Objective:Evaluation of a polyclonal and a monoclonal Helicobacter pylori stool antigen test(HpSAT)for the detection of Helicobacter pylori(HP)infection in children.Methods:43 children underwent a 13C-urea breath test...Objective:Evaluation of a polyclonal and a monoclonal Helicobacter pylori stool antigen test(HpSAT)for the detection of Helicobacter pylori(HP)infection in children.Methods:43 children underwent a 13C-urea breath test(13C UBT)and a HpSAT for the detection of HP.A child was considered HP positive if the 13C UBT was positive.Two HpSATs were tested:the “Premier Platinum HpSA”test(PP HpSAT)(polyclonal enzyme immunoassay)and the “ImmunoCard STAT! HpSA”test(ICS HpSAT)(one-step immunochromatographic assay).Results:The mean age of the children was 8.9 y(range 3.5-17.5 y).Of the 43 children,18(41.9%)were HP positive and 25(58.1%)were HP negative.The PP HpSAT showed a sensitivity of 94.4%and a specificity of 100.0%.With the ICS HpSAT,equivocal results occurred in 5/42(11.9%)of the tests due to a problem with the visual interpretation of the change in colour of the test-line.The ICS HpSAT had a sensitivity of 100.0%and a specificity of 76.0%when the test was considered positive in case of any change of colour of the test-line,which is the correct practice according to the manufacturer.The ICS HpSAT had a sensitivity of 100.0%and a specificity of 96.0%when the test was considered positive only in case of a “significant change of colour”of the test-line.Conclusion:Compared to the 13C UBT,the PP HpSAT shows a comparably good sensitivity and specificity,the ICS HpSAT has a comparably good sensitivity but lower specificity due to a high percentage of equivocal results when the test is used according to the manufacturer’s instructions,and the ICS HpSAT has a comparably good sensitivity and specificity when a weakly positive test is considered negative for the diagnosis of HP infection in children.The ICS HpSAT is easy to perform with results available within 10 min,and is therefore of particular interest in ambulatory medicine.展开更多
AIM:To evaluate the reliability of the Helicobacter pylori stool antigen test, ImmunoCard STAT HpSA, for detecting Hpylori infection.METHODS:Stool specimens were collected from 53 patients who received upper endoscopy...AIM:To evaluate the reliability of the Helicobacter pylori stool antigen test, ImmunoCard STAT HpSA, for detecting Hpylori infection.METHODS:Stool specimens were collected from 53 patients who received upper endoscopy examination due to gastrointestinal symptoms.ImmunoCard STAT HpSA was used to detect Hpylori stool antigens. Hpylori infection was detected based on three different tests:the urease test,Warthin-Starry staining and culture. Hpylori status was defined as positive when both the urease test and histology or culture alone was positive.RESULTS:Sensitivity,specificity,positive predictive and negative predictive values and the total accuracy of ImmunoCard STAT HpSA for the diagnosis of Hpyloriinfection were 92.6% (25/27), 88.5% (23126), 89.3% (25/28), 92%(23/25) and 90.6% (48/53), respectively.CONCLUSION:The stool antigen test, ImmunoCard STAT HpSA,is a simple noninvasive and accurate test for the diagnosis of Hpylori infection.展开更多
文摘Objective:Evaluation of a polyclonal and a monoclonal Helicobacter pylori stool antigen test(HpSAT)for the detection of Helicobacter pylori(HP)infection in children.Methods:43 children underwent a 13C-urea breath test(13C UBT)and a HpSAT for the detection of HP.A child was considered HP positive if the 13C UBT was positive.Two HpSATs were tested:the “Premier Platinum HpSA”test(PP HpSAT)(polyclonal enzyme immunoassay)and the “ImmunoCard STAT! HpSA”test(ICS HpSAT)(one-step immunochromatographic assay).Results:The mean age of the children was 8.9 y(range 3.5-17.5 y).Of the 43 children,18(41.9%)were HP positive and 25(58.1%)were HP negative.The PP HpSAT showed a sensitivity of 94.4%and a specificity of 100.0%.With the ICS HpSAT,equivocal results occurred in 5/42(11.9%)of the tests due to a problem with the visual interpretation of the change in colour of the test-line.The ICS HpSAT had a sensitivity of 100.0%and a specificity of 76.0%when the test was considered positive in case of any change of colour of the test-line,which is the correct practice according to the manufacturer.The ICS HpSAT had a sensitivity of 100.0%and a specificity of 96.0%when the test was considered positive only in case of a “significant change of colour”of the test-line.Conclusion:Compared to the 13C UBT,the PP HpSAT shows a comparably good sensitivity and specificity,the ICS HpSAT has a comparably good sensitivity but lower specificity due to a high percentage of equivocal results when the test is used according to the manufacturer’s instructions,and the ICS HpSAT has a comparably good sensitivity and specificity when a weakly positive test is considered negative for the diagnosis of HP infection in children.The ICS HpSAT is easy to perform with results available within 10 min,and is therefore of particular interest in ambulatory medicine.
文摘AIM:To evaluate the reliability of the Helicobacter pylori stool antigen test, ImmunoCard STAT HpSA, for detecting Hpylori infection.METHODS:Stool specimens were collected from 53 patients who received upper endoscopy examination due to gastrointestinal symptoms.ImmunoCard STAT HpSA was used to detect Hpylori stool antigens. Hpylori infection was detected based on three different tests:the urease test,Warthin-Starry staining and culture. Hpylori status was defined as positive when both the urease test and histology or culture alone was positive.RESULTS:Sensitivity,specificity,positive predictive and negative predictive values and the total accuracy of ImmunoCard STAT HpSA for the diagnosis of Hpyloriinfection were 92.6% (25/27), 88.5% (23126), 89.3% (25/28), 92%(23/25) and 90.6% (48/53), respectively.CONCLUSION:The stool antigen test, ImmunoCard STAT HpSA,is a simple noninvasive and accurate test for the diagnosis of Hpylori infection.
