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1.
BACKGROUND: A number of noncommercial preparations of urease test have been described. The present prospective study evaluated the accuracy of one such preparation for the diagnosis of Helicobacter pylori infection. METHODS: From February 1996 to November 1996, all patients undergoing elective upper endoscopy in a single endoscopy facility were included. Three antral biopsy specimens were taken. Two specimens were subjected to histologic examination, and one specimen was placed into a "locally made rapid urease test" (LRUT). Results of histologic examinations were taken as standards for comparison. The final result of LRUT was obtained on scrutiny of color changes at 4 hours after the start of the test. RESULTS: Two thousand three hundred sixteen patients (male/female = 1.5:1) with a mean age of 56.7 +/- 0.4 years were included. Five hundred sixty-two patients (24.3%) had a history of eradication treatment for H. pylori. Nine hundred fifty-three patients (41.1%) were found to be positive for H. pylori on histologic examination. In patients in whom a history of eradication therapy was absent, the sensitivity, specificity, and positive and negative predictive values of the LRUT were 92.8%, 97.6%, 97.5%, and 93.0%, respectively. In patients with a history of eradication treatment, the corresponding figures were 76.1%, 99.6%, 96.2%, and 96.9%. CONCLUSIONS: The locally made rapid urease test provides a simple, safe, rapid, inexpensive, and accurate test for the diagnosis of H. pylori infection.  相似文献   

2.
Helicobacter pylori infection can be detected by several invasive tests based on gastroscopy and by noninvasive methods such as serologic assays. Noninvasive tests can be used not only in addition to invasive tests but also by themselves to screen for H. pylori infection in patients who are not in urgent need of endoscopy. Lately, rapid qualitative serologic tests have been developed. In the present study, the accuracy of a novel rapid whole-blood test, Pyloriset Screen, detecting immunoglobulin G (IgG) and IgA antibodies against H. pylori was evaluated. A total of 207 consecutive adult outpatients referred for upper endoscopy were enrolled. Gastric biopsy specimens were taken from the antrum and corpus for histologic examination and rapid urease testing. Cultures were available for 113 patients. Serum samples collected from all patients were tested for H. pylori antibodies by two enzyme immunoassays (EIAs) (Pyloriset EIA and an in-house EIA), a rapid latex agglutination test (Pyloriset Dry), and Pyloriset Screen. Patients were considered H. pylori positive if helicobacters were seen on histologic examination (77 patients) or, if in combination with histologically verified (although helicobacter-negative) gastritis, their IgG antibody titers were elevated in the two EIAs (five patients). The Pyloriset Screen test had a sensitivity of 95%, a specificity of 94%, a positive predictive value of 91%, and a negative predictive value of 97%. Among 63 patients under the age of 45 years, the Pyloriset Screen test did not miss a single H. pylori diagnosis, and only 1 patient had a false-positive result. Pyloriset Screen could be used reliably to screen for H. pylori infection.  相似文献   

3.
OBJECTIVE: Rapid, inexpensive, reliable tests are needed to facilitate the diagnosis of Helicobacter pylori infection. We evaluated the accuracy of the new FlexSure HP whole blood test (SmithKline Diagnostics, Inc.), a rapid, qualitative in-office test for the detection of antibodies to H. pylori utilizing whole blood obtained from a fingerstick. METHODS: Five North American sites enrolled patients not previously treated for H. pylori who underwent upper endoscopy. Patients had not received antibiotics, bismuth, or proton pump inhibitors within 4 wk before study enrollment. Bacterial infection was established by the presence of H. pylori in gastric biopsies (minimum of two) or positive rapid urease test of antral tissue. The presence of IgG antibodies was determined using FlexSure HP whole blood tests with blood obtained by fingerstick and FlexSure HP serum and ELISA (HM-CAP) tests with serum obtained from venipuncture. RESULTS: Three hundred ninety-three patients were enrolled (56% male; mean age, 46.8 +/- 16.0 yr). H. pylori infection was present in 187 (48%). Compared with the standard of histology and rapid urease test, sensitivity for FlexSure HP whole blood, FlexSure HP serum, and HM-CAP EIA were, respectively, 84%, 90%, and 95% (p < 0.05 compared with FlexSure HP whole blood). There were no statistical differences in specificity or overall accuracy between the three tests. CONCLUSIONS: FlexSure HP whole blood demonstrated an accuracy not significantly different from the FlexSure HP serum test but had sensitivity significantly lower than the HM-CAP EIA. FlexSure HP whole blood may be useful for in-office H. pylori diagnosis.  相似文献   

4.
BACKGROUND: Detection of Helicobacter pylori is usually performed by culture, polymerase chain reaction (PCR), histology, or urease test on gastric biopsy samples. Although methods based on feces are non-invasive, their sensitivity has been relatively low. In this study, to improve its sensitivity, immunomagnetic separation (IMS) was used as a pre-PCR step for direct detection of H. pylori in feces. METHODS: Fresh fecal samples were taken from 72 patients attending for endoscopy. Of these, 57 patients had a positive H. pylori status according to the results of culture, histology, and PCR on gastric biopsy samples. Anti-H. pylori antibody-sensitized immunomagnetic beads were used to concentrate the bacteria. PCR was then performed to detect the H. pylori urease A-encoding gene. RESULTS: Of the 57 H. pylori-positive patients, 35 (61.4%) had positive fecal samples by IMS-based PCR method. None of the 15 H. pylori-negative patients had positive fecal samples. The sensitivity of this method was 61.4%, and the specificity 100.0%. CONCLUSIONS: This study confirms that non-invasive diagnosis of H. pylori infection could be made from feces by using IMS-based PCR.  相似文献   

5.
BACKGROUND: Serological rapid whole-blood tests for the detection of H. pylori are presently being promoted for use in primary care. We conducted a multi-center study to investigate the diagnostic accuracy of the Boehringer Mannheim Helicobacter pylori test (BM test), which is identical with the Cortecs Helisal test. PATIENTS AND METHODS: A previous diagnosis of H. pylori, a history of peptic ulcer diseases, or proton-pump inhibitor, bismuth or antibiotic use during the preceding month were exclusion criteria. The BM test was performed prior to endoscopy by 7 primary care physicians, 5 practicing gastroenterologists, or a single physician in the university hospital outpatient service. During endoscopy, antral and corpus biopsies were obtained for histology and rapid urease testing (RUT). H. pylori positivity was defined by histology and/or RUT as reference methods. H. pylori IgG-ELISA was performed additionally. RESULTS: Of the 203 patients included, 151 were H. pylori-positive by reference methods (74.4%). The overall accuracy of the BM test was 77.3%. Eight BM tests were indeterminate, and in the other 195 patients the test performed as follows: sensitivity 80.3%, specificity 81.3%, positive predictive value 92.9%, negative predictive value 57.4%. Using IgG-ELISA as reference, the BM test performance was similar. It also did not differ substantially among the three groups of physicians involved. CONCLUSIONS: We found the performance of the BM test to be insufficiently accurate, as both over- and underdiagnosis of H. pylori infection were not infrequent. This test needs to be improved before its use in primary care can be recommended.  相似文献   

6.
OBJECTIVE: The accuracy of the PyloriTek test (a 1-h rapid urease test) used after eradication therapy of Helicobacter pylori (H. pylori) has not been well clarified. This study was done to evaluate the accuracy of the PyloriTek test results for cases with and without eradication therapy, using culture and histology as gold standard methods, and to establish the suitable timing of the PyloriTek test after eradication treatment. METHODS: One hundred sixty-three patients undergoing upper endoscopy were randomly selected; 100 patients had not received eradication therapy and 63 had. Three biopsy specimens each were obtained from the gastric antrum and the body for examination by PyloriTek, culture, and histology. The absence of H. pylori was established with negative results from both culture and histology. RESULTS: In cases without eradication therapy, PyloriTek, correctly identified 66 of 67 H. pylori-positive cases and 30 of 33 H. pylori-negative cases, yielding 98.5% sensitivity and 90.9% specificity. In cases with eradication therapy, PyloriTek gave correct diagnoses in 10 of 17 H. pylori-positive cases and in 45 of 46 H. pylori-negative cases, for 58.8% sensitivity and 97.8% specificity. However, when PyloriTek was used more than 4 months after the end of eradication therapy, both the sensitivity and the specificity increased to 100%. CONCLUSION: Considering time and cost, the use of PyloriTek alone may be satisfactory for detecting H. pylori infection in cases without eradication therapy. When patients are examined more than 4 months after intervention, the use of PyloriTek alone may be sufficient for correctly diagnosing H. pylori infections.  相似文献   

7.
OBJECTIVES: Gastric carcinoma is the world's second most common cancer. Recent studies suggest an association between Helicobacter pylori and gastric carcinoma. The aim of this study was to address the effects of H. pylori infection on gastric antrum mucosal cell proliferation. METHODS: Forty patients undergoing upper endoscopy for standard indications were included in the study. A rapid urease test was used to determine the presence of H. pylori. Epithelial cell proliferation was determined by immunohistochemical techniques utilizing monoclonal antibody to bromodeoxyuridine. RESULTS: There were no significant differences in the number of labeled cells and in the proliferation fraction (p > 0.1) when patients with H. pylori were compared with those without, and when those over the age of 50 were compared to those under 50. The presence of ulcers similarly had no effect (p > 0.1). CONCLUSION: Helicobacter pylori infection does not increase gastric antrum mucosal cell proliferation.  相似文献   

8.
The aim of this study was to evaluate the accuracy of the 14C-urea breath test by comparing the results to those obtained by endoscopy with mucosal biopsy. We also examined the value of the breath test result obtained prior to endoscopy in predicting peptic ulcer disease. Forty-two individuals underwent the 14C-urea breath test. Collections of expired C02 were analysed using a liquid scintillation counter. All individuals then underwent endoscopy with biopsy. Biopsy material was evaluated by the rapid urease method and by histology for the presence of H. pylori. Our results demonstrated that the 14C-urea breath test was 100% sensitive and specific when compared to the rapid urease test as the 'gold standard' for the detection of H. pylori. In comparison to pathology, the sensitivity remained 100% and the specificity was 89%. The results of the 14C-urea breath test had a poor predictive value for the determination of peptic ulcer disease. We conclude that the 14C-urea breath test can be easily performed at any medical facility equipped with a liquid scintillation counter and can accurately detect H. pylori. A negative breath test result could not exclude the presence of peptic ulcer disease.  相似文献   

9.
OBJECTIVES: Helicobacter pylori (H. pylori) is involved in the pathogenesis of gastric inflammatory disorders. Both antral chronic gastritis and H. pylori infection prevalence increase with age. The aim of the study was to assess the prevalence of H. pylori infection in young adults and to study the relationship between endoscopical and histological features and H. pylori infection. METHODS: The study concerned 547 young patients (age: 18-25 years), undergoing endoscopy for upper gastrointestinal symptoms. The severity and the activity of chronic gastritis was graded by histological examination of antral biopsies. The diagnosis of H. pylori infection was based on histology and culture or urease test. RESULTS: Fifty-three percent of the patients had a normal endoscopy; 44 ulcers were found: 34 duodenal ulcers and 10 gastric ulcers. H. pylori infection was detected in 34% of cases. The prevalence of H. pylori infection was 29.8% in non-ulcer patients, 50% in gastric ulcers and 91% in duodenal ulcers (P < 0.01). Duodenal ulcer, aspect of antral mosaic mucosa and nodular gastritis, were closely related to the presence of H. pylori. There was a significant relationship between H. pylori infection and both the severity (P < 0.01) and the activity (P < 0.01) of the antral chronic gastritis. The prevalence of follicular gastritis was 22% : it was present in 60% of H. pylori positive patients and 2.4% of H. pylori negative patients. H. pylori infection was more frequent in patients from Africa than in Europeans (P < 0.01). There was no significant association between H. pylori infection and different types of diets, settlements (rural vs urban) or symptoms. CONCLUSION: These results show that in the young population studied, duodenal ulcer, nodular gastritis, antral mosaic mucosa, active chronic gastric and follicular gastritis are closely related to H. pylori infection. They suggest that in the subgroup of non ulcer symptomatic patients, H. pylori prevalence is higher than in the general population.  相似文献   

10.
Consecutive Chinese patients undergoing endoscopy for dyspepsia were tested for Helicobacter pylori infection by two rapid whole-blood tests: FlexPack HP (Abbott Laboratories) and Helisal One-Step (Cortecs Diagnostics). Biopsy-based tests (rapid urease test and histology) and the [13C]urea breath test were used as the "gold standard." One hundred sixty-one consecutive patients were studied, and 88 (54.7%) were confirmed to have H. pylori infection. The sensitivities, specificities, and positive and negative predictive values were 81.8%, 83.6% (P = 0.008), 85.7% (P = 0.04), and 79.2% for FlexPack HP and 84.1%, 63.0% (P = 0.008), 73.3% (P = 0.047), and 76.7% for Helisal One-Step, respectively.  相似文献   

11.
The 13C-urea breath test (13C-UBT) is a non-invasive method for detecting Helicobacter pylori. This study was performed to determine the cutoff value and evaluate the sensitivity and specificity of 13C-UBT in Taiwan. 13C-Urea (100 mg of 99% 13C-labeled urea) was dissolved in 50 ml sterile water for the test. The test meal for delaying gastric emptying was 100 ml fresh milk. Patients fasted for at least 6h. A baseline breath sample was collected 5 min after they had the test meal. Two other samples were collected at 15 and 30 min after the patients ingested the 13C-urea. The test was evaluated in 352 patients after routine upper gastrointestinal endoscopy, and the urease test, culture, and histopathology were taken as the gold standards for detecting H. pylori. According to the receiver operating characteristic (ROC) curves, we chose values of 2.8 and 4.2 excess delta 13CO2 per mil as the cut-off values for 15 and 30 min, respectively, post 13C-urea. The sensitivity and specificity of 13C-UBT were 99% and 93% at 15 min, and 98% and 93% at 30 min post 13C-urea, respectively. The 13C-UBT breath test is an efficient non-invasive method of high sensitivity and high specificity for detecting H. pylori infection. We suggest that the use of fresh milk as the test meal and the detection of excess delta 13CO2 15 min after the ingestion of 13C-urea are suitable for the clinical use of 13C-UBT. This test is simple and rapid.  相似文献   

12.
Helicobacter pylori infection has been associated with stimulation of gastric mucosal reactive oxygen metabolite production. To provide further evidence of a causal relationship we looked for a dose-response relationship. We studied antral biopsy material from 110 patients. Quantitative H. pylori assessments were made using histologic and microbiologic methods. Reactive oxygen metabolite production was measured by luminol-dependent chemiluminescence. The usefulness of timed urease test colour changes as a guide to infective load was assessed. There was a positive association between mucosal reactive oxygen metabolite production and histologic (p = 0.002, n = 69) and microbiologic (Spearman's R = +0.6, p = 0.05, n = 18) quantitative H. pylori assessments. H. pylori infective load varied markedly over small areas (coefficient of repeatability of paired cultures (in colony-forming units/mg) = 1.9 x 10(6). Urease test timing correlated with histologic (p = 0.01) and microbiologic (p = 0.03) H. pylori quantitation. Histologically assessed mucosal damage was related to quantitative H. pylori assessment and to mucosal reactive oxygen metabolite production (p = 0.0001). These results support the hypothesis that H. pylori stimulates gastric mucosal reactive oxygen metabolite production and that this phenomenon is of pathogenic importance.  相似文献   

13.
Helicobacter pylori gastric infection in children is a public health problem. Classical diagnostic tools such as endoscopy are excessively invasive in the usual clinical context. Serology at this age has multiple drawbacks. The urea-13C breath test seems today the most appropriate alternative method. The principle of the test relies upon the indirect detection of H pylori through its high urease activity. The test uses a stable (ie, non radioactive) isotope, which allows its repeated use. The main indications are the detection and the follow-up of H pylori infection.  相似文献   

14.
BACKGROUND: To describe the prevalence of Helicobacter pylori infection in patients with reflux esophagitis, and compare it with that in patients with normal endoscopy. METHODS: Fifty-five patients with endoscopic peptic esophagitis and 55 symptomatic patients with normal endoscopy were studied. Age and sex distribution were similar in both groups. At endoscopy biopsy specimens were taken from gastric antrum and body (H & E, Gram stain and culture). RESULTS: H. pylori was found in 74.5% (95% CI = 62-84%) of patients with reflux esophagitis, and in 76.4% (CI = 64-86%) of cases with normal endoscopy (a non-significant difference). In patients with esophagitis and H. pylori infection normal histologic antral mucosa was observed in 7.3% of cases (CI = 2.5-19.4%). In patients with normal endoscopy the corresponding figure was 4.8% (CI = 1.3-15.8%) (a non-significant difference). At gastric body from infected patients the percentages of patients with normal histologic mucosa was 29.3% (n = 12) and 23.8% (n = 10), in both groups respectively. CONCLUSIONS: The prevalence of H. pylori infection in patients with reflux esophagitis was 74.5%, and no difference was observed when comparing with infection rate in patients with normal endoscopy (76.4%). Therefore, a non-significant association was found between this esophageal disorder and H. pylori infection.  相似文献   

15.
Helicobacter pylori: the mouth, stomach, and gut axis   总被引:1,自引:0,他引:1  
The aim of this study was to identify the natural reservoir and route of transmission of Helicobacter pylori infection. Two hundred eight (208) dyspeptic patients (114 males, 94 females; peak age of cohort, 50-59.9) were recruited. Specimens were collected from saliva, supra- and subgingival dental plaque, tongue scrapings, and oropharyngeal swabs. At subsequent endoscopy, gastric antral biopsy was performed for the rapid urease test (RUT), microbiological culture, and, in some patients, histology. Gastric juice samples were aspirated, and in 50 patients duodenal aspirate was collected. Polymerase chain reaction (PCR) with primers targeted to the 16S rRNA sequence of H. pylori was also employed for each of the specimens. In those patients where H. pylori was detected from multiple sites (dental plaque, gastric juice, gastric biopsy, and duodenal aspirate), restriction endonuclease digestion with Hae III was performed to determine if they were epidemiologically linked. The results indicated that 15/208 patients (7%) tested positively for H. pylori by PCR in dental plaque; only 2 samples were positive by culture. In none of the other oral sites sampled was H. pylori detected by any test used in the study. Gastric juice and gastric biopsy specimens from 36/ 208 patients (17%) and 114/208 patients (55%), respectively, were positive by PCR. Duodenal aspirate from 6/50 patients (12%) also tested positively by PCR. All specimens tested by restriction endonuclease digestion with Hae III (15/15 patients) were positive in both antral biopsy and gastric juice specimens, as well as 5 specimens from the duodenal aspirate. Four of the dental plaque strains had restriction patterns similar to those of the stomach and duodenal sites, providing evidence that these sites were infected with the same strain of H. pylori. In conclusion, the results suggest that H. pylori selects the gastric mucosa as its preferred site. The detection in dental plaque could indicate that the oral cavity may act as a reservoir or sanctuary for the organism. Whether H. pylori is a resident or transient oral microorganism is still unclear, although it is more likely to be transient in nature.  相似文献   

16.
C-X-C Chemokines play an important role for neutrophil extravasation through microvessels. Although the level of interleukin (IL)-8 is known to increase in the Helicobacter pylori-infected gastric mucosa, another C-X-C chemokine, GROalpha, has not been evaluated in the H. pylori-associated gastric mucosal injury. The present study was designed to investigate gastric contents of GROalpha in relation to those of IL-8 in the gastric mucosa of H. pylori-infected peptic ulcer patients. Thirty-eight patients with gastric ulcer and 41 with gastritis underwent endoscopy with informed consent and 49 were found to be H. pylori positive and 30 H. pylori negative. Biopsies from the gastric corpus were performed in each patient to examine the H. pylori colonization by bacterial culture, the rapid urease test and histological specimens as well as measurement of the contents of human GROalpha and IL-8. Helicobacter pylori infection was eradicated in 21 patients by triple therapy (lansoprazole 30 mg, amoxycillin 2.0 g, clarithromycin 600 mg; 2 weeks). The samples for GROalpha and IL-8 assay were homogenized in 0.02% aprotinin containing phosphate-buffered solution and the mucosal contents of GROalpha and IL-8 in the supernatants were quantified by sandwich enzyme immunoassay methods. The levels of GROalpha and IL-8 in H. pylori-positive gastric mucosa were significantly higher than those in the H. pylori-negative mucosa. There was a significant linear correlation between the levels of GROalpha and IL-8 (r = 0.798, P < 0.01). After the eradication of H. pylori by the triple therapy, the levels of GROalpha and IL-8 were significantly decreased. The GROalpha showed an increase in the H. pylori-positive gastric mucosa in a similar fashion as IL-8 contents, suggesting a pathogenetic role for GROalpha in H. pylori-associated gastric mucosal injury.  相似文献   

17.
Endoscopic evaluation of the presence or absence of gastritis is often performed in lieu of biopsy and histologic diagnosis. The purpose of our study was to assess the value of endoscopic examination as a diagnostic test for gastritis. Two endoscopists prospectively assessed the antrum of 73 patients undergoing upper gastrointestinal endoscopy and graded, on a scale of 0-4 (0 = completely absent, 4 = definitely present), the likelihood of gastritis. The following features were also assessed at the time of endoscopy: erythema, nodularity, erosion, edema, and friability. Two concomitant antral biopsies (3 cm from the pylorus on the greater curvature of the stomach) were performed regardless of the endoscopic impression. The histologic findings were graded independently on a scale of 0-3 by two pathologists who were not aware of the endoscopic findings. The following histologic features were graded: acute inflammation, chronic inflammation, lymphoid aggregates, intestinal metaplasia, and quantity of Helicobacter pylori organisms. Receiver operator characteristic analysis, a method derived from signal detection theory, assesses the trade-off of sensitivity and specificity over all cutoff points of a test and is considered the best method by which to compare tests and determine the diagnostic utility of a given test. Receiver operator characteristic analysis gave an area of 0.65 +/- 0.01 SE for endoscopy as a test for gastritis (0.5 = chance, 1 = perfect) as defined by the histologic presence of inflammation. Additionally, endoscopy as a test for the presence of histologically proven Helicobacter pylori gave an area of 0.55 +/- 0.01 SE. All endoscopically graded features treated as separate tests for gastritis and/or H. pylori gave areas of approximately 0.44-0.61, indicative of a poor test. While H. pylori was always associated with at least some degree of inflammation, linear regression analysis revealed no correlation among any of the histologic features or of any histologic feature with any endoscopic feature. We conclude that a tissue diagnosis is essential for the proper diagnosis of gastritis.  相似文献   

18.
To clarify the prevalence of Helicobacter pylori infection in enlarged fold gastritis, serum immunoglobulin (Ig) G antibody to H pylori was determined in 19 patients with severely enlarged gastric body folds (the widest fold greater than 10 mm on the radiograph), 55 patients with moderately enlarged folds (6 to 10 mm) and 44 control subjects (5 mm or less). The prevalence of serum IgG antibody to H pylori in the severe (100%) and moderate groups (100%) was significantly higher than that in controls (34.1%) (P < 0.01). There were significant differences among the three groups in serum gastrin, pepsinogen I and pepsinogen II levels (severe had the highest levels, followed by moderate and then controls, P < 0.001). H pylori colonization in the gastric mucosa was confirmed by culture, urease test or both, and inflammation by hematoxylin and eosin stain in the 25 H pylori seropositive patients who underwent endoscopy and biopsy. Results suggest that H pylori infection is highly prevalent in enlarged fold gastritis. Further studies on enlarged fold gastritis and H pylori infection are needed.  相似文献   

19.
BACKGROUND/AIMS: The role of Helicobacter pylori in various gastroduodenal diseases is universally accepted. In this study, we aimed to determine the proper number and sites of the gastric biopsies in order to achieve the highest diagnostic yield through the use of a urease test and histopathology. We also compared the histological findings encountered in patients who had Helicobacter pylori (H. pylori) colonization. METHODOLOGY: Fifty patients referred for upper gastrointestinal endoscopy for dyspeptic complaints were included in the study. Our mapping protocol included 2 biopsies from antrum and 2 biopsies from corpus. We obtained 2 biopsies from each biopsy site for urease test and histopathological assessment. Golden standard positivity for the presence of H. pylori colonization was defined as concomitantly positive urease test and histologically detected bacteria found at the same biopsy site. RESULTS: Forty-three patients had H. pylori colonization. Colonization rates of H. pylori, sensitivities of urease testing, and histopathology in 4 biopsy sites were not statistically different. Sensitivity of urease testing was 81.4% for 1 biopsy and 100% for 4 cumulative biopsies. Sensitivities of histological assessment were 93% and 100% for 1 and 4 biopsies, respectively. CONCLUSIONS: Results of this study suggest that 2 biopsies for urease testing and 1 biopsy for histopathology obtained from the antrum or corpus of the stomach were sufficient to obtain the highest statistically significant diagnostic sensitivity.  相似文献   

20.
BACKGROUND: Rapid urease tests are commonly used as a convenient method to detect Helicobacter pylori infection. Our previous experiments demonstrated enhanced efficacy of agar gel rapid urease test compared with reagent strip rapid urease tests. We evaluated the efficacy of PyloriTek, a new reagent strip rapid test for detecting H. pylori infection. METHODS: Gastric antral mucosal biopsy specimens were obtained for comparison between agar gel rapid urease tests and PyloriTek (200 specimens). The rapid urease test to be used first was selected randomly. H. pylori status was determined using the Genta stain. Culture was performed to confirm H. pylori status when false rapid urease tests were suspected. RESULTS: One hundred patients were studied; 68 had H. pylori infection. There were two false-negative and one false-positive PyloriTek when scored at 1 hour, compared with only one false-positive and no false-negative tests at 2 hours. With the agar gel rapid urease tests, there were no false-positive tests and 5 false-negative tests when scored at 1 hour, 2 false-negative tests at 12 hours and 1 at 24 hours; there were no false-positive tests. At 1 hour, 3% (95% CI = 1% to 9%) of PyloriTek tests had an erroneous categorization of H. pylori status compared with 5% for the agar gel rapid urease tests (95% CI = 1.6% to 11%) (p > 0.7). CONCLUSION: The new reagent strip rapid urease test, PyloriTek, is rapid and comparable in accuracy to agar gel rapid urease tests for detecting H. pylori Infection.  相似文献   

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