the C. difficile quik chek complete enzyme immunoassay and GeneXpert C. difficile polymerase chain reaction assay |
| title_full_unstemmed | Detection of clostridium difficile antigen and toxin in stool specimens: Comparison of the C. difficile quik chek complete enzyme immunoassay and GeneXpert C. difficile polymerase chain reaction assay |
| title_short | Detection of clostridium difficile antigen and toxin in stool specimens: Comparison of the C. difficile quik chek complete enzyme immunoassay and GeneXpert C. difficile polymerase chain reaction assay |
| title_sort | detection of clostridium difficile antigen and toxin in stool specimens comparison of the c difficile quik chek complete enzyme immunoassay and genexpert c difficile polymerase chain reaction assay |
| topic | Clostridium difficile enzyme immunoassay GeneXpert PCR assay |
| url | http://www.saudijgastro.com/article.asp?issn=1319-3767;year=2017;volume=23;issue=4;spage=259;epage=262;aulast=Senok |
| work_keys_str_mv | AT abiolacsenok detectionofclostridiumdifficileantigenandtoxininstoolspecimenscomparisonofthecdifficilequikchekcompleteenzymeimmunoassayandgenexpertcdifficilepolymerasechainreactionassay AT kamelmaldosari detectionofclostridiumdifficileantigenandtoxininstoolspecimenscomparisonofthecdifficilequikchekcompleteenzymeimmunoassayandgenexpertcdifficilepolymerasechainreactionassay AT rayanaalowaisheq detectionofclostridiumdifficileantigenandtoxininstoolspecimenscomparisonofthecdifficilequikchekcompleteenzymeimmunoassayandgenexpertcdifficilepolymerasechainreactionassay AT othmanaabid detectionofclostridiumdifficileantigenandtoxininstoolspecimenscomparisonofthecdifficilequikchekcompleteenzymeimmunoassayandgenexpertcdifficilepolymerasechainreactionassay AT khalidaalsuhaibani detectionofclostridiumdifficileantigenandtoxininstoolspecimenscomparisonofthecdifficilequikchekcompleteenzymeimmunoassayandgenexpertcdifficilepolymerasechainreactionassay AT mohammadakhan detectionofclostridiumdifficileantigenandtoxininstoolspecimenscomparisonofthecdifficilequikchekcompleteenzymeimmunoassayandgenexpertcdifficilepolymerasechainreactionassay AT alimsomily detectionofclostridiumdifficileantigenandtoxininstoolspecimenscomparisonofthecdifficilequikchekcompleteenzymeimmunoassayandgenexpertcdifficilepolymerasechainreactionassay |