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

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

The HSV-2 IgG/IgM Rapid Test is intended for the simultaneous detection and differentiation of IgG and IgM antibodies against Herpes Simplex Virus Type 2 (HSV-2) in human whole blood, serum, or plasma. Genital herpes infection is one of the most widespread sexually transmitted diseases globally. It is usually caused by Herpes Simplex Virus Type 2, whereas HSV-1 is more commonly associated with orofacial infections (cold sores).

Herpes Simplex Virus Types 1 and 2 (HSV-1 and HSV-2) are two members of the Herpesviridae family that infect humans. Transmission can occur when an infected individual produces and spreads the virus. Symptoms of HSV infection include watery blisters on the skin or on the mucous membranes of the mouth, lips, or genital area. HSV-1 and HSV-2 exhibit different biological characteristics, which influence disease development and related conditions. Both viruses are capable of entering and replicating within the central nervous system (CNS) and establishing latent infections in the spinal ganglia.

The most common sites of HSV infection are the skin and mucous membranes. HSV-1 and HSV-2 infections generally spread through different routes and affect different parts of the body, but the signs and symptoms caused by either virus are similar. Typically, infections caused by HSV-1 occur above the waist, while infections caused by HSV-2 occur below the waist. However, in recent decades, significant overlap has developed in the sites of infection.

Serological diagnosis can confirm both current and past HSV infections. The antibody response against HSV is highly specific. Detection of HSV-specific IgG antibodies indicates past infection, while detection of IgM antibodies indicates a current and acute infection. The test kit is available for professional use only.

Specifications

Product Name: Herpes Simplex Virus 2 (HSV-2) IgG/IgM Rapid Test Kit

Sample Type: Whole blood / Serum / Plasma

Packaging: 1 pc/box

Format: Cassette

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd., 3rd Floor, Building 4, No.1418 Moganshan Road, Hangzhou, Zhejiang, 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: 2026-09-30

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

• 1 × Test cassette

• 1 × Buffer solution

• 1 × Pipette

• 1 × Lancet

• 1 × Alcohol swab

• 1 × User manual in English

Use of the Lancet

1. Remove the yellow single-use lancet from the packaging.
2. Take off the transparent cap.
3. Press it firmly against the fingertip. The needle will automatically be released.
4. After use, dispose of the lancet in the trash.

Test Procedure

Please read the Instructions for Use carefully before starting the test! Allow the test device, specimen, and/or controls to reach room temperature (15-30 °C) before use.

1. Remove the test device from the sealed pouch and use it as soon as possible. For best results, perform the test immediately after opening the foil pouch.

2. Place the test cassette on a clean, flat 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, then add 1 drop of buffer and start the timer.

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

HSV-2 IgG/IgM Rapid Test Performance

• 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

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