Product Manual

2. Check the Solution to make sure that it appears pink. This means
t
hat the blood was correctly mixed into the Solution (see picture
10B ). If the Solution is not pink, discard all test materials in a
b
iohazard waste container. Start the test over. Use a new Pouch and
a new blood sample.
STEP 3: TEST
1. Remove the Device from the Pouch. DO NOT touch the Flat Pad
(
see picture 11B ). Check to make sure that an Absorbent Packet is
included with the Device (see picture 12B ). If no Absorbent Packet
i
s present, discard the Device and obtain a new Pouch for testing.
2. Insert the Flat Pad of the Device all the way into the Vial containing
t
he blood sample (see picture 13B ). 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 14B ).
3
. Start timing the test (see picture 15B ). 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 16B ). Read the results after 20
minutes but not more than 40 minutes in a fully lighted area.
4. Refer to the Test Result and Interpretation of Test Result section in
this package insert.
PLASMA PROCEDURE
NOTE: Testing of plasma samples may only be
performed by laboratories certified to perform
Moderate Complexity tests.
STEP 1: COLLECT
1. Using standard venous phlebotomy procedures, collect a whole
blood sample using a tube containing EDTA (lavender top)
anticoagulant. Other anticoagulants have not been tested
and may give an incorrect result. If the specimens are not
tested at the time of collection, the specimen may be stored as
whole blood for up to 5 days at 2º-30ºC (36º-86ºF) or as plasma for
up to 7 days at 2º-8ºC (36º-46ºF).
2. Centrifuge the tube of blood [1000-1300 x g, for approximately
5 minutes, no refrigeration required] to separate the cells from the
plasma. Carefully uncap the tube by gently rocking the stopper
towards you so that it vents away from you.
3. Pick up an unused Specimen Collection Loop (“Loop”) by the thick
“handle” end (see picture 1C ). Put the “rounded” end of the Loop
into the tube of plasma (see picture 2C ). Make sure that the Loop
is completely filled with plasma (see picture 3C ). 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
plasma sample.
STEP 2: MIX
1. Immediately insert the plasma-filled end of the Loop all the way
into the Vial (see picture 4C ). Use the Loop to stir the plasma
sample in the Developer Solution (“Solution”) (see picture 5C ).
Remove the used Loop from the Solution. Throw the used Loop
away in a biohazard waste container.
10B
13B 14B
15B 16B
2C
4C 5C
Flat Pad
A
bsorbent
Packet
11B 12B
Handle
1C
3C
6
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