INTENDED USE

TheHAV Gold Rapid Screen Test (RST) is a Chromatographic immunoassay (CIA) for direct qualitative detection of antibodies to Hepatitis A type virus (HAV) in human serum/ plasma.

 

PRINCIPLE

HAV RST is a chromatographic immunoassay (CIA) for the detection of antibodies to HAV in human serum/plasma. Mouse anti human-IgM μ strands 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 HAV recombinant antigens. If antibodies to HAV are present, a pink colored band will develop on the membrane in proportion to the amount of HAV 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 HAV.

 

REAGENTS AND MATERIALS PROVIDED

1.  One sealed pouched cassette with desiccant &disposable pipettet.

1. Blood diluent in a dropper bottle. Store at 4-30°C.

2. 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 AND STABILITY

Store HAV Rapid Screen Test at temperature ranges 4-30 °C in the sealed pouch. Refer to the expiration date for stability. Do not freeze.

 

SAMPLE COLLECTION AND PREPARATION

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 2-8°C for up to two weeks. Plasma may be frozen at -20°C for up to one year.

    

   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.

1. Carefully withdraw the serum for testing or label and store it at 2-8°C for up to two weeks. Serum may be frozen at -20°C for up to one year.