Testing and Laboratory

• CDC Interim Guidance for COVID-19 Infection Prevention and Control Recommendations for Healthcare Personnel  

• 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

• 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
• CDC: Interim Guidance for Antigen Testing for SARS-CoV-2 
• 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
• CDC’s Interim Guidelines for COVID-19 Antibody 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

Clinicians should utilize the Confidential Morbidity Portal to report suspected and confirmed COVID-19 cases as soon as they are identified or can report point-of- care test results and all other required data elements using the  VDH Point-of-Care (POC) Portal if they hold a CLIA Certificate of Waiver.  

• Disease Reporting and Control Regulations

• 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.