The 15 diagnostic guidelines weigh the currently accepted definition of coronavirus, and consider the prevalence of regional cases in at-risk patients.
The Infectious Diseases Society of America (IDSA) has released new guidelines for diagnosing coronavirus 2019 (COVID-19).
A panel of IDSA experts, led by Kimberley E. Hanson, MD, MHS, of the University of Utah, agreed upon 15 new diagnostic recommendations for healthcare workers faced with possible SARS-CoV-2 infection in patients.
The guideline, they wrote, used a “methodologically rigorous process” to appraise current diagnostic literature and inform their testing recommendations. That said, limitations exist.
The team noted a critical issue being that current COVID-19 diagnostic guidance and literature lacks a standard COVID-19 definition. As such, the variable case definitions and classifications of the virus used in this guidance come from systematic reviews which used index testing under clinical investigation.
“Incorporation of the investigational index test into the diagnostic “gold” standard falsely inflates sensitivity and specificity estimates,” they wrote. “It is recognized that not all individuals with COVID-19 will have detectable SARS-CoV-2 nucleic acid. Therefore, a “probable” case definition is also proposed.”
A summarization of the recommendations are as follows:
Hanson and colleagues noted that significant clinical interested has centered around the use of serologic SARS-CoV-2 tests for both diagnosis and public health surveillance. However, more data is necessary before a clinical recommendation could be made.
“Important areas that need to be addressed include assessment of the sensitivity and specificity of commercial antibody tests, determinations of protective immunity and measures of antibody responses over time,” they wrote.
Antigen detection tests, experts noted, are coming soon, and will need to be compared with NAAT. Future assessments should determine the significance of nucleic acid or antigen shedding in patients who have recovered from the virus to help define “test of cure” algorithms.
Ultimately, the experts wrote, it is the available resources of an institution that will dictate the prioritization of testing strategies.
“The critical components of future COVID-19 diagnostic studies include use of a well-defined reference standard with detailed descriptions of specimen types, collection methods and their timeframe after symptom onset or exposure to a laboratory-confirmed case,” they wrote.