Testing Information for Healthcare Providers
General Information:
- VDH Health Professionals Guidance Page
- CDC Information for Laboratories about Coronavirus (COVID-19)
- CDC COVID-19 Testing: What you Need to Know
- VDH COVID-19 Testing Webpage
- VDH COVID-19 Therapeutics Webpage
Setting-Specific Guidance:
- CDC Interim Guidance for Managing Healthcare Personnel with SARS-CoV-2 Infection or Exposure to SARS-CoV-2
- CMS Long-Term Care (LTC) Facility Testing Requirements
Specimen Collection:
- CDC Interim Guidelines for Collecting and Handling of Clinical Specimens for COVID-19 Testing
- VDH How-To Self Collection Guide for Local Health Districts
- CDC How to Collect an Anterior Nasal Swab Specimen for COVID-19 Testing
- Educational Videos: Patient Self-Collecting Nasal Swab for COVID-19 and How to Obtain a Nasopharyngeal Swab Specimen
- CDC Guidance on Self-Testing At Home or Anywhere
Types of Testing and Guidance:
- FDA In Vitro Diagnostics EUAs
- FDA’s Policy for COVID-19 Tests
- FDA At-Home OTC Test Kits
- IDSA Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing
- IDSA Guidelines on the Diagnosis of COVID-19: Antigen Testing
- FDA: SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests
- CDC: Interim Guidance for Antigen Testing for SARS-CoV-2
Serologic Testing:
- FDA In Vitro Diagnostics EUAs - Serology and Other Adaptive Immune Response Tests for SARS-CoV-2
- Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Serologic Testing
- CDC’s Interim Guidelines for COVID-19 Antibody Testing
- For information on whole genome sequencing, contact your local health district https://www.vdh.virginia.gov/local-health-districts/
On-site Testing Requirements:
Laboratory and testing professionals who conduct diagnostic or screening testing for SARS-CoV-2 with antigen tests must comply with Clinical Laboratory Improvement Amendments (CLIA) regulations. Any laboratory or testing site that intends to report patient-specific test results must first obtain a CLIA certificate and meet all requirements to perform that test. For more information, see the Centers for Medicare & Medicaid Services’ (CMS) summary of the CLIA regulations.
- Review the document on how to obtain a certificate of waiver
- Review the CMS quick start guide to help complete the form
- Submit form CMS-116 to: Virginia Department of Health Office of Licensure and Certification 9960 Mayland Drive, Suite 401, Richmond, Virginia 23233
- Over-The-Counter (OTC) Home Testing and CLIA Applicability Frequently Asked Questions
Questions can be sent to CLIAlab@vdh.virginia.gov
Reporting to VDH:
Clinicians should utilize the Confidential Morbidity Portal to report suspected and confirmed COVID-19 cases as soon as they are identified and point-of- care test results using the VDH Point-of-Care (POC) Portal.
Reporting requirements for providers:
- Disease Reporting and Control Regulations
- HHS reporting requirements under the CARES Act
- VDH Clinician Letter (4/5/23)
Variants:
- For the latest information, the FDA’s SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests.
- To see how commonly variants are being identified in the U.S. and where variant viruses are being identified, visit CDC’s COVID Data Tracker.
- With variants continuing to evolve and the potential impacts on available therapeutics, VDH continues to update this resource to help providers stay up to date on what COVID-19 drugs are expected to be effective. (PDF) (3pp, 327kb)
- The National Institutes of Health COVID-19 Treatment Guidelines Panel Provides information about newer SARS-CoV-2 variants/subvariants along with their recommendations for medication use in specific clinical circumstances.
Page last updated: November 9, 2023
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