Testing and Laboratory

Testing Information for Healthcare Providers

General Information:

• VDH Health Professionals Guidance Page
• CDC COVID-19 Testing: What you Need to Know
• VDH COVID-19 Webpage
  • Testing of those with symptoms 
  • Testing those exposed to someone with COVID-19
  • Testing for Domestic and International Travel  
• VDH COVID-19 Testing Webpage
• VDH COVID-19 Therapeutics Webpage
• CDC: Information for Laboratories about Coronavirus (COVID-19) (Updated 3/28/21)

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 (Revised  03/10/2022)

Specimen Collection:

• CDC’s 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 (4/4/2022)

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: 

• HHS reporting requirements under the CARES Act  
• VDH Clinician Letter (4/5/22)

Variants:

For the latest information, the FDA’s SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests. To see where variant viruses are being identified in Virginia, visit VDH’s Variants of Concern Dashboard. 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. 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.