The severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) (coronavirus disease 2019 [COVID-19]) pandemic has led to the rapid development of many diagnostic tests. The initial focus of these tests was on molecular tests that detect viral RNA.

These are relatively straightforward in their design and interpretation since the amplification of unique nucleic acid sequences provides intrinsic sensitivity and specificity. Due to heavy demand for molecular tests and limited availability of reagents and test kits, molecular testing has focused on symptomatic patients in a variety of healthcare facilities (e.g., hospitals, clinics, and nursing homes).

Serological assays currently undergoing development and deployment can complement molecular testing, providing information not only about acute infection but also recovery from infection and prevalence of infection in the community. Nevertheless, these assays can be difficult to interpret because of potential cross-reactions with other coronaviruses as well as the variable magnitude and timing of the immune response to SARS-CoV-2.

In addition, rapid immunoassays and routine enzyme-linked immunosorbent assay (ELISA) assays do not necessarily detect neutralizing antibodies that correlate with protective immunity.

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