The World Health Organization (WHO) declared the COVID-19 pandemic in March of 2020, which began in December of 2019 as a severe acute respiratory virus 2 (SARS-CoV-2) outbreak in Wuhan, China. The novel COVID-19 pandemic has severely disrupted medical laboratory science. Laboratories had to rapidly expand infectious disease testing to meet SARS-CoV-2 testing demand. This involved purchasing new equipment, hiring additional staff, and increasing the capacity of lab operations to ensure people would get their results quickly. At the same time, the testing volumes for routine lab tests plummeted due to the cancellation of many in-person medical appointments to comply with governmental stay at home regulations. However, many labs have since reported routine test volumes to be back at pre-pandemic levels.
Laboratories had to overcome multiple challenges to adapt to the pandemic. Many labs did not possess the equipment needed for high volume, high throughput, and low turnaround time (TAT) testing. When the pandemic was ramping up, vendors did not have enough instruments for the sudden rush of orders from around the world. To compensate, laboratories used multiple platforms for testing, which complicated training, standardization, and quality control. Furthermore, there were supply chain issues for reagents and consumables.
Additionally, laboratories struggled with personnel and staffing problems. Laboratory technicians were retrained to perform SARS-CoV-2 testing and new employees were hired. Many labs had to run around the clock to keep up with demand. Labs also instituted new safety precautions such as social distancing, new cleaning protocols, extra personal protective equipment, etc., to prevent a workplace outbreak. Working under the intense pressure of a global pandemic has contributed to burnout and employee turnover. In response, laboratory management started to see the value of mental health employee benefits and the fostering a supportive work culture, which encourages employee well-being.
Fortunately, test volumes for SARS-CoV-2 testing have tapered from the unsustainable surge. Quest Diagnostics estimates a 50% drop and LabCorp estimates a 60% drop in COVID-19 testing revenue in 2022 compared to 2021. Many labs have reported laying off personnel who performed SARS-CoV-2 testing and/or transferring staff to other departments to support other testing efforts. Undoubtedly, laboratories will need to shift their business model away from COVID-19 to stay competitive in this rapidly evolving testing landscape.
Labs are repurposing equipment and staff to add new test panels such as a combined respiratory syncytial virus (RSV), influenza A and B, and SARS-CoV-2 test. Labs have also optimized infectious disease testing to be more automated, which lowers TAT and provides better patient care. Laboratories must learn from the pandemic to be prepared as much as possible for the next health crisis, which includes having an ample supply of reagents and consumables used for testing.
Another way for labs to pivot is to utilize the specimens and data from the residual samples processed for SARS-CoV-2. It is estimated that 25-30 million people in the United States will be affected with long COVID, also known as Post-Acute Sequelae (PASC) of COVID-19. These are people who experience symptoms such as fatigue, memory issues, heart palpitations, among other symptoms, after infection. Very little is understood about the biology of PASC, and labs performing SARS-CoV-2 testing have a wealth of information in the form of the data and residual specimens. Labs can partner with researchers that specialize in drug development, vaccine design, diagnostics, medical devices, biomarkers, and clinical trials. This would positively contribute to the global efforts of COVID-19 research while providing a stream of revenue. However, it is crucial that patients are properly consented for their specimen to be used in a manner that is compliant with HIPAA and other regulations when labs partner with researchers.
The pendulum has swung dramatically in the field of medical laboratory science over the last two and a half years. There was a rush of testing demand for SARS-CoV-2. Labs abruptly adjusted their instrumentation, testing menu, personnel, and laboratory operations to meet the surge. Now that volumes have decreased to a sustainable load, once again, labs must make further adjustments. Adding new panels to testing menus, increasing automation, and repurposing lab personnel and equipment may be a piece to this puzzle. Furthermore, there is an incredible opportunity for labs to partner with researchers using the specimens they have already collected for diagnostic SARS-CoV-2 testing. Labs must be nimble and pivot in this “new normal” of COVID-19 to be competitive and to serve patients and clients who entrust them with their specimens.
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