Product Manual

MATRICES EFFECT STUDY
Effect of specimen matrices on the result of the OSOM H. pylori Test was evaluated using
5
9 matched specimen sets each consisting of venous whole blood, capillary whole blood,
plasma and serum. Of the 59 samples tested, 46 samples were positive and 13 samples
were negative. Excellent agreement (>99%) was found between venous whole blood,
capillary whole blood, plasma and serum indicating no significant effect of matrices on
t
he test.
REPRODUCIBILITY
R
eproducibility of OSOM H. pylori was evaluated by testing negative, low positive and
high positive samples. The samples were tested in replicates of 10 in a blind study by 4
technicians, on 3 different dates and at 4 different locations. The results showed 100%
agreement with the expected results.
PROFICIENCY (PHYSICIAN OFFICE LABORATORY) STUDY
OSOM H. pylori was evaluated at 3 different physicians’ office laboratories using a panel
of 90 coded samples. The proficiency panel contained negative, low positive and high
p
ositive specimens in either serum or whole blood. Either technical or non-technical
personnel at three different institutions and three different days conducted the tests.
The results obtained from 270 tests had a >99% agreement with the expected results.
N
o significant differences were observed between the laboratories or personnel results.
INTERFERENCE STUDY
Possible interference materials found in blood, such as, bilirubin, hemoglobin, triglycerides,
or albumin, were tested in the OSOM H. pylori Test at approximately 10-fold higher than
normal physiological concentrations. These substances did not alter the test results of
OSOM H. pylori.