Evaluation of a Single-Step Serological Assay for Laboratory Diagnosis of Helicobacter pylori Infection

Sd, Ladas; Varzakakos, I.; Malamou, Helen; Georgopoulos, Stamatis; Giota, Georgia; Triantafyllou, Konstantinos; Rokkas, Theodore; Spiliadi, Charis; Sa, Raptis

doi:10.1007/s10096-001-0653-5

Cited by 3 publications

(2 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Although it has been recommended that antibody assays be evaluated locally (4,13), this has rarely been carried out for different age groups. Our results of the accuracy of the H. pylori IgG and IgA tests were superior to those reported earlier (3,11,12,24). To avoid any misjudgment in the validation of serological tests for H. pylori antibodies in adult subjects, the validation should be carried out separately for different age groups with special emphasis not only on the known H. pylori status but also on the presence of atrophic gastritis.…”

contrasting

confidence: 50%

Age-Dependent Accuracy of Helicobacter pylori Antibody Assays for Adults, with Special Emphasis on Atrophic Gastritis

Salomaa-Räsänen

Kosunen

Mattila

et al. 2004

Clin Vaccine Immunol

View full text Add to dashboard Cite

The accuracy of Helicobacter pylori antibody assays for 561 consecutive adult outpatients who had undergone gastroscopy was studied. The sensitivity of an immunoglobulin G test was 99 to 100% for all age groups, but the specificity declined by age group, from 99% for those aged 15 to 49 years to 75% for those aged >65 years. The exclusion of false-positive results for patients with atrophic gastritis improved the specificity to 93 to 97% for the older age groups.Helicobacter pylori infection is associated with gastritis, peptic ulcer disease, and gastric malignancies (1). In about onethird or up to one-half of those infected with H. pylori, gastritis proceeds to atrophic gastritis, resulting in a loss of mucosal glands, decreased helicobacter colonization and, when affecting the corpus mucosa, decreased secretion of pepsinogen I (PGI) (10, 23).Most helicobacter-infected subjects have specific circulating immunoglobulin G (IgG) antibodies. However, IgA antibodies are found in approximately two-thirds of infected subjects (9). Of infected individuals, 2 to 7% show an elevated level of IgA antibody only (5, 9). Patients with atrophic corpus gastritis often have positive helicobacter serology, although microscopic examination (6, 22), culture of biopsy samples, and even the urea breath test remain helicobacter negative (8). These particular patients may still be infected, as shown by rapidly falling antibody titers after therapy (7).Enzyme immunoassay (EIA) is the most commonly used serological method for detecting antibodies to H. pylori. The best commercial kits have shown sensitivities and specificities of 90% to in excess of 95% (3, 12 Biopsy samples. Gastroscopies were performed by one of the authors (A.S.-R.) in a routine manner, with two biopsies from the gastric antrum (2 cm or more from the pylorus), two biopsies from the large curve of the gastric corpus for histological examination, and additional biopsies (one from the antrum and one from the corpus) for culture.Formalin-fixed biopsy specimens were embedded in paraffin. Tissue sections of 3 m were cut at three levels per biopsy and placed on one slide. The tissue sections were stained with hematoxylin and eosin, Alcian blue (pH 2.5)-periodic acidSchiff, and modified Giemsa. Gastritis was classified according to the Sydney System, in a blinded fashion, by one pathologist (J.M.) (20).The biopsies were mailed for culture in Transpocult tubes (Orion Diagnostica, Espoo, Finland). The specimens were cultured for H. pylori for up to 12 days on Brucella agar plates (Becton Dickinson, Sparks, Md.) (18) supplemented with whole horse blood (7%) and on selective Brucella agar plates containing Iso-Vitalex (1%), vancomycin (6 mg/liter), amphotericin B (2 mg/liter), and nalidixic acid (20 mg/liter).Results were considered helicobacter positive if culture or histology or both were positive.Serum tests. Serum samples were taken during each patient's visit to the endoscopic unit and were stored at Ϫ20°C until analyzed. Sera were tested for H. pylori IgG and IgA antibodie...

show abstract

contrasting

confidence: 50%

Age-Dependent Accuracy of Helicobacter pylori Antibody Assays for Adults, with Special Emphasis on Atrophic Gastritis

Salomaa-Räsänen

Kosunen

Mattila

et al. 2004

Clin Vaccine Immunol

View full text Add to dashboard Cite

show abstract

“…The general view to date is that they are not very sensitive or specific. An analysis of a single step IgG assay (Test Pack Plus Abbott, Germany) on 153 adults (110 positive 43 negative for H. pylori ) showed it was comparable in sensitivity and specificity to the more usual ELISA format 18 . 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.…”

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

View full text Add to dashboard Cite

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.

show abstract

Non-invasive diagnostic tests forHelicobacter pyloriinfection

Best

Takwoingi

Siddique

et al. 2018

Cochrane Database of Systematic Reviews

157

130

View full text Add to dashboard Cite

In people without a history of gastrectomy and those who have not recently had antibiotics or proton ,pump inhibitors, urea breath tests had high diagnostic accuracy while serology and stool antigen tests were less accurate for diagnosis of Helicobacter pylori infection.This is based on an indirect test comparison (with potential for bias due to confounding), as evidence from direct comparisons was limited or unavailable. The thresholds used for these tests were highly variable and we were unable to identify specific thresholds that might be useful in clinical practice.We need further comparative studies of high methodological quality to obtain more reliable evidence of relative accuracy between the tests. Such studies should be conducted prospectively in a representative spectrum of participants and clearly reported to ensure low risk of bias. Most importantly, studies should prespecify and clearly report thresholds used, and should avoid inappropriate exclusions.

show abstract

Evaluation of a Single-Step Serological Assay for Laboratory Diagnosis of Helicobacter pylori Infection

Cited by 3 publications

References 14 publications

Age-Dependent Accuracy of Helicobacter pylori Antibody Assays for Adults, with Special Emphasis on Atrophic Gastritis

Age-Dependent Accuracy of Helicobacter pylori Antibody Assays for Adults, with Special Emphasis on Atrophic Gastritis

Diagnosis and treatment of Helicobacter: a 2002 updated review

Non-invasive diagnostic tests forHelicobacter pyloriinfection

Contact Info

Product

Resources

About