Disease Screened: | Hepatitis E Virus (HEV) | Specimen: | Serum/Plasma/Whole Blood |
---|---|---|---|
Usage: | In Vitro Diagnostics Use | Species Reactivity: | Human |
Format: | Cassette | Shelf Time: | Two Years |
Principle: | Chromatographic Immunoassay | Result: | Read At 15 Mins |
Highlight: | HEV IgM Rapid Test Cassette,Hepatitis E Rapid Test Cassette,10mins Hepatitis E Virus Diagnostic Kit |
HEV IgM Rapid Test Cassette Hepatitis E Virus Diagnostic Kit
【HEV INTRODUCTION】
Hepatitis E is a liver infection caused by the hepatitis E virus (HEV). HEV is found in the stool of an infected person. It is spread when someone unknowingly ingests the virus – even in microscopic amounts. In developing countries, people most often get hepatitis E from drinking water contaminated by feces from people who are infected with the virus.
【RAPID TEST INTENDED USE】
HEV IgM Rapid Test is a lateral flow immunoassay for the qualitative detection of IgM antibodies to hepatitis E virus (HEV) in human serum, plasma or whole blood. It is intended to be used by professionals as a preliminary test result to aid in the diagnosis of infection with HEV.
【DIAGNOSTIC PRINCIPLE】
Colloidal Gold Chromatographic Immunoassay
【RAPID TEST SPECIMEN】
Serum/Plasma/Whole blood
【MAIN CONTENTS】
【SAMPLE COLLECTION】
【TEST OPERATION】
Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the cassette with patient or control identification. For best results the assay should be performed within one hour.
2. Transfer 10 μl whole blood/serum/plasma sample to the specimen well (S) of the cassette with the provided disposable pipette, and add 2 drop (appx.60-80μl) of buffer, then start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
3. Wait for the colored band(s) to appear. The result should be read at 15 minutes.
【RESULT INTERPRETATION】
NEGATIVE RESULT:
If only the C line develops, the test indicates that no detectable anti-HEV IgM is present in the specimen. The result is negative or non-reactive.
POSITIVE RESULT:
If both the C and the T lines develop, the test indicates the presence of detectable anti-HEV IgM in the specimen. The result is positive or reactive.
INVALID:
If no C line develops, the assay is invalid regardless of any color development on the T line as indicated below. Repeat the assay with a new device.
【STORAGE AND STABILITY】
The kit should be stored at 2-30°C until the expiry date is 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 it if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers, or reagents can lead to false results.