An evaluation of whole blood testing for Helicobacter pylori in general practice.
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.


OBJECTIVE
To investigate the test characteristics of the BM-Test (Helisal Quick Test) when used in general practice.


METHODS
One hundred and ten dyspeptic patients attending local general practitioners were recruited into the study. The BM-Test was administered by the general practitioner at the screening visit according to standard instructions supplied with the test kit. The patient was then referred to Nepean or Mornington Peninsula Hospitals for further assessment. including a 14C-urea breath test. The test kit was forwarded to the appropriate hospital centre for an independent, blinded reading. The sensitivity and specificity of the BM-Test were evaluated against the results of the 14C-UBT.


RESULTS
Based on general practitioner readings, the BM-Test had a sensitivity of 59.3% and a specificity of 90.2%. The positive and negative predictive values were 87.5% and 65.7%, respectively. When based on independent readings, sensitivity rose to 71.2% and specificity fell to 88.2%. The BM-Test was more sensitive for older patients than for younger patients when based on both the general practitioner and independent readings.


CONCLUSIONS
The BM-Test performs below the generally recommended sensitivity and specificity of 90% required for clinical practice.
Department of Medicine, University of Sydney & Nepean Hospital, Penrith, NSW, Australia.
N J
NJ
Talley
J R
JR
Lambert
S
S
Howell
H H
HH
Xia
S K
SK
Lin
L
L
Agreus
D000328:Adult; D017677:Age Distribution; D000368:Aged; D000369:Aged, 80 and over; D000907:Antibodies, Bacterial / Q000097:blood*; D001315:Australia / Q000453:epidemiology; D001944:Breath Tests; D005069:Evaluation Studies as Topic; D005194:Family Practice; D005260:Female; D016481:Helicobacter Infections / Q000097:blood / Q000175:diagnosis* / Q000453:epidemiology; D016480:Helicobacter pylori / Q000276:immunology / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D015995:Prevalence; D011933:Reagent Kits, Diagnostic
D000907:Antibodies, Bacterial; D011933:Reagent Kits, Diagnostic