HIV Rapid Test (1 pc/box)

• All orders are shipped carefully sealed, in 100% discreet packaging, with a neutral sender name.

• The product can be ordered for professional use.

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 used to assist in establishing the diagnosis of HIV infection.

HIV is the causative agent of acquired immunodeficiency syndrome (AIDS), an infection that affects the entire world. According to 2021 data, a total of 38.4 million people worldwide were living with HIV, with the number of infected individuals increasing by roughly 1.5 million per year. In Hungary, approximately 200-300 new infections are registered each year. Although there is no epidemic in Hungary, there are still a large number of undetected cases — estimates suggest that as many as 4,000 people may be HIV-positive, and more than half of those affected are unaware of their status. This is why regular screening is so important, as early diagnosis can save lives.

HIV is a virus that attacks the body's immune system, causing a lifelong infection as a result of which the body is unable to properly defend itself against other infections. People living with HIV can lead a full life if the disease is recognized in its early stages, as with medication the disease does not even progress to the AIDS stage. The product can be ordered for professional use.

HIV Rapid Test specification

Product name: HIV Rapid Test
Sample: whole blood/serum/plasma
Size: 1 pc/box
Format: Cassette test
Manufacturer: Assure Tech. (Hangzhou) Co., Ltd., 3RD FLOOR, BUILDING 4, NO. 1418, MOGANSHAN ROAD, HANGZHOU, ZHEJIANG, China
EC REP: Lotus NL B.V. Koningin Julianaplein 10, le Verd, 2595AA, The Hague, Netherlands
Expiry date: 31/03/2028

HIV Rapid Test kit contents

• 1 test cassette
• 1 disposable pipette
• 1 buffer solution
• 1 fingerstick lancet
• 1 alcohol wipe
• 1 instructions for use

How to use the fingerstick lancet

1. Remove the yellow, single-use fingerstick lancet from the packaging. Remove the transparent cap.

2. Press it against your fingertip. The lancet will release automatically.

3. After use, dispose of the lancet in the trash.

Testing procedure

Before performing the test, please carefully read the instructions for use! Collect the sample as described in the instructions for use.

Before use, allow the devices, reagents, samples and/or controls to reach room temperature (15°C–30°C).

After sample collection:

1. Remove the test from the sealed pouch and place it on a clean, horizontal surface! Label the test with the patient's or control's identifier! For best results, the test should be performed within one hour of opening.

2.A For serum/plasma samples:

Using the included disposable pipette, add 1 drop of serum/plasma (approx. 25 μL) into the sample well (S), then add 1 drop of buffer solution.

2.B For whole blood samples:

Using the included dropper, carefully transfer 2 drops (50 μL) of whole blood into the sample well (S), then add 1 drop of buffer solution!

2.C For fingerstick whole blood samples:

Add 2 drops of fingerstick whole blood into the sample well (S) of the test device, then add 1 drop of buffer, and start the timer! Avoid trapping air bubbles in the sample well (S), and do not add solution to the result area.

3. The result should be read after 10 minutes. After 20 minutes, the result is invalid.

Interpreting results

Positive: Two colored lines appear on the membrane. One line appears in the control area (C), and the other in the test area (T).

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

Invalid: No visible line appears in the control area. Any test result where no visible line appears in the control area within the specified reading time should be considered invalid. Please repeat the test with a new kit! If the problem 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 the results were compared with the results of commercially available tests.

The diagnostic sensitivity of the test is >99% (95% CI: 99.4% ~ 100.0%).

The diagnostics specified in Section 3 §(5) of Hungarian Ministry of Health Decree 2/2008 (I. 8.) on products distributable in pharmacies and products that must be kept in stock — namely in vitro diagnostics (rapid tests) for the diagnosis of HIV as well as hepatitis B, C, and D — may only be kept in institutional pharmacies for use in inpatient healthcare institutions. This test may only be purchased by healthcare institutions, physicians, or licensed organizations engaged in AIDS screening!

The test may only be used by competent professional staff, healthcare professionals! Carbon Web Kft. accepts no liability for its use for self-testing purposes.

ATTENTION!
Under Hungarian Government Decree 45/2014 (II. 26.), for health protection or hygiene reasons, this product cannot be returned after delivery; therefore, the 14-day right of withdrawal does not apply to this product. Section 29 §(1) The consumer may not exercise their right under Section 20 (right of withdrawal) e) in respect of a sealed product which, for health protection or hygiene reasons, cannot be returned after opening following delivery.

Carbon Web Kft. is not responsible for the Buyer's compliance with legal obligations related to their procurement process, as this falls under the Buyer's responsibility; its liability is limited solely to providing information on intended use and to the delivered goods.