Implementation of an organized colorectal cancer screening program through quantitative fecal immunochemical test followed by colonoscopy in an urban low-income community: Guidance and strategies.

Fecal Immunochemical Test (FIT) followed by a colonoscopy is an efficacious strategy to improve the adenoma detection rate and Colorectal Cancer (CRC). There is no organized national screening program for CRC in Brazil. The aim of this research was to describe the implementation of an organized screening program for CRC through FIT followed by colonoscopy, in an urban low-income community of São Paulo city. The endpoints of the study were: FIT participation rate, FIT positivity rate, colonoscopy compliance rate, Positive Predictive Values (PPV) for adenoma and CRC, and the rate of complications. From May 2016 to October 2019, asymptomatic individuals, 50-75 years old, received a free kit to perform the FIT. Positive FIT (≥ 50 ng/mL) individuals were referred to colonoscopy. 10,057 individuals returned the stool sample for analysis, of which (98.2%) 9,881 were valid. Women represented 64.8% of the participants. 55.3% of individuals did not complete elementary school. Positive FIT was 7.8% (776/9881). The colonoscopy compliance rate was 68.9% (535/776). There were no major colonoscopy complications. Adenoma were detected in 63.2% (332/525) of individuals. Advanced adenomatous lesions were found in 31.4% (165/525). CRC was diagnosed in 5.9% (31/525), characterized as adenocarcinoma: in situ in 3.2% (1/31), intramucosal in 29% (9/31), and invasive in 67.7% (21/31). Endoscopic treatment with curative intent for CRC was performed in 45.2% (14/31) of the cases. Therefore, in an urban low-income community, an organized CRC screening using FIT followed by colonoscopy ensued a high participation rate, and high predictive positive value for both, adenoma and CRC.

Implementation of an organized colorectal cancer screening program through quantitative fecal immunochemical test followed by colonoscopy in an urban low-income community: Guidance and strategies

Abstract Fecal Immunochemical Test (FIT) followed by a colonoscopy is an efficacious strategy to improve the adenoma detection rate and Colorectal Cancer (CRC). There is no organized national screening program for CRC in Brazil. The aim of this research was to describe the implementation of an organized screening program for CRC through FIT followed by colonoscopy, in an urban low-income community of São Paulo city. The endpoints of the study were: FIT participation rate, FIT positivity rate, colonoscopy compliance rate, Positive Predictive Values (PPV) for adenoma and CRC, and the rate of complications. From May 2016 to October 2019, asymptomatic individuals, 50-75 years old, received a free kit to perform the FIT. Positive FIT (≥ 50 ng/mL) individuals were referred to colonoscopy. 10,057 individuals returned the stool sample for analysis, of which (98.2%) 9,881 were valid. Women represented 64.8% of the participants. 55.3% of individuals did not complete elementary school. Positive FIT was 7.8% (776/9881). The colonoscopy compliance rate was 68.9% (535/776). There were no major colonoscopy complications. Adenoma were detected in 63.2% (332/525) of individuals. Advanced adenomatous lesions were found in 31.4% (165/525). CRC was diagnosed in 5.9% (31/525), characterized as adenocarcinoma: in situ in 3.2% (1/31), intramucosal in 29% (9/31), and invasive in 67.7% (21/31). Endoscopic treatment with curative intent for CRC was performed in 45.2% (14/31) of the cases. Therefore, in an urban low-income community, an organized CRC screening using FIT followed by colonoscopy ensued a high participation rate, and high predictive positive value for both, adenoma and CRC.

DIAGNOSTIC ACCURACY OF ONE SAMPLE OR TWO SAMPLES QUANTITATIVE FECAL IMMUNOCHEMICAL TESTS FOR INTESTINAL NEOPLASIA DETECTION.

BACKGROUND: Rectal bleeding is the most important symptom of intestinal neoplasia; thus, tests of occult blood detection in stools are widely used for pre neoplastic lesions and colorectal cancer (CRC) screening. OBJECTIVE: Evaluate the accuracy of OC-Sensor quantitative test (Eiken Chemical, Tokyo, Japan) at cut-off 10 µg Hb/g feces (50 ng/mL) in a cohort of subjects that had to undergo diagnostic colonoscopy, and if more than one sample collected in consecutive days would improve the diagnostic accuracy of the test. METHODS: Patients (mean age 56.3±9.7 years) that underwent colonoscopy prospectively randomly received one (1-sample FIT, FIT 1) or two (2-sample FIT, FIT 2) collection tubes. They collected the stool sample before starting colonoscopy preparation. Samples were analyzed by the OC-Auto Micro 80 (Eiken Chemical, Tokyo, Japan). The performance of FIT 1 and FIT 2 were compared to the colonoscopy findings. RESULTS: Among 289 patients, CRC was diagnosed in 14 (4.8%), advanced adenoma in 37 (12.8%), early adenoma in 71 (24.6%) and no abnormalities in 141 (48.8%). For FIT 1, the sensitivity for CRC was 83.3% (95%CI 36.5-99.1%), for advanced adenoma was 24% (95%CI 10.1-45.5%), with specificity of 86.9% (95%CI 77.3-92.9%). For FIT 2, the sensitivity for CRC was 75% (95%CI 35.6-95.5%), for advanced adenoma was 50% (95%CI 22.3-77.7%), with specificity of 92.9% (95%CI 82.2-97.7%). The positive likelihood ratios were 1.8 (95%CI 0.7-4.4 for FIT 1) and 7.1 (95%CI 2.4-21.4 for FIT 2) for advanced adenoma, and 6.4 (95%CI 3.3-12.3, for FIT 1) and 10.7 (95%CI 3.8-29.8, for FIT 2) for CRC. The negative likelihood ratio were 0.9 (95%CI 0.7-1, for FIT 1) and 0.5 (95%CI 0.3-0.9, for FIT 2) for advanced adenoma, and 0.2 (0.03-1.1, for FIT 1) and 0.3 (0.08-0.9, for FIT 2) for CRC. The differences between FIT 1 and FIT 2 performances were not significant. However, the comparison of the levels of hemoglobin in feces of patients of FIT 1 and FIT 2 showed that the differences between no polyp group and advanced adenoma and CRC were significant. CONCLUSION: The accuracy of OCR Sensor with 10 µg Hb/g feces cut-off was comparable to other reports and two-sample collection improved the detection rate of advanced adenoma, a pre neoplastic condition to prevent CRC incidence.

Acurácia diagnóstica de teste quantitativo imunoquímico fecal com uma amostra ou com duas amostras para detectar neoplasia intestinal / Diagnostic accuracy of one sample or two samples quantitative fecal immunochemical tests for intestinal neoplasia detection

ABSTRACT BACKGROUND: Rectal bleeding is the most important symptom of intestinal neoplasia; thus, tests of occult blood detection in stools are widely used for pre neoplastic lesions and colorectal cancer (CRC) screening. OBJECTIVE: Evaluate the accuracy of OC-Sensor quantitative test (Eiken Chemical, Tokyo, Japan) at cut-off 10 µg Hb/g feces (50 ng/mL) in a cohort of subjects that had to undergo diagnostic colonoscopy, and if more than one sample collected in consecutive days would improve the diagnostic accuracy of the test. METHODS: Patients (mean age 56.3±9.7 years) that underwent colonoscopy prospectively randomly received one (1-sample FIT, FIT 1) or two (2-sample FIT, FIT 2) collection tubes. They collected the stool sample before starting colonoscopy preparation. Samples were analyzed by the OC-Auto Micro 80 (Eiken Chemical, Tokyo, Japan). The performance of FIT 1 and FIT 2 were compared to the colonoscopy findings. RESULTS: Among 289 patients, CRC was diagnosed in 14 (4.8%), advanced adenoma in 37 (12.8%), early adenoma in 71 (24.6%) and no abnormalities in 141 (48.8%). For FIT 1, the sensitivity for CRC was 83.3% (95%CI 36.5-99.1%), for advanced adenoma was 24% (95%CI 10.1-45.5%), with specificity of 86.9% (95%CI 77.3-92.9%). For FIT 2, the sensitivity for CRC was 75% (95%CI 35.6-95.5%), for advanced adenoma was 50% (95%CI 22.3-77.7%), with specificity of 92.9% (95%CI 82.2-97.7%). The positive likelihood ratios were 1.8 (95%CI 0.7-4.4 for FIT 1) and 7.1 (95%CI 2.4-21.4 for FIT 2) for advanced adenoma, and 6.4 (95%CI 3.3-12.3, for FIT 1) and 10.7 (95%CI 3.8-29.8, for FIT 2) for CRC. The negative likelihood ratio were 0.9 (95%CI 0.7-1, for FIT 1) and 0.5 (95%CI 0.3-0.9, for FIT 2) for advanced adenoma, and 0.2 (0.03-1.1, for FIT 1) and 0.3 (0.08-0.9, for FIT 2) for CRC. The differences between FIT 1 and FIT 2 performances were not significant. However, the comparison of the levels of hemoglobin in feces of patients of FIT 1 and FIT 2 showed that the differences between no polyp group and advanced adenoma and CRC were significant. CONCLUSION: The accuracy of OCR Sensor with 10 µg Hb/g feces cut-off was comparable to other reports and two-sample collection improved the detection rate of advanced adenoma, a pre neoplastic condition to prevent CRC incidence.

RESUMO CONTEXTO: Sangramento retal é o sintoma mais importante de neoplasia intestinal; portanto, testes para detecção de sangue oculto nas fezes são amplamente usados para rastreamento de lesões pré-neoplásicas e de câncer colorretal (CCR). OBJETIVO: Avaliar a acurácia do teste quantitativo OC-Sensor (Eiken Chemical, Tokyo, Japan) com o valor de corte de 10 µg Hb/g fezes (50 ng/mL) numa coorte de indivíduos que se submeteram à colonoscopia diagnóstica, e se mais de uma amostra coletada em dias consecutivos melhoraria a acurácia diagnóstica do teste. MÉTODOS: Pacientes (idade média 56,3±9,7 anos) que se submeteram à colonoscopia prospectivamente, randomicamente, receberam tubos de coleta: um (1-amostra FIT, FIT 1), ou dois (2-amostra FIT, FIT 2). Eles coletaram as amostras de fezes antes de iniciar o preparo da colonoscopia. As amostras foram analisadas pelo OC-Auto Micro 80 (Eiken Chemical, Tokyo, Japan). As performances do FIT 1 e do FIT 2 foram comparadas com os achados da colonoscopia. RESULTADOS: Entre 289 pacientes, CCR foi diagnosticado em 14 (4,8%), adenoma avançado em 37 (12,8%), adenoma precoce em 71 (24,6%) e sem anormalidades em 141 (48,8%). Para FIT 1, a sensibilidade para CCR foi 83,3% (95%IC 36,5-99,1%), para adenoma avançado foi 24% (95%IC 10,1-45,5%), com especificidade de 86,9% (95%IC 77,3-92,9%). Para FIT 2, a sensibilidade para CCR foi 75% (95%IC 35,6-95,5%), para adenoma avançado foi 50% (95%IC 22,3-77,7%), com especificidade de 92,9% (95%IC 82,2-97,7%). A razão de verossimilhança positiva foi 1,8 (95%IC 0,7-4,4 para FIT 1) e 7,1 (95%IC 2,4-21,4 para FIT 2) para adenoma avançado, e 6,4 (95%IC 3,3-12,3, para FIT 1) e 10,7 (95%IC 3,8-29,8, para FIT 2) para CCR. A razão de verossimilhança negativa foi 0,9 (95%IC 0,7-1, para FIT 1) e 0,5 (95%IC 0,3-0,9, para FIT 2) para adenoma avançado, e 0,2 (0,03-1,1, para FIT 1) e 0,3 (0,08-0,9, para FIT 2) para CCR. As diferenças de performance entre FIT 1 e FIT 2 não foram significantes. Entretanto, a comparação dos níveis de hemoglobina nas fezes dos pacientes de FIT 1 e FIT 2 mostraram que as diferenças entre sem pólipo e adenoma avançado e CCR foram significantes. CONCLUSÃO: A acurácia do OCR Sensor com valor de corte de 10 µg Hb/g de fezes foi comparável a outras publicações e a coleta de duas amostras melhorou a taxa de detecção de adenoma avançado, lesão pré-neoplásica, para prevenir CCR.

DIAGNOSTIC ACCURACY OF GASTROPANEL® FOR ATROPHIC GASTRITIS IN BRAZILIAN SUBJECTS AND THE EFFECT OF PROTON PUMP INHIBITORS.

BACKGROUND: It has been proposed that the combination of gastrin-17 (G-17), pepsinogens I and II (PGI and PGII), and anti-Helicobacter pylori (H. pylori) antibodies (GastroPanel®, BIOHIT HealthCare, Helsinki, Finland) could serve as biomarkers of atrophic gastritis. OBJECTIVE: This study aimed to ensure the diagnostic accuracy of GastroPanel® and evaluate the effect of proton pump inhibitors (PPIs) on these biomarkers. METHODS: Dyspeptic patients who underwent gastrointestinal endoscopy were enrolled in the present study. Histological findings, which were the gold standard to stratify groups, were as follows: no atrophy (controls); antrum atrophy; corpus atrophy; multifocal atrophy; and neoplasia. G-17, PGI, PGII, and anti-H. pylori immunoglobulin (Ig)G antibodies were assayed using commercially available kits. The ratio of PGI/PGII was calculated. RESULTS: Among 308 patients, 159 (51.6%) were PPI users. The overall prevalence of atrophy was 43.8% (n=135). Ninety-two (29.9%) patients were H. pylori positive according to anti-H. pylori IgG levels. G-17 levels were not low in those with antrum atrophy but were high in those with corpus and multifocal atrophies. PGI levels were significantly lower in those with corpus and multifocal atrophies. The sensitivity of PGI <30 µg/L to detect corpus atrophy was 50% (95% CI 27.8-72.1%), with a specificity of 93.2% (95% CI 84.3-97.5%), a positive likelihood ratio of 7.4 (95% CI 2.9-19.2), and a negative likelihood ratio of 0.5 (95% CI 0.3-0.8). A small number of subjects (n=6) exhibited moderate to intense atrophy (4%), among whom 66.7% exhibited decreased PGI levels. PPI significantly increased the levels of G-17 and PGI, except in those with corpus and multifocal atrophies, in whom PGI levels were not increased by PPIs. CONCLUSION: GastroPanel® (Gastrin-17, PGI, and PGI/PGII ratio) did not demonstrate high sensitivity for detecting gastric atrophy.

Acurácia diagnóstica do painel gástrico para gastrite atrófica em brasileiros e o efeito dos inibidores de bomba de prótons / Diagnostic accuracy of gastropanel® for atrophic gastritis in brazilian subjects and the effect of proton pump inhibitors

ABSTRACT BACKGROUND: It has been proposed that the combination of gastrin-17 (G-17), pepsinogens I and II (PGI and PGII), and anti-Helicobacter pylori (H. pylori) antibodies (GastroPanel®, BIOHIT HealthCare, Helsinki, Finland) could serve as biomarkers of atrophic gastritis. OBJECTIVE: This study aimed to ensure the diagnostic accuracy of GastroPanel® and evaluate the effect of proton pump inhibitors (PPIs) on these biomarkers. METHODS: Dyspeptic patients who underwent gastrointestinal endoscopy were enrolled in the present study. Histological findings, which were the gold standard to stratify groups, were as follows: no atrophy (controls); antrum atrophy; corpus atrophy; multifocal atrophy; and neoplasia. G-17, PGI, PGII, and anti-H. pylori immunoglobulin (Ig)G antibodies were assayed using commercially available kits. The ratio of PGI/PGII was calculated. RESULTS: Among 308 patients, 159 (51.6%) were PPI users. The overall prevalence of atrophy was 43.8% (n=135). Ninety-two (29.9%) patients were H. pylori positive according to anti-H. pylori IgG levels. G-17 levels were not low in those with antrum atrophy but were high in those with corpus and multifocal atrophies. PGI levels were significantly lower in those with corpus and multifocal atrophies. The sensitivity of PGI <30 µg/L to detect corpus atrophy was 50% (95% CI 27.8-72.1%), with a specificity of 93.2% (95% CI 84.3-97.5%), a positive likelihood ratio of 7.4 (95% CI 2.9-19.2), and a negative likelihood ratio of 0.5 (95% CI 0.3-0.8). A small number of subjects (n=6) exhibited moderate to intense atrophy (4%), among whom 66.7% exhibited decreased PGI levels. PPI significantly increased the levels of G-17 and PGI, except in those with corpus and multifocal atrophies, in whom PGI levels were not increased by PPIs. CONCLUSION: GastroPanel® (Gastrin-17, PGI, and PGI/PGII ratio) did not demonstrate high sensitivity for detecting gastric atrophy.

RESUMO CONTEXTO: Foi proposto que a combinação de gastrina 17 (G-17), pepsinogênios I e II (PGI e PGII), e anticorpos anti-Helicobacter pylori (H. pylori) (GastroPanel®, BIOHIT HealthCare), poderiam indicar gastrite atrófica. OBJETIVO: Portanto, o objetivo foi averiguar a acurácia diagnóstica do painel gástrico e avaliar o efeito dos inibidores de bomba de prótons (IBP) nesses marcadores. MÉTODOS: Pacientes dispépticos que se submeteram à endoscopia gastrointestinal entraram no estudo. Os achados histológicos foram o padrão ouro para estratificar os grupos: sem atrofia (controles), atrofia de antro, atrofia de corpo, atrofia multifocal e neoplasia. G-17, PGI, PGII, e anticorpos IgG anti-H. pylori foram determinados por kits comerciais. A razão PGI/PGII foi calculada. RESULTADOS: Entre 308 pacientes que foram incluídos, 159 estavam usando IBP (51,6%). A prevalência de atrofia foi de 43,8% (135 pacientes). H. pylori foi positivo em 92 (29,9%) pacientes por IgG anti-H. pylori. G-17 não estava diminuída na atrofia do antro, mas estava elevada nas atrofias do corpo e multifocal. PGI estava significantemente menor nas atrofias de corpo e multifocal. A sensibilidade da PGI <30 µg/L de indicar atrofia do corpo foi 50% (95%IC 27,8-72,1%) com especificidade de 93,2% (95%IC 84,3-97,5%), razão de verossimilhança positiva de 7,4 (95%IC 2,9-19,2) e razão de verossimilhança negativa de 0,5 (95%IC 0,3-0,8). O número de indivíduos com atrofia moderada para intensa foi pequeno (n=6;4%), dos quais 66,7% tinham diminuição dos níveis de PGI. IBP significantemente aumentou os níveis de G-17 e PGI, exceto nas atrofias de corpo e multifocal que não apresentaram aumento de PGI. CONCLUSÃO: O painel gástrico não teve alta sensibilidade de indicar gastrite atrófica.

FECAL OCCULT BLOOD: A COMPARISON OF CHEMICAL AND IMMUNOCHEMICAL TESTS.

BACKGROUND: Colorectal bleeding is a warning sign that may be identified by fecal occult blood testing. A positive fecal occult blood test result requires a subsequent colonoscopy, a costly and invasive examination. Therefore, the use of diagnostic tests with optimal sensitivity and specificity is warranted. In this study, we evaluated four different fecal occult blood tests in 176 patients undergoing colonoscopy and compared their results. OBJECTIVE: To assess the sensitivity, specificity and predictive values of chemical and immunochemical fecal occult blood tests in patients undergoing colonoscopy and to evaluate the degree of concordance between the tests and colonoscopy. METHODS: Patients with indications for colonoscopy also underwent fecal occult blood testing by chemical (toluidine test) and immunochemical methods, employing three commercially available kits. Based on the endoscopic findings, the colonoscopy was rated as positive or negative for colorectal bleeding. The degree of concordance between the fecal occult blood tests and the colonoscopy was evaluated by the kappa index. RESULTS: Forty-four (25%) colonoscopies were categorized as positive for colorectal bleeding. The toluidine test presented lower concordance than the immunochemical tests, which showed moderate concordance with the colonoscopy. The toluidine test had the least sensitivity, specificity, and positive and negative predictive values. CONCLUSION: The immunochemical fecal occult blood tests showed greater sensitivity, specificity and predictive values in detecting colorectal bleeding. The immunochemical tests had superior indexes of agreement with colonoscopy compared to the toluidine test.

Sangue oculto nas fezes: uma comparação entre os métodos químico e imunoquímico / Fecal occult blood: a comparison of chemical and immunochemical tests

ABSTRACT BACKGROUND: Colorectal bleeding is a warning sign that may be identified by fecal occult blood testing. A positive fecal occult blood test result requires a subsequent colonoscopy, a costly and invasive examination. Therefore, the use of diagnostic tests with optimal sensitivity and specificity is warranted. In this study, we evaluated four different fecal occult blood tests in 176 patients undergoing colonoscopy and compared their results. OBJECTIVE: To assess the sensitivity, specificity and predictive values of chemical and immunochemical fecal occult blood tests in patients undergoing colonoscopy and to evaluate the degree of concordance between the tests and colonoscopy. METHODS: Patients with indications for colonoscopy also underwent fecal occult blood testing by chemical (toluidine test) and immunochemical methods, employing three commercially available kits. Based on the endoscopic findings, the colonoscopy was rated as positive or negative for colorectal bleeding. The degree of concordance between the fecal occult blood tests and the colonoscopy was evaluated by the kappa index. RESULTS: Forty-four (25%) colonoscopies were categorized as positive for colorectal bleeding. The toluidine test presented lower concordance than the immunochemical tests, which showed moderate concordance with the colonoscopy. The toluidine test had the least sensitivity, specificity, and positive and negative predictive values. CONCLUSION: The immunochemical fecal occult blood tests showed greater sensitivity, specificity and predictive values in detecting colorectal bleeding. The immunochemical tests had superior indexes of agreement with colonoscopy compared to the toluidine test.

RESUMO CONTEXTO: O sangramento colorretal é considerado um sinal de alarme e não deve ser ignorado. O resultado positivo de um teste de pesquisa de sangue oculto nas fezes (PSOF) requer investigação complementar com colonoscopia, exame invasivo e de alto custo. Justifica-se, portanto, a aplicação de um teste diagnóstico mais sensível e específico. No presente estudo, foram avaliados quatro diferentes testes de PSOF em 176 pacientes submetidos à colonoscopia e seus resultados foram comparados. OBJETIVO: Avaliar a sensibilidade, a especificidade e os valores de predição dos testes químico e imunoquímico de PSOF em pacientes submetidos à colonoscopia e avaliar o grau de concordância entre os testes de PSOF e a colonoscopia. MÉTODOS: Pacientes com indicação de realizar colonoscopia foram submetidos também à PSOF pelo método químico (o-toluidina) e pelo método imunoquímico, empregando três kits comerciais disponíveis no mercado. Fundamentado nos achados endoscópicos, a colonoscopia foi categorizada em positiva ou negativa, de acordo com a possível fonte de sangramento colorretal. O grau de concordância entre os testes de PSOF foi avaliado pelo índice kappa. RESULTADOS: Quarenta e quatro (25%) colonoscopias foram categorizadas como positivas quanto à fonte de sangramento colorretal. O teste da o-toluidina mostrou menor concordância que os testes imunoquímicos, os quais apresentaram moderada concordância com a colonoscopia. O teste da o-toluidina revelou menor sensibilidade, especificidade, valor preditivo positivo e valor preditivo negativo. CONCLUSÃO: Os testes imunoquímicos revelaram maior sensibilidade, especificidade e valores de predição na detecção de sangramento colorretal. Os testes imunoquímicos apresentaram melhores índices de concordância com a colonoscopia, quando comparados ao teste da o-toluidina.

Evaluation of diagnostic accuracy of two rapid stool antigen tests using an immunochromatographic assay to detect Helicobacter pylori.

OBJECTIVES: The stool antigen assay for H. pylori infection diagnosis with monoclonal antibodies is a simple and recommended technique by the Maastricht V/Florence consensus report. Recently, Pylori K-Set K-1219 (Coris Bioconcept Sprl, Belgium) and HP-F23 (Symbiosys, Brazil) have been made commercially available in Brazil. Thus, the aim of this study was to evaluate the diagnostic accuracies of these two rapid stool antigen tests by immunochromatographic assays (index tests) for the clinical practice. DESIGN AND METHODS: A total of 98 patients who underwent upper gastrointestinal endoscopy and 13C-urea breath test entered the study. H. pylori infection status was defined by the combination of the rapid urease test and the 13C-urea breath test (reference standard). Two observers who were aware of H. pylori status performed the reading of index tests. Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value with 95% confidence intervals, positive likelihood ratio, negative likelihood ratio and kappa index measure of agreement) were determined. RESULTS: The index tests where in perfect agreement with the H. pylori status with kappa values of 0.87 for Pylori K-Set K-1219 and 0.92 for HP-F23. The sensitivity of HP-F23 was 97.9% (IC95%: 87.5-100) and specificity was 93.8% (IC95%; 84-97.2).The positive likelihood ratio was 15.8, and the negative likelihood ratio was 0.02. The Pylori K-Set K-1219 had a sensitivity of 87.7% (IC95%: 74.5-94.9) and a specificity of 100% (IC95%: 91.6-100); the positive likelihood ratio was ∞, and the negative likelihood ratio was 0.1. The test line on the cassette device of HP-F23 was stronger than of the Pylori K-Set K-1219. CONCLUSION: The HP-F23 test performed better in clinical practice. Nonetheless, the 13C-urea breath test is more reliable technique. Moreover, caution must be paid to the trace or clear pale test line readings that were observed in false positive and false negative results, leading to incorrect management of the patient.

Hypolactasia is associated with insulin resistance in nonalcoholic steatohepatitis.

AIM: To assess lactase gene (LCT)-13910C>T polymorphisms in Brazilian non-alcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) patients in comparison with healthy controls. METHODS: This was a transverse observational clinical study with NAFLD patients who were followed at the Hepatology Outpatient Unit of the Hospital das Clínicas, São Paulo, Brazil. The polymorphism of lactase non-persistence/lactase persistence (LCT-13910C>T) was examined by PCR-restriction fragment length polymorphism technique in 102 liver biopsy-proven NAFLD patients (steatosis in 9 and NASH in 93) and compared to those of 501 unrelated healthy volunteers. Anthropometric, clinical, biochemical and liver histology data were analyzed. Continuous variables were compared using the t or Mann-Whitney tests, and categorical data were compared with the Fisher's exact test. Univariate logistic regression and multivariate logistic regression adjusted for gender and age were performed. RESULTS: No differences in the LCT-13910 genotype frequencies were noted between the NAFLD patients (66.67% of the patients with steatosis were CC, 33.33% were CT, and none were TT; 55.91% of the patients with NASH were CC, 39.78% were CT, and 4.3% were TT; P = 0.941) and the healthy controls (59.12% were CC, 35.67% were CT, and 5.21% were TT) or between the steatosis and NASH patients. That is, the distribution of the lactase non-persistence/lactase persistence polymorphism (LCT-13910C>T) in the patients with NAFLD was equal to that in the general population. In the NASH patients, the univariate analysis revealed that the lactase non-persistence (low lactase activity or hypolactasia) phenotype was associated with higher insulin levels (23.47 ± 15.94 µU/mL vs 15.8 ± 8.33 µU/mL, P = 0.027) and a higher frequency of insulin resistance (91.84% vs 72.22%, P = 0.02) compared with the lactase persistence phenotype. There were no associations between the LCT genotypes and diabetes (P = 0.651), dyslipidaemia (P = 0.328), hypertension (P = 0.507) or liver histology in these patients. Moreover, in the NASH patients, hypolactasia was an independent risk factor for insulin resistance even after adjusting for gender and age [OR = 5.0 (95%CI: 1.35-20; P = 0.017)]. CONCLUSION: The LCT-13910 genotype distribution in Brazilian NAFLD patients was the same as that of the general population, but hypolactasia increased the risk of insulin resistance in the NASH patients.

Standard Triple Therapy versus Sequential Therapy in Helicobacter pylori Eradication: A Double-Blind, Randomized, and Controlled Trial.

Aim. To compare 10-day standard triple therapy versus sequential therapy as first-line treatment in patients infected with H. pylori. Methods. One hundred H. pylori positive patients (diagnosed by rapid urease test and histology), with average age of 47.2, M/F = 28/72, were randomized to receive either standard triple treatment (TT) as follows: lansoprazole 30 mg, clarithromycin 500 mg, and amoxicillin 1 g, b.i.d. for ten days, or sequential treatment (ST) as follows: lansoprazole 30 mg, amoxicillin and placebo 1.0 g b.i.d for the first five days, followed by lansoprazole 30 mg, clarithromycin 500 mg, and tinidazole 500 mg b.i.d, for the remaining five days. Eradication rates were determined 60 days after treatment by urease, histology, or (13)C-urea breath test. Results. In intention to treat (ITT) analysis, the rate of H. pylori eradication in the TT and ST groups was the same for both regimens as follows: 86% (43/50), 95% CI 93,3 to 73.4%. In Per protocol (PP) analysis, the rate of H. pylori eradication in the TT and ST groups was 87.8% (43/49), 95% CI 94,5 to 75.3% and 89.6% (43/48), 95% CI 95,8 to 77.3%, respectively. Conclusions. In Brazil, standard triple therapy is as equally effective as sequential therapy in eradicating Helicobacter pylori patients. This study was registered under Clinical Trials with number ISRCTN62400496.

Efficacy of levofloxacin, amoxicillin and a proton pump inhibitor in the eradication of Helicobacter pylori in Brazilian patients with peptic ulcers.

OBJECTIVES: The eradication of Helicobacter (H.) pylori allows peptic ulcers in patients infected with the bacteria to be cured. Treatment with the classic triple regimen (proton pump inhibitor, amoxicillin and clarithromycin) has shown decreased efficacy due to increased bacterial resistance to clarithromycin. In our country, the eradication rate by intention to treat with this regimen is 83%. In Brazil, a commercially available regimen for bacterial eradication that uses levofloxacin and amoxicillin with lansoprazole is available; however, its efficacy is not known. Considering that such a treatment may be an alternative to the classic regimen, we aimed to verify its efficacy in H. pylori eradication. METHODS: Patients with peptic ulcer disease infected with H. pylori who had not received prior treatment were treated with the following regimen: 30 mg lansoprazole bid, 1,000 mg amoxicillin bid and 500 mg levofloxacin, once a day for 7 days. RESULTS: A total of 66 patients were evaluated. The patients' mean age was 52 years, and women comprised 55% of the sample. Duodenal ulcers were present in 50% of cases, and gastric ulcers were present in 30%. The eradication rate was 74% per protocol and 73% by intention to treat. Adverse effects were reported by 49 patients (74%) and were mild to moderate, with a prevalence of diarrhea complaints. CONCLUSIONS: Triple therapy comprising lansoprazole, amoxicillin and levofloxacin for 7 days for the eradication of H. pylori in Brazilian peptic ulcer patients showed a lower efficacy than that of the classic triple regimen.

Efficacy of levofloxacin, amoxicillin and a proton pump inhibitor in the eradication of Helicobacter pylori in Brazilian patients with peptic ulcers

OBJECTIVES: The eradication of Helicobacter (H.) pylori allows peptic ulcers in patients infected with the bacteria to be cured. Treatment with the classic triple regimen (proton pump inhibitor, amoxicillin and clarithromycin) has shown decreased efficacy due to increased bacterial resistance to clarithromycin. In our country, the eradication rate by intention to treat with this regimen is 83%. In Brazil, a commercially available regimen for bacterial eradication that uses levofloxacin and amoxicillin with lansoprazole is available; however, its efficacy is not known. Considering that such a treatment may be an alternative to the classic regimen, we aimed to verify its efficacy in H. pylori eradication. METHODS: Patients with peptic ulcer disease infected with H. pylori who had not received prior treatment were treated with the following regimen: 30 mg lansoprazole bid, 1,000 mg amoxicillin bid and 500 mg levofloxacin, once a day for 7 days. RESULTS: A total of 66 patients were evaluated. The patients’ mean age was 52 years, and women comprised 55% of the sample. Duodenal ulcers were present in 50% of cases, and gastric ulcers were present in 30%. The eradication rate was 74% per protocol and 73% by intention to treat. Adverse effects were reported by 49 patients (74%) and were mild to moderate, with a prevalence of diarrhea complaints. CONCLUSIONS: Triple therapy comprising lansoprazole, amoxicillin and levofloxacin for 7 days for the eradication of H. pylori in Brazilian peptic ulcer patients showed a lower efficacy than that of the classic triple regimen. .

Comparison of fccal elastase 1 for exocrine panreatic insufficiency evaluationn between ex-alcoholics and chronic pancreatitis patietts / Comparação da elastase fecal 1 para avaliação de insuficiência pancreática exócrina entre ex-alcoólatras e pacientes com pancreatite crônica

Context Fecal elastase is a noninvasive test for pancreatic insufficiency diagnosis. Objectives Evaluate the usefulness of fecal elastase 1 for the indication of exocrine pancreatic insufficiency among former alcohol addicts and patients with chronic pancreatitis. Methods Forty-three patients with chronic pancreatitis and thirty-three asymptomatic former alcohol addicts entered the study. The levels of fecal elastase 1 were measured using a commercial kit. Pancreatic imaging findings were used to categorize the groups. Results The levels of fecal elastase 1 were significantly lower in the patients than in the former alcohol addicts and in the group with tissue calcifications, duct alterations, or atrophy. With a cutoff level of 100 μg/g, the sensitivity of fecal elastase 1 in chronic pancreatitis was 46.51% and its specificity was 87.88% with a positive predictive value of 83.33% and a negative predictive value of 55.77%. When patients were stratified according to the severity of their pancreatitis, the sensitivity was 6.25% for mild pancreatitis and 70.37% for marked pancreatitis. Conclusion Low level of fecal elastase 1 was associated with marked rather than mild chronic pancreatitis; however, it may be useful to indicate pancreatic exocrine insufficiency in asymptomatic former alcohol addicts. .

Contexto O teste de elastase fecal é um teste não invasivo para diagnosticar insuficiência pancreática. Objetivos Avaliar a utilidade da elastase fecal 1 como indicador de insuficiência pancreática entre ex alcoólatras e pacientes com pancreatite crônica. Métodos Quarenta e três pacientes com pancreatite crônica e 33 ex alcoólatras assintomáticos entraram no estudo. Os níveis de elastase fecal 1 foram medidos usando kit comercial. Os achados de imagem pancreática foram usados para categorizar os grupos. Resultados Os níveis de elastase fecal 1 foram significantemente menores nos pacientes que nos ex alcoólatras e no grupo com calcificações teciduais, alterações de ductos, ou atrofia. A sensibilidade da elastase fecal 1 na pancreatite crônica foi de 46,51% e a especificidade foi de 87,88%, com valor preditivo positivo de 83,33% e valor preditivo negativo de 55,77%. Quando os pacientes foram estratificados segundo a severidade da pancreatite, a sensibilidade foi de 6,25% para pancreatite crônica leve e 70,37% para pancreatite crônica severa. Conclusão Baixo nível de elastase fecal foi associado com pancreatite crônica severa mais do que com a leve; entretanto, pode ser útil para indicar insuficiência pancreática exócrina entre os ex alcoólatras. .

Low dose capsule based 13c-urea breath test compared with the conventional 13c-urea breath test and invasive tests.

CONTEXT: One of the limitations of 13C-urea breath test for Helicobacter pylori infection diagnosis in Brazil is the substrate acquisition in capsule presentation. OBJECTIVES: The purpose of this study was to evaluate a capsule-based 13C-urea, manipulated by the Pharmacy Division, for the clinical practice. METHODS: Fifty patients underwent the conventional and the capsule breath test. Samples were collected at the baseline and after 10, 20 and 30 minutes of 13C-urea ingestion. Urease and histology were used as gold standard in 83 patients. RESULTS: In a total of 50 patients, 17 were positive with the conventional 13C-urea (75 mg) breath test at 10, 20 and 30 minutes. When these patients repeated breath test with capsule (50 mg), 17 were positive at 20 minutes and 15 at 10 and 30 minutes. The relative sensitivity of 13C-urea with capsule was 100% at 20 minutes and 88.24% at 10 and at 30 minutes. The relative specificity was 100% at all time intervals. Among 83 patients that underwent capsule breath test and endoscopy the capsule breath test presented 100% of sensitivity and specificity. CONCLUSIONS: Capsule based breath test with 50 mg 13C-urea at twenty minutes was found highly sensitive and specific for the clinical setting.

Quantificação do ácido 5-hidroxi-indolacético urinário por técnica caseira do nitrosonaftol comparada com ensaio de nitrosonaftol em microcoluna de cromatografia e imunoensaio enzimático / Quantification of urinary 5-hydroxyindoleacetic acid by in-house nitrosonaphthol reaction compared with nitrosonaphthol micro column chromatography and enzyme-linked immunosorbent assay

The aim of this study was to compare the colorimetric "kit" and enzyme-linked immunosorbent assay (ELISA) methods to quantify urinary 5-hydroxyindoleacetic acid through the Goldenberg's technique, exploring the potential of replacing it. 24-hour urine samples were tested by Goldenberg's assay and compared with kits. The agreement was almost perfect for the comparison of Goldenberg's assay with both colorimetric kit, and with ELISA kit, considering ≤ 7.5 mg/24h normal cutoff value. Therefore, both "kits" would be good alternatives to Goldenberg's technique due to practicality and agreement between values...

O objetivo deste estudo foi comparar métodos por kit colorimétrico e por ensaio imunossorvente ligado à enzima (ELISA) para quantificar o ácido 5-hidroxi-indolacético urinário com a técnica de Goldenberg, explorando o potencial de substituí-la. Amostras de urina de 24 horas foram testadas pela técnica de Goldenberg e com os kits. A concordância foi quase perfeita, tanto para a comparação do ensaio de Goldenberg com o kit colorimétrico quanto para com o kit ELISA, considerando normal o valor de corte de ≤ 7.5 mg/24h. Portanto, ambos os kits seriam boa alternativa para a técnica de Goldenberg devido à praticidade e à concordância entre os valores...

Low dose capsul based 13c-urea breath test comared with the conventional 13c--urea breath test and invasive tests / Teste respiratório com 13C-uréia em cápsula de baixa dose em comparação com o teste respiratório com 13C-uréia convencional e testes invasivos

Context One of the limitations of 13C-urea breath test for Helicobacter pylori infection diagnosis in Brazil is the substrate acquisition in capsule presentation. Objectives The purpose of this study was to evaluate a capsule-based 13C-urea, manipulated by the Pharmacy Division, for the clinical practice. Methods Fifty patients underwent the conventional and the capsule breath test. Samples were collected at the baseline and after 10, 20 and 30 minutes of 13C-urea ingestion. Urease and histology were used as gold standard in 83 patients. Results In a total of 50 patients, 17 were positive with the conventional 13C-urea (75 mg) breath test at 10, 20 and 30 minutes. When these patients repeated breath test with capsule (50 mg), 17 were positive at 20 minutes and 15 at 10 and 30 minutes. The relative sensitivity of 13C-urea with capsule was 100% at 20 minutes and 88.24% at 10 and at 30 minutes. The relative specificity was 100% at all time intervals. Among 83 patients that underwent capsule breath test and endoscopy the capsule breath test presented 100% of sensitivity and specificity. Conclusions Capsule based breath test with 50 mg 13C-urea at twenty minutes was found highly sensitive and specific for the clinical setting. HEADINGS- Helicobacter pylori. Breath Test. Urea, analysis. .

Contexto Uma das limitações para o teste respiratório com 13C-uréia ser incorporado na prática clínica no Brasil para diagnóstico de infecção pelo Helicobacter pylori (H. pylori) é a aquisição do substrato em apresentação de cápsula. Objetivos O objetivo deste estudo foi avaliar a utilidade de 13C-uréia em cápsula, manipulada pela Divisão de Farmácia de um Hospital terciário para a prática clínica. Métodos Cinquenta pacientes foram submetidos ao teste respiratório convencional com 75mg de 13C-uréia e ao teste com cápsula de 50 mg de 13C-uréia. Amostras de ar expirado foram coletadas no basal e após 10, 20 e 30 minutos da ingestão de 13C-uréia para definição do melhor tempo de coleta. A urease e a histologia foram usadas como padrão ouro em 83 pacientes que se submeteram ao teste respiratório com único ponto de coleta. Resultados Num total de 50 pacientes, 17 foram positivos com teste respiratório convencional com 75 mg de 13C-uréia aos 10, 20 e 30 minutos. Quando esses pacientes repetiram o teste respiratório com 13C-uréia em cápsulas de 50 mg, 17 foram positivos aos 20 minutos (Índice Kappa 1,0; P<0,05) e 15 aos 10 e 30 minutos (Índice Kappa 0,90; P<0,05). A sensibilidade relativa da 13C-uréia em cápsulas de 50 mg foi 100% aos 20 minutos e 88,24% aos 10 e 30 minutos. A especificidade relativa foi de 100% em todos os intervalos de tempo. Entre 83 pacientes que se submeteram ao teste respiratório com cápsula e endoscopia, aqueles que eram H. pylori positivos tiveram teste respiratório positivo e aqueles H. pylori negativo tiveram teste respiratório negativo, mostrando sensibilidade e especificidade de 100%. Conclusões O teste respiratório com cápsula de 50 mg de 13C-uréia ...

Comparison of fecal elastase 1 for exocrine pancreatic insufficiency evaluation between ex-alcoholics and chronic pancreatitis patients.

CONTEXT: Fecal elastase is a noninvasive test for pancreatic insufficiency diagnosis. OBJECTIVES: Evaluate the usefulness of fecal elastase 1 for the indication of exocrine pancreatic insufficiency among former alcohol addicts and patients with chronic pancreatitis. METHODS: Forty-three patients with chronic pancreatitis and thirty-three asymptomatic former alcohol addicts entered the study. The levels of fecal elastase 1 were measured using a commercial kit. Pancreatic imaging findings were used to categorize the groups. RESULTS: The levels of fecal elastase 1 were significantly lower in the patients than in the former alcohol addicts and in the group with tissue calcifications, duct alterations, or atrophy. With a cutoff level of 100 µg/g, the sensitivity of fecal elastase 1 in chronic pancreatitis was 46.51% and its specificity was 87.88% with a positive predictive value of 83.33% and a negative predictive value of 55.77%. When patients were stratified according to the severity of their pancreatitis, the sensitivity was 6.25% for mild pancreatitis and 70.37% for marked pancreatitis. CONCLUSION: Low level of fecal elastase 1 was associated with marked rather than mild chronic pancreatitis; however, it may be useful to indicate pancreatic exocrine insufficiency in asymptomatic former alcohol addicts.