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Infectious Diseases

- Intended Use

The One Step HAV IgM Test is a rapid chromatographic immunoassay for the qualitative detection of IgM antibodies to Hepatitis A Virus (HAV) in Serum/Plasma to aid in the diagnosis of Hepatitis A Virus.

- Storage and Stability

Store at 4 to 30℃ in a dry place and avoid direct sunlight. Do not freeze. It is valid for 24 months from date of manufacturing.

- Assay Procedure

1. Take samples out from a frozen condition, allow samples to reach room temperature and label them.

2. Remove the cassette from the foil pouch prior to use and place it on a flat surface. Add 10 μl of serum sample into the sample well, and immediately add 3 drops (90ul-100ul) of buffer.

3. Positive results should be obtained within 10-15 minutes. It is recommended to wait for 15 minutes and read results. Results obtained after 15 minutes should be considered invalid.

- Interpretation of Results

1. Positive: Two purple bands appearing at both test line (T) and control line (C) indicates positive result.

2. Negative: Only one color band appearing at the control line (C) indicates negative result.

3. Invalid: No purple band at the control line (C) indicates incorrect assay process or failure of the kit. Read this instruction carefully and repeat test with a new test kit. If the problem persists, you should immediately stop using the kit with the same LOT No. and contact your local supplier.

- Product Properties

Product Format: Cassette

Products name: HAV IgM Test Cassette

Methodology: Colloidal Gold

Specification: 4mm

Specimen: Serum/Plasma

Reading Time: with 10-15 minutes

Service: OEM and ODM, Technology and Policy support

Shelf life: 24 months

Certificates: ISO13485, SGS