Product Manual

TEST PROCEDURE
Procedural Notes
• The test procedure provided must be followed to obtain accurate and reproducible results.
• Reagents, specimens, and devices must be at room temperature (18–30°C) for testing.
• Do not open the foil pouch until you are ready to perform the test.
• Several tests may be run at one time.
• Label the device with the patient identification or control to be tested.
• Place test device on a level surface.
OSOM ULTRA FLU A & B OSOM ULTRA FLU A & B
Swab Sample Procedure Nasopharyngeal Wash/Aspirate
Sample Procedure
Purchase of 1007 required)
Status Flu A
&
B
Nasopharyngeal Wash/Aspirate Sample Procedure
(Purchase of BSP-510AS required)
PROCEDURE
TEST DEVICE
Slowly
Tap
1
2
5
6
7
8
9
10
4
Extraction
Reagent
B
C
Influenza
Date______
ID________
A
B
C
Influenza
Date______
ID________
A
Influenza
Date ID
C B A
Extraction Well
Result Window
Squeeze
here
Start timing.
Sample
Slowly
Tap
2
3
6
7
8
9
B
A
C
Influenza
Date______
ID________
B
A
C
Influenza
Date______
ID________
4
B
A
C
Influenza
Date______
ID________
5
B
A
C
Influenza
Date______
ID________
PROCEDURE
TEST DEVICE
1
Influenza
Date ID
C B A
Extraction Well
Result Window
Swab Stand
Start timing.
Status Flu A
&
B
Swab Sample Procedure
Squeeze the Extraction Reagent
capsule to dispense all of the
solution into the Extraction Well
of the test device.
Place the specimen swab on
the Swab Stand in the
Extraction Well.
Incubate 1 minute
with the swab in
Extraction Well.
Tear the tab o the Extraction
Reagent Capsule.
Draw nasal wash or
nasopharyngeal aspirate sample
to the rst (lowest) mark of the
graduated transfer pipette.
Dispense all of the solution
in the transfer pipette into
the Extraction Well of the
test device.
Incubate 1 minute.
Re-cap the Extraction
Reagent bottle.
Raise the test device
upright (see picture).
Let it stand for 1-2 seconds.
Tap the device on a at surface
to ensure that the liquid ows
into the hole.
Read test results at 10-15
minutes.
Conrm negative results at 15
minutes.
Immediately after tapping,
slowly lay the device back
down onto the at surface.
Dispense the entire
sample in the transfer
pipette into the
Extraction Well of the
test device.
Hold the device with
one hand and the
swab with the other.
While pressing down
on the swab, rotate it
completely in one
direction 3 times to
mix the specimen.
Hold the device with
one hand and the
swab with the other.
While pressing down
on the swab, rotate it
in one direction 3
times to mix the
specimen.
Remove and discard
the swab.
Raise the device upright
(see picture).
Let it stand for 1–2
seconds. Gently tap the
device on a at surface to
ensure that the liquid
ows into the hole.
Immediately after tapping,
slowly lay the device back
down onto the at surface.
Read test results at 10-15 minutes.
Conrm negative results at 15
minutes.
Using a new transfer
pipette, draw Extraction
Reagent Solution to the
rst (lowest) mark.
3
Remove the cap from the
Extraction Reagent bottle.
Status Flu A
&
B
Nasopharyngeal Wash/Aspirate Sample Procedure
(Purchase of BSP-510AS required)
PROCEDURE
TEST DEVICE
Slowly
Tap
1
2
5
6
7
8
9
10
4
Extraction
Reagent
B
C
Influenza
Date______
ID________
A
B
C
Influenza
Date______
ID________
A
Influenza
Date
ID
C B A
Extraction Well
Result Window
Squeeze
here
Start timing.
Sample
Slowly
Tap
2
3
6
7
8
9
B
A
C
Influenza
Date______
ID________
B
A
C
Influenza
Date______
ID________
4
B
A
C
Influenza
Date______
ID________
5
B
A
C
Influenza
Date______
ID________
PROCEDURE
TEST DEVICE
1
Influenza
Date ID
C B A
Extraction Well
Result Window
Swab Stand
Start timing.
Status Flu A
&
B
Swab Sample Procedure
Squeeze the Extraction Reagent
capsule to dispense all of the
solution into the Extraction Well
of the test device.
Place the specimen swab on
the Swab Stand in the
Extraction Well.
Incubate 1 minute
with the swab in
Extraction Well.
Tear the tab o the Extraction
Reagent Capsule.
Draw nasal wash or
nasopharyngeal aspirate sample
to the rst (lowest) mark of the
graduated transfer pipette.
Dispense all of the solution
in the transfer pipette into
the Extraction Well of the
test device.
Incubate 1 minute.
Re-cap the Extraction
Reagent bottle.
Raise the test device
upright (see picture).
Let it stand for 1-2 seconds.
Tap the device on a at surface
to ensure that the liquid ows
into the hole.
Read test results at 10-15
minutes.
Conrm negative results at 15
minutes.
Immediately after tapping,
slowly lay the device back
down onto the at surface.
Dispense the entire
sample in the transfer
pipette into the
Extraction Well of the
test device.
Hold the device with
one hand and the
swab with the other.
While pressing down
on the swab, rotate it
completely in one
direction 3 times to
mix the specimen.
Hold the device with
one hand and the
swab with the other.
While pressing down
on the swab, rotate it
in one direction 3
times to mix the
specimen.
Remove and discard
the swab.
Raise the device upright
(see picture).
Let it stand for 1–2
seconds. Gently tap the
device on a at surface to
ensure that the liquid
ows into the hole.
Immediately after tapping,
slowly lay the device back
down onto the at surface.
Read test results at 10-15 minutes.
Conrm negative results at 15
minutes.
Using a new transfer
pipette, draw Extraction
Reagent Solution to the
rst (lowest) mark.
3
Remove the cap from the
Extraction Reagent bottle.