HIV Rapid Test (1 pc/box)

HIV Rapid Test

The HIV rapid test (whole blood/serum/plasma) is a visual immunoassay for the qualitative detection of HIV-1/HIV-2 antibodies in human whole blood, serum, or plasma. The test is intended to aid in the diagnosis of HIV infection.

HIV is the causative agent of Acquired Immunodeficiency Syndrome (AIDS), a global health issue. According to 2021 data, there were approximately 38.4 million people living with HIV worldwide, and about 1.5 million new infections occur each year. In Hungary, around 200–300 new cases are registered annually. Although there is no epidemic in Hungary, many cases remain undetected—estimates suggest up to 4,000 people may be HIV-positive, with more than half unaware of their condition. Therefore, regular screening is essential, as early diagnosis can save lives.

HIV attacks the immune system and causes a lifelong infection, weakening the body’s ability to defend itself against other infections. Individuals with HIV can live full, healthy lives if diagnosed early, as proper medical treatment can prevent the development of AIDS. This product is available exclusively for professional use.

HIV Rapid Test Specifications

Product name: HIV Rapid Test

Sample type: Whole blood / serum / plasma

Packaging: 1 pc/box

Format: Cassette test

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd., 3RD FLOOR, BUILDING 4, NO. 1418, MOGANSHAN ROAD, HANGZHOU, ZHEJIANG, 50 CHINA, imd.assuretech@diareagent.com

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

Expiration date: 2027.02

HIV Test Kit Contents

• 1 test cassette

• 1 disposable dropper

• 1 buffer solution

• 1 lancet

• 1 alcohol pad

• 1 instruction manual in English

How to Use the Lancet

1. Remove the yellow single-use lancet from the packaging and take off the transparent cap.

2. Press the lancet firmly against your fingertip. The needle will automatically trigger.

3. Discard the lancet in household waste after use.

Test Procedure

Please read the instruction manual carefully before testing. Perform sample collection as described in the instructions.

Allow the test device, reagents, samples, and/or controls to reach room temperature (15°C-30°C) before use.

After collecting the sample:

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

2.A For serum/plasma samples:
Use the provided disposable dropper to add 1 drop of serum/plasma (approx. 25 µL) into the sample well (S), then add 1 drop of buffer.

2.B For whole blood samples:
Use the dropper to carefully transfer 2 drops (50 µL) of whole blood into the sample well (S), then add 1 drop of buffer.

2.C For fingertip capillary blood samples:
Add 2 drops of capillary blood into the sample well (S), followed by 1 drop of buffer, then start the timer. Avoid air bubbles in the sample well and do not add any solution to the result area.

3. Read the result at 10 minutes. Results read after 20 minutes are invalid.

Interpretation of Results

Positive: Two colored lines appear on the membrane - one in the control (C) region and one in the test (T) region.

Negative: Only one colored line appears in the control (C) region. No visible line appears in the test (T) region.

Invalid: No visible line appears in the control (C) region. Any test without a control line within the specified reading time must be considered invalid. Repeat the test with a new device. If the issue persists, contact your local distributor.

Performance of the HIV Rapid Test

A total of 602 HIV-positive samples were tested using the HIV rapid test (whole blood/serum/plasma) and results were compared with commercially available reference tests.

Diagnostic sensitivity: >99% (95% CI: 99.4% ~ 100.0%).

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