Product Details
HAV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a single-use, rapid device intended for qualitative and differential detection of IgG-class antibodies and IgM-class antibodies to hepatitis A virus (HAV) in human whole blood, serum, or plasma samples. It is intended to be used as a screening test and as an aid in the diagnosis of infection with HAV. Any reactive specimen with the HAV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) must be confirmed with an alternative testing method(s) and clinical findings.
HAV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is based on the principle of agglutinating sera on the membrane and utilizes the technique of immunochromatography. The sample pad is coated with HAV antigen. As the test specimen flows through the sample pad assembly of the device, the HAV antigen complex with the HAV specific antibodies in the test specimen. When this complex travels on the conjugated pad which is impregnated with mouse anti-HAV antibody conjugated to the colloidal gold, the HAV colloidal gold reacts with the complex then travels on the membrane due to capillary action. If HAV IgM antibodies present in the specimen, the complex will be captured on the membrane by the pre-coated anti-human IgM antibody, forming a burgundy colored IgM band, indicating an IgM positive test result. Alternatively, if HAV IgG antibodies present in the specimen, the complex will be captured on the membrane by the pre-coated anti-human IgG antibody, forming a burgundy colored IgG band, indicating an IgG positive test result.
The absence of any T bands indicates a negative result. The test contains an internal control (C band) which is coated with goat anti-mouse IgG should exhibit a burgundy colored band regardless of the color development on any of the T bands. Otherwise, the test result is invalid and the specimen must be retested with another device.
STORAGE AND STABILITY
All reagents are ready to use as supplied. Store unused test device unopened at 2°C-30°C. If stored at 2°C-8°C, ensure that the test device is brought to room temperature before opening. The test device is stable through the expiration date printed on the sealed pouch. Do not freeze the kit or expose the kit over 30°C.
Ordering Information
SPECIMEN COLLECTION
1. There is no need to prepare the patient prior to sample collection by approved techniques.
2. Anticoagulated whole blood as well as serum/plasma can be used. Whole blood or plasma specimens containing anticoagulants other than EDTA, Oxalate, or Heparin may give incorrect results. Serum/plasma may be stored at 2- 8℃ up to 3 days in case of delay in testing. For long-term storage, freeze the specimen at –20℃. Whole blood should be used immediately and should not be frozen.
3. Repeated freezing and thawing of the serum/plasma specimen should be avoided. Maximum of 2 freeze/thaw cycles are allowed.
4. Do not use haemolysed, clotted, contaminated, viscous/turbid specimens.
5. Specimen containing precipitates or particulate matter must be centrifuged and the clear supernatant only used for testing.
6. Do not heat inactivate the sample before use.
TEST PROCEDURE
Allow test cassette, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1.Add 6 drops (about 250 μL) of buffer to a specimen tube.
2.Add 1μL of the specimen into the specimen tube by pipette and mix completely.
3.Remove the device from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
4.Place the test device on a clean and level surface. Be sure to label the device with the specimen’s ID number.
5.Reverse the sample tube, and add 2-3 drops (about 70-100μL) of the test sample into the sample well (S) by squeezing the sample tube. Then start the timer.
6.Wait for the red line(s) to appear. The result should be read in 15 minutes. Do not interpret the result after 15 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
1.Positive:
1.1 IgM Positive: In addition to the presence of a C band, if only an IgM band is developed, the test indicates the possibility of primary infection.
1.2 IgG Positive: In addition to the presence of a C band, if only an IgG band is developed, the test indicates the possibility of the secondary infection or past infection.
1.3 Both IgG and IgM Positive: In addition to the presence of C band, both IgM and IgG bands are developed, the test indicates the possibility of acute secondary infection.
2. Negative: If only the C band is present, the absence of any burgundy color in both test bands (IgM and IgG) indicates that no HAV antibody is detected in the specimen. The result is negative or non-reactive.
3. Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
http://www.douglasmed.com/
Company Profile
