| dc.description.abstract | Non commercial ureasa tests are used to detect
Helicobacter pylori. They have the advantage of its low
cost. The necessity has been revised of carrying out
clinical studies that validate them appropriately, in the
places where they are used.
Objective.
To validate a preparation of ureasa test made in our
unit ("laboratory test") in comparison with CLOtest and
histologic result.
Methods.
prospective, randomized study of ureasa tests
validation and results comparison, in patients with
digestives symptoms and endoscopy indication. Random gastric antral biopsies were performed for
the CLO-test and the lab test. In addition, two biopsies
were performed for the histological study. We excluded
patients who had recently taken medication that could
change the HP diagnosis. The evaluation of the results
was independently carried out.
Results.
105 patients were included (mean age 45.43 ± 17
DS). 70.4% tested positive on the histological exam,
whereas 65.8% and 64.3% tested positive on the CLOtest
and on the lab test respectively: these differences
were not statiscaly significants (p>0,05). The global
value of the laboratory test was 93.33% (95% IC: 86.27
– 97.04); with 7 false negative and no false positive.
The sensibility, specificity, value positive and negative
predictive values were 90.54%, 100%, 100% and
81.57% respectively. The results of the CLOtest were
similar: global value of 95.23% (95% IC: 88.70 – 98.23);
5 false negative and no false positives. The sensibility,
specificity, value positive and negative predictive values
were 93,24%, 100%, 100% and 86,11% respectively.
None of the parameters showed significant differences
(p>0.05). The reaction times of the tests were similar.
Conclusion.
The validation of our laboratory test provided similar
results to the CLOtest. | |
