Detection of Helicobacter pylori Antibodies in a Pediatric Population: Comparison of Three Commercially Available Serological  Tests and One In-House Enzyme Immunoassay

A serum immunoglobulin G enzyme immunoassay (EIA) forHelicobacter pylori antibodies already in use in adults was evaluated with 99 pediatric serum samples to determine its usefulness for the study of H. pylori disease in children. The reference method used was either the 13C-urea breath test or a biopsy culture of gastric mucosa. In children, an EIA cutoff of 0.35 absorbancy unit yielded sensitivity, specificity, and positive and negative predictive values of 93, 97, 93, and 97%, respectively. The cutoff recommended when this EIA was published for use in adults was 0.70 absorbancy unit (H. Gnarpe, P. Unge, C. Blomqvist, and S. Mäkitalo, APMIS 96:128–132, 1988). Another subset of 169 serum samples taken from children was analyzed by four serological tests in order to compare the performance of the in-house EIA with the Pyloriset, HM-CAP, and Helico-G kits. For the 169 samples, 10 (5.9%) false-positives and no false-negatives occurred with the Helico-G, 3 (1.8%) false-positives and no false-negatives occurred with the Pyloriset, and 3 (1.8%) false-positives and 1 (0.6%) false-negative occurred with the HM-CAP. For the 169 samples, 1 (0.6%) false-positive and no false-negatives occurred with the in-house EIA. Serological detection of H. pylori antibodies with our EIA seems to be valuable in diagnosing H. pylori infection in children, but only if a lowered, specific pediatric cutoff is established. The commercial kits, particularly the Helico-G, seem to overdiagnose pediatric H. pylori infection. A positive serological test for H. pylori infection, particularly for children, needs to be confirmed by a reference method because of the possibility of spontaneous eradication of infection, with a lingering serological response.

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Use of a Novel Enzyme Immunoassay Based on Detection of Circulating Antigen in Serum for Diagnosis of Helicobacter pylori Infection

Clinical and Diagnostic Laboratory Immunology ◽

10.1128/cdli.11.4.775-779.2004 ◽

2004 ◽

Vol 11 (4) ◽

pp. 775-779 ◽

Cited By ~ 5

Author(s):

Abdelfattah M. Attallah ◽

Hisham Ismail ◽

Gellan G. Ibrahim ◽

Mohamed Abdel-Raouf ◽

Ahmed M. El-Waseef ◽

...

Keyword(s):

Helicobacter Pylori ◽

Endoscopic Biopsy ◽

Enzyme Linked Immunosorbent Assay ◽

Target Antigen ◽

Serum Samples ◽

Predictive Values ◽

Biopsy Specimens ◽

Significant Difference ◽

Circulating Antigen ◽

H Pylori

ABSTRACT Recently, noninvasive diagnostic tests for Helicobacter pylori infection have gained in significance. We have developed a sensitive and specific noninvasive immunoassay based on the detection of an H. pylori circulating antigen (HpCA) in sera from H. pylori-infected individuals. Monospecific antibody and Western blot analyses were used to demonstrate the presence of the target antigen in H. pylori cell lysate and serum samples. A novel enzyme-linked immunosorbent assay (ELISA) was developed for the detection of HpCA in serum. Endoscopic biopsy specimens from the gastric antra of 221 individuals (143 males and 78 females) with dyspeptic symptoms were evaluated for H. pylori infection, with culture used as a “gold standard” for diagnosis. The target H. pylori antigen was identified at 58 kDa. HpCA has been detected by ELISA with high degrees of sensitivity, specificity, and efficiency (>90%), and ELISA results show no significant difference (P > 0.05) from results of H. pylori culture of gastric biopsy specimens. The test's positive and negative predictive values were also high (95 and 86%, respectively). In conclusion, a sensitive and specific immunoassay was developed for the detection of HpCA in human serum. This test can be applied for noninvasive laboratory and field diagnoses of H. pylori infection.

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Prevalence rate of Helicobacter pylori infection among population of Ryazan region

I P Pavlov Russian Medical Biological Herald ◽

10.23888/pavlovj201927135-40 ◽

2019 ◽

Vol 27 (1) ◽

pp. 35-40

Author(s):

Tatyana V. Zhestkova ◽

Mikhail A. Butov ◽

Yulian Yu. Lymar ◽

Sergey V. Papkov

Keyword(s):

Helicobacter Pylori ◽

Enzyme Immunoassay ◽

Serological Test ◽

Adult Population ◽

Test System ◽

Helicobacter Pylori Infection ◽

Quantitative Detection ◽

Serological Tests ◽

H Pylori

Aim. Determination of the prevalence of Helicobacter pylori (H. pylori) infection among the population of the Ryazan region. Materials and Methods. 833 individuals (809 adults and 24 children) were examined for presence of IgG class antibodies using the enzyme immunoassay (2017-2018). The criteria for inclusion into the study were: a desire of a patient to undergo examination for the presence of antibodies to H. pylori in blood. Criteria for exclusion: past treatment for helicobacteriosis. The presence of helicobacteriosis was determined by enzyme immunoassay for quantitative detection of IgG class antibodies (anti-H. pylori IgG) using BCM Diagnostics Helicobacter pylori IgG (USA) test system and for qualitative determination of IgG antibodies to H. pylori in blood serum on IMMULITE 2000 (Germany; test IMMULITE 2000 H. pylori IgG). Sensitivity of the used test systems was 95.0%, specificity 98.0%. Results. High contamination of adult residents of Ryazan with H. pylori 65.6% was found (70.6% of males, 64.4% of females). Prevalence of H. pylori infection among adults in 2017 was 64.4% and in 2018 70.2%, however, the observed increase in the number of infected individuals was not statistically significant (p0.05). The highest prevalence of H. pylori infection was observed in individuals 40 years of age (67.2%). Gender-related differences in the prevalence of Helicobacter pylori infection were revealed in individuals of 40 years and older. H. pylori infection in males of 40 years was 75.2%, against 65.5% in females of the same age (p0.05). In children of 4-16 years, the share of individuals with positive serological test with anti-H. pylori IgG reached 20.8%. All H. pylori infected children were above 9 years of age. Individuals with positive serological tests received consultation of a gastroenterologist, and on indications underwent additional examination with administration of eradication treatment. In patients with indefinite results the examination was repeated after a week and/or the presence of H. pylori antigen in feces was determined. Conclusion. The data obtained indicate a high level of infection with H. pylori in the adult population in the Ryazan region 65.6%. The incidence of detection of anti-H. pylori IgG in the population was maximal in individuals 40 years (67.2%).

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Evaluation of Three Commercial Serological Tests with Different Methodologies To Assess Helicobacter pyloriInfection

Journal of Clinical Microbiology ◽

10.1128/jcm.37.12.4150-4152.1999 ◽

1999 ◽

Vol 37 (12) ◽

pp. 4150-4152 ◽

Cited By ~ 19

Author(s):

A. van der Ende ◽

R. W. M. van der Hulst ◽

P. Roorda ◽

G. N. J. Tytgat ◽

J. Dankert

Keyword(s):

Helicobacter Pylori ◽

Enzyme Immunoassay ◽

Immunosorbent Assay ◽

Solid Phase ◽

Enzyme Linked Immunosorbent Assay ◽

Serological Tests ◽

H Pylori ◽

Chemiluminescent Enzyme Immunoassay

The sera of 142 Helicobacter pylori-positive and 32H. pylori-negative patients were assessed by a desktop test (QuickVue), an enzyme-linked immunosorbent assay (ELISA) (HM-CAP), and a solid-phase, two-step chemiluminescent enzyme immunoassay (Immulite). These tests yielded sensitivities of 97, 97, and 91% and specificities of 97, 94, and 100%, respectively. In conclusion, the desktop test and the ELISA are more sensitive than the chemiluminescent enzyme immunoassay (P < 0.05). The chemiluminescent enzyme immunoassay has the advantage that it is fully automated.

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The Impact of Increasing Prevalence, False Omissions, and Diagnostic Uncertainty on Coronavirus Disease 2019 (COVID-19) Test Performance

Archives of Pathology & Laboratory Medicine ◽

10.5858/arpa.2020-0716-sa ◽

2021 ◽

Author(s):

Gerald J. Kost

Keyword(s):

Test Performance ◽

Influenza A ◽

Geometric Mean ◽

False Positives ◽

Test Quality ◽

False Negatives ◽

Predictive Values ◽

Sensitivity Specificity ◽

Tier 3 ◽

The Impact

ABSTRACT Context. Coronavirus disease 2019 (COVID-19) test performance depends on predictive values in settings of increasing disease prevalence. Geospatially distributed diagnostics with minimal uncertainty facilitate efficient point-of-need strategies. Objectives. To use original mathematics to interpret COVID-19 test metrics; assess Food and Drug Administration Emergency Use Authorizations and Health Canada targets; compare predictive values for multiplex, antigen, polymerase chain reaction kit, point-of-care antibody, and home tests; enhance test performance; and improve decision-making. Design. PubMed/newsprint generated articles documenting prevalence. Mathematica and open access software helped perform recursive calculations, graph multivariate relationships, and visualize performance by comparing predictive value geometric mean-squared patterns. Results. Tiered sensitivity/specificity comprise: T1) 90%, 95%; T2) 95%, 97.5%; and T3) 100%, ≥99%. Tier 1 false negatives exceed true negatives at >90.5% prevalence; false positives exceeded true positives at <5.3% prevalence. High sensitivity/specificity tests reduce false negatives and false positives yielding superior predictive values. Recursive testing improves predictive values. Visual logistics facilitate test comparisons. Antigen test quality falls off as prevalence increases. Multiplex severe acute respiratory syndrome (SARS)-CoV-2)*Influenza A/B*Respiratory-Syncytial Virus (RSV) testing performs reasonably well compared to Tier 3. Tier 3 performance with a Tier 2 confidence band lower limit will generate excellent performance and reliability. Conclusions. The overriding principle is select the best combined performance and reliability pattern for the prevalence bracket. Some public health professionals recommend repetitive testing to compensate for low sensitivity. More logically, improved COVID-19 assays with less uncertainty conserve resources. Multiplex differentiation of COVID-19 from Influenza A/B-RSV represents an effective strategy if seasonal flu surges next year.

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Genistein attenuated gastric inflammation and apoptosis in Helicobacter pylori-induced gastropathy in rats

BMC Gastroenterology ◽

10.1186/s12876-020-01555-x ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Prasong Siriviriyakul ◽

Duangporn Werawatganon ◽

Nisarat Phetnoo ◽

Kanjana Somanawat ◽

Tanittha Chatsuwan ◽

...

Keyword(s):

Helicobacter Pylori ◽

Inflammatory Mediators ◽

Kinase Inhibitor ◽

Specific Protein ◽

Control Group ◽

Sprague Dawley ◽

Serum Samples ◽

Necrosis Factor Alpha ◽

Tunel Reaction ◽

H Pylori

Abstract Background Helicobacter pylori (H. pylori) infection is a major cause of chronic gastritis, peptic ulcer diseases and cancer. Genistein (4′,5,7-trihydroxyisoflavone), a tyrosine-specific-protein kinase inhibitor, has been shown to exert an anti-inflammatory property. The aim of this study was to examine the treatment effects of genistein and its mechanisms in rats with H. pylori infection. Methods Eighteen male Sprague-Dawley rats were divided into three groups (6 rats per group): (1) control group (Con); (2) H. pylori infected group (HP): the rats were inoculated with H. pylori (108− 1010 CFU/mL; 1 mL/rat.) for 3 consecutive days; and (3) HP + genistein group (HP + Gen): the rats were inoculated with H. pylori as above. Then, they were gavaged with genistein (16 mg/kg BW) for 14 days. Gastric tissue was used for the determination of nuclear factor (NF)-κB expression by immunohistochemistry (IHC), degree of apoptosis by the terminal deoxynucleotidyl transferasemediated dUTP nick-end labeling (TUNEL) reaction, and histopathology. Serum samples were used to measure the levels of tumor necrosis factor-alpha (TNF-α) and cytokine-induced neutrophil chemoattractant-1 (CINC-1). Results Rats in the HP group had significantly higher levels of pro-inflammatory mediators, NF-κB expression and apoptotic cells when compared with the Con group, and these markers significantly decreased in HP + Gen group when compared with the HP group. The histopathology of HP group showed moderate gastric inflammation and many HP colonization. Gastric pathology in HP + Gen group demonstrated the attenuation of inflammatory cell infiltration and H. pylori colonization. Conclusion Genistein exerted its gastroprotective effects through the reduction of pro-inflammatory mediators, nuclear receptor NF-κB expression and gastric mucosal apoptosis in rats with H. pylori-induced gastropathy.

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Good diagnostic accuracy of a chemiluminescent immunoassay in stool samples for diagnosis of Helicobacter pylori infection in patients with dyspepsia

Journal of Investigative Medicine ◽

10.1136/jim-2015-000004 ◽

2016 ◽

Vol 64 (2) ◽

pp. 388-391 ◽

Cited By ~ 6

Author(s):

María José Ramírez-Lázaro ◽

Josep Lite ◽

Sergio Lario ◽

Pepa Pérez-Jové ◽

Antònia Montserrat ◽

...

Keyword(s):

Helicobacter Pylori ◽

Gold Standard ◽

Rapid Urease Test ◽

Diagnostic Reliability ◽

Predictive Values ◽

Urease Test ◽

Stool Samples ◽

H Pylori ◽

Good Diagnostic Accuracy ◽

Sensitivity Specificity

Laboratory-based chemiluminescence immunoassays (CLIA) are widely used in clinical laboratories. Some years ago, a CLIA test was developed for the detection of Helicobacter pylori in stool samples, known as LIAISON H. pylori SA, but little information on its use has been reported. To evaluate the accuracy of the LIAISON H. pylori SA assay for diagnosing H. pylori infection prior to eradication treatment. Diagnostic reliability was evaluated in 252 untreated consecutive patients with dyspepsia. The gold standard for diagnosing H. pylori infection was defined as the concordance of the rapid urease test (RUT), histopathology and urea breath test (UBT). The CLIA assay was performed according to the manufacturer's instructions. Sensitivity, specificity, positive and negative predictive values, and 95% CIs were calculated. According to the gold standard selected, 121 patients were positive for H. pylori infection and 131 negative. LIAISON H. pylori SA had a sensitivity of 90.1% and a specificity of 92.4%, with positive and negative predictive values of 91.6% and 90.1%, respectively. The accuracy of the LIAISON H. pylori SA chemiluminescent diagnostic assay seems comparable to that of ELISA or the best-performing LFIAs. Its sensitivity and specificity, however, seem slightly lower than those of histology, RUT or UBT. The advantages of the assay are that it is cheap, automated, and minimally labor-intensive.

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Relationship of Anti-Lewis x and Anti-Lewis y Antibodies in Serum Samples from Gastric Cancer and Chronic Gastritis Patients toHelicobacter pylori-Mediated Autoimmunity

Infection and Immunity ◽

10.1128/iai.69.8.4774-4781.2001 ◽

2001 ◽

Vol 69 (8) ◽

pp. 4774-4781 ◽

Cited By ~ 25

Author(s):

Michael A. Heneghan ◽

Ciaran F. McCarthy ◽

Daiva Janulaityte ◽

Anthony P. Moran

Keyword(s):

Gastric Cancer ◽

Helicobacter Pylori ◽

Gastric Mucosa ◽

Antibody Production ◽

Enzyme Linked Immunosorbent Assay ◽

Serum Samples ◽

Lewis Y ◽

H Pylori ◽

Negative Controls ◽

Relationship Of

ABSTRACT Lewis (Le) antigens have been implicated in the pathogenesis of atrophic gastritis and gastric cancer in the setting ofHelicobacter pylori infection, and H. pylori-induced anti-Le antibodies have been described that cross-react with the gastric mucosa of both mice and humans. The aim of this study was to examine the presence of anti-Le antibodies in patients with H. pylori infection and gastric cancer and to examine the relationships between anti-Le antibody production, bacterial Le expression, gastric histopathology, and host Le erythrocyte phenotype. Anti-Le antibody production and H. pylori Le expression were determined by enzyme-linked immunosorbent assay, erythrocyte Le phenotype was examined by agglutination assays, and histology was scored blindly. Significant levels of anti-Lex antibody (P < 0.0001, T = 76.4, DF = 5) and anti-Ley antibody (P < 0.0001, T = 73.05, DF = 5) were found in the sera of patients with gastric cancer and other H. pylori-associated pathology compared with H. pylori-negative controls. Following incubation of patient sera with synthetic Le glycoconjugates, anti-Lex and -Ley autoantibody binding was abolished. The degree of the anti-Lex and -Leyantibody response was unrelated to the host Le phenotype but was significantly associated with the bacterial expression of Lex (r = 0.863,r 2 = 0.745, P < 0.0001) and Ley (r = 0.796,r 2 = 0.634, P < 0.0001), respectively. Collectively, these data suggest that anti-Le antibodies are present in most patients with H. pyloriinfection, including those with gastric cancer, that variability exists in the strength of the anti-Le response, and that this response is independent of the host Le phenotype but related to the bacterial Le phenotype.

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DIAGNOSTIC ACCURACY OF UREA BREATH TEST FOR HELICOBACTER PYLORI INFECTION IN CHILDREN WITH DYSPEPSIA IN COMPARISON TO HISTOPATHOLOGY

Arquivos de Gastroenterologia ◽

10.1590/s0004-28032016000200011 ◽

2016 ◽

Vol 53 (2) ◽

pp. 108-112 ◽

Cited By ~ 4

Author(s):

Naser HONAR ◽

Alireza MINAZADEH ◽

Nader SHAKIBAZAD ◽

Mahmood HAGHIGHAT ◽

Forough SAKI ◽

...

Keyword(s):

Helicobacter Pylori ◽

Carbon Isotope ◽

Sensitivity And Specificity ◽

Breath Test ◽

Close Association ◽

Urea Breath Test ◽

Helicobacter Pylori Infection ◽

Cross Sectional ◽

Predictive Values ◽

H Pylori

ABSTRACT Background - Helicobacter pylori infection is the gram negative bacillus with the close association with chronic antral gastritis. Objective - In this study, we evaluate the accuracy of urea breath test (UBT) with carbon isotope 13 in comparison with histopathology of gastric antrum for detection of H. pylori infection in children with dyspepsia. Methods - This cross-sectional study was performed at specialized laboratory of Shiraz Gastroenterohepatology Research Center and Nemazee Hospital, Iran, during a 12-months period. This study investigated the sensitivity, specificity, and positive and negative predictive values of UBT in comparison with biopsy-based tests. We included a consecutive selection of 60 children who fulfilled Rome III criteria for dyspepsia. All children were referred for performing UBT with carbon isotope 13 (C13) as well as endoscopy. Biopsies were taken from antrum of stomach and duodenum. The pathologic diagnosis was considered as the standard test. Results - The mean age of the participants was 10.1±2.6 (range 7-17 years). From our total 60 patients, 28 (46.7%) had positive UBT results and 32 (53.3%) had negative UBT results. Pathologic report of 16 (57.1%) out of 28 patients who had positive UBT were positive for H. pylori and 12 (42.9%) ones were negative. Sensitivity and specificity of C13-UBT for detection of H. pylori infection were 76.2% and 69.2% respectively. Conclusion - Sensitivity and specificity of C13-UBT for detection of H. pylori infection were 76.2% and 69.2% respectively. Another multicenter study from our country is recommended.

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Relation between Helicobacter pylori infection and gastrointestinal symptoms and syndromes

Gut ◽

10.1136/gut.41.2.169 ◽

1997 ◽

Vol 41 (2) ◽

pp. 169-176 ◽

Cited By ~ 49

Author(s):

S Rosenstock ◽

L Kay ◽

C Rosenstock ◽

L P Andersen ◽

O Bonnevie ◽

...

Keyword(s):

Helicobacter Pylori ◽

Epigastric Pain ◽

Gastrointestinal Symptoms ◽

Igg Antibodies ◽

Serum Samples ◽

Ulcer Disease ◽

Abdominal Symptoms ◽

Nocturnal Pain ◽

H Pylori ◽

Upper Dyspepsia

Background—Helicobacter pylori is a human pathogen that colonises the gastric mucosa and causes permanent gastric inflammation.Aims—To assess the symptoms of H pylori infection in an adult unselected population.Subjects—A random sample of 3589 adult Danes who were examined in 1982 and 1987 (n=2987).Methods—Abdominal symptoms within the preceding year were recorded at both attendances. Circulating IgG antibodies against H pylori in serum samples drawn in 1982 were measured by using in-house indirect enzyme linked immunosorbent assays (ELISA).Results—People with increased levels of IgG antibodies to H pylori were more likely than uninfected individuals to report heartburn (odds ratio (OR) = 1.26, 95% confidence interval (CI) 1.03–1.54) and abdominal pain characterised by daily length (OR = 1.33, 95% CI 0.92–1.91), nocturnal occurrence (OR = 1.62, 95% CI 1.19–2.19), spring aggravation (OR = 1.68, 95% CI 0.70–4.05), and no relation to meals (OR = 0.62, 95% CI 0.43–0.91) or stress (OR = 0.69, 95% CI 0.50–0.95). The inclusion of people with increased levels of IgG antibodies to H pylori, but without upper dyspepsia, at study entry significantly increased the likelihood of reporting upper dyspepsia at follow up (OR = 1.71, 95% CI 1.24–2.36). People with epigastric pain and increased levels of IgM antibodies to H pylori only indicative of acute H pylori infection were more likely to report nocturnal pain, heartburn, nausea, and vomiting.Conclusions—H pylori infection may precede the development of dyspepsia and is associated with a variety of gastrointestinal symptoms in people with no history of peptic ulcer disease.

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Utility of Serology in DeterminingHelicobacter pyloriEradication after Therapy

Canadian Journal of Gastroenterology ◽

10.1155/1998/303628 ◽

1998 ◽

Vol 12 (2) ◽

pp. 117-124 ◽

Cited By ~ 10

Author(s):

Carlo A Fallone ◽

Vivian G Loo ◽

Alan N Barkun

Keyword(s):

Test Performance ◽

Controlled Trial ◽

Treatment Delay ◽

Noninvasive Method ◽

Serum Samples ◽

Serological Tests ◽

Duodenal Ulcers ◽

Antibody Titres ◽

H Pylori ◽

To Receive

OBJECTIVE: To determine the usefulness of four serological tests in confirming cure ofH pyloriinfection before the previously reported six-month post-treatment delay.PATIENTS AND METHODS: As part of a prospective, blinded, controlled trial, in which patients with duodenal ulcers were randomized to receive different combinations of antibiotics, serum samples were obtained in 89 patients before treatment, as well as on several occasions after treatment. Antibody titres were determined by ELISA with Bio-Rad immunoglobulin (Ig) A, Bio-Rad IgG, Pyloriset EIA-A for IgA and Pyloriset EIA-G for IgG. Eradication was confirmed with antral biopsy three months after therapy.RESULTS: The percentage drop in titre following treatment was significantly larger for the group of patients who were treated successfully with all four kits. Optimal cut-offs for identifying successful therapy were determined, and accuracy improved as the interval between testing and therapy was prolonged. Six months after therapy, the IgG test from Bio-Rad achieved 100% sensitivity and 80% specificity, and that from Pyloriset achieved 88% sensitivity and 100% specificity. At three months, however, test performance was quite good, with 90% sensitivity and 80% specificity when using a Pyloriset IgA titre drop of 20% or greater to predict successful eradication.CONCLUSION: Serology is a simple, easily available, noninvasive method that exhibits good positive predictive value in the confirmation of successful cure ofH pyloriinfection three or six months after treatment.

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