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Vörhendi N, Soós A, Anne Engh M, Tinusz B, Szakács Z, Pécsi D, Mikó A, Sarlós P, Hegyi P, Eröss B. Accuracy of the Helicobacter pylori diagnostic tests in patients with peptic ulcer bleeding: a systematic review and network meta-analysis. Therap Adv Gastroenterol 2020; 13:1756284820965324. [PMID: 33403002 PMCID: PMC7747116 DOI: 10.1177/1756284820965324] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/04/2020] [Accepted: 09/21/2020] [Indexed: 02/04/2023] Open
Abstract
INTRODUCTION Some studies suggest that the accuracy of Helicobacter pylori diagnostic tests is decreased in peptic ulcer bleeding (PUB). We aimed to assess the accuracy of diagnostic tests for H. pylori in patients with PUB in a diagnostic test accuracy (DTA) network meta-analysis. METHODS A systematic search was carried out in seven databases until November 2019. We collected or calculated true and false positive and negative values, and constructed 2×2 diagnostic contingency tables with reference standards including histology, rapid urease test, urea breath test, serology, stool antigen test, culture, and polymerase chain reaction. We ranked the index tests by the superiority indices (SI) and calculated pooled sensitivity and specificity of each test. DISCUSSION Our search yielded 40 eligible studies with 27 different diagnostic strategies for H. pylori. In 32 articles, the reference standard was a combination of multiple tests. In 12 studies, the index tests were compared with a single testing method. We analyzed seven networks with the reference standards against a single or a combination of diagnostic index tests. None of the index tests had better diagnostic accuracy (SI between 9.94 and 2.17) compared with the individual index tests as all the confidence intervals included 1. Combined testing strategies had higher sensitivities (0.92-0.62) and lower specificities (0.85-0.46) while single tests proved to have higher specificities (0.83-0.77) and lower sensitivities (0.73-0.42). CONCLUSION Use of combined tests may have a rationale in clinical practice due to their higher sensitivities. The differences between the included DTA studies limited the comparison of the testing strategies.
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Affiliation(s)
- Nóra Vörhendi
- Institute for Translational Medicine, Medical School, Szentágothai Research Centre, University of Pécs, Pécs, Hungary
| | - Alexandra Soós
- Institute for Translational Medicine, Medical School, Szentágothai Research Centre, University of Pécs, Pécs, Hungary
| | - Marie Anne Engh
- Institute for Translational Medicine, Medical School, Szentágothai Research Centre, University of Pécs, Pécs, Hungary
| | - Benedek Tinusz
- Institute for Translational Medicine, Medical School, Szentágothai Research Centre, University of Pécs, Pécs, Hungary
- Division of Gastroenterology, First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary
| | - Zsolt Szakács
- Institute for Translational Medicine, Medical School, Szentágothai Research Centre, University of Pécs, Pécs, Hungary
| | - Dániel Pécsi
- Institute for Translational Medicine, Medical School, Szentágothai Research Centre, University of Pécs, Pécs, Hungary
| | - Alexandra Mikó
- Institute for Translational Medicine, University of Pécs, Medical School, Szentágothai Research Centre, University of Pécs, Pécs, Hungary
- Division of Gastroenterology, First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary
| | - Patrícia Sarlós
- Division of Gastroenterology, First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary
| | - Péter Hegyi
- Institute for Translational Medicine, Medical School, Szentágothai Research Centre, University of Pécs, Pécs, Hungary
- Division of Gastroenterology, First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary
| | - Bálint Eröss
- Institute for Translational Medicine, University of Pécs, 12 Szigeti út. II. floor, PÉCS, 7624, Hungary
- Division of Gastroenterology, First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary
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Best LMJ, Takwoingi Y, Siddique S, Selladurai A, Gandhi A, Low B, Yaghoobi M, Gurusamy KS, Cochrane Upper GI and Pancreatic Diseases Group. Non-invasive diagnostic tests for Helicobacter pylori infection. Cochrane Database Syst Rev 2018; 3:CD012080. [PMID: 29543326 PMCID: PMC6513531 DOI: 10.1002/14651858.cd012080.pub2] [Citation(s) in RCA: 90] [Impact Index Per Article: 12.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/30/2023]
Abstract
BACKGROUND Helicobacter pylori (H pylori) infection has been implicated in a number of malignancies and non-malignant conditions including peptic ulcers, non-ulcer dyspepsia, recurrent peptic ulcer bleeding, unexplained iron deficiency anaemia, idiopathic thrombocytopaenia purpura, and colorectal adenomas. The confirmatory diagnosis of H pylori is by endoscopic biopsy, followed by histopathological examination using haemotoxylin and eosin (H & E) stain or special stains such as Giemsa stain and Warthin-Starry stain. Special stains are more accurate than H & E stain. There is significant uncertainty about the diagnostic accuracy of non-invasive tests for diagnosis of H pylori. OBJECTIVES To compare the diagnostic accuracy of urea breath test, serology, and stool antigen test, used alone or in combination, for diagnosis of H pylori infection in symptomatic and asymptomatic people, so that eradication therapy for H pylori can be started. SEARCH METHODS We searched MEDLINE, Embase, the Science Citation Index and the National Institute for Health Research Health Technology Assessment Database on 4 March 2016. We screened references in the included studies to identify additional studies. We also conducted citation searches of relevant studies, most recently on 4 December 2016. We did not restrict studies by language or publication status, or whether data were collected prospectively or retrospectively. SELECTION CRITERIA We included diagnostic accuracy studies that evaluated at least one of the index tests (urea breath test using isotopes such as 13C or 14C, serology and stool antigen test) against the reference standard (histopathological examination using H & E stain, special stains or immunohistochemical stain) in people suspected of having H pylori infection. DATA COLLECTION AND ANALYSIS Two review authors independently screened the references to identify relevant studies and independently extracted data. We assessed the methodological quality of studies using the QUADAS-2 tool. We performed meta-analysis by using the hierarchical summary receiver operating characteristic (HSROC) model to estimate and compare SROC curves. Where appropriate, we used bivariate or univariate logistic regression models to estimate summary sensitivities and specificities. MAIN RESULTS We included 101 studies involving 11,003 participants, of which 5839 participants (53.1%) had H pylori infection. The prevalence of H pylori infection in the studies ranged from 15.2% to 94.7%, with a median prevalence of 53.7% (interquartile range 42.0% to 66.5%). Most of the studies (57%) included participants with dyspepsia and 53 studies excluded participants who recently had proton pump inhibitors or antibiotics.There was at least an unclear risk of bias or unclear applicability concern for each study.Of the 101 studies, 15 compared the accuracy of two index tests and two studies compared the accuracy of three index tests. Thirty-four studies (4242 participants) evaluated serology; 29 studies (2988 participants) evaluated stool antigen test; 34 studies (3139 participants) evaluated urea breath test-13C; 21 studies (1810 participants) evaluated urea breath test-14C; and two studies (127 participants) evaluated urea breath test but did not report the isotope used. The thresholds used to define test positivity and the staining techniques used for histopathological examination (reference standard) varied between studies. Due to sparse data for each threshold reported, it was not possible to identify the best threshold for each test.Using data from 99 studies in an indirect test comparison, there was statistical evidence of a difference in diagnostic accuracy between urea breath test-13C, urea breath test-14C, serology and stool antigen test (P = 0.024). The diagnostic odds ratios for urea breath test-13C, urea breath test-14C, serology, and stool antigen test were 153 (95% confidence interval (CI) 73.7 to 316), 105 (95% CI 74.0 to 150), 47.4 (95% CI 25.5 to 88.1) and 45.1 (95% CI 24.2 to 84.1). The sensitivity (95% CI) estimated at a fixed specificity of 0.90 (median from studies across the four tests), was 0.94 (95% CI 0.89 to 0.97) for urea breath test-13C, 0.92 (95% CI 0.89 to 0.94) for urea breath test-14C, 0.84 (95% CI 0.74 to 0.91) for serology, and 0.83 (95% CI 0.73 to 0.90) for stool antigen test. This implies that on average, given a specificity of 0.90 and prevalence of 53.7% (median specificity and prevalence in the studies), out of 1000 people tested for H pylori infection, there will be 46 false positives (people without H pylori infection who will be diagnosed as having H pylori infection). In this hypothetical cohort, urea breath test-13C, urea breath test-14C, serology, and stool antigen test will give 30 (95% CI 15 to 58), 42 (95% CI 30 to 58), 86 (95% CI 50 to 140), and 89 (95% CI 52 to 146) false negatives respectively (people with H pylori infection for whom the diagnosis of H pylori will be missed).Direct comparisons were based on few head-to-head studies. The ratios of diagnostic odds ratios (DORs) were 0.68 (95% CI 0.12 to 3.70; P = 0.56) for urea breath test-13C versus serology (seven studies), and 0.88 (95% CI 0.14 to 5.56; P = 0.84) for urea breath test-13C versus stool antigen test (seven studies). The 95% CIs of these estimates overlap with those of the ratios of DORs from the indirect comparison. Data were limited or unavailable for meta-analysis of other direct comparisons. AUTHORS' CONCLUSIONS In people without a history of gastrectomy and those who have not recently had antibiotics or proton ,pump inhibitors, urea breath tests had high diagnostic accuracy while serology and stool antigen tests were less accurate for diagnosis of Helicobacter pylori infection.This is based on an indirect test comparison (with potential for bias due to confounding), as evidence from direct comparisons was limited or unavailable. The thresholds used for these tests were highly variable and we were unable to identify specific thresholds that might be useful in clinical practice.We need further comparative studies of high methodological quality to obtain more reliable evidence of relative accuracy between the tests. Such studies should be conducted prospectively in a representative spectrum of participants and clearly reported to ensure low risk of bias. Most importantly, studies should prespecify and clearly report thresholds used, and should avoid inappropriate exclusions.
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Affiliation(s)
- Lawrence MJ Best
- Royal Free Campus, UCL Medical SchoolDepartment of SurgeryRowland Hill StreetLondonUKNW32PF
| | - Yemisi Takwoingi
- University of BirminghamInstitute of Applied Health ResearchEdgbastonBirminghamUKB15 2TT
| | | | | | | | | | - Mohammad Yaghoobi
- McMaster University and McMaster University Health Sciences CentreDivision of Gastroenterology1200 Main Street WestHamiltonONCanada
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Diagnosis, treatment, and outcome in patients with bleeding peptic ulcers and Helicobacter pylori infections. BIOMED RESEARCH INTERNATIONAL 2014; 2014:658108. [PMID: 25101293 PMCID: PMC4101224 DOI: 10.1155/2014/658108] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Received: 04/15/2014] [Accepted: 06/10/2014] [Indexed: 12/13/2022]
Abstract
Upper gastrointestinal (UGI) bleeding is the most frequently encountered complication of peptic ulcer disease. Helicobacter pylori (Hp) infection and nonsteroidal anti-inflammatory drug (NSAID) administration are two independent risk factors for UGI bleeding. Therefore, testing for and diagnosing Hp infection are essential for every patient with UGI hemorrhage. The presence of the infection is usually underestimated in cases of bleeding peptic ulcers. A rapid urease test (RUT), with or without histology, is usually the first test performed during endoscopy. If the initial diagnostic test is negative, a delayed 13C-urea breath test (UBT) or serology should be performed. Once an infection is diagnosed, antibiotic treatment is advocated. Sufficient evidence supports the concept that Hp infection eradication can heal the ulcer and reduce the likelihood of rebleeding. With increased awareness of the effects of Hp infection, the etiologies of bleeding peptic ulcers have shifted to NSAID use, old age, and disease comorbidity.
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Sharbatdaran M, Kashifard M, Shefaee S, Siadati S, Jahed B, Asgari S. Comparison of stool antigen test with gastric biopsy for the detection of Helicobacter Pylori infection. Pak J Med Sci 2013; 29:68-71. [PMID: 24353510 PMCID: PMC3809175 DOI: 10.12669/pjms.291.2865] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/27/2012] [Accepted: 10/16/2012] [Indexed: 02/02/2023] Open
Abstract
Objective: Helicobacter Pylori (H.pylori) is one of the most important causes of dyspepsia and diagnosis can be made by invasive or non-invasive methods. One of the non-invasive methods, H.pylori stool antigen test (HpSA) is simple, fast and relatively inexpensive. According to this view with regard to gastric biopsy as a gold standard the sensitivity, specificity, positive and negative predictive values of this method were calculated. Methodology: Stool samples of 61 patients who underwent upper endoscopy and gastric biopsy due to dyspepsia were evaluated for H. Pylori stool antigen using sandwich ELISA method. Results: From the 61 patients who participated in this study, H.pylori was diagnosed in 38 (62.3%) gastric biopsies, 25(66%) of these had positive HpSA test. Also, of 27 (37.7%) positive HpSA cases, H.pylori was seen in 25 gastric biopsies. For this method, sensitivity of 66% with 93% positive predictive value was calculated. Also, 91% specificity with 62% negative predictive value was estimated. Conclusion: High positive HpSA indicates high risk of H.pylori infection and high specificity shows that the likelihood of false positive is low. Therefore, physicians can trust on this method and start patient`s treatment.
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Affiliation(s)
- Majid Sharbatdaran
- Majid Sharbatdaran, Assistant Professor, Department of Pathology, Babol university of Medical Sciences, Babol, Iran
| | - Mehrdad Kashifard
- Mehrdad Kashifard, Associate Professor, Department of Internal Medicine, Babol university of Medical Sciences, Babol, Iran
| | - Shahriar Shefaee
- Shahriar Shefaee, Assistant Professor, Department of Pathology, Babol university of Medical Sciences, Babol, Iran
| | - Sepideh Siadati
- Sepideh Siadati, Assistant Professor, Department of Pathology, Babol university of Medical Sciences, Babol, Iran
| | - Babak Jahed
- Babak Jahed, Pathologist, Babol university of Medical Sciences, Babol, Iran
| | - Samaneh Asgari
- Samaneh Asgari, Master of Biostatistics, Clinical Research Development Center, Shahid Beheshti Hospital, Babol, Iran
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Real-time PCR for diagnosing Helicobacter pylori infection in patients with upper gastrointestinal bleeding: comparison with other classical diagnostic methods. J Clin Microbiol 2012; 50:3233-7. [PMID: 22837325 DOI: 10.1128/jcm.01205-12] [Citation(s) in RCA: 40] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022] Open
Abstract
The aim of this study was to determine the diagnostic usefulness of quantification of the H. pylori genome in detection of infection in patients with upper gastrointestinal bleeding (UGB). A total of 158 consecutive patients with digestive disorders, 80 of whom had clinical presentation of UGB, were studied. The number of microorganisms was quantified using a real-time PCR system which amplifies the urease gene with an internal control for eliminating the false negatives. A biopsy sample from the antrum and corpus of each patient was processed. The rapid urease test, culture, histological study, stool antigen test, and breath test were done. The gold standard was a positive culture or positive results in at least two of the other techniques. When a positive result was defined as any number of microorganisms/human cell, the sensitivity of real-time PCR was greater in bleeding patients, especially in the gastric corpus: 68.4% (95% confidence interval [CI], 52.3 to 84.5%) in non-UGB patients versus 91.5% (95% CI, 79.6 to 97.6%) in UGB patients. When a positive result was defined as a number of microorganisms/human cell above the optimal value that maximizes the Youden index (>3.56 microorganisms/human cell in the antrum and >2.69 in the corpus), the sensitivity and specificity in UGB patients were over 80% in both antrum and corpus. Our findings suggest that some bleeding patients with infection caused by H. pylori may not be correctly diagnosed by classical methods, and such patients could benefit from the improved diagnosis provided by real-time PCR. However, the clinical significance of a small number of microorganisms in patients with negative results in classical tests should be evaluated.
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Management of non-variceal upper gastrointestinal tract hemorrhage: Controversies and areas of uncertainty. World J Gastroenterol 2012; 18:1159-1165. [DOI: 10.3748/wjg.v18.i11.1159] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
Upper gastrointestinal tract hemorrhage (UGIH) remains a common presentation requiring urgent evaluation and treatment. Accurate assessment, appropriate intervention and apt clinical skills are needed for proper management from time of presentation to discharge. The advent of pharmacologic acid suppression, endoscopic hemostatic techniques, and recognition of Helicobacter pylori as an etiologic agent in peptic ulcer disease (PUD) has revolutionized the treatment of UGIH. Despite this, acute UGIH still carries considerable rates of morbidity and mortality. This review aims to discuss current areas of uncertainty and controversy in the management of UGIH. Neoadjuvant proton pump inhibitor (PPI) therapy has become standard empiric treatment for UGIH given that PUD is the leading cause of non-variceal UGIH, and PPIs are extremely effective at promoting ulcer healing. However, neoadjuvant PPI administration has not been shown to affect hard clinical outcomes such as rebleeding or mortality. The optimal timing of upper endoscopy in UGIH is often debated. Upon completion of volume resuscitation and hemodynamic stabilization, upper endoscopy should be performed within 24 h in all patients with evidence of UGIH for both diagnostic and therapeutic purposes. With rising healthcare cost paramount in today’s medical landscape, the ability to appropriately triage UGIH patients is of increasing value. Upper endoscopy in conjunction with the clinical scenario allows for accurate decision making concerning early discharge home in low-risk lesions or admission for further monitoring and treatment in higher-risk lesions. Concomitant pharmacotherapy with non-steroidal anti-inflammatory drugs (NSAIDs) and antiplatelet agents, such as clopidogrel, has a major impact on the etiology, severity, and potential treatment of UGIH. Long-term PPI use in patients taking chronic NSAIDs or clopidogrel is discussed thoroughly in this review.
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Trawick EP, Yachimski PS. Management of non-variceal upper gastrointestinal tract hemorrhage: controversies and areas of uncertainty. World J Gastroenterol 2012; 18:1159-65. [PMID: 22468078 PMCID: PMC3309904 DOI: 10.3748/wjg.v18.11.1159] [Citation(s) in RCA: 18] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/02/2011] [Revised: 08/26/2011] [Accepted: 09/03/2011] [Indexed: 02/06/2023] Open
Abstract
Upper gastrointestinal tract hemorrhage (UGIH) remains a common presentation requiring urgent evaluation and treatment. Accurate assessment, appropriate intervention and apt clinical skills are needed for proper management from time of presentation to discharge. The advent of pharmacologic acid suppression, endoscopic hemostatic techniques, and recognition of Helicobacter pylori as an etiologic agent in peptic ulcer disease (PUD) has revolutionized the treatment of UGIH. Despite this, acute UGIH still carries considerable rates of morbidity and mortality. This review aims to discuss current areas of uncertainty and controversy in the management of UGIH. Neoadjuvant proton pump inhibitor (PPI) therapy has become standard empiric treatment for UGIH given that PUD is the leading cause of non-variceal UGIH, and PPIs are extremely effective at promoting ulcer healing. However, neoadjuvant PPI administration has not been shown to affect hard clinical outcomes such as rebleeding or mortality. The optimal timing of upper endoscopy in UGIH is often debated. Upon completion of volume resuscitation and hemodynamic stabilization, upper endoscopy should be performed within 24 h in all patients with evidence of UGIH for both diagnostic and therapeutic purposes. With rising healthcare cost paramount in today's medical landscape, the ability to appropriately triage UGIH patients is of increasing value. Upper endoscopy in conjunction with the clinical scenario allows for accurate decision making concerning early discharge home in low-risk lesions or admission for further monitoring and treatment in higher-risk lesions. Concomitant pharmacotherapy with non-steroidal anti-inflammatory drugs (NSAIDs) and antiplatelet agents, such as clopidogrel, has a major impact on the etiology, severity, and potential treatment of UGIH. Long-term PPI use in patients taking chronic NSAIDs or clopidogrel is discussed thoroughly in this review.
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Evaluation of Helicobacter pylori eradication by triple therapy plus Lactobacillus acidophilus compared to triple therapy alone. Eur J Clin Microbiol Infect Dis 2011; 30:555-9. [PMID: 21207091 DOI: 10.1007/s10096-010-1119-4] [Citation(s) in RCA: 33] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/05/2010] [Accepted: 11/13/2010] [Indexed: 02/07/2023]
Abstract
The purpose of this study was to evaluate the influence of adding Lactobacillus acidophilus to a triple regimen for Helicobacter pylori eradication in untreated patients with peptic ulcers or ulcer-scars. This was a pre-randomized, single-blind, interventional, treatment-efficacy study with active controls and parallel-assignment, set in Coimbra, Portugal, on 62 consecutive H. pylori-positive untreated adults with peptic ulcers or ulcer-scars, diagnosed by gastroduodenoscopy, with pre-treatment direct Gram-staining and culture of gastric biopsies. The first 31 patients received esomeprazole 20 mg, amoxicillin 1000 mg and clarithromycin 500 mg (EAC), all b.i.d., for 8 days. The remaining 31 added L. acidophilus, 5 × 10(9) organisms per capsule, 3 + 2 i.d. for 8 days (EACL). The main outcome measure was (13)C urea breath test (UBT), ≥6 weeks after completion of therapy. Successful eradication (UBT-negativity after treatment), was similar in both groups (EAC = 80.6%; EACL = 83.9%, p = 0.740) by both intention-to-treat and per-protocol analysis. The non-eradicated strains were susceptible in vitro to both antibiotics. Adding L. acidophilus to EAC triple therapy did not increase H. pylori eradication rates. Considering the cost and the burden of ingesting five extra capsules daily, supplementing the EAC therapy with L. acidophilus, at this dose, shows no benefit. Further studies with different dosages and duration of treatment, and other probiotics or probiotic combinations are required to improve eradication.
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Lo CC, Lai KH, Peng NJ, Lo GH, Tseng HH, Lin CK, Shie CB, Wu CM, Chen YS, Huang WK, Chen A, Hsu PI. Polymerase chain reaction: a sensitive method for detecting Helicobacter pylori infection in bleeding peptic ulcers. World J Gastroenterol 2005; 11:3909-3914. [PMID: 15991292 PMCID: PMC4504895 DOI: 10.3748/wjg.v11.i25.3909] [Citation(s) in RCA: 27] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/23/2004] [Revised: 04/10/2004] [Accepted: 04/14/2004] [Indexed: 02/06/2023] Open
Abstract
AIM To assess the sensitivity and specificity of polymerase chain reaction (PCR) in detecting Helicobacter pylori (H pylori) infection in patients with bleeding peptic ulcers, and to compare its diagnostic efficacy with other invasive and non-invasive tests. METHODS From April to September 2002, H pylori status in 60 patients who consecutively presented with gastroduodenal ulcer bleeding was examined by rapid urease tests (RUT), histology, culture, PCR, serology and urea breath tests (UBT). RESULTS The sensitivity of PCR was significantly higher than that of RUT, histology and culture (91% vs 66%, 43% and 37%, respectively; P = 0.01, <0.001, <0.001, respectively), but similar to that of serology (94%) and UBT (94%). Additionally, PCR exhibited a greater specificity than serology (100% vs 65%, P<0.01). However, the specificity of PCR did not differ from that of other tests. Further analysis revealed significant differences in the sensitivities of RUT, culture, histology and PCR between the patients with and those without blood in the stomach (P<0.01, P = 0.09, P<0.05, and P<0.05, respectively). CONCLUSION PCR is the most accurate method among the biopsy-based tests to detect H pylori infection in patients with bleeding peptic ulcers. Blood may reduce the sensitivities of all biopsy-based tests.
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Affiliation(s)
- Ching-Chu Lo
- Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Taiwan, China
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Lin HJ, Lo WC, Perng CL, Tseng GY, Li AFY, Ou YH. Mucosal polymerase chain reaction for diagnosing Helicobacter pylori infection in patients with bleeding peptic ulcers. World J Gastroenterol 2005; 11:382-5. [PMID: 15637749 PMCID: PMC4205342 DOI: 10.3748/wjg.v11.i3.382] [Citation(s) in RCA: 17] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
AIM: Helicobacter pylori (H pylori) has been linked to chronic gastritis, peptic ulcers, gastric cancer and MALT-lymphoma. Conventional invasive tests are less sensitive than non-invasive tests in diagnosing H pylori infection in patients with bleeding peptic ulcers. Polymerase chain reaction is a sensitive and accurate method for diagnosing H pylori infection. The aim of this study was to evaluate the diagnostic role of mucosal polymerase chain reaction for H pylori infection in patients with bleeding peptic ulcers.
METHODS: In patients with bleeding, non-bleeding peptic ulcers and chronic gastritis, we checked rapid urease test, histology, bacterial culture and mucosal polymerase chain reaction for detecting H pylori infection. Positive H pylori infection was defined as positive culture or both a positive histology and a positive rapid urease test. For mucosal polymerase chain reaction of H pylori, we checked vacA (s1a, s1b, s1c, s2, m1, m1T, m2), iceA1, iceA2 and cag A.
RESULTS: Between October 2000 and April 2002, 88 patients with bleeding peptic ulcers (males/females: 60/28, gastric ulcers/duodenal ulcers: 55/33), 81 patients with non-bleeding peptic ulcers (males/females: 54/27, gastric ulcers/duodenal ulcers: 45/36) and 37 patients with chronic gastritis (males/females: 24/13) were enrolled in this study. In patients with bleeding peptic ulcers, non-bleeding peptic ulcers and chronic gastritis, 45 patients (51%), 71 patients (88%) and 20 patients (54%) respectively were found to have positive H pylori infection (P<0.001). In patients with bleeding peptic ulcers, non-bleeding peptic ulcers and chronic gastritis, polymerase chain reaction for H pylori infection was positive in 54 patients (61%), 70 patients (86%) and 20 patients (54%) respectively (P<0.001). The sensitivity, positive predictive value and diagnostic accuracy of mucosal polymerase reaction for H pylori infection were significantly lower in patients with bleeding peptic ulcers (84%, 79% and 81%) than in patients with non-bleeding peptic ulcers (99%, 99% and 98%) (P<0.001, P<0.01 and P<0.001 respectively). The sensitivity, negative predictive value and diagnostic accuracy of mucosal polymerase reaction for H pylori were significantly lower in patients with bleeding peptic ulcers (84%, 83% and 81%) than in patients with chronic gastritis (100%, 100% and 100%) (P = 0.02, P = 0.02 and P = 0.001).
CONCLUSION: Mucosal polymerase chain reaction for detecting H pylori infection is not reliable in patients with bleeding peptic ulcers.
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Affiliation(s)
- Hwai-Jeng Lin
- Division of Gastroenterology, Department of Medicine, VGH-Taipei, Taiwan, China.
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Gisbert JP, Trapero M, Calvet X, Mendoza J, Quesada M, Güell M, Pajares JM. Evaluation of three different tests for the detection of stool antigens to diagnose Helicobacter pylori infection in patients with upper gastrointestinal bleeding. Aliment Pharmacol Ther 2004; 19:923-9. [PMID: 15080854 DOI: 10.1111/j.1365-2036.2004.01932.x] [Citation(s) in RCA: 26] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/26/2022]
Abstract
AIM To evaluate the accuracy of several methods aimed to detect Helicobacter pylori stool antigens in patients with upper gastrointestinal bleeding. METHODS Thirty-four patients with upper gastrointestinal bleeding because of peptic ulcer were included. The first stool sample during hospitalization was collected, and stool antigens were determined with: polyclonal enzyme-linked immunosorbent assay (Premier-Platinum-HpSA); monoclonal enzyme-linked immunosorbent assay (Amplified-IDEIA-HpStAR); and rapid monoclonal immunochromatographic test (ImmunoCard-STAT HpSA). A patient was considered infected when H. pylori was diagnosed with invasive tests (rapid urease test or histology) or with (13)C-urea breath test. When all tests were negative, a new breath test was repeated after stopping proton pump inhibitors. RESULTS All patients were infected and, therefore, only sensitivity of the tests could be calculated: polyclonal enzyme-linked immunosorbent assay (74%), monoclonal enzyme-linked immunosorbent assay (94%), and rapid monoclonal immunochromatographic test (60%; concordance between the two observers was high, kappa = 0.9). Neither the presence of maelena nor the delay in obtaining stool samples explained false negatives. CONCLUSIONS Neither the polyclonal enzyme-linked immunosorbent assay stool antigen test nor the rapid immunochromatographic stool antigen test can be recommended to diagnose H. pylori infection in patients with upper gastrointestinal bleeding. However, the monoclonal enzyme-linked immunosorbent assay stool antigen test is highly sensitive for detecting the infection in patients with this complication, although more studies are necessary to evaluate the specificity of the method.
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Affiliation(s)
- J P Gisbert
- Gastroenterology Unit, Hospital Universitario de la Princesa, Universidad Autónoma de Madrid, Spain.
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Li YH, Guo H, Zhang PB, Zhao XY, Da SP. Clinical value of Helicobacter pylori stool antigen test, ImmunoCard STAT HpSA, for detecting H pylori infection. World J Gastroenterol 2004; 10:913-4. [PMID: 15040045 PMCID: PMC4727001 DOI: 10.3748/wjg.v10.i6.913] [Citation(s) in RCA: 27] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/15/2022] Open
Abstract
AIM: To evaluate the reliability of the Helicobacter pylori stool antigen test, ImmunoCard STAT HpSA, for detecting H pylori infection.
METHODS: Stool specimens were collected from 53 patients who received upper endoscopy examination due to gastrointestinal symptoms. ImmunoCard STAT HpSA was used to detect H pylori stool antigens. H pylori infection was detected based on three different tests: the urease test, Warthin-Starry staining and culture. H pylori status was defined as positive when both the urease test and histology or culture alone was positive.
RESULTS: Sensitivity, specificity, positive predictive and negative predictive values and the total accuracy of ImmunoCard STAT HpSA for the diagnosis of H pylori infection were 92.6% (25/27), 88.5% (23/26), 89.3% (25/28), 92% (23/25) and 90.6% (48/53), respectively.
CONCLUSION: The stool antigen test, ImmunoCard STAT HpSA, is a simple noninvasive and accurate test for the diagnosis of H pylori infection.
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Affiliation(s)
- Yi-Hui Li
- Department of Gastroenterology, Xinqiao Hospital, Third Military Medical University, Chongqing 400037, China
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