Atencion primaria · 2002
[Study of the validity of "rapid" serology in diagnosing Helicobacter pylori infection].
СтатьяВалидационное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Gisbert J P, Vázquez M A, Cantero J, Pajares J M
Аннотация
OBJECTIVE: To evaluate prospectively the validity of a <<rapid>> serology diagnosis method (using capillary blood) in our ambit, taking for reference a combination of standard diagnostic methods.
DESIGN: Prospective. The endoscopist, pathologist and those responsible for interpreting the rapid urease test, the breath test and <<rapid>> serology did not know the results of the other diagnostic methods.
SETTING: Gastro-enterology service of a tertiary hospital.Participants. 30 consecutive patients with symptoms attributable to the upper digestive tract and who underwent an oral gastroscopy. Main measurements. Gastric biopsies for histology examination and for the rapid urease test and a breath test with 13C-urea were conducted. For <<rapid>> serology, the commercial SureStep HP WB test kit was used. A patient was considered infected when at least two of the three validated techniques (rapid urease test, histology, breath test) were positive; and not infected, when all three were negative.
RESULTS: 30 patients, 30% male, with a mean age of 51, were included. The reference standard indicated 61% prevalence of infection, with two cases classed as undetermined. <<Rapid>> serology was positive in 8 patients and negative in 22. Sensitivity, specificity, positive predictive value and negative predictive value were, respectively, 41% (95% CI, 18-65), 91% (74-100), 87% (65-100) and 50% (28-72). The positive probability quotient was 4.5; and the negative, 0.65.
CONCLUSION: The <<rapid>> serology used in the current study has deficient diagnostic accuracy. Therefore, it should not be used in clinical practice to identify H. pylori infection.
DESIGN: Prospective. The endoscopist, pathologist and those responsible for interpreting the rapid urease test, the breath test and <<rapid>> serology did not know the results of the other diagnostic methods.
SETTING: Gastro-enterology service of a tertiary hospital.Participants. 30 consecutive patients with symptoms attributable to the upper digestive tract and who underwent an oral gastroscopy. Main measurements. Gastric biopsies for histology examination and for the rapid urease test and a breath test with 13C-urea were conducted. For <<rapid>> serology, the commercial SureStep HP WB test kit was used. A patient was considered infected when at least two of the three validated techniques (rapid urease test, histology, breath test) were positive; and not infected, when all three were negative.
RESULTS: 30 patients, 30% male, with a mean age of 51, were included. The reference standard indicated 61% prevalence of infection, with two cases classed as undetermined. <<Rapid>> serology was positive in 8 patients and negative in 22. Sensitivity, specificity, positive predictive value and negative predictive value were, respectively, 41% (95% CI, 18-65), 91% (74-100), 87% (65-100) and 50% (28-72). The positive probability quotient was 4.5; and the negative, 0.65.
CONCLUSION: The <<rapid>> serology used in the current study has deficient diagnostic accuracy. Therefore, it should not be used in clinical practice to identify H. pylori infection.