Validation of four Helicobacter pylori rapid blood tests in a multi-ethnic Asian population.
OBJECTIVE
To validate the accuracy of four rapid blood tests in the diagnosis of Helicobacter pylori.


METHODS
Consecutive dyspeptic patients scheduled for endoscopy at the National University Hospital, Singapore, were interviewed and had blood drawn for serology. The first 109 patients were tested with BM-test (BM), Pyloriset Screen (PS) and QuickVue (QV), and the next 99 subjects were tested with PS and Unigold (UG). Endoscopies were performed blinded to rapid blood test results and biopsies were taken for culture and rapid urease test. Urea breath tests were performed after endoscopies. The rapid blood test results were compared with four reference tests (rapid urease test, culture, serology, and breath test).


RESULTS
The study population composed of 208 patients (mean age 43.1 years; range 18-73 years; 119 males; 174 Chinese). The number of evaluable patients for BM, QV, UG and PS were 102, 102, 95, and 197, respectively. The sensitivity and specificity, respectively were: PS 80.2%, 95.8%; UG 55.9%, 100%; QV 43.3%, 100%; BM 67.2%, 97.1%.


CONCLUSIONS
The rapid blood test kits showed high specificity and positive predictive value (97-100%), while sensitivity and negative predictive value ranged widely (43%-80% and 47%-73%, respectively). Among test kits, PS showed the best sensitivity (80%), best negative predictive value (73%) and best negative likelihood ratio (0.207). PS had a specificity of 96%, positive predictive value of 97% and positive likelihood ratio of 19.1.
Lim
Lee-Guan
LG
Department of Gastroenterology and Hepatology, National University Hospital, Singapore 119074, Republic of Singapore.
Yeoh
Khay-Guan
KG
Ho
Bow
B
Lim
Seng-Gee
SG
D000293:Adolescent; D000328:Adult; D000368:Aged; D044466:Asian People; D001944:Breath Tests; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis*; D016480:Helicobacter pylori / Q000737:chemistry*; D006403:Hematologic Tests; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012846:Singapore