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Adjusted cut-off for H. pylori antigen stool test for determination of H.pylori status after eradication
April 2000
AGAA697
between IgA-AEM and IgA-tTG in assessment of diet compliance in adult celiacs on a GFD.
3820 CELIAC SPRUE: ANOTHER AUTOIMMUNE SYNDROME ASSOCIATED WITH HEPATITIS C. Kenneth D. Fine, Frederick O. Ogunji, Yasser A. Saloum, Shari L. Beharry, Jeffrey S. Crippin, Jeffrey S. Weinstein, Baylor Univ Med Ctr, Dallas, TX; Intestinal Health Institute, Dallas, TX. Background: Celiac sprue is epidemiologically associated with other autoimmune syndromes, including autoimmune liver disease. We hypothesized that chronic infection with the hepatitis C virus (HCV) also may be associated with celiac sprue because it can trigger autoimmune reactions, both within the liver and extrahepatically. Methods: 259 consecutively evaluated patients with chronic HCV infection underwent serologic screening for celiac sprue. 59 patients with autoimmune liver disease served as positive controls, and 138 with other hepatic diseases, 356 with various GI syndromes, and 221 normal volunteers were screened as negative controls. Patients with serum antigliadin (AGA), antiendomysial (AEA), and antitissue transglutaminase antibody (ATTA) underwent duodenoscopy and biopsy, and HLA-DQ typing. Results: There was a higher prevalence of AGA in all groups of patients with liver disease compared to GI controls and normal controls (see Table). However, only patients with HCV (n=3; 1%) or autoimmune hepatitis (n=2;3%) had AENATTA. One of 221 normal volunteers (0.4%) was AGA,AEA,and ATTA positive; this individual had HCV infection as well (previously undiagnosed). All six AEA! ATTA positive individuals had mild intestinal symptoms, duodenal histopathology consistent with celiac sprue, and the celiac-associated HLADQ2 allele. Five of the six followed a prescribed gluten-free diet and experienced symptomatic improvement. Conclusion: Celiac sprue is epidemiologically associated with chronic HCV infection and with autoimmune liver disease. Because HCV is encountered much more frequently than autoimmune liver disease, HCV appears to be the most common hepatic disease predisposing to celiac sprue.
Group Hepatitis C Autoimmune liverdz. Uverpatient controls Glpatient controls Honnal volunteers
AGA positive
AEAJAITA positive
8201259 (32%)' 330159 (56%)' 5301138 (38%)' 4801356 (13%) 2301221 (10%)
301259 (1.2%) b 20159 (3.4%) c 001138 (0%) 001356 (0%) l' of221 (0.4%)
3822 EARLY DIAGNOSIS OF FAILED HELICOBACTER PYLORI (HP) ERADICATION USING A STOOL ANTIGEN TEST. Ben Wm van't Hoff, Dino Vaira, Nimish B. Vakil, Giovanni Gasbarrini, Mario Quina, Jose' M. Pajares Garcia, Alexander van der Ende, Chiara Ricci, Robert Wm van der Hulst, Carmela Acciardi, Luigi Gatta, Marcello Menegatti, Mario Miglioli, Acad Med Ctr, Amsterdam, Netherlands; Dept of Internal Medicine and Gastroenterology, Bologna, Italy; Univ of Wisconsin, Milwaukee, WI; Dept of Internal Medicine, Roma, Italy; Dept of Internal Medicine and Gastroenterology, Lisboa, Portugal; Dept of Internal Medicine and Gastroenterology, Madrid, Spain. The aim of this study was to determine the sensitivity and specificity of the stool antigen test (HpSA) (Platinum Premier, Meridian Diagnostics) in predicting successful eradication during and after antimicrobial therapy. Methods:Dyspeptic pts with biopsy proven HP (culture,histology and rapid urease test) plus 13C-UBT, not using acid suppressive therapy, were eligible for this study. The European 7-day eradication therapy, was used. Stool specimens were collected on day 0,1,3,5,7,10,15,22,28,35 and 42. Manufacturers guidelines were used neg=optical density (OD) <0.140 at 450 nm; pos>O.l59, gray zone=O.l40-0.l59. Successful eradication was assessed by histology, urease test, culture and 13C-UBT on day 42. Results: 81 pts were studied; 64 had successful eradication 17 did not. Baseline HpSA values were similar in the eradicated (OD:l.l±.9) and in the uneradicated (OD: 1.2±.8) groups. Values fell in both groups in the first week and by day 7 mean values in both groups were in the neg range (eradicated OD:0.05±.02; not eradicated 0.08±.05, ns). By day 10 however, values had risen above the cut-off value in pts who did not have eradication (OD:0.243±.6) & were significantly higher than in non-eradicated pts who remained in the neg range (0.05±.03; p=0.05). At day IS, 22, 28, 35, 42 values in the non-eradicated pts continued to rise and remained pas while values in the eradicated group remained low and in the neg range. The HpSA was highly specific in determining eradication at 10, 15,22,28,35 and 42 days (specificity = 98%, 100%,98%, 100%, 100%, 98%) but sensitivity was lower at earlier time points (20%, 63%, 82%, 88%, 88%, 100%); likelihood ratio of a pos test (12.8, infinity, 52.7, infinity, infinity, 64) likelihood of a neg test (0.81,0.38,0.18,0.13,0.13,0.0). Conclusions: HpSA secretion decreases in all pts but 3 days after completing therapy the HpSA is specific in detecting pts who do not have eradication. Sensitivity rises with time and the best results are obtained 3 weeks after therapy. A pas test at 3 days is strongly suggestive of failed eradication but a neg test may require confirmation at 28 or 35 days.
, p
b.c p=O.06,O,02
3821 NOT ALL SHORT-TERM PROTON PUMP INHIBITORS (PPI) IMPAIR THE ACCURACY OF 13C-UREA BREATH TEST AND H.PYLORI STOOL ANTIGEN ASSAY. Fabrizio Parente, Massimo Sainaghi, Giovanni Maconi, Venerina Imbesi, Claudia Cucino, Gabriele Bianchi Porro, L Sacco Hosp, Milano, Italy. Background & aim. PPIs may interfere with the effectiveness of 13 C-UBT, whereas no information are available so far about their effect on H.pylori stool antigen (HpSA) excretion. Aim of this work was to study the effect of short-term standard doses of omeprazole, lansoprazole and pantoprazole on the accuracy of 13 C-UBT and HpSA assay. Methods. 99 patients with H.pylori infection diagnosed on the basis of gastric histology, 13C-UBT and HpSA assay were studied. They received omeprazole (OM) 20 mg, lansoprazole (LAN) 30 mg or pantoprazole(PAN) 40 mg/day for 2 weeks according to a randomized protocol. 3 C-UBT and HpSA were repeated on days 4, 8 and 14 while on therapy and 7 days after the PPI withdrawal. 13C-UBT was performed in accordance with the European Protocol. The test was considered to be positive when 8 value was >4. Analysis of the stool specimens was performed with Premier HpSA assay (Meridian Diagnostics Europe Srl,Italy). The cut offlevel was at 0.14 optical density for single wave lenght spectrophotometry at 450 nm. Results. 24% and 18% of patients receiving OM and LAN, respectively became UBT negative during therapy as compared with none of those treated with PAN. 10% of OMand 6% of LAN-treated patients became also HpSA negative during treatment. whereas HpSA assays remained positive in all PAN-treated patients. All the false negative 13C-UBT and HpSA results returned to fositive within one week of drug withdrawal. Conclusions. False negative 3C-UBT and HpSA are fairly common during short-term OM and LAN use but return to positive test results invariably occurs one week after PPI is ceased. In contrast, short-term PAN therapy does not impair the accuracy of 13C-UBT or HpSA and therefore this drug does not require to be withdrawn before testing.
••+
/'
0,00
.0
1. 100 • speclflclty (% )
2.
AGAA697
between IgA-AEM and IgA-tTG in assessment of diet compliance in adult celiacs on a GFD.
3820 CELIAC SPRUE: ANOTHER AUTOIMMUNE SYNDROME ASSOCIATED WITH HEPATITIS C. Kenneth D. Fine, Frederick O. Ogunji, Yasser A. Saloum, Shari L. Beharry, Jeffrey S. Crippin, Jeffrey S. Weinstein, Baylor Univ Med Ctr, Dallas, TX; Intestinal Health Institute, Dallas, TX. Background: Celiac sprue is epidemiologically associated with other autoimmune syndromes, including autoimmune liver disease. We hypothesized that chronic infection with the hepatitis C virus (HCV) also may be associated with celiac sprue because it can trigger autoimmune reactions, both within the liver and extrahepatically. Methods: 259 consecutively evaluated patients with chronic HCV infection underwent serologic screening for celiac sprue. 59 patients with autoimmune liver disease served as positive controls, and 138 with other hepatic diseases, 356 with various GI syndromes, and 221 normal volunteers were screened as negative controls. Patients with serum antigliadin (AGA), antiendomysial (AEA), and antitissue transglutaminase antibody (ATTA) underwent duodenoscopy and biopsy, and HLA-DQ typing. Results: There was a higher prevalence of AGA in all groups of patients with liver disease compared to GI controls and normal controls (see Table). However, only patients with HCV (n=3; 1%) or autoimmune hepatitis (n=2;3%) had AENATTA. One of 221 normal volunteers (0.4%) was AGA,AEA,and ATTA positive; this individual had HCV infection as well (previously undiagnosed). All six AEA! ATTA positive individuals had mild intestinal symptoms, duodenal histopathology consistent with celiac sprue, and the celiac-associated HLADQ2 allele. Five of the six followed a prescribed gluten-free diet and experienced symptomatic improvement. Conclusion: Celiac sprue is epidemiologically associated with chronic HCV infection and with autoimmune liver disease. Because HCV is encountered much more frequently than autoimmune liver disease, HCV appears to be the most common hepatic disease predisposing to celiac sprue.
Group Hepatitis C Autoimmune liverdz. Uverpatient controls Glpatient controls Honnal volunteers
AGA positive
AEAJAITA positive
8201259 (32%)' 330159 (56%)' 5301138 (38%)' 4801356 (13%) 2301221 (10%)
301259 (1.2%) b 20159 (3.4%) c 001138 (0%) 001356 (0%) l' of221 (0.4%)
3822 EARLY DIAGNOSIS OF FAILED HELICOBACTER PYLORI (HP) ERADICATION USING A STOOL ANTIGEN TEST. Ben Wm van't Hoff, Dino Vaira, Nimish B. Vakil, Giovanni Gasbarrini, Mario Quina, Jose' M. Pajares Garcia, Alexander van der Ende, Chiara Ricci, Robert Wm van der Hulst, Carmela Acciardi, Luigi Gatta, Marcello Menegatti, Mario Miglioli, Acad Med Ctr, Amsterdam, Netherlands; Dept of Internal Medicine and Gastroenterology, Bologna, Italy; Univ of Wisconsin, Milwaukee, WI; Dept of Internal Medicine, Roma, Italy; Dept of Internal Medicine and Gastroenterology, Lisboa, Portugal; Dept of Internal Medicine and Gastroenterology, Madrid, Spain. The aim of this study was to determine the sensitivity and specificity of the stool antigen test (HpSA) (Platinum Premier, Meridian Diagnostics) in predicting successful eradication during and after antimicrobial therapy. Methods:Dyspeptic pts with biopsy proven HP (culture,histology and rapid urease test) plus 13C-UBT, not using acid suppressive therapy, were eligible for this study. The European 7-day eradication therapy, was used. Stool specimens were collected on day 0,1,3,5,7,10,15,22,28,35 and 42. Manufacturers guidelines were used neg=optical density (OD) <0.140 at 450 nm; pos>O.l59, gray zone=O.l40-0.l59. Successful eradication was assessed by histology, urease test, culture and 13C-UBT on day 42. Results: 81 pts were studied; 64 had successful eradication 17 did not. Baseline HpSA values were similar in the eradicated (OD:l.l±.9) and in the uneradicated (OD: 1.2±.8) groups. Values fell in both groups in the first week and by day 7 mean values in both groups were in the neg range (eradicated OD:0.05±.02; not eradicated 0.08±.05, ns). By day 10 however, values had risen above the cut-off value in pts who did not have eradication (OD:0.243±.6) & were significantly higher than in non-eradicated pts who remained in the neg range (0.05±.03; p=0.05). At day IS, 22, 28, 35, 42 values in the non-eradicated pts continued to rise and remained pas while values in the eradicated group remained low and in the neg range. The HpSA was highly specific in determining eradication at 10, 15,22,28,35 and 42 days (specificity = 98%, 100%,98%, 100%, 100%, 98%) but sensitivity was lower at earlier time points (20%, 63%, 82%, 88%, 88%, 100%); likelihood ratio of a pos test (12.8, infinity, 52.7, infinity, infinity, 64) likelihood of a neg test (0.81,0.38,0.18,0.13,0.13,0.0). Conclusions: HpSA secretion decreases in all pts but 3 days after completing therapy the HpSA is specific in detecting pts who do not have eradication. Sensitivity rises with time and the best results are obtained 3 weeks after therapy. A pas test at 3 days is strongly suggestive of failed eradication but a neg test may require confirmation at 28 or 35 days.
, p
b.c p=O.06,O,02
3821 NOT ALL SHORT-TERM PROTON PUMP INHIBITORS (PPI) IMPAIR THE ACCURACY OF 13C-UREA BREATH TEST AND H.PYLORI STOOL ANTIGEN ASSAY. Fabrizio Parente, Massimo Sainaghi, Giovanni Maconi, Venerina Imbesi, Claudia Cucino, Gabriele Bianchi Porro, L Sacco Hosp, Milano, Italy. Background & aim. PPIs may interfere with the effectiveness of 13 C-UBT, whereas no information are available so far about their effect on H.pylori stool antigen (HpSA) excretion. Aim of this work was to study the effect of short-term standard doses of omeprazole, lansoprazole and pantoprazole on the accuracy of 13 C-UBT and HpSA assay. Methods. 99 patients with H.pylori infection diagnosed on the basis of gastric histology, 13C-UBT and HpSA assay were studied. They received omeprazole (OM) 20 mg, lansoprazole (LAN) 30 mg or pantoprazole(PAN) 40 mg/day for 2 weeks according to a randomized protocol. 3 C-UBT and HpSA were repeated on days 4, 8 and 14 while on therapy and 7 days after the PPI withdrawal. 13C-UBT was performed in accordance with the European Protocol. The test was considered to be positive when 8 value was >4. Analysis of the stool specimens was performed with Premier HpSA assay (Meridian Diagnostics Europe Srl,Italy). The cut offlevel was at 0.14 optical density for single wave lenght spectrophotometry at 450 nm. Results. 24% and 18% of patients receiving OM and LAN, respectively became UBT negative during therapy as compared with none of those treated with PAN. 10% of OMand 6% of LAN-treated patients became also HpSA negative during treatment. whereas HpSA assays remained positive in all PAN-treated patients. All the false negative 13C-UBT and HpSA results returned to fositive within one week of drug withdrawal. Conclusions. False negative 3C-UBT and HpSA are fairly common during short-term OM and LAN use but return to positive test results invariably occurs one week after PPI is ceased. In contrast, short-term PAN therapy does not impair the accuracy of 13C-UBT or HpSA and therefore this drug does not require to be withdrawn before testing.
••+
/'
0,00
.0
1. 100 • speclflclty (% )
2.