HAV Hepatitis A Virus IgG IgM Test

HAV Hepatitis A Virus IgG/IgM Test
INTENDED USE
This test is a single use, rapid device intended for qualitativedetection of IgM-class antibodies to hepatitis A virus (HAV)in serum, plasma samples. It is intended tobe used in clinical laboratories for diagnosis of acutehepatitis A and management of patients related to infectionwith hepatitis A virus.
COMPONENTS
Forty tests/kit
40 HAV IgM colloidal gold rapid test strips, each placed in white plastic cassette and packed in foil pouch, instructions for use, 1x6 ml vial of sample diluents. Materials required but not provided: clock or timer, safety
lancets, alcohol prep-pad, disposable pipettes, specimen collection container, centrifuge, biohazard waste container, sterile gauze or cotton.
SAMPLE REQUEST
-Serum/plasma samples:
Fresh serum or plasma samples can be used. No special patient preparation required. Care should be taken to ensure blood full clotting and any visible particulate matter in the sample should be removed by centrifugation or filtration. Avoid the use of highly hemolytic, turbid, microorganism contaminated samples or samples stored for over 30days at 2-8°C. Store samples at 2-8°C. Samples not required for assay within 3 days should be stored frozen (-20°C or lower). Avoid sample deterioration by multiple freeze-thaw cycles.
-Plasma: Collect whole blood into a collection tube (containing EDTA, citrate or heparin, respectively) by venipuncture. Separate the plasma by centrifugation.
-Serum: Collect whole blood into a collection tube (containing no anticoagulants) by venipuncture. Allow the blood to clot. Separate by centrifugation.
The original samples cannot be tested directly, must be diluted with sample diluents before testing!
INTERPRETATION OF RESULTS
Quality Control: One red line will always appear next to the Control Zone(C) indicating the validity of the test. If no red line appears, the test is invalid - discard the test and repeat with new sample and new cassette.
Positive Results: One red line next to the Test Zone (T) indicates that IgM antibodies to HAV have been detected using this HAV IgM Rapid Test.
Negative Results: No red line appears within 10 minutes next to the Test Zone (T) indicating that no IgM antibodies to HAV have been detected with this HAV IgM Rapid Test.
Related information
Accuracy: >98%
Origin: China
Using: self-testing
TEST PROCEDURE
1. Open a pouch containing a cassette, lay the cassette.
2. Carefully apply 10ul of sample onto 2ml buffer-0.85% NaCL(1:200), then drop 75ul(3 drops)well mixed buffer onto the sample well.
3. Read results within 10 minutes.
Negative: only one pink band appears on test region of the Cassette. This indicates that there is no detectable HAV
antibody in the serum.
Positive: Two pink bands appear on test region of the Cassette. This indicates that the specimen contains detectable
amount of HAV antibody.
Invalid: If without colored band appears on test region, this is an indication of a possible error in performing the
test. The test should be repeated using a new device.
Quality Control
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FAQ:
Q1. How can I get a sample of any product for confirm the quality?
A:1. Please give us your exactly specs details. We can provide you a sample according to your specification.
2.You can send us a sample, we can give you a counter sample according to your sample.
Q2. How can I get a price of needed product?
A: 1. Please give your exactly specs details to us. We can give you a sample and price according to your specification .
2.You can send us a sample, we can give you a counter sample and price according to your sample .
3. If you don't know any specification, You can give us the pictures of the product, and the usage, we can give you a estimated price according to our experience. But exactly price must after we checking your original sample.
Q3. I don't know the material or any other material information, how can i order this from you.
A: It's the best way if you can send us a sample, so we can according to your sample give you a counter sample for checking the quality, also we will quote a price for you checking the cost. After confirmed all of this. You can contact our sales for an order.
Q4. I am a small wholesaler, do you accept small order?
A: It's no problem if you are a small wholesaler, we would like to grow up with you together.
Q5. I am a designer, Can you help me to produce the sample which we designed?
A: Our mission is to help customers to be successful. So it's welcome if we can help you solve problem and make your design come true.
Q6.Can you make OEM or ODM service?
A: Yes. We can accept OEM service. Meanwhile it's also welcome to choose our ODM products.