Use of a novel enzyme immunoassay based on detection of circulating antigen in serum for diagnosis of Helicobacter pylori infection

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.     

Correlation of serum antibody titres with invasive methods for rapid detection of Helicobacter pylori infections in symptomatic children

Helicobacter pylori (H. pylori) is causally associated with peptic ulcer disease and gastric carcinoma. Typically, children get infected during the first decade of life, but diseases associated with H. pylori are seen mainly in adults. Multiple diagnostic methods are available for the detection of H. pylori infection. The aim of this study was to evaluate the correlation and diagnostic accuracy of three invasive methods [rapid urease test (RUT), histology and bacterial culture] and one non-invasive method (IgG serology) for diagnosis of H. pylori infection in a prospective cohort study conducted on 50 symptomatic children between two and eighteen years of age. Endoscopies with gastric biopsies were performed for RUT, culture and histopathological examination, respectively. IgG antibodies were measured in patient sera using a commercially available enzyme-linked immunosorbent assay (ELISA). RUT and positive H. pylori IgG antibodies were concordant in 88% (44/50) of patients. Both tests were negative in 32% (16/50), and both were positive in 56% (28/50). Disagreement occurred in 12% (6/50) of the patients: three of them (6%) had positive RUT and negative H. pylori IgG, and another three (6%) had negative RUT and positive H. pylori IgG. A combination of RUT with non-invasive serology constituted the optimum approach to the diagnosis of H. pylori infection in symptomatic children. The non-invasive serological test (ELISA) could not be used alone as the gold standard because it cannot distinguish between active and recently treated infection; and bacterial culture could not be used alone because of its low sensitivity.     

Serological detection of Helicobacter pylori antibodies in children and their parents.

The antibody response to Helicobacter pylori was examined in 56 children (ages 5 to 18) to determine whether serological tests can be used for diagnosis. Twenty-four children (43%) were H. pylori positive and 32 children (57%) were H. pylori negative by culture and histological examination of endoscopic biopsy specimens. The immune response was also examined in 39 nonendoscoped parents of the children. H. pylori-specific immunoglobulin G (IgG) and IgA antibodies were detected by the flow microsphere immunofluorescent assay (FMIA). IgG was also detected by using the Pyloristat enzyme-linked immunosorbent assay (ELISA). The sensitivity, specificity, and positive and negative predictive values for the FMIA for IgG were 100, 97, 96, and 100%, respectively. The respective values for the Pyloristat ELISA for IgG were 96, 94, 92, and 97%. The respective values for the FMIA for IgA were 50, 100, 100, and 73%. Both assays identified the same 19 parents as IgG positive, while FMIA identified 17 of the 19 parents as IgA positive.     

Detection by enzyme immunoassay of serum immunoglobulin G antibodies that recognize specific Cryptosporidium parvum antigens

Human infection with Cryptosporidium parvum usually elicits characteristic immunoglobulin G (IgG), IgA, and IgM antibody responses against two sporozoite surface antigens with apparent molecular masses of approximately 27 and 17 kDa. We have determined that these two antigens are actually complex families of related antigens. We have developed two new enzyme-linked immunosorbent assays (ELISAs) for the detection and quantitation of serum IgG antibodies against both antigens. The assays utilize a recombinant form of the 27-kDa antigen and a partially purified native fraction isolated from sonicated whole oocysts that contains 17-kDa antigen. An immunoblot assay previously developed in our laboratory served as the reference, or "gold standard," seroassay for the assessment of the new ELISAs. Positive responses with the recombinant-27-kDa-antigen ELISA were correlated with the immunoblot results for the 27-kDa antigen, with a sensitivity and specificity of 90 and 92%, respectively. Similarly, positive responses with the partially purified native-17-kDa-antigen ELISA correlated with the immunoblot results for the 17-kDa antigen, with a sensitivity and specificity of 90 and 94%, respectively. For both ELISAs the median IgG antibody levels for serum sets collected during outbreaks of waterborne C. parvum infection were at least 2.5-fold higher than the levels determined for a nonoutbreak set. Using the immunoblot as the "gold standard," the new ELISAs were more specific and, in the case of the 27-kDa-antigen ELISA, more sensitive than the crude oocyst antigen ELISA currently in use. These assays will be useful in future epidemiologic studies.     

Diagnosis of Helicobacter pylori infection by using pyloriset EIA-G and EIA-A for detection of serum immunoglobulin G (IgG) and IgA antibodies.

We evaluated the performance of new enzyme immunoassay (EIA) kits (Pyloriset; Orion Corporation, Orion Diagnostica, Espoo, Finland) for the detection of immunoglobulin G (IgG) and IgA antibodies to Helicobacter pylori in serum. Serum samples from 195 patients with upper abdominal complaints were collected. Biopsy specimens of the gastric mucosae were taken for histological analysis and bacterial culture. The sensitivity, specificity, and positive and negative predictive values, and efficacy of the Pyloriset EIA-G in detecting IgG antibodies to H. pylori were 92, 84, 88, 90, and 89%, respectively, when compared with those of the reference methods used. The corresponding data for detection of IgA antibodies were 80, 89, 89, 79, and 84%, respectively. The overall prevalence of defined H. pylori positivity was 54%. Moreover, the antibody tests showed a very good correlation with the biopsy findings. IgG antibodies were found in 93% of sera from patients with documented gastritis and H. pylori positivity, whereas only 4% of the sera from patients with documented gastritis and H. pylori-negative patients was positive. The results obtained for IgA antibodies were 81 and 6%, respectively. We conclude that the Pyloriset EIA-G, the test for IgG antibodies, is a good and reliable test for the detection of antibodies to H. pylori and as an indication of H. pylori infection. The determination of IgA antibodies may be used as a test that complements the IgG antibody assay.     

Comparison of PCR and other diagnostic techniques for detection of Helicobacter pylori infection in dyspeptic patients.

A sensitive and specific PCR-based assay to detect the Helicobacter pylori 16S rRNA gene present in formalin-fixed paraffin-embedded gastric biopsy specimens has been developed. A total of 95 patients with dyspepsia were evaluated for the presence of chronic active gastritis and an infection with H. pylori through the use of diagnostic assays based on biopsy specimens and serology. The "gold standard" for the presence of the bacteria was direct detection in histological sections of biopsy specimens by Giemsa stain. The results obtained with the PCR assay performed on the biopsy specimens (94% sensitivity and 100% specificity) were equivalent to the detection of H. pylori immunoglobulin G antibodies by the commercially available second-generation Cobas Core anti-H. pylori immunoglobulin G enzyme immunoassay (94% sensitivity and 98% specificity) for the diagnosis of H. pylori infection. Urease testing and bacterial culture of the biopsy specimens were inferior (88 and 70% sensitivity and 96% and 98% specificity, respectively). A Western blot (immunoblot) analysis had slightly greater sensitivity (96%), although specificity was reduced to 93%. This research prototype PCR assay was shown to be highly reliable for the detection of infection with H. pylori and the presence of chronic active gastritis in the population studied.     

Diagnosis of Helicobacter pylori infection by specific gastric mucosal IgA and IgG pylori antibodies.

AIMS--To investigate the diagnostic value of mucosal IgA and IgG Helicobacter pylori antibodies. METHODS--The study population comprised 209 consecutive patients with severe dyspeptic complaints referred for upper gastrointestinal endoscopy. A positive culture or histological identification of H pylori in gastric biopsy specimens, or both, were used to confirm infection. Specific IgA and IgG H pylori antibodies were determined using a modified ELISA technique. RESULTS--Of the 209 patients, 137 were infected with H pylori. The diagnostic value of systemic IgA and IgG H pylori antibodies was confirmed. Systemic IgA antibodies had a sensitivity of 76.6% (95% confidence interval 69.5-83.7) and a specificity of 94.4% (89.1-99.7). The sensitivity and specificity for systemic IgG antibodies were, respectively, 97.1% (94.3-99.9) and 98.6% (95.9-100). A moderate but clinically important correlation was found between local and systemic IgA and IgG. Mucosal IgA H pylori antibodies had a sensitivity of 98.5% (96.5-100) and a specificity of 91.7% (85.3-98.1), while for IgG these figures were, respectively, 88.3% (82.9-93.7) and 98.6% (95.9-100). As a diagnostic test mucosal IgA H pylori antibodies were comparable with culture and histology. CONCLUSION--Determination of local IgA and IgG H pylori antibody levels is a highly sensitive and specific test for the diagnosis of H pylori infection.     

Isolation and preliminary evaluation of a low-molecular-mass antigen preparation for improved detection of Helicobacter pylori immunoglobulin G antibodies.

Previously, immunoglobulin G (IgG) antibodies to five antigens with a relative molecular mass of between 15 and 30 kDa from Helicobacter pylori were found to be significantly more frequent in H. pylori-infected patients than in noninfected patients. In this study, these specific low-molecular-mass (LMW) antigens were separated by ultrafiltration of whole-cell sonicates. The LMW antigen preparation was evaluated by enzyme-linked immunosorbent assay with serum samples from 76 children with abdominal symptoms and 151 adults with dyspeptic symptoms. H. pylori was cultured or seen in 40 (53%) children and 83 (55%) adults. Increased antibody levels to H. pylori were found in serum from 35 (46%) children and 88 (58%) adults. Values for sensitivity, specificity, and predictive value of positive and negative results of the test were higher with LMW antigens than with the heat-stable antigen previously described. The low specificity and predictive value of a positive result were due to seropositive results for 21 persons with a negative culture for H. pylori and negative microscopy results for Helicobacter-like organisms in biopsies from gastric mucosa. Histologically, chronic gastritis was demonstrated in 43% of these persons, and 19% had peptic ulcer, indicating that they have or have had H. pylori infection. Specific antibodies to H. pylori were confirmed in all 21 patients by the Western immunoblot technique. Use of the LMW antigen improved the IgG antibody detection in patients with H. pylori infection, even though the results reflect the difficulties in establishing a true gold standard for diagnosis of H. pylori infection.     

Salivary immunoglobulin G assay to diagnose Helicobacter pylori infection in children.

An in-house enzyme-linked immunosorbent assay (ELISA) for measurement of Helicobacter pylori-specific immunoglobulin G (IgG) and IgA in saliva was evaluated by comparison with histopathologic (Giemsa staining) and biochemical (urease quick test) examination of gastric biopsy specimens obtained from 112 children referred for diagnostic gastroscopy. Serum H. pylori IgG was also measured in a subgroup of 50 children by the same ELISA. Salivary H. pylori IgG levels were significantly higher in H. pylori-positive (n = 57) than in H. pylori-negative (n = 55) children (P < 0.001). The sensitivity and specificity of the salivary IgG test were 93 and 82%, respectively; the positive and negative predictive values were 84 and 92%, respectively; and the accuracy was 87.5%. Salivary H. pylori IgA did not distinguish H. pylori-positive from H. pylori-negative children. The performance of serum H. pylori IgG was slightly (3 to 6%) better than that of salivary H. pylori IgG. The salivary IgG test can be considered a useful tool for the screening of H. pylori infection in children.     

Immunoblot analysis of immune response to Campylobacter pylori and its clinical associations.

Systemic immune response to Campylobacter pylori was detected by the immunoblot technique in serum samples from 200 patients, 129 blood donors, and 96 children. The results of the IgG immunoblot test showed excellent correlation with the detection of C pylori by culture and also with histopathological examination of the antrum, as well as with peptic ulcer disease. An IgA response also occurred and gave results comparable with those of the IgG immunoblot test, although on a quantitatively lower scale. The IgM immunoblots were of no help in the serodiagnosis of C pylori infection. The protein bands that seemed to be the most specific for C pylori and which were consistently observed in patients positive for C pylori were a 110 kilodalton and a 63 kilodalton band on the IgG immunoblot and an 89 kilodalton band on the IgA immunoblot. A 94 kilodalton and a 28 kilodalton band were also included in the evaluation. While immunoblot analysis may be used effectively for the serodiagnosis of C pylori infection and can distinguish between patients with normal antrum mucosa and those with gastritis, the test does not help to distinguish between those patients with antrum gastritis who subsequently develop peptic ulcers and those who do not.     

Monoclonal antibody-based capture enzyme immunoassays for specific serum immunoglobulin G (IgG), IgA, and IgM antibodies to respiratory syncytial virus

Monoclonal antibodies (MAbs) to the fusion protein (F), attachment protein (G), and nucleoprotein (N) of respiratory syncytial (RS) virus were evaluated for use as detector antibodies in immunoglobulin G (IgG), IgA, and IgM capture enzyme immunoassays. MAb assays were tested against assays using polyclonal antibodies (PAbs) with serum specimens from patients with and without evidence of recent RS virus infection. Assays developed with N MAbs were comparable to or better than PAb assays for detecting specific IgG and IgM antibodies but were somewhat less sensitive for IgA. F MAb assays were less sensitive for IgG and IgM antibodies but identified specific IgA in some specimens negative by N MAb assay. G MAb assays were insensitive for IgG and IgM antibodies but did detect about 50% of the IgA antibodies identified by the PAb assay. The basis for the low sensitivity of the G MAb assays is unclear, since many of these specimens were positive for IgG antibodies to G by Western immunoblot. The sensitivity of MAb assays varied with patient age: N MAb assays detected specific antibody responses to RS virus in all immunoglobulin classes in both adults and infants less than 1 year of age, F MAb assays detected specific IgG responses in adults and IgA responses in both adults and infants, and G MAb assays only detected IgA responses in adults. A mixture of N and F MAbs was complementary overall, identifying 54 of 55 (IgG), 51 of 52 (IgA), and 16 of 17 (IgM) serum specimens positive by PAb assay. These MAb assays were also specific with specimens tested from persons without a history of recent RS virus infection. The availability of these MAb-based assays offers other laboratories the opportunity to have long-term, standardized reagents and tests for serological diagnosis of RS virus infection.     

Evaluation of the novel Helicobacter pylori ClariRes real-time PCR assay for detection and clarithromycin susceptibility testing of H. pylori in stool specimens from symptomatic children

The aim of the present study was to evaluate the Helicobacter pylori ClariRes assay (Ingenetix, Vienna, Austria) for the detection of H. pylori infection and the simultaneous clarithromycin susceptibility testing of the H. pylori isolates in stool samples from 100 symptomatic children. The results obtained by this novel biprobe real-time PCR method were directly compared with the results obtained from histological examination of gastric biopsy specimens, culturing, the [13C]urea breath test, and a monoclonal antibody-based stool antigen enzyme immunoassay (EIA). Fecal specimens from all 54 children who were shown to be noninfected by "gold standard" tests gave true-negative PCR results (specificity, 100%). Of the remaining 46 individuals with a positive H. pylori status, 29 were found to be positive by real-time PCR (sensitivity, 63%). For these 29 cases, the H. pylori ClariRes assay confirmed all results from phenotypic clarithromycin susceptibility testing by Etest. In summary, this investigation demonstrates that detection of Helicobacter DNA in stool samples by real-time PCR is a difficult task and that this method cannot replace the stool antigen EIA (sensitivity, 95.7%) for the accurate diagnosis of H. pylori infection in children.     

Serodiagnosis of Helicobacter pylori infection by immunoblot assay

We compared a noninvasive serological test using a commercial immunoblot assay (Helicoblot 2.0) to tissue-based methods [rapid urease test (CLO test), histology and culture] in eighty Thai patients undergoing upper endoscopy. A true positive test was defined as at least two of the biopsy-related tests being positive. The CLO test was the most accurate test with sensitivity and specificity as high as 100%, whereas histology and culture had sensitivity of 100% and 72.2%, respectively, and the specificity of 72.7% and 96%, respectively. The serological test had a high sensitivity (97.2%) but exhibited an unsatisfactory specificity (40.9%). We concluded that the rapid urease test using multiple gastric biopsies was the most appropriate method for diagnosing H. pylori status. The role of immunoblot assay as a serological screening test in our population remains doubtful, but it may identify patients who have been infected with certain strains of H. pylori.     

Serological differentiation of Helicobacter pylori CagA(+) and CagA(-) infections

Many Helicobacterpylori strains causing gastroduodenal diseases have a cagA gene encoding CagA protein, a virulence factor of these bacteria. Anti-CagA antibodies produced by the majority of people infected with CagA(+) strains can indicate such an infection. In this study, the efficacy of three immunoenzymatic tests for detecting CagA(+) and CagA(-) infections were compared: immunoblot (Milenia ID Blot H. pylori IgG; MB) and ELISA conducted either with a recombinant immunodominant fragment of CagA (rCagA) or the full-length CagA molecule (flCagA). The 13C-urea breath test (13C-UBT) was used for establishing H. pylori status. The serum samples from 157 individuals were used for serodiagnosis. H. pylori CagA(+) infection was detected in H. pylori-infected individuals with similar frequencies by MB (64%) and flCagA-ELISA (60%) and a little less frequently by rCagA-ELISA (53%). There was a high coincidence between the negative results of these three tests for H. pylori-uninfected individuals with no anti-CagA IgG in the serum (96-100%). The results show that rCagA-ELISA and, especially, flCagA-ELISA are easy, inexpensive and useful noninvasive assays for the discrimination of CagA(+) and CagA(-) H. pylori infections in subjects examined by urea breath test.     

Evaluation of two commercial enzyme immunoassays, testing immunoglobulin G (IgG) and IgA responses, for diagnosis of Helicobacter pylori infection in children

Serological testing to diagnose Helicobacter pylori infection in children is still controversial, although commonly used in clinical practice. We compared the immunoglobulin G (IgG) and IgA results of two commercially available enzyme immunoassays (EIAs) (Pyloriset IgG and IgA and Enzygnost II IgG and IgA) for 175 children with abdominal symptoms divided into three age groups (0 to < or =6 years, n = 47; >6 to < or =12 years, n = 77; >12 years, n = 51). A child was considered H. pylori infected if at least two of three tests (histology, rapid urease test, 13C-urea breath test) or culture were positive and noninfected if all results were concordantly negative. Of 175 children, 93 (53%) were H. pylori negative and 82 were H. pylori positive. With the recommended cutoff values, the overall specificity was excellent for all four EIAs (95.7 to 97.8%) regardless of age. Sensitivity varied markedly between tests and was 92.7, 70.7, 47.5, and 24.4% for Enzygnost II IgG, Pyloriset IgG, Enzygnost II IgA, and Pyloriset IgA, respectively. Sensitivity was low in the youngest age group (25 to 33.3%), except for Enzygnost II IgG (91.6%). Receiver-operating curve analyses revealed that lower cutoff values would improve the accuracy of all of the tests except Enzygnost II IgG. Measurement of specific IgA, in addition to IgG, antibodies hardly improved the sensitivity. The specificity of commercial serological tests is high in children when the cutoff values obtained from adults are used. In contrast, sensitivity is variable, with a strong age dependence in some, but not all, tests. We speculate that young children may have a different immune response to H. pylori, with preferable responses to certain antigens, as well as lower titers than adults. The Pyloriset test may fail to recognize these specific antibodies.     

Comparison of three commercially available peptide-based immunoglobulin G (IgG) and IgA assays to microimmunofluorescence assay for detection of Chlamydia trachomatis antibodies

Three commercially available, peptide-based enzyme-linked immunosorbent assay (ELISA) systems (Chlamydia trachomatis IgG and IgA EIA [CT-EIA; Labsystems OY, Helsinki, Finland], SeroCT IgG and IgA [SeroCT; Savyon Diagnostics Ltd., Ashdod, Israel], and Chlamydia trachomatis IgG and IgA pELISA [CT pELISA; Medac, Wedel, Germany]) were evaluated for the detection of serum immunoglobulin G (IgG) and IgA antibodies specific for Chlamydia trachomatis and compared to the "gold standard" assay, the microimmunofluorescence (MIF) assay. Serological responses were analyzed in 149 women aged 20 to 30 years. Cervical swabs obtained from these women were examined for C. trachomatis by PCR, and 43 were found to be positive. The overall seroprevalence rates detected by CT-EIA, SeroCT, CT pELISA, and the MIF assay were 42, 42, 35, and 39%, respectively, for IgG and 7, 7, 3, and 7%, respectively, for IgA. The IgG seroprevalence rates for the PCR-positive women were two to three times higher than those for the PCR-negative women, i.e., 72 versus 29%, 72 versus 29%, 47 versus 26%, and 74 versus 25% for CT-EIA, SeroCT, CT pELISA, and the MIF assay, respectively. After discrepancy analysis, the sensitivity, specificity, positive predictive value, and negative predictive value were calculated for the IgG assays; for CT-EIA they were 84.7, 98.6, 98.4, and 86.7%, respectively; for CT pELISA they were 71.4, 97.3, 96.2, and 78.3%, respectively; for SeroCT they were 84.7, 98.6, 98.4, and 86.3%, respectively; and for the MIF assay they were 79.2, 83.1, 98.3, and 83.1%, respectively. In conclusion, these peptide-based ELISA systems for the serological detection of C. trachomatis infection performed as well as the MIF assay. Since these tests are less time-consuming, less expensive, and easier to perform than the MIF assay, they might be useful in the serodiagnosis of chlamydial infection.     

Immune responses to Helicobacter pylori in children with recurrent abdominal pain.

The systemic immune response to Helicobacter pylori was examined in 69 children with recurrent abdominal pain and upper gastrointestinal symptoms. Twenty one (30%) children were histologically positive for H pylori. Eighteen of the 21 positive subjects and two H pylori negative subjects (one with normal mucosa, one with lymphocytic gastritis) were positive for H pylori IgG antibodies by enzyme linked immunosorbent assay (ELISA) (86% sensitivity, 98% specificity). In children with H pylori associated gastritis, there was a significant positive correlation (p less than 0.05) between IgG antibody titres and patient age. Intra-assay comparison of sera from histologically negative adults with those of histologically negative children showed that the cut off for positivity in the ELISA for adults was greater than that for children. Immunoblotting showed IgG positivity in 20 of the 21 patients with H pylori infection (95% sensitivity). Both ELISA and immunoblotting for IgA and IgM H pylori antibodies had poor discriminatory value for determining infection. Serological detection of H pylori IgG antibodies seems to be valuable in the assessment of children presenting with recurrent abdominal pain and other gastrointestinal symptoms, but assays must first be validated in paediatric populations.     

Evaluation of a Western blot technique (Helicoblot 2.1) for the diagnosis of Helicobacter pylori infection in children

AIM: We evaluated the performance of Helicoblot 2.1 which differentiates the reactivity to each of the various Helicobacter pylori antigens, and compared the results with those obtained by standard techniques (rapid urease test and histological examination of gastric biopsy) in symptomatic children of different ages living in Antalya, Turkey. METHODS: Eighty-eight children (mean age, 9.15 years) were divided into two groups. The first group included 66 children who were found to be infected with H. pylori. The second group included 22 children who were negative for H. pylori. Serum samples collected from all patients were tested for H. pylori IgG antibodies by immunoblot assay (Helicoblot 2.1). RESULTS: The sensitivity, specificity, positive and negative predictive values for detection of H. pylori infection were 80%, 100%, 100% and 85%, respectively. In children under 7 years of age, the sensitivity of the test was found to be lower than other age groups (P<0.05). No relationship was found between peptic ulcer and cagA antibody positivity (P>0.05). CONCLUSION: Helicoblot 2.1 is a useful non-invasive diagnostic tool for H. pylori infection in children over 6 years of age.     

Use of Helicobacter pylori-specific antibodies in the evaluation of intestinal metaplasia and gastric dysplasia

It is believed that Helicobacter pylori acts mainly during the initial phases of gastric carcinogenesis. Therefore, this study aims to assess the usefulness of H. pylori diagnosis in patients with chronic gastritis (CG), intestinal metaplasia (IM) and dysplasia--conditions that are associated with gastric cancer. A cross-sectional study of 94 patients was performed, which involved endoscopic biopsy and determination of specific serum anti-H. pylori antibodies (IgA, IgG and IgM) by enzyme-linked immunosorbent assay (ELISA). Biopsies were taken from the gastric antrum and corpus, and from endoscopic lesions. Two specimens per patient were used for bacterial culture. H. pylori infection status, used as the gold standard, was based on culture results. Validity measures were determined and receiver operating curve (ROC) was used to determine the best cut-off for serum antibody levels. Histopathological evaluation (n = 160) was performed independently by two pathologists. Lesions consistent with CG were found in 86 patients (91%), consistent with IM in 69 patients (73%) and with dysplasia in five patients (5%). In the 86 patients with CG, 38 (44%) were infected by H. pylori, as were 26 (38%) and one (20%) with IM and dysplasia, respectively (P=0.039). Area under the curve (AUC) was 0.40 (95% confidence interval [CI]: 0.28-0.51) for IgM, 0.69 (0.58-0.80) for IgA and 0.83 (0.74-0.92) for IgG for the diagnosis of H. pylori infection. Best cut-off was 41 u/mL for IgG, with a sensitivity (95% CI) of 90% (84-96%) and a negative predictive value (NPV) of 91% (85-97%). For IgA the results were 22 u/mL, 74% (65-83%) and 77% (68-86%), respectively. Prevalence of H. pylori appeared to decrease with increasing severity of the gastric lesion. In conclusion, it is suggested that non-invasive serological evaluation of anti-H. pylori (IgG) status after eradication therapy for peptic ulcer disease could be extended, after proper assessment of cut-off values and their validation, to the follow-up of patients with CG and IM.     

幽门螺杆菌粪便抗原检测方法学评价

目的 评价幽门螺杆菌粪便抗原（ HpSA）检测在诊断患者幽门螺杆菌（Hp）感染中的价值.方法 以胃镜病理学诊断结果为金标准,对328例有消化道症状患者粪便,同时应用酶联免疫吸附实验检测幽门螺杆菌粪便抗原,计算HpSA检测诊断Hp感染的特异性、灵敏度和准确性等性能指标.结果 幽门杆菌粪便抗原酶免疫检测法对Hp感染诊断与金标准相比无统计学差异（P＞0.05）,其敏感性为94.6％、特异性为96.9％、准确性为96.3％、阳性预期值为89.7％、阴性预期值为98.4％.结论 幽门螺杆菌粪便抗原酶免疫检测是一种简便、易行、准确性高、便宜、易重复的非侵入性检测方法.