Helicobacter pylori infection diagnostic test: Difference between revisions

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*Antibody testing is inexpensive and widely available but poor PPV in populations with a low prevalence of H. pylori infection limits its usefulness in clinical practice.
*[[Antibody]] testing is inexpensive and widely available but poor PPV in populations with a low [[prevalence]] of ''[[H. pylori]]'' infection limits its usefulness in clinical practice.
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*The UBTs and fecal antigen tests provide reliable means of identifying active H. pylori infection before antibiotic therapy.  
*The UBTs and fecal antigen tests provide reliable means of identifying active ''[[H. pylori]]'' infection before antibiotic therapy.  
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|-  
| colspan="4" |
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*The UBT is the most reliable nonendoscopic test to document eradication of H. pylori infection.  
*The UBT is the most reliable non endoscopic test to document eradication of ''[[H. pylori]]'' infection.  
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*The monoclonal fecal antigen test provides another nonendoscopic means of establishing H. pylori cure after antibiotic treatment.  
*The monoclonal fecal antigen test provides another nonendoscopic means of establishing ''[[H. pylori]]'' cure after antibiotic treatment.  
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*Testing to prove H. pylori eradication appears to be most accurate if performed at least 4 wk after the completion of antibiotic therapy.  
*Testing to prove ''[[H. pylori]]'' eradication appears to be most accurate if performed at least 4 wk after the completion of [[antibiotic therapy]].  
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The nonendoscopic diagnostic testing methods for H.pylori include:
The nonendoscopic diagnostic testing methods for ''[[H. pylori]] include:
*Antibody tests
*Antibody tests
*Urea breath test
*Urea breath test
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===Antibody tests===
===Antibody tests===
*Antibody testing depends on the detection of H.pylori specific IgG antibodies in serum, whole blood, or urine.<ref name="pmid11190069">{{cite journal| author=Ho B, Marshall BJ| title=Accurate diagnosis of Helicobacter pylori. Serologic testing. | journal=Gastroenterol Clin North Am | year= 2000 | volume= 29 | issue= 4 | pages= 853-62 | pmid=11190069 | doi= | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=11190069  }} </ref>
*Antibody testing depends on the detection of ''[[H. pylori]]'' specific [[IgG]] antibodies in [[serum]], [[whole blood]], or [[urine]].<ref name="pmid11190069">{{cite journal| author=Ho B, Marshall BJ| title=Accurate diagnosis of Helicobacter pylori. Serologic testing. | journal=Gastroenterol Clin North Am | year= 2000 | volume= 29 | issue= 4 | pages= 853-62 | pmid=11190069 | doi= | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=11190069  }} </ref>
*The IgG antibodies typically become detected 21 days after infection and can remain present long after eradication.
*The [[IgG]] antibodies typically become detected 21 days after [[infection]] and can remain present long after eradication.
*Antibodies are detected using enzyme-linked immunosorbent assay (ELISA) and latex agglutination techniques.
*[[Antibodies]] are detected using [[enzyme-linked immunosorbent assay|enzyme-linked immunosorbent assay (ELISA)]] and [[latex agglutination]] techniques.


===Urea Breath Tests===
===Urea Breath Tests===
*Urea breath test identifies active H.pylori infection.<ref name="pmid15569102">{{cite journal| author=Gisbert JP, Pajares JM| title=Review article: 13C-urea breath test in the diagnosis of Helicobacter pylori infection -- a critical review. | journal=Aliment Pharmacol Ther | year= 2004 | volume= 20 | issue= 10 | pages= 1001-17 | pmid=15569102 | doi=10.1111/j.1365-2036.2004.02203.x | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=15569102  }} </ref>
*Urea breath test identifies active ''[[H. pylori]]'' infection.<ref name="pmid15569102">{{cite journal| author=Gisbert JP, Pajares JM| title=Review article: 13C-urea breath test in the diagnosis of Helicobacter pylori infection -- a critical review. | journal=Aliment Pharmacol Ther | year= 2004 | volume= 20 | issue= 10 | pages= 1001-17 | pmid=15569102 | doi=10.1111/j.1365-2036.2004.02203.x | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=15569102  }} </ref>
*'''Procedure'''
*'''Procedure'''
:*The urea labeled with either the nonradioactive isotope 13C or the radioactive isotope 14C is ingested.
:*The urea labeled with either the nonradioactive isotope 13C or the radioactive isotope 14C is ingested.
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The urea breath test has 95% sensitivity and specificity.
The urea breath test has 95% sensitivity and specificity.
*This test is an accurate means of post-treatment testing.
*This test is an accurate means of post-treatment testing.
*As this test mainly depends on urease activity of H.pylori, the sensitivity of the test is decreased by medications such as bismuth containing products, PPIs, and antibiotics as they reduce organism density or urease activity. It is recommended to withhold PPIs for 7-14 days prior to the test, and bismuth and antibiotics are withheld for at least 28days.  
*As this test mainly depends on [[urease]] activity of ''[[H. pylori]], the sensitivity of the test is decreased by medications such as [[bismuth]] containing products, [[proton pump inhibitor|PPIs]], and [[antibiotics]] as they reduce organism density or [[urease]] activity. It is recommended to withhold [[proton pump inhibitor|PPIs]] for 7-14 days prior to the test, and bismuth and antibiotics are withheld for at least 28 days.  
*Antacids do not affect the efficacy of the test.
*[[Antacids]] do not affect the efficacy of the test.


===Fecal Antigen Test (FAT)===
===Fecal Antigen Test (FAT)===
*The fecal antigen test (FAT) is an enzyme immunoassay which identifies H.pylori antigen with the use of polyclonal anti-H.pylori antibody.
*The [[fecal antigen test|fecal antigen test (FAT)]] is an [[enzyme immunoassay]] which identifies ''[[H. pylori]]'' antigen with the use of [[polyclonal]] anti-H.pylori antibody.
*Monoclonal antibodies can also be used to identify fecal H.pylori antigens.
*[[Monoclonal antibodies]] can also be used to identify fecal ''[[H. pylori]]'' antigens.
*Both tests are used to screen for infection and post-treatment testing.
*Both tests are used to screen for infection and post-treatment testing.
*Fecal antigen test is approved by U.S Food and Drug Administration as an alternative means of establishing H.pylori cure to urea breath test.
*Fecal antigen test is approved by U.S Food and Drug Administration as an alternative means of establishing ''[[H. pylori]]'' cure to urea breath test.
*The polyclonal test has excellent sensitivity, specificity, and predictive values before treatment but less satisfactory after the treatment.
*The polyclonal test has excellent sensitivity, specificity, and predictive values before treatment but less satisfactory after the treatment.
*This test may be effective in confirming eradication of H.pylori infection as early as 14 days after treatment. However, it is suggested that it should be done more than 4 wk and up to 8-12 wk after h.pylori treatment.
*This test may be effective in confirming eradication of ''[[H. pylori]]'' infection as early as 14 days after treatment. However, it is suggested that it should be done more than 4 wk and up to 8-12 wk after ''[[H. pylori]]'' treatment.
*The sensitivity of the test is affected by the use of PPIs, bismuth compounds, and antibiotics. The specificity is affected by the bleeding peptic ulcer disease.
*The sensitivity of the test is affected by the use of [[proton pump inhibitors|PPIs]], [[bismuth|bismuth compounds]], and [[antibiotics]]. The specificity is affected by the bleeding [[peptic ulcer disease]].




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!Disadvantages
!Disadvantages
|-
|-
|1. ELISA serology
|1. [[ELISA]] serology
(quantitative and qualitative)
(quantitative and qualitative)
|
|
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* Sensitivity (85-92%) and specificity (70-83%)
* Sensitivity (85-92%) and specificity (70-83%)
|
|
* PPV dependent upon background ''H. pylori prevalence. ''
* PPV dependent upon background ''[[H. pylori]]'' prevalence.  
* ''Not recommended after ''H. pylori therapy
* ''Not recommended after ''[[H. pylori]]'' therapy
* Less accurate and does not identify infection
* Less accurate and does not identify infection
|-
|-
|*2. Urea breath tests (13C and 14C)
|*2. Urea breath tests (13C and 14C)
|
|
* Identifies active ''H. pylori'' infection.
* Identifies active ''[[H. pylori]]'' infection.
* Excellent PPV and NPV regardless of ''H. pylori'' prevalence.  
* Excellent PPV and NPV regardless of ''[[H. pylori]]'' prevalence.  
* Useful before and after ''H. pylori'' therapy
* Useful before and after ''[[H. pylori]]'' therapy
* Sensitivity (95%) and specificity (96%)
* Sensitivity (95%) and specificity (96%)
|
|
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|*3. Fecal antigen test
|*3. Fecal antigen test
|
|
* Identifies active ''H. pylori'' infection.  
* Identifies active ''[[H. pylori]]'' infection.  
* Excellent positive and negative predictive values regardless of ''H. pylori'' prevalence.  
* Excellent positive and negative predictive values regardless of ''[[H. pylori]]'' prevalence.  
* Useful before and after ''H. pylori'' therapy
* Useful before and after ''[[H. pylori]]'' therapy
* Sensitivity (95%) and specificity (94%)
* Sensitivity (95%) and specificity (94%)
|
|
* Polyclonal test less well validated than the UBT in the posttreatment setting.  
* Polyclonal test less well validated than the UBT in the post treatment setting.  


* The monoclonal test appears reliable before and after antibiotic therapy.  
* The monoclonal test appears reliable before and after [[antibiotic]] therapy.  
* Unpleasantness associated with collecting stool
* Unpleasantness associated with collecting stool
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Revision as of 20:14, 23 January 2017

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Associate Editor(s)-in-Chief: Yamuna Kondapally, M.B.B.S[2]

Overview

The nonendoscopic diagnostic testing methods for H. pylori include antibody tests, urea breath test and fecal antigen test.

Nonendoscpic diagnostic studies

  • Antibody testing is inexpensive and widely available but poor PPV in populations with a low prevalence of H. pylori infection limits its usefulness in clinical practice.
  • The UBTs and fecal antigen tests provide reliable means of identifying active H. pylori infection before antibiotic therapy.
  • The UBT is the most reliable non endoscopic test to document eradication of H. pylori infection.
  • The monoclonal fecal antigen test provides another nonendoscopic means of establishing H. pylori cure after antibiotic treatment.
  • Testing to prove H. pylori eradication appears to be most accurate if performed at least 4 wk after the completion of antibiotic therapy.

The nonendoscopic diagnostic testing methods for H. pylori include:

  • Antibody tests
  • Urea breath test
  • Fecal antigen test

Antibody tests

Urea Breath Tests

  • Urea breath test identifies active H. pylori infection.[2]
  • Procedure
  • The urea labeled with either the nonradioactive isotope 13C or the radioactive isotope 14C is ingested.
  • The H.pylori urease converts labeled urea to CO2, which can be quantitated in expired breath.
  • 13C labeled urea is preferred in children and pregnant females.

The urea breath test has 95% sensitivity and specificity.

  • This test is an accurate means of post-treatment testing.
  • As this test mainly depends on urease activity of H. pylori, the sensitivity of the test is decreased by medications such as bismuth containing products, PPIs, and antibiotics as they reduce organism density or urease activity. It is recommended to withhold PPIs for 7-14 days prior to the test, and bismuth and antibiotics are withheld for at least 28 days.
  • Antacids do not affect the efficacy of the test.

Fecal Antigen Test (FAT)

  • The fecal antigen test (FAT) is an enzyme immunoassay which identifies H. pylori antigen with the use of polyclonal anti-H.pylori antibody.
  • Monoclonal antibodies can also be used to identify fecal H. pylori antigens.
  • Both tests are used to screen for infection and post-treatment testing.
  • Fecal antigen test is approved by U.S Food and Drug Administration as an alternative means of establishing H. pylori cure to urea breath test.
  • The polyclonal test has excellent sensitivity, specificity, and predictive values before treatment but less satisfactory after the treatment.
  • This test may be effective in confirming eradication of H. pylori infection as early as 14 days after treatment. However, it is suggested that it should be done more than 4 wk and up to 8-12 wk after H. pylori treatment.
  • The sensitivity of the test is affected by the use of PPIs, bismuth compounds, and antibiotics. The specificity is affected by the bleeding peptic ulcer disease.


Nonendoscopic testing Advantages Disadvantages
1. ELISA serology

(quantitative and qualitative)

  • Inexpensive and widely available
  • Very good NPV
  • Sensitivity (85-92%) and specificity (70-83%)
  • PPV dependent upon background H. pylori prevalence.
  • Not recommended after H. pylori therapy
  • Less accurate and does not identify infection
*2. Urea breath tests (13C and 14C)
  • Identifies active H. pylori infection.
  • Excellent PPV and NPV regardless of H. pylori prevalence.
  • Useful before and after H. pylori therapy
  • Sensitivity (95%) and specificity (96%)
  • Reimbursement and availability remain inconsistent
*3. Fecal antigen test
  • Identifies active H. pylori infection.
  • Excellent positive and negative predictive values regardless of H. pylori prevalence.
  • Useful before and after H. pylori therapy
  • Sensitivity (95%) and specificity (94%)
  • Polyclonal test less well validated than the UBT in the post treatment setting.
  • The monoclonal test appears reliable before and after antibiotic therapy.
  • Unpleasantness associated with collecting stool

References

  1. Ho B, Marshall BJ (2000). "Accurate diagnosis of Helicobacter pylori. Serologic testing". Gastroenterol Clin North Am. 29 (4): 853–62. PMID 11190069.
  2. Gisbert JP, Pajares JM (2004). "Review article: 13C-urea breath test in the diagnosis of Helicobacter pylori infection -- a critical review". Aliment Pharmacol Ther. 20 (10): 1001–17. doi:10.1111/j.1365-2036.2004.02203.x. PMID 15569102.