- 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 gG1 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.
- 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.
|
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 |
PRECAUNONS
- For professional in vitro diagnostic use only. Do not use after expiration date.
- Do not eat, drink or smoke in the area where the specimens and kits are handled.
- Handle all specimens as if they contain infectious agents.
- Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens.
- Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
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Follow standard biosafety guidelines for handling and disposal of potential infective material.
-
Humidity and temperature can adversely affect results.
SPECIMEN COLLECTION AND PREPARATION
- The HSV IgG/IgM Rapid Test Device can be performed using whole blood/serum/plasma.
- Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated at the earliest opportunity to avoid hemolysis.
- Perform the testing immediately after the specimen collection. Do not leave the specimens at room temperature for prolonged periods. Specimens may be stored at 2-8°C for up to 3 days. For long-term storage, serum/plasma specimens should be kept below -20°C.
- Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.
- Pack the specimens in compliance with applicable regulations for the transportation of etiological agents, in case they need to be shipped.
- Icteric, lipemic, hemolyzed, heat-treated and contaminated sera may cause erroneous results.
FAQ
Q: What is the clinical reading window for the Rapid HSV 1 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 Rapid HSV 1 Test differentiate between HSV-1 and HSV-2 infections?
A: Yes. This device utilizes specific recombinant type-specific glycoprotein G1 (gG1) antigens, ensuring highly accurate differentiation of HSV-1 antibodies without cross-reacting with HSV-2.
Q:What is the minimum order quantity (MOQ) for Wholesale Oral 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/ODM HSV-1/HSV-2 Differential Diagnostic 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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