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

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

The HSV-1 IgG/IgM Rapid Test Kit is intended for the simultaneous detection and differentiation of IgG and IgM antibodies against Herpes Simplex Virus Type 1 (HSV-1) in human whole blood, serum, or plasma specimens. Orofacial infections are typically associated with HSV-1, while HSV-2 is more often linked to genital infections.

HSV-1 and HSV-2 are two members of the Herpesviridae family that infect humans. Symptoms of HSV infection include watery blisters on the skin or mucous membranes of the mouth, lips, or genitals. Although HSV-1 and HSV-2 have distinct biological behaviors, both can infect the central nervous system (CNS) and establish latency in the spinal ganglia.

HSV-1 and HSV-2 infections generally affect different areas of the body and are transmitted via different routes. However, there has been significant overlap in their presentation in recent decades. HSV-1 is typically found above the waistline, and HSV-2 below, though this distinction is increasingly blurred.

Serological diagnosis is useful for confirming both current and past HSV infections. The antibody response to HSV is highly specific: IgG antibodies indicate prior infection, whereas IgM antibodies signal an active or acute infection. For professional use.

Specifications

Product name: Herpes Simplex Virus 1 (HSV-1) IgG/IgM Rapid Test Kit

Sample type: Whole blood / Serum / Plasma

Format: Cassette

Packaging: 1 pc/box

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, Email: peter@lotusnl.com

Expiration date: 2026.05.

Kit Contents

• 1 test cassette

• 1 buffer solution

• 1 pipette

• 1 sterile lancet

• 1 alcohol pad

• 1 instruction manual in English

Lancet Use Instructions

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.

Test Performance

• 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

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