Product Manual

S
TEP 2: TEST
1. Insert the Flat Pad of the Device all the way into the Vial (see picture
5
A ). 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 6A ).
2. Start timing the test (see picture 7A ). DO NOT remove the Device
from the Vial while the test is running. Pink fluid will appear and
t
ravel up the Result Window. The pink fluid will gradually disappear
as the test develops (see picture 8A ). Read the results after 20
m
inutes but not more than 40 minutes in a fully lighted area.
3. Refer to the Test Result and Interpretation of Test Result section in
t
his package insert.
FINGERSTICK WHOLE BLOOD AND VENIPUNCTURE WHOLE BLOOD PROCEDURE
STEP 1: COLLECT
Whole blood specimens may be collected either by fingerstick (see Step 1.A ) or by venipuncture (see Step 1.B ).
STEP 1.A: FINGERSTICK WHOLE BLOOD
1. Using an antiseptic wipe, clean the finger of the person being
tested. After cleansing the skin puncture site, allow the area to air
dry, so the antiseptic action of the alcohol can take effect. Using a
sterile lancet, puncture the skin just off the center of the finger pad.
Hold the finger downward. Apply gentle pressure beside the point
of the puncture. Avoid squeezing the finger to make it bleed (see
picture 1B ). Wipe away this first drop of blood with a sterile gauze
pad. Allow a new drop of blood to form.
2. Pick up an unused Specimen Collection Loop (“Loop”) by the thick
“handle” end (see picture 2B ). Put the “rounded” end of the Loop
on the drop of blood (see picture 3B ). Make sure that the Loop is
completely filled with blood (see picture 4B ). 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.
STEP 1.B: VENIPUNCTURE WHOLE BLOOD
1. 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 2º-30ºC (36º-86ºF) for up to 5 days. Prior to
testing, mix the blood tube gently by inversion several times to
ensure a homogeneous sample.
2. Pick up an unused Specimen Collection Loop (“Loop”) by the thick
“handle” end (see picture 5B ). Put the “rounded” end of the Loop
into the tube of blood (see picture 6B ). Make sure that the Loop is
completely filled with blood (see picture 7B ). 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.
STEP 2: MIX
1. Immediately insert the blood-filled end of the Loop all the way into
the Vial (see picture 8B ). Use the Loop to stir the blood sample in
the Developer Solution (“Solution”) (see picture 9B ). Remove the
used Loop from the Solution. Throw the used Loop away in a
biohazard waste container.
5A 6A
7A 8A
1B 2B
3B 4B
6B
7B
Handle
8B 9B
Handle
5B
5
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