Testing and Laboratory

• • 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: Information on Types of COVID-19 Testing 
• FDA At-Home OTC Test Kits & Expiration date information
• FDA SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests
• FDA Guidance on the Diagnosis of COVID-19: Molecular Diagnostic Testing  
• IDSA Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing
• FDA: SARS-CoV-2 EUAs for Antigen Diagnostic 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

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

• VDH Disease Reporting and Control Regulations