What are the types of coronavirus disease 2019 (COVID-19) diagnostic tests?

Updated: Apr 02, 2021
  • Author: James J Dunn, PhD, D(ABMM), MT(ASCP); more...
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Answer

Answer

Currently, there are three basic types of tests to determine if an individual has been infected with SARS-CoV-2: viral nucleic acid (RNA) detection, viral antigen detection, and detection of antibodies to the virus. Viral tests (nucleic acid or antigen detection tests) are used to assess acute infection, whereas antibody tests provide evidence of prior infection with SARS-CoV-2. (The US Food and Drug Administration [FDA] has not authorized the use of antibody tests for the diagnosis of acute infection.)

Cell culture isolation of SARS-CoV-2 is possible, but the Centers for Disease Control and Prevention (CDC) recommends that clinical laboratories not attempt this unless it is performed in a biosafety level 3 (BSL-3)–certified laboratory.

With any type of laboratory test, the clinical accuracy or reliability depends on performance characteristics such as sensitivity and specificity, as well as the pretest probability that a person has SARS-CoV-2 infection and the prevalence of COVID-19 in the local community. Taken together, these parameters determine whether a positive or negative result should be interpreted as correct.

In March 2021, the FDA granted an EUA for the Tiger Tech COVID Plus Monitor (Tiger Tech Solutions, Inc), to screen individuals aged 5 years or older for biomarkers that suggest the presence of asymptomatic SARS-CoV-2 infection. Sensors in the device’s armband pick up biometric signals, with a small computer processor and a probabilistic machine-learning model used to interpret whether an asymptomatic individual is displaying signs of possible infection. [75]


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