HCV Antibody rapid test
    Publish time 1970-01-01 08:00    
HCV Antibody rapid test kit

40 tests/box
1.40 test cassettes

2.Each pouch contains one cassettes with one desiccant bag

3.One bottle of diluent buffer (5ml)

4.40 disposable plastic dropper

5.Instruction use

 1test/box

1. 1 test cassettes (individually pouched)

2. Each pouch contains one cassette with one desiccant bag

3. One bottle of diluent buffer (1ml)

4. 1 disposable plastic dropper

5. Instruction use

6. Sterile lancet

7. Alcohol pad
INTENDED USE
The HCV Gold Rapid Screen Test (RST) is a Chromatographic immunoassay (CIA) for direct qualitative detection of antibodies to Hepatitis C type virus (HCV) in human serum/ plasma and whole blood.
PRINCIPLE

HCV RST is a chromatographic immunoassay (CIA) for the detection of
antibodies to HCV in human serum/plasma and whole blood. HCV
recombinant antigens are precoated onto membrane as a capture
reagent on the test region. During the test, specimen is allowed to react
with the colloidal gold particles, which have been labeled with HCV
recombinant antigens. If antibodies to HCV are present, a pink colored
band will develop on the membrane in proportion to the amount of HCV
antibodies present in the specimen. Absence of this pink colored band
in the test region suggests a negative result. To serve as a procedural
control, a pink colored band in the control region will always appear
regardless the presence of antibodies to HCV.
REAGENTS AND MATERIALS PROVIDED
1. One sealed pouched cassette with desiccant &disposable pipettet.
2. Blood diluent in a dropper bottle. Store at 4-30°C.
3. One piece of operating instruction with 40 test pouches.
WARNING AND PRECAUTIONS
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.

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