Lumos FebriDx Mode D'emploi page 6

BLOOD TRANSFER CHECK
Confirm the Blood Transfer Confirmation Window
changed from white to pink/red
transfer of the blood sample.
If the Blood Transfer Confirmation Window does not
change to a pink/red color, then the sample was not
transferred correctly and the test needs repeating.
TEST RESULTS
A blue control line must appear in the Result Window for the test to be valid.
Viral
infection
Bacterial
infection
Negative
result
Invalid
result
QUALITY CONTROL
Control Line
A blue control line must appear in the Result Window for the
test to be valid. The absence of a
an invalid result.
Blood Transfer Confirmation Window
Confirm the Blood Transfer Confirmation Window changed
from white to pink/red to indicate the correct transfer of the
blood sample.
If the Blood Transfer Confirmation Window does not
change to a pink/red color, then the sample was not
transferred correctly and the test needs repeating.
to indicate the correct
Positive Result
*
The positive result lines should appear as
Result Window. An uneven or incomplete result line is due to an uneven
sample distribution on the test strip. Even if the result line is faint in color,
incomplete over the width of the test strip, or uneven in color, it should be
interpreted as positive. A positive result indicates the presence of elevated
MxA and/or CRP proteins.
* Cannot preclude co-infection. The incidence of co-infection is low and
varies on severity of illness and setting.
Negative Result
If only a blue
negative. A negative result indicates a lack of elevated MxA and CRP
proteins.
Invalid Result
The absence of the
result occurs, the test must be discarded and the patient retested using a
new FebriDx
when retesting the patient.
If the background of the Result Window has not cleared sufficiently for
interpretation of results after 30 minutes, discard the test and retest the patient
with a new FebriDx
blue control line indicates
Blood Transfer Confirmation Window
Any blood in Blood Transfer
Confirmation Window,
read result.
control line is visible in the Result Window, the test is deemed
blue control line indicates an invalid result. If an invalid
test. Choose an alternative puncture site on a different finger
®
test.
®
External Controls
External controls may be used to demonstrate that the
reagents and assay perform properly. FebriDx
controls are available directly through Lumos Diagnostics
and consist of one (1) positive control and one (1) negative
control. Refer to the FebriDx
insert for instructions on how to use. If the FebriDx
controls do not perform as expected, please repeat the test.
If external controls fail on repeat testing do not perform
patient testing and contact Lumos Diagnostics Technical
Support.
6
Blood sample not
transferred. Discard test
and retest patient with
a new FebriDx test.
red or black lines in the
external
®
external controls package
®
external
®