Extending the reading time increases the accuracy of rapid whole blood test for diagnosis of <i>Helicobacter pylori</i> infection

Chen, Tseng‐Shing; Chang, Full‐Young; Lee, Shou‐Dong

doi:10.1046/j.1440-1746.2001.02630.x

Cited by 8 publications

(6 citation statements)

References 16 publications

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“…There were several studies demonstrating that the sensitivity of serological diagnosis of H. pylori infection was higher in the older group (Ն45 years) than in the younger group (Ͻ45 years) (2,7,20). Our study showing higher antibody levels in the older group in H. pylori-infected patients could explain this phenomenon, because the higher the antibody levels, the fewer false negatives there will be.…”

Section: Discussionmentioning

confidence: 43%

Immunoglobulin G Antibody against Helicobacter pylori : Clinical Implications of Levels Found in Serum

Chen

Chang

et al. 2002

Clin Vaccine Immunol

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The clinical significance of high levels of antibody against Helicobacter pylori is still unclear. We sought to evaluate whether the serum antibody levels could predict the presence of macroscopic gastroduodenal disease, to identify factors that correlate with antibody levels in a multivariate context, and to determine the predictive value of antibody levels for diagnosing H. pylori infection. The grades of gastritis and density of H. pylori colonization were scored separately using the updated Sydney system for antral and body mucosa. An enzymelinked immunosorbent assay (ELISA) for the quantitative detection in serum of IgG antibodies to H. pylori was performed. Of the 170 dyspeptic patients, 105 (62%) had H. pylori infection. There was no difference in antibody levels among endoscopic findings of normal mucosa, chronic gastritis, and duodenal ulcer. On multivariate linear regression analysis, the status of H. pylori infection, mononuclear cell infiltration of body mucosa, and age correlated with antibody levels. The negative predictive value for antibody levels of <30 U/ml is 94%, and the positive predictive value of antibody levels of >70 U/ml is 98%. We conclude that serum antibody levels do not predict the severity of gastroduodenal diseases or the density of H. pylori colonization in H. pylori-infected dyspeptic patients. Higher levels are associated with the presence of H. pylori infection, the chronic gastritis score of the corpus, and older age. Setting a gray zone is necessary for ELISA, since the accuracy in this zone does not allow a precise determination of H. pylori status.Helicobacter pylori has been established as an important etiological factor for chronic gastritis and duodenal ulcer (10,15,16). It is also associated with gastric ulcer and gastric cancer (4). As the test-and-treat policy for H. pylori infection is gradually being accepted by general practitioners, a simple, reliable, and noninvasive diagnostic test for H. pylori has become essential in clinical practice (5, 12). An easier and cheaper way to diagnose H. pylori infection noninvasively is to test for antibodies to the infection. Enzyme-linked immunosorbent assay (ELISA) has been the most commonly used serological test because it is suited for screening large populations (11, 13). Clinically, some patients are very concerned about contracting H. pylori infection when they are told they have high antibody levels. However, the clinical significance of the levels is still unclear. The correlation between anti-H. pylori antibody levels and the severity of histological gastritis or H. pylori density has been studied with conflicting results (8,9,14,18,19,21). This discrepancy in results may arise from differences in classification and grading of gastritis, the numbers of subjects, consideration of confounding factors, and statistical methods. One study reported that immunoglobulin G (IgG) antibody levels correlated with the grades of antral polymorphonuclear leukocyte infiltration and antral bacterial density (8), while another study de...

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Section: Discussionmentioning

confidence: 43%

Immunoglobulin G Antibody against Helicobacter pylori : Clinical Implications of Levels Found in Serum

Chen

Chang

et al. 2002

Clin Vaccine Immunol

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“…Qualitative rapid antibody tests have in general been clearly inferior to the quantitative enzyme immunoassay based serological tests and thus, the use of rapid tests has not been recommended [1]. The weak performance of rapid tests was further supported in a recent study [52], although somewhat better results were also reported [53,54].…”

Section: Serological Testsmentioning

confidence: 99%

Diagnosis of Helicobacter pylori infection

López‐Brea¹,

Alarcón²,

Mégraud³

2003

Helicobacter

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Numerous studies are still published on diagnostic tests for Helicobacter pylori, essentially for noninvasive tests. The urea breath test is applied in different types of patients, and there are attempts to have quicker and simpler protocols. Stool tests using monoclonal antibodies are now evaluated while serology is still a subject of interest. The progress in PCR (multiplex PCR, real-time PCR) has also stimulated the research in this area of invasive tests, in order to get insight into virulence factors, macrolide susceptibility and to detect H. pylori in nonconventional specimens.

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“…A further study of two rapid whole blood tests (BM Test Helicobacter pylori and QuickPacIVOne Step H. pylori Whole Blood Test) in a Chinese population compared to a conventional ELISA (HEL‐p TEST II) in 141 patients, showed a sensitivity and specificity of 94.4% and 94.1% at 360 min and 74.2% and 96.1% at 10 min for the BM Test; 80.9% and 76.5% at 395 min and 3.4% and 100% at 10 min for the QuickPakIVtest. When the length of incubation of the test are increased beyond the manufacturers recommended time the BM test particularly seems to be a good screening test 19 …”

Section: Assessment Of Near‐patient Testsmentioning

confidence: 99%

Diagnosis and treatment of Helicobacter: a 2002 updated review

Basset

Holton

Ricci

et al. 2003

Aliment Pharmacol Ther

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Summary The year 2002 saw advances on many fronts in the study of Helicobacter and gastroduodenal disease. Several studies have confirmed endoscopy as a valuable management procedure with confirmation of the diagnostic utility of the rapid urease test and the description of a new formulation of the test, which is more rapid in giving a result. Serology has been re‐confirmed as a useful investigation in selected populations. Some commercial kits for near patient testing have also been assessed and although generally regarded as less accurate than laboratory based tests some have shown acceptable accuracy. The recent exciting development in diagnostic serology is the availability of the faecal antigen test; further studies have confirmed its usefulness as recommended screening tests. There have been several studies demonstrating that a test and treat policy has a significant patient benefit, both economic and medical, although there is some doubt if eradication of Helicobacter leads to regression of atrophy and metaplasia. However, in low Helicobacter‐prevalence areas the test and treat policy is being challenged as an effective management strategy. Further studies have shown that compliance with treatment regimens is an important determinant of successful eradication. Finally several new eradication regimens have been reported particularly for use in patients who have had previous unsuccessful eradication attempts.

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Extending the reading time increases the accuracy of rapid whole blood test for diagnosis of Helicobacter pylori infection

Abstract: The BM-Test is an appropriate office-based test for diagnosing H. pylori infection in Chinese patients. Extending the reading time would facilitate the readability of rapid blood tests with a resultant increase in accuracy.

Cited by 8 publications

References 16 publications

Immunoglobulin G Antibody against Helicobacter pylori : Clinical Implications of Levels Found in Serum

Immunoglobulin G Antibody against Helicobacter pylori : Clinical Implications of Levels Found in Serum

Diagnosis of Helicobacter pylori infection

Diagnosis and treatment of Helicobacter: a 2002 updated review

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