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

• The product may be ordered for professional use.

Herpes Simplex Virus 1 rapid test

The HSV-1 IgG/IgM rapid test is intended for the simultaneous detection and differentiation of IgG and IgM antibodies produced against herpes simplex virus type 1 (HSV-1) in human whole blood/serum/plasma. Orofacial infections (cold sores) are generally associated with HSV-1, while herpes simplex virus type 2 is responsible for genital infections (genital herpes).

Herpes simplex viruses types 1 and 2 (HSV-1 and HSV-2) are two members of the Herpesviridae family of herpesviruses that cause infections in humans. Symptoms of HSV infection include fluid-filled blisters on the skin or on the mucous membranes of the mouth, lips, or genitals. HSV-1 and HSV-2 have different biological properties that influence the development of the disease and subsequent illnesses. Both viruses are capable of entering and multiplying in the central nervous system (CNS), as well as establishing latent infections in the spinal nerves.

The most common sites of HSV infection are the skin and mucous membranes. HSV-1 and HSV-2 infections are generally transmitted in different ways and infect different parts of the body, but the signs and symptoms caused by infection with either virus are similar. Generally, infections caused by HSV-1 occur above the waistline, while infections caused by HSV-2 occur below the waistline. However, significant overlap has developed regarding the site of infection in recent decades.

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

HSV-1 rapid test specifications

Product name: Herpes Simplex Virus 1 (HSV-1) IgG/IgM Rapid Test Kit
Sample: whole blood/serum/plasma
Package 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
EC REP: Lotus NL B.V. Koningin Julianaplein 10, le Verd, 2595AA,The Hague,Netherlands
Expiry date: 2026.05.

Contents of the Herpes Simplex Virus 1 (HSV-1) IgG/IgM rapid test kit

• 1 test cassette
• 1 buffer solution
• 1 pipette
• 1 lancet
• 1 alcohol swab
• 1 instruction manual in Hungarian

How to use the finger-prick lancet

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

Testing procedure

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

1. Before opening, wait until the test pouch has reached room temperature. Remove the test device from the sealed pouch and use it as soon as possible. The best results are obtained when the test is performed immediately after opening the foil pouch.

2. Place the test cassette on a clean and level surface. Hold the pipette vertically and transfer 2 drops of whole blood (or 1 drop of serum or plasma) into the sample 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-1 IgG/IgM rapid test

• Relative sensitivity: 86.8% (76.7% ~ 92.9%) *
• Relative specificity: 92.3% (85.6%~96.1%)*
• Overall agreement: 90.1% (84.7%~93.7 %)*
  *95% confidence interval

The test may only be used by qualified professional personnel and healthcare workers! Carbon Web Kft. accepts no responsibility for use of the test for self-testing purposes.

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

Carbon Web Kft. is not responsible for fulfilling the legal obligations related to the Buyer's procurement procedure, as these fall within the Buyer's responsibility. Its responsibility is limited exclusively to providing information concerning intended use and to the goods delivered.