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Infectious Disease & COVID-19 Validation

We’re excited to offer our turnkey Infectious Disease Program

Whether you are a clinic interested in bringing Infectious Disease testing in-house or an independent lab looking to add it as a new line of testing, we can assist you with getting your lab quickly validated to offer these high-margin tests that can immediately improve patient care outcomes:

  • COVID-19
  • Wound
  • Gastro
  • UTI

  • Respiratory (RPP)
  • Nail/Fungal
  • Women’s Health
  • STI
  • AntiBiotic Resistance (ABR)

Our Program Services

Method Validation in as little as 10 days

Fully-interfaced, cloud-based Laboratory Information System

Instrument Procurement and Installation

Remote Data Analysis and Data Review

Access to Lighthouse’s Supply Management software

Expert Guidance on Panel Selection

Initial CLIA Paperwork and State Lab Applications

Lab Staffing (Unrivaled in quality and speed)

Physician-crafted, customizable lab reports

Ongoing Quality Assurance & Quality Management Programs

Lighthouse Lab Services performs coronavirus validation

We are actively performing coronavirus testing validation projects within our client labs which will enable them to offer testing for COVID-19 as a laboratory-developed test on the molecular PCR platform.

We can validate this in your lab for $19,500.

COVID-19 Antibody (Serology) Validation Program

  • There are currently no COVID-19 Antibody tests approved for use in a Physician Office/Clinic without a CLIA Certificate of Accreditation/Compliance.
  • There are currently no CLIA waived POC COVID-19 (serology) tests approved by the FDA on the market, and only a handful have EUA approval.
  • We can help quickly upgrade your CLIA Certificate from Waived to Moderate or High Complexity.
  • We can assist you in completing a compliant validation for the antibody test which includes verified COVID-19 positive and negative antibody samples.

Lighthouse can partner with you in the following ways to validate for COVID-19 Antibody testing:

SUPPORT

We can provide daily controls for continued use to ensure compliance and accurate results.

ACCURACY

We will coordinate testings with a correlation partner to ensure the accuracy of your testing.

PRICING

$9,250 for COVID-19 Antibody test validation and 6+months of validation materials & controls.