Step 1 – COLLECT
•
Using standard venous phlebotomy procedures, collect a whole blood
sample using a tube containing any of the following anticoagulants: EDTA
(lavender top), sodium heparin (green top), or sodium citrate (light blue top).
Other anticoagulants have not been tested and may give an incorrect
result.
If the specimens are not tested at the time of collection, the whole
blood may be stored at 2°– 30°C (36°– 86°F) for up to 5 days.
•
Prior to testing, mix the blood tube gently by inversion several times to
ensure a homogeneous sample.
•
Pick up an unused Specimen Collection Loop ("Loop") by the thick “handle”
end
(see picture C1)
.
•
Put the "rounded" end of the Loop into the tube of blood
(see picture C2)
.
Make sure the Loop is completely filled with blood
(see picture C3)
.
Step 2 – MIX
•
Immediately insert the blood-filled end of the Loop all the way into the Vial
(see picture C4)
.
•
Use the Loop to stir the blood sample in the Developer Solution (“Solution”)
(see picture C5)
.
•
Remove the used Loop from the Solution. Throw the used Loop away in a
biohazard waste container.
•
Check the Solution to make sure that it appears pink. This means that the
blood was correctly mixed into the Solution
(see picture C6)
. If the Solution is
not pink, discard all the test materials in a biohazard waste container. Start
the test over. Use a new Pouch and a new blood sample.
Step 3 – TEST
•
Remove the Device from the Pouch.
DO NOT
touch the Flat Pad
(see
picture C7)
.
•
Check to make sure that an Absorbent Packet is included with the Device
(see picture C8)
. If no Absorbent Packet is present, discard the Device and
obtain a new Pouch for testing.
•
Insert the Flat Pad of the Device all the way into the Vial containing the
blood sample
(see picture C9)
. Make sure that the Flat Pad touches the
bottom of the Vial. The Result Window on the Device should be facing
towards you
(see picture C10)
.
•
Start timing the test
(see picture C11)
.
DO NOT
remove the Device from the
Vial while the test is running. Pink fluid will appear and travel up the Result
Window. The pink fluid will gradually disappear as the test develops
(see
picture C12)
.
•
Read the results after 20 minutes but not more than 40 minutes in a fully
lighted area.
•
Refer to the
Reading Test Result and Interpretation of Test Result
sections on
the back of these instructions.
Handle
NOTE: If the Loop is dropped or comes in contact with
any other surface, discard it in a biohazard waste
container. Get a new Loop for the collection of the
blood sample.
VENIPUNCTURE WHOLE BLOOD
– SPECIMEN COLLECTION AND TESTING PROCEDURE
C1
C3
Flat
Pad
Absorbent
Packet
C4
C5
C6
C7
C8
C9
C10
C11
C12
C2
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