Herpes Simplex Virus 2 (HSV-2) IgG/IgM Rapid Test (1 pc/box)

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• The product can be ordered for professional use.

Herpes Simplex Virus 2 Rapid Test

The HSV-2 IgG/IgM Rapid Test is intended for the simultaneous detection and differentiation of IgG and IgM antibodies to herpes simplex virus 2 (HSV-2) in human whole blood/serum/plasma. Genital herpes infection is one of the most common sexually transmitted diseases worldwide. It is usually caused by herpes simplex virus type 2, whereas HSV-1 is more often associated with orofacial infections (cold sores).

Herpes simplex viruses 1 and 2 (HSV-1 and HSV-2) are two members of the herpesvirus family Herpesviridae, which cause infections in humans. They can be transmitted when an infected person produces and sheds the virus. Symptoms of HSV infection include watery blisters on the skin or on the mucous membranes of the mouth, lips or genitals. HSV-1 and HSV-2 show different biological properties, which influence the development of the disease and subsequent diseases. Both viruses are able to invade and replicate in the central nervous system (CNS) and to establish latent infection in the dorsal root ganglia.

The most common sites of HSV infection are the skin and mucous membranes. HSV-1 and HSV-2 infections are usually transmitted by different routes and infect different parts of the body, but the signs and symptoms of infection caused by either virus are similar. In general, infections caused by HSV-1 occur above the waist, while infections caused by HSV-2 occur below the waist. However, in recent decades there has been considerable overlap in the site of infection.

Serological diagnosis can confirm current and past HSV infections. The antibody response to HSV is highly specific. Detection of IgG antibodies to HSV indicates that the individual has had a previous infection, while detection of IgM antibodies indicates a current, acute infection. The test kit can be ordered for professional use.

HSV-2 Rapid Test Specification

Product name: Herpes Simplex Virus 2 (HSV-2) IgG/IgM Rapid Test Kit
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: 31/03/2028

Contents of the Herpes Simplex Virus 2 (HSV-2) IgG/IgM Rapid Test Kit

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

How to use the lancet

1. Remove the yellow single-use lancet from its packaging. Remove the transparent cap.
2. Press it against your fingertip. The needle will be ejected automatically.
3. After use, dispose of the lancet in the waste bin.

The visual aid is intended for healthcare professionals only. The product is not intended for self-testing.

Test procedure

Read the Instructions for Use carefully before performing the test. Allow the test, the specimen and/or the controls to reach room temperature (15-30°C) before testing.

1. Before opening, allow the pouch to reach room temperature. Remove the test device from the sealed pouch and use it as soon as possible. The best results are obtained if the test is performed immediately after opening the foil pouch.

2. Place the test cassette on a clean, level surface. Hold the pipette vertically and transfer 2 drops of whole blood (or 1 drop of serum or plasma) to the specimen well (S) of the test device, add 1 drop of buffer, and then start the timer.

3. Wait for the colored line(s) to appear. Read the results after 15 minutes. Do not interpret the results after 20 minutes.

Performance of the HSV-2 IgG/IgM Rapid Test

• Relative sensitivity: 85.7% (75.03% ~ 92.30%)
• Relative specificity: 90.5% (82.30% ~ 94.94%)
• Overall agreement: 88.6% (82.71% ~ 92.67%)
  *95% confidence interval

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

ATTENTION!
Pursuant to Government Decree No. 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 sealed product 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 exclusively to information on the intended use and to the goods delivered.