Hepatitis A IgM Rapid Test (1 pc/box)

Hepatitis A IgM Rapid Test (1 pc/box)

The Hepatitis A IgM Rapid Test (whole blood/serum/plasma) is an in vitro diagnostic device designed for the qualitative, presumptive detection of specific anti-HAV IgM antibodies in human whole blood, serum, or plasma samples. Hepatitis A is an acute infectious liver disease caused by the Hepatitis A Virus (HAV), responsible for approximately 40% of all acute hepatitis cases. It is endemic worldwide, with an estimated 1.5 million symptomatic cases and potentially tens of millions of asymptomatic infections annually.

HAV is excreted in feces and transmitted orally, typically through contaminated food, unwashed vegetables, undercooked seafood, or unbottled water. A single infected individual can spread the virus through direct contact. Unlike hepatitis B and C, hepatitis A does not cause chronic liver disease and is rarely fatal, but can lead to debilitating symptoms or fulminant hepatitis (acute liver failure), which carries a high mortality rate. For professional use only.

Specifications

Product name: HAV IgM Rapid Test

Sample type: Whole blood / serum / plasma

Format: Cassette

Packaging: 1 pc/box

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd., 3rd Floor, Building 4, No. 1418 Moganshan Road, Hangzhou, Zhejiang, China, imd.assuretech@diareagent.com

EC REP: Lotus NL B.V., Koningin Julianaplein 10, le Verd, 2595AA, The Hague, Netherlands, peter@lotusnl.com

Expiry date: 03/2027

Kit Contents

• 1 test cassette

• 1 disposable pipette

• 1 HAV buffer solution

• 1 sterile lancet

• 1 alcohol prep pad

• 1 user manual in English

How to Use the Lancet

1. Remove the yellow single-use lancet from the packaging.

2. Detach the transparent cap.

3. Press firmly on the fingertip to activate the lancet.

4. Dispose of the used lancet in a waste bin.

Test Procedure

Before starting, allow all components to reach room temperature (15°C-30°C). Follow the user manual instructions carefully.

1. Open the sealed pouch and place the test on a clean, flat surface. Label the test with patient or control ID. For best results, perform the test within one hour of opening.

For serum/plasma samples:

• Use the disposable pipette to draw the sample up to the fill line.

• Add 1 drop (~5 μL) into the sample well (S), followed by 3 drops of buffer solution.

For whole blood samples:

• Fill the pipette just above the fill line (0.5–1 cm), and add 2 drops (~10 μL) of blood into the sample well (S), followed by 3 drops of buffer solution.

Avoid air bubbles in the sample well. Do not apply solution to the result window.

2. The liquid will migrate across the membrane.

3. Read the result after 15 minutes. Do not interpret the result after 20 minutes.

Result Interpretation

Positive:
Two red lines appear – one in the control region (C) and one in the test region (T). Even a faint line in the test region indicates a positive result.

Negative:
One red line appears in the control region (C); no line appears in the test region (T).

Invalid:
No control line (C) appears, or only the test line (T) is visible. The result is invalid due to improper sampling or test execution.

Test Performance

• Relative Sensitivity: 99.5% (97.5%–99.9%)

• Relative Specificity: 99.3% (95.9%–99.9%)

• Overall Agreement: 99.4% (98.0%–99.8%)

Legal Notices

Professional Use

This product is an in vitro diagnostic (IVD) and intended exclusively for professional use by medical personnel. Use for self-testing is not permitted. The manufacturer/distributor accepts no liability for damages resulting from improper or unauthorized use.

Right of Withdrawal

In accordance with § 312g (2) No. 3 of the German Civil Code (BGB), there is no right of withdrawal for sealed goods which, for reasons of health protection or hygiene, are not suitable for return if their seal has been removed after delivery.

Disclaimer

The seller assumes no responsibility for compliance with legal regulations within the buyer’s procurement process. The seller’s responsibility is limited solely to the delivery of the ordered goods and the provision of information regarding their proper use.

Instructions