COVID-19 Overview: Testing

Author: David J Moffa, PhD, BCLD
Reviewers: Sharon Strauss, MS, SM(NRCM), MLS(ASCP)CMSMCMDLMCM and Laurie Bjerklie, MA, MLS(ASCP)CM
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Continuing Education Credits

P.A.C.E.® Contact Hours: 1.5 hour(s)

Florida Board of Clinical Laboratory Science CE Credit Hours

Florida Board of Clinical Laboratory Science CE - General (Serology/Immunology): 1.5 hour(s)

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This course provides essential background information on COVID-19, with an emphasis on the various testing methodologies available for the identification/diagnosis of suspected COVID-19 infections. The course also discusses how to identify possible prior COVID-19 infections and provides useful information for epidemiological and research studies. In addition, the course emphasizes the difference between diagnostic (viral) tests and antibody (serology) tests when used for COVID-19 testing.

Objectives

  • Describe the structure and characteristics of coronaviruses.
  • Discuss the emergence of COVID-19 and its transmission, symptoms, and severity.
  • Discuss the prevention and treatment of COVID-19.
  • Review the current vaccines available for COVID-19.
  • Discuss the diagnosis of COVID-19 and the types of testing available.

Course Outline

  • Coronavirus Background
    • Overview
    • Overview, continued
    • Key Terms and Abbreviations
    • Which statement is not correct when describing Coronaviruses (CoVs)?
    • True or False: Coronaviruses that primarily infect human lung cells typically do so via a receptor for angiotensin-converting enzyme 2 (ACE2).
  • Coronavirus Disease 2019
    • Emergence
    • Transmission
    • Symptoms and Severity
    • Which of the following statements is true regarding COVID-19 transmission?
    • True or False: Older people and individuals of all ages with medical conditions, such as heart disease, diabetes, or lung disease, may be at higher risk of developing COVID-19.
    • Prevention
    • Treatment
    • Treatment: Monoclonal Antibodies
    • Treatment No Longer Recommended
    • Which of the following best reflects current treatment approaches for patients with severe COVID-19 requiring hospitalization?
    • COVID-19 Vaccines
    • COVID-19 Vaccines, continued
    • COVID-19 Vaccines: Pfizer-BioNTech and Moderna
    • COVID-19 Vaccines: Novavax
    • COVID-19 Variants
    • Which of the following statements is false regarding COVID-19 vaccines in the U.S.?
  • COVID-19 Diagnosis
    • Diagnosis Overview
  • COVID Testing
    • Emergency Use Authorization
    • Types of COVID-19 Tests
    • True or False: A definitive diagnosis of COVID-19 is made using an antibody (serology) test to detect antibodies produced in response to the COVID-19 infection.
    • During the COVID-19 pandemic, the FDA can issue a special type of approval for a product, device, test, or treatment without full FDA approval processing. What is the name of this special type of approval?
  • Diagnostic (Viral) Tests
    • Diagnostic (Viral) Tests: Molecular Tests
    • Diagnostic (Viral) Tests: Antigen Tests
    • Diagnostic (Viral) Tests: NAAT
    • Diagnostic (Viral) Tests: PCR
    • Diagnostic (Viral) Tests: RT-PCR and Real-Time RT-PCR
    • Diagnostic (Viral) Tests: Antigen Tests
    • Diagnostic (Viral) Tests: Immunoassays
    • Diagnostic (Viral) Tests: ELISA
    • Diagnostic (Viral) Tests: Sandwich ELISA
    • Diagnostic (Viral) Tests: Chemiluminescent Immunoassay
    • Diagnostic (Viral) Tests: Lateral Flow Immunoassay
    • Diagnostic (Viral) Tests: Conclusions
    • All of the following statements are true when describing molecular tests for COVID-19 except:
    • True or False: Antigen tests for COVID-19 infection are typically immunoassays that detect a specific viral antigen and are used to indicate current COVID-19 infection.
    • Which statement correctly describes COVID-19 antigen tests?
  • Antibody (Serology) Tests
    • Antibody (Serology) Tests
    • Antibody (Serology) Tests, continued
    • True or False: The CDC does not recommend using antibody testing to diagnose COVID-19 infections.
    • Which method is not currently used for antibody (serology) screening tests for COVID-19?
  • Other COVID-19 Tests
    • Point-of-Care Tests and “At-Home” Testing
    • Point-of-Care Tests and "At-Home" Testing: Advantages and Disadvantages
    • Point-of-Care Tests and "At-Home" Testing: BinaxNOW™
    • True or False: Point-of-care tests for COVID-19 are performed at or near where specimens are collected, with results obtained within minutes rather than hours or several days.
    • All of the following statements correctly describe "at-home" testing for COVID-19, except:
    • The BinaxNOW™ Ag Card test is a commonly used at-home self-test to detect the SARS-CoV-2 nucleocapsid protein from nasal swabs. What specific methodology does the test kit use?
  • Commercially Available COVID-19 Tests
    • Example of Commercial Molecular Test
    • Example of Commercial Antigen Test
    • Example of Commercial Antibody Test
    • Match the COVID-19 test to the type of commercial test.
    • All of the following statements correctly describe the BioPerfectus COVID-19 real-time RT-PCR test, except:
    • Which test is a two-step enzyme chemiluminescent immunoassay that uses paramagnetic particles to detect IgG antibodies to the SARS-CoV-2 virus?
  • References
    • References

Additional Information

Level of Instruction: Basic
Intended Audience: Medical laboratory scientists, medical laboratory technicians, laboratory supervisors, and laboratory managers. This course is also appropriate for MLS and MLT students and pathology residents.
Author Information: David J. Moffa, PhD, BCLD, has over 30 years of experience in the healthcare industry as an executive manager, clinical laboratory director, and medical laboratory scientist. He is currently a technical consultant for Kentmere Healthcare, Wilmington, DE, and until his retirement, was the Regional Director for LabCorp, Inc. He holds a PhD in medical biochemistry from the School of Medicine, West Virginia University.
The author has no conflict of interest to disclose.
Reviewer Information:
Sharon Strauss, MS, SM(NRCM), MLS(ASCP)CMSMCMDLMCM, completed her Bachelor of Science in Medical Technology at Kutztown State College and Master of Science in Training and Organization Development at Saint Joseph's University. She currently serves as Microbiology Supervisor at Penn Medicine Chester County Hospital in West Chester, PA. She has been a medical laboratory scientist in a supervisory role for over 45 years. She is board-certified as a Medical Laboratory Scientist and Diplomat in Laboratory Management through the ASCP Board of Certification and holds Specialist in Microbiology certifications through the ASCP Board of Certification and National Registry of Certified Microbiologists.
Laurie Bjerklie, MA, MLS(ASCP)CM, is a Lead Education Developer. She earned a B.S. in Medical Laboratory Science from the University of North Dakota and an M.A. in Curriculum and Instruction from Saint Xavier University. She has over 15 years of experience in higher education and has held program director and faculty positions in both MLT and MLS programs.
Course Description: This course provides essential background information on COVID-19, with emphasis on various testing methodologies for the identification/diagnosis of suspected COVID-19 infections, for identifying possible prior COVID-19 infections, and for providing useful information for epidemiological and research studies. In addition, the course emphasizes the difference between diagnostic (viral) tests and antibody (serology) tests when used for COVID-19 testing.