Comparison of two enzyme-linked immunosorbent assay tests for diagnosis of Helicobacter pylori infection in China (original) (raw)
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Diagnostic Microbiology and Infectious Disease, 1999
Most of the commercial serological assays for H. pylori are developed and validated in western countries. We evaluated the accuracy of three popular commercial ELISA tests for H. pylori in the Chinese population. Eighty dyspeptic patients were recruited and diagnosis of H. pylori infection was based on biopsy urease test, histology and urea breath test. Thirtysix patients (45%) were positive for H. pylori infection by two or more positive reference tests. Anti-H. pylori IgG antibody was detected by three commercial ELISA tests: GAP IgG (Bio-Rad), HM-CAP (Enteric Products) and Pyloriset EIA-G (Orion). The respective sensitivity, specificity, positive and negative predictive values of the three tests were: GAP IgG (50%, 97.4%, 93.8%, 71.7%), 68.4%, 66.7%, 74.3%) and 86.4%, 81.8%, 80.9%). Despite the high accuracy reported in the West, the performance of these commercial serological tests was unsatisfactory when used in Chinese patients.
Alimentary Pharmacology and Therapeutics, 2005
Background: The performance of commercial Helicobacter pylori diagnostic kits developed for particular geographic regions has often been found to be of poor diagnostic value when applied to other regions, possibly because of infections being caused by different H. pylori strains in different regions. Aim: To evaluate the performance of an IgG2 anti-H. pylori enzyme-linked immunoassay test (Helirad Alert) for detection of H. pylori infection in both Australian and Hong Kong (Chinese) subjects. Methods: Serum samples were tested for H. pylori specific IgG2 and IgG antibodies by enzyme-linked immunoassay kits using identical antigen preparation in 168 Australian and 160 Hong Kong (Chinese) subjects diagnosed with dyspepsia. Results: Using a cutoff value determined by analysis of H. pylori-negative Australian samples, the sensitivity, specificity and accuracy of the IgG2 assay were 77.8, 97.4 and 91.1%, respectively, for the Australian samples and 96.3, 83.8 and 90% for Hong Kong samples. For the IgG assay, sensitivity, specificity and accuracy were 87.0, 99.1 and 95.2% for Australian samples and 97.5, 75 and 86.3% for Hong Kong samples respectively. Receiver-operating characteristic analysis showed better discrimination of H. pylori status when the IgG2 assay was applied to Hong Kong samples, while the IgG assay was better in the Australian samples. Conclusion: These data demonstrate that the Helirad Alert enzyme-linked immunoassay could provide a reliable method for screening H. pylori infection in both western and Chinese populations.
Quantitative detection of Helicobacter pylori specific antibodies in a multi-ethnic asian population
Gastroenterology, 2000
Aims: A new real-time PCR assay that simultaneously amplifies a 102-bp fragment of the cagE gene from Helicobacter pylori and a new internal positive control containing a specific sequence of the gyrB gene from Aeromonas hydrophila, was developed and validated for the detection of H. pylori in environmental samples. Methods and Results: The specificity, limits of detection and quantification, repeatability, reproducibility, and accuracy of the method were calculated. The resulting values confirmed the applicability of the method for the quantitative detection of H. pylori. The feasibility of the method was also evaluated by testing 13 pyloric antrum-positive biopsies and 69 water samples, including potable (10), surface (19) and wastewater (40) matrices. The results showed that all the biopsies and 3 of the 40 wastewater samples analysed were positive. Conclusions: This real-time PCR method provides a sensitive, specific, and accurate method for the rapid quantification of H. pylori in environmental samples. Significance and Impact of the Study: The PCR diagnostic system proposed in this work, provides a suitable tool for the quantitative detection of H. pylori in environmental samples and can be useful for verifying the role of water as a potential route of its transmission.
2004
Helicobacter pylori infection and peptic ulcer disease are common in developing countries, e.g., Vietnam. An enzyme-linked immunosorbent assay (ELISA) for screening of patients and for seroepidemiology is a useful tool but needs to be validated in the population studied. We used in-house ELISA with sonicated Swedish and Vietnamese strains as antigens to measure immunoglobulin G antibodies after absorption with sonicated Campylobacter jejuni in sera from 270 H. pylori culture-confirmed peptic ulcer patients, 128 Swedish ureabreath test and immunoblot-positive healthy controls, and 432 Vietnamese immunoblot-positive population controls. Sonicated whole-cell antigen based on the local strains showed a significantly better performance. Immunoblot-positive peptic ulcer patients had significantly higher antibody concentrations than immunoblotpositive population controls, necessitating a lower cutoff level if serology is used for screening or epidemiological purposes. The study shows that the parameters of ELISA for H. pylori need to be adjusted for the population being investigated.
Acta paediatrica Taiwanica = Taiwan er ke yi xue hui za zhi
To investigate the prevalence of Helicobacter pylori (H. pylori) infection in adolescents and children in Changhua and to compare the differences between urban and rural areas, we used enzyme immunoassay to detect H. pylori stool antigen for feco-prevalence study. In addition, a questionnaire was designed to obtain demographic and clinical information. Children and adolescents under 18 years of age living in Changhua city and Yung-Chin village were divided into 6 groups respectively, ie. 0-3, 3-6, 6-9, 9-12, 12-15, and 15-18 years. A minimum of 30 persons were investigated in each group. A total of 567 subjects (M/F 295/272) were included in this study. There was no significant difference in H. pylori infection with regard to residential area, gender, education of the mother, occupation of parents, family history of peptic ulcer, and number of family members, except for epigastralgia of the subjects (p=0.001) and education of the father (p=0.039). The overall prevalence was 13.75%. ...
2003
OBJECTIVE: To evaluate the accuracy of a rapid assay that was developed to detect Helicobacter pylori antigen in the stool, using the principle of immunochromatography, in the Chinese population. METHODS: Eligible patients without prior treatment of H. pylori were recruited. An in-house rapid urease test (RUT) and histology were used as the gold standard. The results of the rapid stool antigen test were compared with the gold standard. RESULTS: Valid rapid stool antigen test results for interpretation were obtained from 94 consecutive patients (mean age: 52.5, range: 22-82 years). Sensitivity, specificity, positive predictive value, negative predictive value and accuracy were, respectively, 77.5%, 87.0%, 81.6%, 83.9% and 83.0%. The test was easy to perform and results were available within 15 min. CONCLUSION: The rapid stool antigen test using immunochromatography accurately diagnoses H. pylori infection in Chinese patients.
Clinical Microbiology and Infection, 2006
Most commercial kits for the detection of Helicobacter pylori were developed and validated with Western populations, and some have been found to perform less well with Asian populations. This study compared the performances of three serological kits with Swedish and Vietnamese peptic ulcer patients and asymptomatic individuals. The Pyloriset EIA-GIII and HM-CAP ELISA kits indicated that Asian populations had lower antibody titres to H. pylori than European populations. Despite the difference, the Pyloriset EIA-GIII kit performed well with Vietnamese peptic ulcer patients and population controls. The HM-CAP ELISA kit had a significantly lower performance with Asian populations that could not be improved by adjustments to the cutoff level. The Helicoblot 2.1 immunoblot kit performed equally well with Vietnamese and Swedish populations, although the response rate to the 35-kDa band was significantly lower with Vietnamese individuals.
Helicobacter pylorus (H. Pylori) is one of the most important human pathogens, infecting more than 50% of the human population. Commonly the first noninvasively testes used for H. pylori infection's detection were immunological tests like blood antibody test and stool antigen test. We investigated the more efficient susceptibility immunological test for detection of H.pylori infection in adult Egypti an patients by comparing the results of H. Pylori IgA (HpIgA), IgG in serum blood (HpIgG) and H.pylori Ag in stool(HpSAg) for 30 adult patient (males and females) against control group using ELISA technique. The results showed that each test could be used successfully for diagnosis of H. pylori with 100% specifity and PPV% with no gender relation. Finally HpSAg showed reliable results with high sensitivity (> 95%) followed by HpIgG (87.5%), while HpIgA showed the lowest sensitivity (37.5%). Our findings con firms the use of the mentioned immunological tests for detecting the H. Pylori infection and suggest the use H. Pylori Ag in stool as the most economic, sensitive and reliable method alone or followed by IgG antibody test as confirmatory test to be the f irst choices for early diagnosis of H. Pylori espe cially in developing countries.