HAV IgG and IgM Combo Rapid Test

Intended Use

HAV IgG and IgM Combo Rapid Test (Serum/Plasma) is an in vitro diagnostic kit for the qualitative and differential detection of anti-HAV IgG and anti-HAV IgM in human, serum or plasma specimens. HAV IgG and IgM Combo Rapid Test is intended to be used as an aid in the diagnosis of hepatitis A virus infection. The results obtained should be confirmed with alternative testing method(s).

Introduction

● Hepatitis A is a viral liver disease that can cause mild to severe illness.

● The HAV is transmitted through ingestion of contaminated food and water or through direct contact with an infectious person.

● In countries where the risk of infection from food or water is low, there are outbreaks among men who have sex with men and persons who inject drugs.

Advantages

99% Accuracy

Results in 15 min

Easy to operate

Materials

● Individually packed test devices

● Package insert

● Disposable droppers (5 μL)

● Buffer

Test Procedure

Bring tests, specimens, buffer 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 device with patient or control identification. For best results, the assay should be performed within an hour.

2. For serum/plasma specimens:

Using the provided disposable dropper, draw the specimen up to the Fill Line, and transfer 1 drop of serum/plasma (approximately 5 μL), to the sample well (S), and then add 3 drops of buffer.

3. As the test begins to work, sample will migrate across the membrane.

4. Read the result at 15 minutes. Do not interpret the result after 20 minutes.

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