Testing and Laboratory

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.