Closing the Gap: The Importance of Performing Diagnostics at the Front Line
During an outbreak such as COVID-19, healthcare providers may evaluate patients whose clinical presentation and travel/exposure history renders them a “patient under investigation” (PUI) for the disease. Although many of these patients ultimately test negative for the outbreak-associated virus, the initial uncertainty regarding the cause of disease often has an important impact on management decisions. For example, PUIs are often placed in conservative isolation precautions (e.g., airborne isolation), and healthcare teams may defer or avoid certain procedures, which may have otherwise been performed to treat, stabilize, and/or diagnose a patient’s condition. Furthermore, clinical laboratories may limit, or significantly modify, their testing approach for a PUI, due to safety concerns for healthcare providers and laboratory personnel. As an example, the CDC has issued interim laboratory biosafety guidelines for handling specimens from suspect cases of COVID-19, and these guidelines recommend against viral culture and state that any procedure with the potential to generate an aerosol (e.g,. vortexing, sonication, pipetting of respiratory samples) be carried out in a certified Class II biosafety cabinet (11). These modifications to routine clinical and laboratory practice are required to ensure the safety of healthcare personnel, laboratory staff, and patients, and are designed to prevent further transmission of the disease. However, any delay in establishing a diagnosis (i.e., resulting from transporting samples to an off-site laboratory or from making modifications to the standard operating procedures of a clinical laboratory that may limit its diagnostic approach) has the potential to negatively impact patient outcomes.
To provide physicians with the answers they need to manage patients effectively during an outbreak setting, laboratory testing is needed at the front lines, whenever feasible and safe. This is especially true during an outbreak such as COVID-19, which is a nonspecific illness during the early stages, similar to other more common infectious diseases such as influenza. So how do we provide rapid answers, while ensuring that the testing is accurate, reproducible, and robust? The author proposes the following as a high-level framework for consideration and discussion.