1. For in vitro diagnostic uses only.
2. All patient samples should be treated as if capable of transmitting
diseases.
3. Do not interchange reagents from different lots. Do not use test kit
beyond expiration date.
4. Icteric, lipemic, hemolysed, heat treated and contaminated sera
may cause erroneous results.
STORAGE
The kits (the sealed pouch) should be stored at room temperature
( 4-30°C), for the duration of the shelf life (24 months).
SAMPLE COLLECTION AND PREPARATION
Whole Blood ( Finger stick Specimens)
1. Clean the area to be lanced with an alcohol swab.
2. Squeeze the end of the fingertip and pierce it with a sterile lancet.
3. Wipe away the first drop of blood with sterile gauze or cotton.
4. Use micropipette to obtain about 100ul fresh blood and dispense
into the sample well.
Plasma
1. Have a certified phlebotomist collect whole blood into a purple,
blue or green top collection tube (containing EDTA, citrate or
heparin, respectively) by veinpuncture.
2. Separate the plasma by centrifugation.
3. Carefully withdraw the plasma for testing, or label and store it at
4°C for up to five days. Plasma may be frozen at -20°C for at least
three months.
Serum
1. Have a certified phlebotomist collect whole blood into a red top
collection tube (containing no anticoagulants) by veinpuncture.
2. Allow the blood to clot.
3. Separate the serum by centrifugation.
4. Carefully withdraw the serum for testing or label and store it at 4°C
for up to five days. Serum may be frozen at -20°C for at least three
months.
ASSAY PROCEDURE
Serum or Plasma Sample
Add 70-100 ul or 2-3 drops of serum or plasma into sample well.
Observe the result in 20-30 minutes.
Whole Blood Sample
Add 1 drop of whole blood into sample well, after all blood completely
absorbed, add 1 drop of whole blood diluent. Observe the result in
20-30 minutes.