Sekisui Diagnostics OSOM 1080 Quick Reference Manual

Flu SARS-CoV-2 Combo Test
QUICK REFERENCE GUIDE
1080
For use under an Emergency Use Authorization (EUA) only
For in vitro diagnostic use
For use with anterior nasal swab specimens.
Read all instructions carefully before performing the test. Failure to
follow the instructions may result in inaccurate test results.
Instructions for Use (IFU) for more complete information.
SAMPLE COLLECTION
GENTLY INSERT the swab no more than ¾ of an inch
1
into the nostril. For young children, swab should not be
inserted more than 1/2 inch.
DO NOT insert the swab any farther if you feel any
resistance.
2 SLOWLY ROTATE the swab at least 4 times against
the nostril wall.
3 REMOVE the swab and repeat in the other nostril
using the same swab.
Right Left
Nostril Nostril
4x
Each Nostril
4 Sample must be mixed in the extraction buffer within
30 minutes of sample collection. Sample should be
processed in the Extraction Buffer as soon as possible
after collection.
RUNNING THE TEST
1 TWIST cap off Buffer vial.
INSERT the swab through the
ridges into the liquid.
MIX thoroughly by spinning the
swab at least 10 times in the liquid.
NOTE: Nasal swabs may not reach
the bottom of the vial. Ensure that
the swab is fully immersed in the
liquid when mixing.
RUNNING THE TEST (CONTINUED)
2 PRESS the swab against the side of
the vial to remove any excess
sample in the swab.
REMOVE and DISCARD the swab.
3 INSERT Test Stick (arrows
pointing downward) into the vial.
SET a timer for 10 minutes
Refer to the
NOTE: Leave the Test Stick in the
vial for the full 10 minutes.
DO NOT handle or remove the
Test Stick for at least 10 minutes.
4 READ test at 10 minutes. Do not read test before 10
minutes or after 30 minutes.
See Interpretation of Results.
NOTE: You may need to remove the
Test Stick to read the test results.
INTERPRETATION OF RESULTS
PLACE Test Stick, arrows
pointing down, within
dashed area of the Result
10X
Interpretation Card included
in the kit. Ensure arrows on the
Test Stick are pointing in the
Interpretation
Vigorously
same direction as the arrows
Key
spin the
on the Result Interpretation
swab
Card and that the Results
Window is aligned.
CONT = CONTROL Line
Results
S = COVID-19 Line
Window B = (Flu B) Line
LOOK CLOSELY WHEN
A = (Flu A) Line
INTERPRETING THE
RESULTS!
NOT ACTUAL SIZE
INVALID TEST RESULT
CHECK to see if a line is visible at the
Control line "CONT". If a Control line is not
visible at "CONT" after 10 minutes, even
Press the
if any of the other lines are visible in the
swab firmly
results window, THE TEST HAS FAILED
when
and is considered invalid.
removing
If the test is invalid, a new test should be
performed with a new patient sample.
Extraction Buffer vial, and Test Stick.
NEGATIVE TEST RESULT
If the Control line at "CONT" is visible and you
do not see a line at "S", "B" or "A", it means
COVID-19, Flu B, or Flu A virus have not been
detected.
Negative results should be reported as a
presumptive negative for the presence of
influenza and/or SARS-CoV-2 antigen.
POSITIVE TEST RESULT
If the Control line at "CONT" is visible and any other line
or multiple lines at "S", "B" and/or "A" appear, the test is
positive.
NOTE: Any pink/red line, no matter how faint, should be
considered an indication of a positive result.
CONT CONT
S S
B B
A A
COVID-19 Flu B
Positive Positive
CONT CONT
S S
B B
A A
COVID-19 COVID-19 Flu B +
+ Flu B + Flu A
Positive Positive Positive
It is possible to have more than one positive Test Line,
which could indicate a co-infection with influenza A, B, and/
or SARS-CoV-2, the virus that causes COVID-19. If more
than one positive Test Line is observed, retest with a new
patient sample, Extraction Buffer vial, and Test Stick. A
differing result should be followed by confirmatory testing
with another test method, such as PCR.
Laboratories within the United States and its territories are
required to report all SARS-CoV-2 results to the appropriate
public health authorities.
SERIAL TESTING
Repeat Testing is needed for all samples that are negative
for SARS-CoV-2 on the first day of testing, even if they
CONT
are positive for influenza A and/or B. Repeat testing is
S
B needed to improve test accuracy for SARS-CoV-2. Please
A
follow the table below when interpreting test results. Serial
(repeat) testing does not need to be performed if patients
have a positive SARS-CoV-2 result on the first day of testing.
Invalid
Status on First Day of Testing: With Symptoms
Day 0 Serial
(First Test) Testing?
SARS-CoV-2 (+)
NO
Influenza A and
B (-)
SARS-CoV-2 (+)
CONT
NO
Influenza A
S
and/or B (+)
B
SARS-CoV-2 (-)
A
YES
Influenza A
and/or B (-)
SARS-CoV-2 (-)
YES
Influenza A
Negative
and/or B (+)
SARS-CoV-2 (-)
YES
Influenza A
and/or B (-)
SARS-CoV-2 (-)
YES
Influenza A
and/or B (-)
SARS-CoV-2 (-)
YES
Influenza A
and/or B (-)
SARS-CoV-2 (-)
YES
Influenza A
and/or B (+)
SARS-CoV-2 (-)
CONT
YES
Influenza A
S
and/or B (+)
B
SARS-CoV-2 (-)
A
YES
Influenza A
and/or B (+)
Flu A
Positive
CONT CONT EXTERNAL QUALITY CONTROL PROCEDURE
S S
B B
To perform a positive or negative control test, complete the
A A
steps in the Test Procedure section, treating the control
swab in the same manner as a patient swab.
Minimally, SEKISUI Diagnostics recommends that positive
COVID-19 +
Flu A Flu B + Flu A
and negative external controls be run with each new lot,
Positive
shipment received, and with each new untrained operator.
Day 2
Interpretation
(Second Test)
Positive for COVID-19
Not needed
Presumptive negative for
Influenza
Positive for COVID-19
Not needed
Positive for Influenza A
and/or B
SARS-CoV-2 (+) Positive for COVID-19
Influenza A and/ Presumptive Negative for
or B (-) Influenza
SARS-CoV-2 (+)
Positive for COVID-19
Influenza A and/
Positive for Influenza A and/or B
or B (+)
SARS-CoV-2 (-) Presumptive Negative for
COVID-19
Influenza A and/
or B (+) Positive for Influenza A and/or B
Presumptive Negative for
SARS-CoV-2 (-)
COVID-19
Influenza A and/
Presumptive Negative for
or B (-)
Influenza
SARS-CoV-2 (+)
Positive for COVID-19
Influenza A and/
Positive for Influenza A and/or B
or B (+)
SARS-CoV-2 (-) Presumptive Negative for
COVID-19
Influenza A and/
or B (-) Positive for Influenza A and/or B
SARS-CoV-2 (-) Presumptive Negative for
COVID-19
Influenza A and/
or B (+) Positive for Influenza A and/or B
SARS-CoV-2 (+)
Positive for COVID-19
Influenza A and/
Positive for Influenza A and/or B
or B (+)