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.