The Facts: How COVID-19 is Really Impacting Labs and Efficiency
Since the novel corona virus became a global pandemic, laboratories have been working round the clock to ramp up testing. Even with their extensive training, few lab technicians were prepared to deal with the unprecedented challenges posed by the corona virus. Until a recent Food and Drug Administration rule change, most laboratories were hamstrung from developing tests. They first had to wait for a review by the agency to develop tests for viruses such as the SARS-CoV-2, which causes COVID-19.
Indeed, such red tape requires time, which health experts don't usually have, especially during pandemics such as the current one. It didn't make sense for a novel infection disease such as the corona virus to be tested in CDC and state public health laboratories only. This was the situation at the beginning of the outbreak, but when cases started multiplying, it became clear that the system wouldn't work. There was a need for laboratories throughout the U.S. to share the burden of testing. Here's how the crisis is impacting labs:
COVID-19 and the Surge in Remote Specimen Sampling
Test volumes have plummeted due to the pandemic. This has made it necessary for labs to consider remote sampling approaches to allow them to reach out to patients who are deferring routine medical care. Remote sampling tools such as dried blood spots have, for a long time, been of interest to the lab industry due to their cost advantages and potential convenience. Nonetheless, the current pandemic has created further interest and adoption of the techniques.
Labs have been forced to adapt by allowing more patients to get tested remotely. Thanks to social distancing rules, patients have been putting off routine visits to labs. Instead, they are increasingly opting for telemedicine services. Remote specimen sampling allows doctors who are seeing patients via telemedicine to order lab testing for those who would have otherwise postponed crucial tests. On their part, labs can get specimens safely while observing social distancing rules.
Depending on how the COVID-19 pandemic lasts, there could also be a change in some types of oncology testing towards liquid biopsy, which allows blood samples to be easily collected compared to conventional biopsies. Since the start of the pandemic, there has been a 30% drop in genetic tumor testing used to determine patients' cancer therapy. This indicates that patients are reluctant to undergo what is usually regarded as urgent testing.
Validating with Viral Material
A high-complexity lab can use different strategies to bring on testing. For instance, it can run already-approved protocols without seeking emergency use authorization (EUA). Nonetheless, the FDA has suggested that all variations on the CDC protocol, including mixing and matching regents, require labs to undertake clinical and analytical validation besides filing for EUA.
If labs choose to create their tests, they can start testing patients as soon as the assay gets validated. They must then seek EUA within 15 days. Currently, it looks like almost every step in the workflow of the polymerase chain reaction (PCR) test can cause labs significant trouble.
The Impact of COVID-19 on Current Research
Thanks to the corona virus pandemic, many scientists are grappling with uncertainty regarding how they will proceed with their research. All attention has shifted to COVID-19 testing and vaccine development. The pandemic has affected early-career researchers since their funding and progress largely depends on the speed with which they conduct research and publish results in journals.
Without the much-needed financial support or addition of their tenure clocks, many researchers fear that the progress they have made will go to waste. Some labs have been shut down to mitigate the spread of the virus. Those that are yet to get closed are not operating at full capacity. This has led to fears that research on other diseases will stall.
Streamlining the Laboratory System
The corona virus pandemic has exposed weak spots in the American public health system, more so when it comes to testing. Many CLIA-certified labs have been handicapped by the pandemic, something that has delayed testing. Therefore, there's a need to ensure that CLIA labs can undertake widespread testing of new infectious agents earlier and more effectively. A more streamlined lab system should be established so that during the initial stages of a pandemic, organizations such as the CDC and WHO can develop new diagnostic tests rapidly.
Once an assay gets developed and proves to meet established performance standards, the organizations should partner with contracted test manufacturers to start mass-producing test reagents while submitting performance data to the FDA. The FDA will then review the tests' performance characteristics before issuing a EUA that allows the kits to be distributed to qualified labs.
Most clinical labs in America are approved and accredited to undertake routine clinical testing. During outbreaks, the approval and accreditation process entails labs confirming that they have the required personnel, safety infrastructure, and equipment to undertake testing. CDC-qualified lab reps must also make a site visit to ascertain that the lab meets all requirements.
Pandemics such as COVID-19 can emerge at any time, and rapid lab testing is the most effective way of dealing with them. Therefore, laboratories should figure out ways of approaching such situations without necessarily recreating the wheel whenever the viral outbreaks occur. Besides, it's also essential to educate the general public about the role of laboratories. The COVID-19 crisis has shone the spotlight on labs and the complexity of lab testing. It has also shown that lab technicians are also front line workers, just like doctors and other healthcare professionals.
Easing the COVID-19 Testing Burden
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The company supplies a range of products from small-capacity countertop freezers and refrigerators to special-purpose cryogenic freezers. We understand how important it is to keep lab compounds and specimens and even medicines at specified temperatures. Therefore, we supply quality equipment that help you to fulfill this need. Contact us for more information about our product portfolio.