Helicobacter pylori infection diagnostic test: Difference between revisions
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==Overview== | ==Overview== | ||
The nonendoscopic diagnostic testing methods for ''[[H. pylori]]'' include antibody tests, urea breath test, and fecal antigen test. | |||
==Nonendoscopic diagnostic studies== | |||
== | |||
{| class="wikitable" | {| class="wikitable" | ||
| colspan="4" | | | colspan="4" | | ||
*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. | ||
|- | |- | ||
| colspan="4" | | | colspan="4" | | ||
*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. | ||
|- | |- | ||
| colspan="4" | | | colspan="4" | | ||
*The UBT is the most reliable | *The UBT is the most reliable non endoscopic test to document eradication of ''[[H. pylori]]'' infection. | ||
|- | |- | ||
| colspan="4" | | | colspan="4" | | ||
*The | *The monoclonal fecal antigen test provides another nonendoscopic means of establishing ''[[H. pylori]]'' cure after antibiotic treatment. | ||
|- | |- | ||
| colspan="4" | | | colspan="4" | | ||
*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]]. | ||
|} | |||
The nonendoscopic diagnostic testing methods for ''[[H. pylori]] include: | |||
*Antibody tests | |||
*Urea breath test | |||
*Fecal antigen test | |||
===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><ref name="pmid8651160">{{cite journal| author=Loy CT, Irwig LM, Katelaris PH, Talley NJ| title=Do commercial serological kits for Helicobacter pylori infection differ in accuracy? A meta-analysis. | journal=Am J Gastroenterol | year= 1996 | volume= 91 | issue= 6 | pages= 1138-44 | pmid=8651160 | doi= | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=8651160 }} </ref><ref name="pmid10364016">{{cite journal| author=Chey WD, Murthy U, Shaw S, Zawadski A, Montague J, Linscheer W et al.| title=A comparison of three fingerstick, whole blood antibody tests for Helicobacter pylori infection: a United States, multicenter trial. | journal=Am J Gastroenterol | year= 1999 | volume= 94 | issue= 6 | pages= 1512-6 | pmid=10364016 | doi=10.1111/j.1572-0241.1999.1135_x.x | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=10364016 }} </ref> | |||
*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|enzyme-linked immunosorbent assay (ELISA)]] and [[latex agglutination]] techniques. | |||
===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><ref name="pmid11190074">{{cite journal| author=Chey WD| title=Accurate diagnosis of Helicobacter pylori. 14C-urea breath test. | journal=Gastroenterol Clin North Am | year= 2000 | volume= 29 | issue= 4 | pages= 895-902 | pmid=11190074 | doi= | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=11190074 }} </ref> | |||
*'''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.<ref name="pmid8540496">{{cite journal| author=Steen T, Berstad K, Meling T, Berstad A| title=Reproducibility of the 14C urea breath test repeated after 1 week. | journal=Am J Gastroenterol | year= 1995 | volume= 90 | issue= 12 | pages= 2103-5 | pmid=8540496 | doi= | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=8540496 }} </ref> | |||
*This test is an accurate means of post-treatment testing.<ref name="pmid10445534">{{cite journal| author=Leodolter A, Domínguez-Muñoz JE, von Arnim U, Kahl S, Peitz U, Malfertheiner P| title=Validity of a modified 13C-urea breath test for pre- and posttreatment diagnosis of Helicobacter pylori infection in the routine clinical setting. | journal=Am J Gastroenterol | year= 1999 | volume= 94 | issue= 8 | pages= 2100-4 | pmid=10445534 | doi=10.1111/j.1572-0241.1999.01284.x | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=10445534 }} </ref><ref name="pmid12425544">{{cite journal| author=Perri F, Manes G, Neri M, Vaira D, Nardone G| title=Helicobacter pylori antigen stool test and 13C-urea breath test in patients after eradication treatments. | journal=Am J Gastroenterol | year= 2002 | volume= 97 | issue= 11 | pages= 2756-62 | pmid=12425544 | doi=10.1111/j.1572-0241.2002.07065.x | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=12425544 }} </ref> | |||
*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.<ref name="pmid12809820">{{cite journal| author=Graham DY, Opekun AR, Hammoud F, Yamaoka Y, Reddy R, Osato MS et al.| title=Studies regarding the mechanism of false negative urea breath tests with proton pump inhibitors. | journal=Am J Gastroenterol | year= 2003 | volume= 98 | issue= 5 | pages= 1005-9 | pmid=12809820 | doi=10.1111/j.1572-0241.2003.07426.x | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=12809820 }} </ref><ref name="pmid9068466">{{cite journal| author=Chey WD, Woods M, Scheiman JM, Nostrant TT, DelValle J| title=Lansoprazole and ranitidine affect the accuracy of the 14C-urea breath test by a pH-dependent mechanism. | journal=Am J Gastroenterol | year= 1997 | volume= 92 | issue= 3 | pages= 446-50 | pmid=9068466 | doi= | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=9068466 }} </ref><ref name="pmid9758575">{{cite journal| author=Laine L, Estrada R, Trujillo M, Knigge K, Fennerty MB| title=Effect of proton-pump inhibitor therapy on diagnostic testing for Helicobacter pylori. | journal=Ann Intern Med | year= 1998 | volume= 129 | issue= 7 | pages= 547-50 | pmid=9758575 | doi= | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=9758575 }} </ref> | |||
*[[Antacids]] do not affect the efficacy of the test.<ref name="pmid15128344">{{cite journal| author=Gatta L, Vakil N, Ricci C, Osborn JF, Tampieri A, Perna F et al.| title=Effect of proton pump inhibitors and antacid therapy on 13C urea breath tests and stool test for Helicobacter pylori infection. | journal=Am J Gastroenterol | year= 2004 | volume= 99 | issue= 5 | pages= 823-9 | pmid=15128344 | doi=10.1111/j.1572-0241.2004.30162.x | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=15128344 }} </ref> | |||
===Fecal Antigen Test (FAT)=== | |||
*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.<ref name="pmid15270750">{{cite journal| author=Gisbert JP, Pajares JM| title=Stool antigen test for the diagnosis of Helicobacter pylori infection: a systematic review. | journal=Helicobacter | year= 2004 | volume= 9 | issue= 4 | pages= 347-68 | pmid=15270750 | doi=10.1111/j.1083-4389.2004.00235.x | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=15270750 }} </ref><ref name="pmid16780557">{{cite journal| author=Gisbert JP, de la Morena F, Abraira V| title=Accuracy of monoclonal stool antigen test for the diagnosis of H. pylori infection: a systematic review and meta-analysis. | journal=Am J Gastroenterol | year= 2006 | volume= 101 | issue= 8 | pages= 1921-30 | pmid=16780557 | doi=10.1111/j.1572-0241.2006.00668.x | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=16780557 }} </ref> | |||
*[[Monoclonal antibodies]] can also be used to identify fecal ''[[H. pylori]]'' antigens. | |||
*Both tests are used to screen for infection and post-treatment testing. | |||
*The 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.<ref name="pmid11848725">{{cite journal| author=Vaira D, Vakil N, Menegatti M, van't Hoff B, Ricci C, Gatta L et al.| title=The stool antigen test for detection of Helicobacter pylori after eradication therapy. | journal=Ann Intern Med | year= 2002 | volume= 136 | issue= 4 | pages= 280-7 | pmid=11848725 | doi= | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=11848725 }} </ref><ref name="pmid15270750">{{cite journal| author=Gisbert JP, Pajares JM| title=Stool antigen test for the diagnosis of Helicobacter pylori infection: a systematic review. | journal=Helicobacter | year= 2004 | volume= 9 | issue= 4 | pages= 347-68 | pmid=15270750 | doi=10.1111/j.1083-4389.2004.00235.x | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=15270750 }} </ref> | |||
*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]].<ref name="pmid11922552">{{cite journal| author=Odaka T, Yamaguchi T, Koyama H, Saisho H, Nomura F| title=Evaluation of the Helicobacter pylori stool antigen test for monitoring eradication therapy. | journal=Am J Gastroenterol | year= 2002 | volume= 97 | issue= 3 | pages= 594-9 | pmid=11922552 | doi=10.1111/j.1572-0241.2002.05535.x | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=11922552 }} </ref> | |||
{| class="wikitable" | |||
!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== | ==References== | ||
{{Reflist|2}} | {{Reflist|2}} |
Latest revision as of 18:58, 24 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.
Nonendoscopic diagnostic studies
| |||
| |||
| |||
| |||
|
The nonendoscopic diagnostic testing methods for H. pylori include:
- Antibody tests
- Urea breath test
- Fecal antigen test
Antibody tests
- Antibody testing depends on the detection of H. pylori specific IgG antibodies in serum, whole blood, or urine.[1][2][3]
- 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.
Urea Breath Tests
- 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.[6]
- This test is an accurate means of post-treatment testing.[7][8]
- 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.[9][10][11]
- Antacids do not affect the efficacy of the test.[12]
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.[13][14]
- Monoclonal antibodies can also be used to identify fecal H. pylori antigens.
- Both tests are used to screen for infection and post-treatment testing.
- The 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.[15][13]
- 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.[16]
Nonendoscopic testing | Advantages | Disadvantages |
---|---|---|
1. ELISA serology
(quantitative and qualitative) |
|
|
*2. Urea breath tests (13C and 14C) |
| |
*3. Fecal antigen test |
|
References
- ↑ Ho B, Marshall BJ (2000). "Accurate diagnosis of Helicobacter pylori. Serologic testing". Gastroenterol Clin North Am. 29 (4): 853–62. PMID 11190069.
- ↑ Loy CT, Irwig LM, Katelaris PH, Talley NJ (1996). "Do commercial serological kits for Helicobacter pylori infection differ in accuracy? A meta-analysis". Am J Gastroenterol. 91 (6): 1138–44. PMID 8651160.
- ↑ Chey WD, Murthy U, Shaw S, Zawadski A, Montague J, Linscheer W; et al. (1999). "A comparison of three fingerstick, whole blood antibody tests for Helicobacter pylori infection: a United States, multicenter trial". Am J Gastroenterol. 94 (6): 1512–6. doi:10.1111/j.1572-0241.1999.1135_x.x. PMID 10364016.
- ↑ 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.
- ↑ Chey WD (2000). "Accurate diagnosis of Helicobacter pylori. 14C-urea breath test". Gastroenterol Clin North Am. 29 (4): 895–902. PMID 11190074.
- ↑ Steen T, Berstad K, Meling T, Berstad A (1995). "Reproducibility of the 14C urea breath test repeated after 1 week". Am J Gastroenterol. 90 (12): 2103–5. PMID 8540496.
- ↑ Leodolter A, Domínguez-Muñoz JE, von Arnim U, Kahl S, Peitz U, Malfertheiner P (1999). "Validity of a modified 13C-urea breath test for pre- and posttreatment diagnosis of Helicobacter pylori infection in the routine clinical setting". Am J Gastroenterol. 94 (8): 2100–4. doi:10.1111/j.1572-0241.1999.01284.x. PMID 10445534.
- ↑ Perri F, Manes G, Neri M, Vaira D, Nardone G (2002). "Helicobacter pylori antigen stool test and 13C-urea breath test in patients after eradication treatments". Am J Gastroenterol. 97 (11): 2756–62. doi:10.1111/j.1572-0241.2002.07065.x. PMID 12425544.
- ↑ Graham DY, Opekun AR, Hammoud F, Yamaoka Y, Reddy R, Osato MS; et al. (2003). "Studies regarding the mechanism of false negative urea breath tests with proton pump inhibitors". Am J Gastroenterol. 98 (5): 1005–9. doi:10.1111/j.1572-0241.2003.07426.x. PMID 12809820.
- ↑ Chey WD, Woods M, Scheiman JM, Nostrant TT, DelValle J (1997). "Lansoprazole and ranitidine affect the accuracy of the 14C-urea breath test by a pH-dependent mechanism". Am J Gastroenterol. 92 (3): 446–50. PMID 9068466.
- ↑ Laine L, Estrada R, Trujillo M, Knigge K, Fennerty MB (1998). "Effect of proton-pump inhibitor therapy on diagnostic testing for Helicobacter pylori". Ann Intern Med. 129 (7): 547–50. PMID 9758575.
- ↑ Gatta L, Vakil N, Ricci C, Osborn JF, Tampieri A, Perna F; et al. (2004). "Effect of proton pump inhibitors and antacid therapy on 13C urea breath tests and stool test for Helicobacter pylori infection". Am J Gastroenterol. 99 (5): 823–9. doi:10.1111/j.1572-0241.2004.30162.x. PMID 15128344.
- ↑ 13.0 13.1 Gisbert JP, Pajares JM (2004). "Stool antigen test for the diagnosis of Helicobacter pylori infection: a systematic review". Helicobacter. 9 (4): 347–68. doi:10.1111/j.1083-4389.2004.00235.x. PMID 15270750.
- ↑ Gisbert JP, de la Morena F, Abraira V (2006). "Accuracy of monoclonal stool antigen test for the diagnosis of H. pylori infection: a systematic review and meta-analysis". Am J Gastroenterol. 101 (8): 1921–30. doi:10.1111/j.1572-0241.2006.00668.x. PMID 16780557.
- ↑ Vaira D, Vakil N, Menegatti M, van't Hoff B, Ricci C, Gatta L; et al. (2002). "The stool antigen test for detection of Helicobacter pylori after eradication therapy". Ann Intern Med. 136 (4): 280–7. PMID 11848725.
- ↑ Odaka T, Yamaguchi T, Koyama H, Saisho H, Nomura F (2002). "Evaluation of the Helicobacter pylori stool antigen test for monitoring eradication therapy". Am J Gastroenterol. 97 (3): 594–9. doi:10.1111/j.1572-0241.2002.05535.x. PMID 11922552.