Hepatitis A Virus (HAV) Rapid Test Kit
【INTENDED USE】
Hepatitis A Virus (HAV) IgG/IgM Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to HAV in human whole blood, serum or plasma.
【INTRODUCTION】
In 1973 Feinslone first used immunoelectron microscopy to detect Hepatitis A virus (HAV) in the stool of patients at the acute stage. Hepatitis A virus (HAV) is a member of the hepaviridae family of small RNA viruses. Most humans infected with HAV present with subclinical or cryptic infection, with only a few presenting with acute hepatitis A. Can restore completely commonly, do not turn for chronic hepatitis, also do not have chronic carrier.
【PRINCIPLE】
Hepatitis A Virus (HAV) Rapid Test is a qualitative membrane-based immunoassay for the detection of HAV antibodies in whole blood, serum, or plasma. This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in IgG test line region. During testing, the specimen reacts with HAV antigen-coated particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in IgG test line region. If the specimen contains IgG antibodies to HAV, a colored line will appear in IgG test line region. In the IgM component, anti-human IgM is coated in IgM test line region. During testing, the specimen reacts with anti-human IgM. IgM antibodies to HAV, if present in the specimen, reacts with the anti-human IgM and the HAV antigen-coated particles in the test cassette, and this complex is captured by the anti-human IgM, forming a colored line in IgM test line region.
Therefore, if the specimen contains IgG antibodies to HAV, a colored line will appear in IgG test line region. If the specimen contains IgM antibodies to HAV, a colored line will appear in IgM test line region. If the specimen does not contain antibodies to HAV, no colored line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
【CONTENTS】
• Rapid Test.
• Buffer
• Disposable dropper.
• Instruction for use.
【STORAGE AND STABILITY】
• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
• The test must remain in the sealed pouch until use.
• Keep away from direct sunlight, moisture and heat.
• Do not freeze.
• Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.
【SAMPLE COLLECTION AND STORAGE】
• The reagent can be used for the serum, plasma and whole blood samples.
• A serum / plasma / whole blood sample must be collected in a clean and dry container. EDTA, sodium citrate, heparin can be used as anticoagulants in plasma / whole blood samples. Detect immediately after collecting blood.
• Serum and plasma samples may be stored at 2-8℃ for 3 days prior to assay. If testing is delayed more than 3 days, the sample should be frozen (-20℃ or colder). Repeat freeze and thaw for no more than 3 times. Whole blood samples with anticoagulant can be stored at 2-8℃ for 3 days, and should not be frozen; whole blood samples without anticoagulant should be used immediately (if the sample has agglutination, it can be detected by serum) .
【OPERATION】
Bring tests, specimens, buffer and/or controls to room temperature (15- 30°C) before use.
1. Remove the test cassette from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Place the test on a clean and level surface. Transfer the specimen by a pipette or a disposable dropper:
• To use a Pipette: Transfer 5 L of whole blood, serum or plasma to Well-S (S) of the test cassette, then add 3~4 full drops of buffer to Well-B (B), and start the timer. (See illustration ① below). Avoid trapping air bubbles in S.
• To use a Disposable Specimen Dropper: Hold the pipette vertically; draw the specimen up to the Fill Line as shown in illustration ① below. Transfer the specimen to S of the test cassette, then add 3~4 full drops of buffer to B and start the timer.Avoid trapping air bubbles in S.
2. Wait for the colored line(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.
【INTERPRETATION OF RESULTS】
Negative (-) :
Only one color line appears on the control region (C).
Positive (+) :
IgG Positive: Both IgG test region (IgG) and control region appear color line.
IgM Positive: Both IgM test region (IgM) and control region appear color line.
IgG/IgM Positive: Both test region (IgG and IgMM) and control region appear color line.
Invalid:
No visible line at all, or there is a visible line only in the test region and not in the control region. Repeat with a new test kit.
For further operation or performance details, please refer to final instruction manual.
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