Evaluation of Urine ELISA Test for Detecting Helicobacter Pylori Infection in Taiwan: a Prospective Study

Overview

Journal World J Gastroenterol

Publisher Baishideng Publishing Group

Specialty Gastroenterology

Date 2005 Oct 14

PMID 16222752

Citations 5

Authors

Fu-Chen Kuo

Sheng-Wen Wang

I-Chen Wu

Fang-Jung Yu

Yuan-Chieh Yang

Jeng-Yih Wu

Wen-Ming Wang

Deng-Chyang Wu

Affiliations

Soon will be listed here.

Abstract

Aim: To evaluate the diagnostic accuracy and clinical utility of a new ELISA (URINELISA) test for detecting Helicobacter pylori (H pylori) antibody in the urine of Taiwanese population.

Methods: In this prospective study, 317 consecutive dyspeptic patients (171 men, 146 women; mean age, 51.0 years) were included. They underwent gastroendoscopy for evaluation. Invasive tests, including culture, histology, and rapid urease test (RUT), and non-invasive (13)C-urea breath test were preformed. At the same time, urine specimens were collected for URINELISA. The status of H pylori infection was considered as positive when either culture was positive, or when two of the other, RUT, histology or 13C-UBT, were positive.

Results: The sensitivity, specificity, positive predictive value, and negative predictive value of URINELISA are 91.7% (211/230), 90.8% (79/87), 96.3% (211/219), and 80.6% (79/98) respectively.

Conclusion: This URINELISA test is reliable, inexpensive and easy-to-use. The high diagnostic accuracy warrants the use of URINELISA as a first-line screening tool for diagnosis of H pylori infection in untreated patients.

Citing Articles

Non-invasive diagnostic tests for Helicobacter pylori infection.

Best L, Takwoingi Y, Siddique S, Selladurai A, Gandhi A, Low B Cochrane Database Syst Rev. 2018; 3:CD012080.

PMID: 29543326 PMC: 6513531. DOI: 10.1002/14651858.CD012080.pub2.

Accuracy of testing for anti- IgG in urine for infection diagnosis: a systematic review and meta-analysis.

Gong Y, Li Q, Yuan Y BMJ Open. 2017; 7(4):e013248.

PMID: 28455424 PMC: 5719657. DOI: 10.1136/bmjopen-2016-013248.

Diagnostic Methods of Helicobacter pylori Infection for Epidemiological Studies: Critical Importance of Indirect Test Validation.

Miftahussurur M, Yamaoka Y Biomed Res Int. 2016; 2016:4819423.

PMID: 26904678 PMC: 4745376. DOI: 10.1155/2016/4819423.

Validation of Urine Test for Detection of Helicobacter pylori Infection in Indonesian Population.

Syam A, Miftahussurur M, Uwan W, Simanjuntak D, Uchida T, Yamaoka Y Biomed Res Int. 2016; 2015:152823.

PMID: 26824034 PMC: 4707432. DOI: 10.1155/2015/152823.

Carbon-13 urea breath test for Helicobacter pylori infection in patients with uninvestigated ulcer-like dyspepsia: an evidence-based analysis.

Ling D Ont Health Technol Assess Ser. 2013; 13(19):1-30.

PMID: 24228082 PMC: 3818027.

References

Vaira D, Miglioli M, Mule P, Holton J, Menegatti M, Vergura M . Prevalence of peptic ulcer in Helicobacter pylori positive blood donors. Gut. 1994; 35(3):309-12. PMC: 1374580. DOI: 10.1136/gut.35.3.309. View

Wong B, Xia H, Cheung H, Ng F, Wong S, Chow K . Evaluation of two stool antigen tests for the detection of Helicobacter pylori infection in the Chinese population. J Gastroenterol Hepatol. 2003; 18(1):26-31. DOI: 10.1046/j.1440-1746.2003.02926.x. View

Yu F, Wu D, Kuo C, Lu C, Su Y, Lee Y . Diagnosis of Helicobacter pylori infection by stool antigen test in southern Taiwan. Kaohsiung J Med Sci. 2001; 17(7):344-50. View

van Zwet A, Thijs J, Roosendaal R, Kuipers E, Pena S, de Graaff J . Practical diagnosis of Helicobacter pylori infection. Eur J Gastroenterol Hepatol. 1996; 8(5):501-7. View

Kostolansky F, Li J, Friedman-Kien A . Detection of false antibodies to HIV-1 in urine. AIDS. 1993; 7(11):1531-2. View

Leodolter A, Vaira D, Bazzoli F, Schutze K, Hirschl A, Megraud F . European multicentre validation trial of two new non-invasive tests for the detection of Helicobacter pylori antibodies: urine-based ELISA and rapid urine test. Aliment Pharmacol Ther. 2003; 18(9):927-31. DOI: 10.1046/j.1365-2036.2003.01761.x. View

Alemohammad M, FOLEY T, Cohen H . Detection of immunoglobulin G antibodies to Helicobacter pylori in urine by an enzyme immunoassay method. J Clin Microbiol. 1993; 31(8):2174-7. PMC: 265717. DOI: 10.1128/jcm.31.8.2174-2177.1993. View

Schembri M, Lin S, Lambert J . Comparison of commercial diagnostic tests for Helicobacter pylori antibodies. J Clin Microbiol. 1993; 31(10):2621-4. PMC: 265948. DOI: 10.1128/jcm.31.10.2621-2624.1993. View

Chey W, Woods M, Scheiman J, Nostrant T, Delvalle J . Lansoprazole and ranitidine affect the accuracy of the 14C-urea breath test by a pH-dependent mechanism. Am J Gastroenterol. 1997; 92(3):446-50. View

10.

Lin J, Wang J, Wang T, Wu M, Lee T, Chen C . Helicobacter pylori infection in a randomly selected population, healthy volunteers, and patients with gastric ulcer and gastric adenocarcinoma. A seroprevalence study in Taiwan. Scand J Gastroenterol. 1993; 28(12):1067-72. DOI: 10.3109/00365529309098311. View

11.

Yamamoto I, Fukuda Y, Mizuta T, Fukada M, Nishigami T, Shimoyama T . Serum anti-Helicobacter pylori antibodies and gastritis. J Clin Gastroenterol. 1995; 21 Suppl 1:S164-8. View

12.

Kato M, Asaka M, Saito M, Sekine H, OHara S, Toyota T . Clinical usefulness of urine-based enzyme-linked immunosorbent assay for detection of antibody to Helicobacter pylori: a collaborative study in nine medical institutions in Japan. Helicobacter. 2000; 5(2):109-19. DOI: 10.1046/j.1523-5378.2000.00017.x. View

13.

Li Y, Guo H, Zhang P, Zhao X, Da S . Clinical value of Helicobacter pylori stool antigen test, ImmunoCard STAT HpSA, for detecting H pylori infection. World J Gastroenterol. 2004; 10(6):913-4. PMC: 4727001. DOI: 10.3748/wjg.v10.i6.913. View

14.

Miwa H, Hirose M, Kikuchi S, Terai T, Iwazaki R, Kobayashi O . How useful is the detection kit for antibody to Helicobacter pylori in urine (URINELISA) in clinical practice?. Am J Gastroenterol. 1999; 94(12):3460-3. DOI: 10.1111/j.1572-0241.1999.01608.x. View

15.

Bravo L, Realpe J, Campo C, Mera R, Correa P . Effects of acid suppression and bismuth medications on the performance of diagnostic tests for Helicobacter pylori infection. Am J Gastroenterol. 1999; 94(9):2380-3. DOI: 10.1111/j.1572-0241.1999.01361.x. View

16.

Maeda S, Ogura K, Yoshida H, Kanai F, Ikenoue T, Kato N . Major virulence factors, VacA and CagA, are commonly positive in Helicobacter pylori isolates in Japan. Gut. 1998; 42(3):338-43. PMC: 1727030. DOI: 10.1136/gut.42.3.338. View

17.

Atherton J, Spiller R . The urea breath test for Helicobacter pylori. Gut. 1994; 35(6):723-5. PMC: 1374863. DOI: 10.1136/gut.35.6.723. View

18.

Vaira D, Malfertheiner P, Megraud F, Axon A, Deltenre M, Gasbarrini G . Noninvasive antigen-based assay for assessing Helicobacter pylori eradication: a European multicenter study. The European Helicobacter pylori HpSA Study Group. Am J Gastroenterol. 2000; 95(4):925-9. DOI: 10.1111/j.1572-0241.2000.01931.x. View

19.

Chen X, Haruma K, Kamada T, Mihara M, Komoto K, Yoshihara M . Factors that affect results of the 13C urea breath test in Japanese patients. Helicobacter. 2000; 5(2):98-103. DOI: 10.1046/j.1523-5378.2000.00015.x. View

20.

Yang J, Wang T, Wang H, Kuo C, Wang J, Wang W . Genetic analysis of the cytotoxin-associated gene and the vacuolating toxin gene in Helicobacter pylori strains isolated from Taiwanese patients. Am J Gastroenterol. 1997; 92(8):1316-21. View