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HSV 2 Rapid Test

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HSV 2 Rapid Test
Details
HSV 2 Rapid Test Device
Targeted Serology Precision: Specifically designed for the qualitative detection and differentiation of IgG and IgM antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human blood specimens.
Rapid Point-of-Care Results: Engineered by Hangzhou Lysun Biotechnology to deliver clear, reliable visual diagnostic bands within 10 to 15 minutes, removing the need for slow laboratory viral cultures.
Global Factory-Direct Supply: As a certified IVD manufacturer, we empower international medical distributors and clinics with highly competitive wholesale pricing, flexible OEM customized branding, and a stable manufacturing supply chain.
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HSV Rapid Test
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Description
Product Overview & Clinical Value
The HSV 2 Rapid Test stands as a vital point-of-care (POCT) screening asset designed for the specialized field of reproductive health and sexually transmitted infection (STI) diagnostics. Engineered by Hangzhou Lysun Biotechnology utilizing advanced colloidal gold lateral flow immunochromatography, this professional rapid diagnostic kit allows healthcare providers to qualitatively evaluate specific anti-HSV-2 antibodies from whole blood, serum, or plasma samples. HSV-2 is the primary causative agent of genital herpes, making early and precise differentiation from HSV-1 clinically vital.
While clinical observation alone can be misleading, this advanced serological screening panel captured by separate IgM and IgG channels fills a critical diagnostic gap. It allows sexual health clinics, public health screening centers, and gynecological hospitals to establish accurate clinical pathways within minutes, effectively assisting in patient counseling, antiviral management, and preventing vertical transmission during pregnancy worldwide.
Key Performance & Technical Specifications
  • Blood-Matrix Fluidics Optimization: Formulated with a specialized sample dilution buffer that ensures seamless, clean lateral flow migration of whole blood, serum, or plasma without background staining or analytical interference.
  • Dual-Band Differential Precision: Features highly optimized recombinant gG2 specific antigens across separate testing channels to guarantee exceptionally sharp visual band formations for both IgG and IgM lines.
  • Convenient Testing Protocol: Delivers trustworthy, laboratory-grade qualitative results in just 10 to 15 minutes at room temperature, requiring zero investment in heavy laboratory platforms or automated readers.
  • All-in-One Professional Kit Presentation: Every kit includes individually sealed foil pouches with antibody test devices, specialized sample dilution buffer vials, disposable capillary droppers, sterile lancets (optional), and instructions.

B2B Sourcing, Wholesale & Custom OEM Services
As an established, ISO 13485 certified medical device factory, Hangzhou Lysun Biotechnology provides reliable high-volume international supply chains for medical wholesalers, sexual health group distributors, and healthcare procurement groups.
  • Flexible OEM Solutions: We offer full private labeling services, including customized inner foil pouch print layouts, branded box packaging, and localized multilingual instructions to match your regional health ministry compliance.
  • Competitive Bulk Wholesale Pricing: Scalable tiered pricing matrixes are structured for container-level bulk purchasing to give your business an extreme advantage in regional IVD tenders and bulk orders.
  • Streamlined Regulatory Dossiers: Complete validation papers, clinical trial metrics, cross-reactivity analyses, and international certificates (such as CE marking) are fully accessible to accelerate cross-border clearance.

 

HSV Rapid Test
HSV rapid test device
China HSV Rapid Test supplier

 

Product name

HSV igG/igM Rapid Test

Specimens

Whole blood

Shelf life

2 years

Test Time

Waiting about 15 minutes

Certificate

CE, ISO:13485

OEM

Acceptable

Storage condition

The kit should be stored at 2-30°C

 

INTENDED USE

The HSV IgG/IgM Rapid Test Device is a rapid chromatographic immunoassay method used to qualitatively detect antibodies (IgG and IgM) against herpes simplex virus to help diagnose Herpes Simplex Virus infection. This test is based on immunochromatography and can provide results within 15 minutes.

PRINCIPLE

 

The HSV IgG/IgM Rapid Test Device is a qualitative membrane strip based immunoassay for the detection of HSV antibodies (IgG and IgM) in whole blood/serum/plasma. The test device consists of:
  1. a burgundy colored conjugate pad containing HSV recombinant envelope antigens conjugated with Colloid gold (HSV conjugates) and rabbit IgG-gold conjugates,
  2. a nitrocellulose membrane strip containing two test bands (IgG and IgM bands) and a control band (C band).

The IgM band is pre-coated with the antibody for the detection of IgM anti-HSV, IgG band is coated with antibody for the detection of IgG anti-HSV, and the C band is pre-coated with goat anti rabbit IgG. When an adequate volume of test specimen is dispensed into the sample well of the test Device, the specimen migrates by capillary action across the Device. IgG anti-HSV, if present in the specimen, will bind to the HSV conjugates. The immunocomplex is then captured by the reagent pre-coated on the IgG band, forming a burgundy colored IgG band, indicating a HSV IgG positive test result and suggesting a recent or repeat infection.
IgM anti-HSV if present in the specimen will bind to the HSV conjugates. The immunocomplex is then captured by the reagent coated on the IgM band, forming a burgundy colored IgM band, indicating a HSV IgM positive test result and suggesting a fresh infection. Absence of any IgG and IgM bands suggests a negative result.
The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the IgG and IgM bands. Otherwise, the test result is invalid and the specimen must be retested with another device.

FAQ

 

Q: What is the clinical reading window for the HSV 2 Rapid Test?

A: The optimal visual readout window is between 10 to 15 minutes after dropping the extracted blood sample mixture into the sample well. Results read after 20 minutes should be considered invalid.

Q: Can the HSV 2 Rapid Test differentiate between HSV-1 and HSV-2 infections?

A: Yes. This device utilizes specific recombinant type-specific glycoprotein G2 (gG2) antigens, ensuring highly accurate differentiation of HSV-2 antibodies without cross-reacting with HSV-1.

Q: What is the minimum order quantity (MOQ) for Wholesale Genital Herpes Serology Diagnostic Kits?

A: As a premier China IVD factory, we offer flexible tiered pricing structures. For wholesale container orders, our standard packaging and bulk MOQs are highly adjustable to accommodate the logistics needs of medical distributors.

Q: Do you support custom clinical branding for OEM Herpes Simplex Virus Type 2 Test Strips?

A: Absolutely. We provide professional OEM services, featuring fully custom branded outer boxes, localized instruction sheets, and personalized inner pouch layouts designed to satisfy your regional regulatory bodies.

Q: How does your facility ensure consistent lot-to-lot accuracy as trusted medical manufacturers and suppliers?

A: We operate strictly under a certified ISO 13485 quality system. Every batch of our factory-direct rapid tests undergoes automated raw material validation and rigorous lot-to-lot screening to ensure stable international supply chain capacity and reliable accuracy.

 

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