Product Manual

INTERPRETATION OF RESULTS
Positive
A reddish purple Control line (C position) and a reddish purple Test line (A or B position) indicate that
Influenza A or B antigen has been detected. Lines at the A and C positions indicate the presence of
Influenza type A viral antigen, and lines at the B and C positions indicate the presence of Influenza type
B viral antigen in the specimen. A positive result does not rule out co-infections with other pathogens or
identify any specific influenza A virus subtype. Determination of a positive result can be made as soon
as both a visible Test line (either A or B) and Control line appear.
NOTE: The Test line (reddish purple line) may vary in shade and intensity (light or dark, weak or strong)
depending on the concentration of antigen detected. The intensity of the Control line should not be
compared to that of the Test line for the interpretation of the test result. Even a light or faint Test line must
be interpreted as a positive result.
Negative
Only a reddish purple Control line (C position), with no Test line at the A or B position, indicates that
Influenza A or B antigen has not been detected. A negative result does not exclude influenza viral
infection. Determination of negative results should not be made before 15 min.
Invalid
A reddish purple line should always appear at the Control line position (C). If a line does not form at the
Control line position in 15 minutes, the test result is invalid and the test should be repeated with a new
OSOM Ultra Flu A & B Test device.
NOTE: Co-infection with Influenza A and B is rare. OSOM Ultra Flu A & B Test “dual positive” clinical
specimens (Influenza A and Influenza B positive) should be re-tested. Repeatable influenza A and B
“dual positive” results should be confirmed by cell culture or PCR testing before reporting results.
LIMITATIONS
• A negative test result does not exclude infection with influenza A or B. Therefore, the results obtained
with the OSOM Ultra Flu A & B Test should be used in conjunction with clinical findings to make an
accurate diagnosis. Additional testing is required to differentiate any specific influenza A and B
subtypes or strains, in consultation with state or local public health departments.
• This test detects both viable (live) and non-viable influenza A and B. Test performance depends on
the amount of virus (antigen) in the specimen and may or may not correlate with cell culture results
performed on the same specimen.
• OSOM Ultra Flu A & B Test uses highly target specific monoclonal antibodies. As in most immunoassays,
it may fail to detect, or detect with less sensitivity, influenza A viruses that have undergone minor
amino acid changes in the target epitope region.
• Performance of the OSOM Ultra Flu A & B Test has not been established for monitoring antiviral
treatment of influenza. Children tend to shed virus more abundantly and for longer periods of time
than adults. Therefore, testing specimens from adults will result in lower sensitivity than testing
specimens from children.
• Positive and negative predictive values are highly dependent on prevalence. False negative test
results are more likely during peak activity when prevalence of disease is high. False positive test
results are more likely during periods of low influenza activity when prevalence is moderate to low.
• Individuals who received nasally administered influenza A vaccine may produce positive test results
for up to three days after vaccination.
• The performance of this assay has not been evaluated for use in patients without signs and symptoms
of respiratory infection.
• This test cannot rule out diseases caused by other bacterial or viral pathogens.
• The performance of this test has not been evaluated for sample types other than those specified in
the Intended Use.
• The performance of this test has not been evaluated for immunocompromised individuals.
• The OSOM Ultra Flu A & B Test can distinguish between influenza A and B viruses, but it cannot
differentiate influenza subtypes.
USER QUALITY CONTROL
Internal Quality Control
Each OSOM Ultra Flu A & B Test device has built-in controls. The Control line at the C position can be
considered as an internal positive procedural control; i.e., a proper amount of sample was used, sample
was properly added to the Extraction Well, sample migrated properly, and the reagent system worked
properly. A distinct reddish-purple Control line should always appear if the test has been performed
correctly. If the Control line does not appear, the test result is invalid and a new test should be
performed. If the problem persists, contact Sekisui Diagnostic’s Technical Support at 800-332-1042 (US
Customer’s Only) for technical assistance. A clear background in the Test Result Window is considered
an internal negative procedural control. If the test is performed correctly and the OSOM Ultra Flu A &
B Test device is working properly, the background in the Test Result Window will be clear, providing a
distinct result.
4
INTERPRETATION OF RESULTS
Influenza
Date
ID
C
B
A
C
B
A
C
B
A
C
B
A
Any visible A and/or B Line(s)
with C Line is
Positive.
C
B
A
C Line only
NEGATIVE
A line:
Inuenza
type A
B line:
Inuenza
type B
A & B lines:
Inuenza
type A & B
C
B
A
C
B
A
C
B
A
No C Line
Invalid
Repeat with new
sample and device.