Multicenter Comparison of Rapid Lateral Flow Stool Antigen Immunoassay and Stool Antigen Enzyme Immunoassay for the Diagnosis of <i>Helicobacter pylori</i> Infection in Children

Kato, Seiichi; Ozawa, Kyoko; Okuda, Masumi; Nakayama, Yoshiko; Yoshimura, Norikazu; Konno, Mutsuko; Minoura, Takanori; Iinuma, Kazuie

doi:10.1111/j.1083-4389.2004.00279.x

Cited by 51 publications

(60 citation statements)

References 28 publications

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“…The stool antigen test may be performed by conventional immunoassay (EIA) using polyclonal antibodies 4,6,7,10,13,17 , showing sensitivity of 88.9% to 98.3% and specificity of 77.8% to 98.4%, and by rapid lateral flow immunoassay using monoclonal antibodies 10,12,14,15,33 , presenting 52.5-94.6% sensitivity, 55.5-98.4% specificity, 94.6% positive predictive value and 98.4% of negative predictive value 2,10,12,33 . The lateral flow immunoassay is useful for small laboratories that do not have equipment for performing the EIA and that work with few samples.…”

Section: Discussionmentioning

confidence: 99%

“…Recently, a noninvasive diagnostic test based on the detection of H. pylori stool antigen has been developed. Some H. pylori stool antigen tests that use polyclonal antibodies to H. pylori have shown heterogeneous results 2,12,17 . More recently, novel stool antigen tests based on monoclonal antibodies which could increase the accuracy of this test, have been developed 2,8,12,14,15,33 .…”

Section: Introductionmentioning

confidence: 99%

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Validation of a rapid stool antigen test for diagnosis of Helicobacter pylori infection

Silva

Villares

Monteiro

et al. 2010

Rev. Inst. Med. trop. S. Paulo

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SUMMARYThe aim of this study was to validate the rapid lateral flow Helicobacter pylori stool antigen test (One step H. pylori antigen test, ACON laboratories, San Diego, USA; Prime diagnostics, São Paulo), using 13 C-Urea Breath Test as the gold standard for H. pylori infection diagnosis. A total of 98 consecutive patients, asymptomatic or dyspeptic, entered the study. Sixty-nine were women, with a mean age of 45.76 ± 14.59 years (14 to 79 years). In the H. pylori-positive group, the rapid stool antigen test detected H. pylori antigen in 44 of the 50 positive patients (sensitivity 88%; 95% CI: 75.7-95.5%), and six false-negative; and in the H. pylori-negative group 42 presented negative results (specificity 87.5%; 95% CI: 74.7-95.3%), and six false-positive, showing a substantial agreement (Kappa Index = 0.75; p < 0.0001; 95% CI: 0.6-0.9). Forty four of fifty patients that had positive stool antigen were H. pylori-positive, the PPV of the stool antigen test was 88% (95% CI: 75.7-95.5%), and 42 patients with negative stool antigen test were H. pylori-negative, the NPV of the stool antigen test was 87.5% (95% CI: 74.7-95.3%). We conclude that the lateral flow stool antigen test can be used as an alternative to breath test for H. pylori infection diagnosis especially in developing countries.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Validation of a rapid stool antigen test for diagnosis of Helicobacter pylori infection

Silva

Villares

Monteiro

et al. 2010

Rev. Inst. Med. trop. S. Paulo

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“…14, 19 The sensitivity and specificity of the rapid HpSA test reported in previous studies in pediatric population were 86-91% and 88-98%, respectively.…”

Section: Discussionmentioning

confidence: 94%

“…17,18 There have been several validation studies on the rapid HpSA test in children. 12,19 However, only a few published studies have compared the diagnostic accuracy of the rapid HpSA test with that of the HpSA ELISA in children. 12,19 In this study, we attempted to compare a new developed rapid HpSA test with a conventional EIA and to determine the prevalence of H. pylori infection in symptomatic Indonesian children.…”

Section: Discussionmentioning

confidence: 99%

“…12,19 However, only a few published studies have compared the diagnostic accuracy of the rapid HpSA test with that of the HpSA ELISA in children. 12,19 In this study, we attempted to compare a new developed rapid HpSA test with a conventional EIA and to determine the prevalence of H. pylori infection in symptomatic Indonesian children. Previous studies on HpSA ELISA in pediatric populations show a sensitivity and specificity that range from 89% to 97% and from 95% to 99%, respectively.…”

Section: Discussionmentioning

confidence: 99%

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Comparison of Enzyme-Immunoassay and Rapid Immunochromatography Test for Detecting Helicobacter pylori Stool Antigen

Prasetyo¹

2014

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The rapid immunochromatography for Helicobacter pylori stool antigen (HpSA) test is a recently developed method for detection of Heicobacter pylori (H. pylori) infection. The objective of this study was to compare rapid HpSA test with a conventional enzyme-immunoassay (EIA) and to determine the prevalence of H. pylori infection in symptomatic (recurrent abdominal pain/RAP) Indonesian children. One hundred and two high school children aged 12-18 years old in Bandung with RAP from July to November 2008 were enrolled, excluding children who had additional symptoms, such as diarrhea or fever. First study was performed in 102 samples in laboratory of Leiden University Medical Center (LUMC), Helicobacter pylori infection was detected by a conventional EIA and rapid test. A second study was performed on a stored collection of 32 feces samples previously tested positive for H. pylori by EIA in laboratory of LUMC; these samples were retested by both assays. The results showed the sensitivity, specificity, positive predictive value, and negative predictive value of the rapid test were 100%, 98.2%, accuracy 98.5%, 92.6% and 100%, respectively, from 134 tested samples. The overall prevalence of H. pylori infection among Indonesian children was 3% by EIA at first testing. In conclusion, the prevalence of H. pylori infection among symptomatic Indonesian children is very low and the new developed Pylori-Strip test shows good performance, very fast, and easy to use compared to EIA. AbstrakPemeriksaan Helicobacter pylori stool antigen (HpSA) menggunakan rapid immunochromatography (rapid HpSA) merupakan metode yang saat ini sedang berkembang untuk mendeteksi infeksi H. pylori. Tujuan penelitian ini untuk membandingkan metode rapid HpSA dengan metode konvensional yaitu enzyme-immunoassay (EIA) dan menentukan prevalensi infeksi H. pylori pada anak dengan gejala sakit perut berulang (SPB) di Indonesia. Sebanyak 102 anak sekolah menengah usia 12-18 tahun di Bandung dengan keluhan SPB ikut dalam penelitian ini, dilaksanakan dari Juli-November 2008. Anak dengan gejala tambahan, seperti diare dan demam, dikeluarkan dari penelitian. Penelitian pertama dilakukan pada sampel feses 102 anak di laboratorium Leiden University Medical Center (LUMC), Helicobacter pylori terdeteksi baik dengan pemeriksaan EIA konvensional maupun rapid test. Penelitian kedua dilakukan pada 32 buah sampel feses simpanan di laboratorium LUMC yang sebelumnya menunjukkan hasil positif dengan pemeriksaan EIA, sampel ini juga diperiksa menggunakan kedua metode. Hasil penelitian menunjukkan sensitifitas, spesifisitas, akurasi, positive predictive value, dan negative predictive value, dengan hasil 100%, 98,2%, 98,5%, 92,6%, dan 100% dari 134 sampel yang diuji. Prevalensi infeksi H. pylori pada anak Indonesia dengan keluhan SPB sekitar 3% pada pemeriksaan pertama. Simpulan, prevalensi infeksi H. pylori pada anak SPB di Indonesia sangat sedikit dan pemeriksaan Pylori-strip (rapid test) merupakan pemeriksaan yang sangat baik dan cepat serta mudah digunakan dibandin...

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What Is New Related to Helicobacter pylori Infection in Children and Teenagers?

Kato

Sherman²

2005

Arch Pediatr Adolesc Med

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Helicobacter pylori infection is a common bacterial infection for humans, and the organism is the most prevalent gastric microbial pathogen. However, the major route of transmission remains poorly understood. The outcome of chronic H pylori infection varies from asymptomatic gastritis to peptic ulceration and gastric malignancies. Recently, H pylori has been associated with the development of extradigestive disorders, including refractory iron-deficiency (sideropenic) anemia and chronic autoimmune thrombocytopenic purpura. Virulence factors of H pylori and host genetic factors are both considered important determinants of disease outcome. Multiple tests, including novel noninvasive approaches, are available for establishing the presence of H pylori infection, but there is still little consensus about which study should be performed and in what clinical setting. Eradicating H pylori uses combination therapy, including a proton pump inhibitor and 2 antibiotics taken twice daily for 7 to 14 days. Antibiotic resistance is a growing and serious problem that interferes with the success of eradication therapy. Testing and eradication therapy for H pylori are currently recommended only for the subset of infected persons in whom the disease sequelae are proven or highly suspected.

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Multicenter Comparison of Rapid Lateral Flow Stool Antigen Immunoassay and Stool Antigen Enzyme Immunoassay for the Diagnosis of Helicobacter pylori Infection in Children

Abstract: The LFI stool antigen method showed a good sensitivity, specificity and accuracy for diagnosing H. pylori infection in children. This novel method may be useful in clinical practice as an office-based test because it is rapid, reliable and easy to perform.

Cited by 51 publications

References 28 publications

Validation of a rapid stool antigen test for diagnosis of Helicobacter pylori infection

Validation of a rapid stool antigen test for diagnosis of Helicobacter pylori infection

Comparison of Enzyme-Immunoassay and Rapid Immunochromatography Test for Detecting Helicobacter pylori Stool Antigen

What Is New Related to Helicobacter pylori Infection in Children and Teenagers?

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