Nj. Talley et al., AN EVALUATION OF WHOLE-BLOOD TESTING FOR HELICOBACTER-PYLORI IN GENERAL-PRACTICE, Alimentary pharmacology & therapeutics, 12(7), 1998, pp. 641-645
Background: Rapid whole blood tests for Helicobacter pylori infection
were developed to assist in the management of patients with dyspepsia
in general practice. However, they have not been extensively tested in
this setting. Aim: To investigate the test characteristics of the BM-
Test (Helisal Quick Test) when used in general practice. Method: One h
undred and ten dyspeptic patients attending local general practitioner
s were recruited into the study. The BM-Test was administered by the g
eneral practitioner at the screening visit according to standard instr
uctions supplied with the test kit, The patient was then referred to N
epean or Mornington Peninsula Hospitals for further assessment, includ
ing a C-14-urea breath test. The test kit was forwarded to the appropr
iate hospital centre for an independent, blinded reading. The sensitiv
ity and specificity of the BM-Test were evaluated against the results
of the C-14-UBT. Results: Based on general practitioner readings, the
BM-Test had a sensitivity of 59.3% and a specificity of 90,2%, The pos
itive and negative predictive values were 87.5% and 65.7%, respectivel
y. When based on independent readings, sensitivity rose to 71.2% and s
pecificity fell to 88.2%, The BM-Test was more sensitive for older pat
ients than for younger patients when based on both the general practit
ioner and independent readings. Conclusion: The BM-Test performs below
the generally recommended sensitivity and specificity of 90% required
for clinical practice.