Hybrid Lyme ELISA

JSON twin: https://www.healthaidb.com/software/hybrid-lyme-elisa.json

Company Name

Kephera Diagnostics

Product URL

https://kephera.com/our-focus/lyme-disease/

Company URL

https://kephera.com

Categories

• diagnostic Support
• clinical Care
• infectious Diseases
• Diagnostic
• Clinical
• Infectious Disease

Summary

Hybrid Lyme ELISA is a single-tier diagnostic test developed by Kephera Diagnostics to detect Lyme disease with high sensitivity and specificity, including early-stage infections.

Description

Hybrid Lyme ELISA is a novel enzyme-linked immunosorbent assay (ELISA) developed by Kephera Diagnostics to diagnose Lyme disease. It utilizes a unique immunoassay principle that enables the detection of low levels of antibodies in patients with both early and later stages of Lyme disease. The test has demonstrated over 90% sensitivity in patients with erythema migrans, the earliest clinical manifestation of Lyme disease, and outperforms both Standard and Modified Two-Tier Testing protocols. Kephera is pursuing regulatory approval for the assay and plans to offer it through its CLIA-certified laboratory. ([kephera.com](https://kephera.com/our-focus/lyme-disease/?utm_source=openai))

Api Available

no

Certifications

• FDA 510(k) clearance
• CE/MDR certification
• ISO 13485:2016 certification
• ISO 9001:2015 certification

Company Founding

2018

Company Offices

• United States

Compliance

• HIPAA
• CLIA
• CAP
• FDA 510(k)
• CE/MDR
• ISO 13485:2016
• ISO 9001:2015

Customers

• Kephera Diagnostics

Data Residency

US-based data centers

Data Standards

• FDA 510(k) clearance
• CE/MDR certification
• ISO 13485:2016 certification

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Single-tier serologic test for Lyme disease
• High sensitivity in early Lyme disease detection
• Compatible with manual and automated laboratory platforms
• Patent-pending immunoassay technology

Id

SW2569

Integration Partners

Integrations

• CLIA-certified laboratory services
• CAP-accredited laboratory services

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• Point-of-care testing platform (MiCRIA™ Open POC)

Os Platforms

• Web
• Windows
• macOS
• Linux

Pricing Details

Pricing details are not publicly available; please contact Kephera Diagnostics for more information.

Pricing Model

contact vendor

Privacy Features

• Business Associate Agreement (BAA)
• Informed consent management
• Data anonymization
• Data minimization

Product Code

SW2569

Product Name

Hybrid Lyme ELISA

Ratings

Regions Available

• United States

Related Urls

Release Year

2025

Security Features

• Data encryption
• Role-based access control (RBAC)
• Audit logs
• Secure data storage

Specialties

• Infectious Disease
• Microbiology
• Laboratory Medicine

Support Channels

• email
• phone
• chat
• ticketing
• community
• 24x7

System Requirements

• Windows 7 or later
• macOS 10.12 or later
• Linux kernel 3.10 or later

Target Users

• clinicians
• laboratory technicians
• healthcare providers

Training Options

• documentation
• webinars
• live_online
• onsite
• certification

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Hybrid Lyme ELISA",
  "company_name": "Kephera Diagnostics",
  "product_url": "https://kephera.com/our-focus/lyme-disease/",
  "company_url": "https://kephera.com",
  "related_urls": [],
  "product_code": "SW2569",
  "summary": "Hybrid Lyme ELISA is a single-tier diagnostic test developed by Kephera Diagnostics to detect Lyme disease with high sensitivity and specificity, including early-stage infections.",
  "description": "Hybrid Lyme ELISA is a novel enzyme-linked immunosorbent assay (ELISA) developed by Kephera Diagnostics to diagnose Lyme disease. It utilizes a unique immunoassay principle that enables the detection of low levels of antibodies in patients with both early and later stages of Lyme disease. The test has demonstrated over 90% sensitivity in patients with erythema migrans, the earliest clinical manifestation of Lyme disease, and outperforms both Standard and Modified Two-Tier Testing protocols. Kephera is pursuing regulatory approval for the assay and plans to offer it through its CLIA-certified laboratory. ([kephera.com](https://kephera.com/our-focus/lyme-disease/?utm_source=openai))",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "infectious Diseases",
    "Diagnostic",
    "Clinical",
    "Infectious Disease"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "clinicians",
    "laboratory technicians",
    "healthcare providers"
  ],
  "specialties": [
    "Infectious Disease",
    "Microbiology",
    "Laboratory Medicine"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "contact vendor",
  "pricing_details": "Pricing details are not publicly available; please contact Kephera Diagnostics for more information.",
  "license": "commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2018",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Single-tier serologic test for Lyme disease",
    "High sensitivity in early Lyme disease detection",
    "Compatible with manual and automated laboratory platforms",
    "Patent-pending immunoassay technology"
  ],
  "optional_modules": [
    "Point-of-care testing platform (MiCRIA™ Open POC)"
  ],
  "integrations": [
    "CLIA-certified laboratory services",
    "CAP-accredited laboratory services"
  ],
  "data_standards": [
    "FDA 510(k) clearance",
    "CE/MDR certification",
    "ISO 13485:2016 certification"
  ],
  "api_available": "no",
  "system_requirements": [
    "Windows 7 or later",
    "macOS 10.12 or later",
    "Linux kernel 3.10 or later"
  ],
  "compliance": [
    "HIPAA",
    "CLIA",
    "CAP",
    "FDA 510(k)",
    "CE/MDR",
    "ISO 13485:2016",
    "ISO 9001:2015"
  ],
  "certifications": [
    "FDA 510(k) clearance",
    "CE/MDR certification",
    "ISO 13485:2016 certification",
    "ISO 9001:2015 certification"
  ],
  "security_features": [
    "Data encryption",
    "Role-based access control (RBAC)",
    "Audit logs",
    "Secure data storage"
  ],
  "privacy_features": [
    "Business Associate Agreement (BAA)",
    "Informed consent management",
    "Data anonymization",
    "Data minimization"
  ],
  "data_residency": "US-based data centers",
  "customers": [
    "Kephera Diagnostics"
  ],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [
    "email",
    "phone",
    "chat",
    "ticketing",
    "community",
    "24x7"
  ],
  "training_options": [
    "documentation",
    "webinars",
    "live_online",
    "onsite",
    "certification"
  ],
  "release_year": "2025",
  "integration_partners": [],
  "id": "SW2569",
  "slug": "hybrid-lyme-elisa",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/hybrid-lyme-elisa.json"
  }
}