Dewei Hepatitis E Virus IgM Antibody Check HEV Rapid Test Cassette

Hepatitis E Virus (HEV) Rapid Test Manual

Product Introduction

The HEV IgM Test Kit is a lateral flow chromatographic 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 as a screening test and as an aid in the diagnosis of infection with HEV. Any reactive specimen with the HEV IgM Test Kit must be confirmed with alternative testing method (s) and clinical findings.

The HEV IgM Test Kit is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing HEV antigens conjugated with colloidal gold (HEV conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing a test line (T line) and a control line (C line). The T line is pre-coated with monoclonal anti-human IgM antibody, and the C line is pre-coated with goat anti-rabbit IgG antibody.

Precautions

• For professional in vitro diagnostic use only.
• Do not use after the expiration date indicated on the package. Do not use the test if the foil pouch is damaged. Do not reuse tests.
• This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does not completely guarantee the absence of transmissible pathogenic agents. It is therefore recommended that these products be treated as potentially infectious, and handled by observing usual safety precautions (e.g., do not ingest or inhale).
• Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.
• Read the entire procedure carefully prior to testing.
• Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow standard procedures for the proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
• Humidity and temperature can adversely affect results.
• Used testing materials should be discarded according to local regulations.

Storage

• Store at 2 ~ 30 º C in the sealed pouch for 24 months.
• Keep away from direct sunlight, moisture and heat.
• DO NOT FREEZE.

Selling Points

• High accuracy.
• Simple, easy to use, no need extra trainee or laboratoty equipments.
• Cost-effective, affordable.
• Fast check, result available in 15 mins.

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. Do not interpret the result after 20 minutes.

4. Results interpretation:

POSITIVE: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.

NEGATIVE: The presence of only control line (C) within the result window indicates a negative result.

INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid.

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