HIV Rapid Test Pack – 5 Tests

• Every order is carefully sealed and shipped in 100% discreet packaging with a neutral sender name.

• The price includes 5% VAT.

• 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 intended to aid in the diagnosis of HIV infection.

HIV is the causative agent of acquired immunodeficiency syndrome (AIDS), and the infection is a problem affecting the whole world. According to data from 2021, a total of 38.4 million people worldwide were living with HIV, and the number of infected people is 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, the number of undetected cases remains high; it is estimated that as many as 4,000 people may be HIV-positive, and more than half of those affected are not aware of their condition. This is why regular screening is very important, since early diagnosis can save lives.

HIV is a virus that attacks the body’s immune system and causes a lifelong infection, as a result of which the body cannot defend itself adequately against other infections. People infected with HIV can live a full life if the disease is detected in its early stage, because with drug treatment the AIDS stage of the disease does not develop at all. The product can be ordered for professional use.

HIV rapid test specification

Product name: HIV rapid test
Specimen: whole blood/serum/plasma
Pack size: 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
Expiry date: 03/2028

Contents of the HIV rapid test kit

• 1 test cassette
• 1 disposable pipette
• 1 buffer solution
• 1 fingertip lancet
• 1 alcohol swab
• 1 instructions for use in Hungarian

How to use the fingertip lancet

1. Take the yellow single-use fingertip lancet out of the packaging. Remove the transparent cap.

2. Press it against your fingertip. The needle will be released automatically.

3. After use, dispose of the lancet in the waste bin.

Test procedure

Read the Instructions for Use carefully before performing the test. Collect the specimen as described in the instructions for use.

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

After specimen collection:

1. Remove the test from the sealed pouch and place it on a clean, level surface. Label the test with the patient or control identification. For best results, the assay should be performed within one hour after opening the pouch.

2.A For serum/plasma specimens:

Using the supplied disposable pipette, add 1 drop of serum/plasma (approx. 25 μL) to the specimen well (S), then add 1 drop of buffer solution.

2.B For whole blood specimens:

Using the supplied dropper, carefully transfer 2 drops (50 μL) of whole blood to the specimen well (S), then add 1 drop of buffer solution.

2.C For fingertip whole blood specimens:

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

3. Read the result after 10 minutes. Do not interpret the result after 20 minutes.

Interpretation of results

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

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

Invalid: No line is visible in the control region. Any test result in which no line is visible in the control region within the specified reading time must be considered invalid. Please repeat the test with a new test. If the problem persists, contact your local distributor.

Performance of the HIV rapid test

A total of 602 HIV-positive specimens were tested with 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%).

Under Section 3 (5) of EüM Decree 2/2008 (I. 8.) on products that may be sold in pharmacies and must be kept in stock, the diagnostic products specified therein, i.e. in vitro diagnostic devices (rapid tests) for the diagnosis of HIV and hepatitis B, C and D, may only be kept in a hospital pharmacy for inpatient care use. The test may only be purchased by healthcare institutions, physicians, or licensed organizations engaged in AIDS screening.

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

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

Carbon Web Kft. is not responsible for fulfilling the legal obligations related to the Buyer’s procurement procedure, as this falls within the Buyer’s competence; its liability is limited solely to information on the intended use and to the goods delivered.