Molecular-Based Point of Care Laboratory Testing Will Revolutionize Healthcare, But Practical Considerations Exist

The American Academy of Microbiology had a point-of-care colloquium in October 2016 that brought together clinical laboratory microbiologists, physicians, investors, global health experts, patient collection experts, government agencies, foundations, and commercial industry to discuss how to enact modern molecular diagnostic protocols most effectively for point-of-care (POC) testing settings.

Contagion^® sat down with the chair of the colloquium and a commentary-author with vast experience in POC clinical trials; Melissa B. Miller, PhD, Professor and Director of the Clinical Molecular Microbiology Laboratory, University of North Carolina School of Medicine, Chapel Hill and Robin Patel, MD, ASM Microbe 2017 Co-Chair, Director, Infectious Diseases Research Laboratory, Mayo Clinic.

Dr. Miller emphasized that one of the issues at the POC colloquium was about changing paradigms. The clinical laboratory will no longer be the only option. POC testing will become available to any pharmacy or laboratory, but first a series of recommendations are needed. These range from an organized workflow, to concerns about the bathroom for sample collection/storage, issues of patient self-collection, and most importantly, a standardized accepted medical record that is accessible and acceptable. Instead of going to the emergency room, patients could go to an urgent care health center and with efficient medical record keeping, an outbreak could be detected earlier, according to Dr. Miller.

Drs. Miller and Patel both emphasized such technology is already here. POC testing never caught on in the past because so many antigen-based test results remained equivocal, but today’s molecular tests are highly accurate, sensitive, and reproducible. Dr. Patel stated that the POC diagnostics technology is now at a point where the test will work as well as if it was done within their laboratory: “In the past, an antigen-based test for strep throat was not as sensitive as a culture, but now, a molecular diagnostic test for strep throat is as sensitive, and it is even quicker and easier to do. This is a disruptive technology. You may not even need to see your primary care physician. Instead, you can just go to your CVS pharmacy; but, pricing has not been figured out yet for these approaches.”

Dr. Patel commented in a piece co-authored with her POC expert Dr. Brad Karon that they must insure the quality of POC tests. Organisms evolve, but tests don’t. Because the circulating influenza strain is different every year, a different test is needed. It is especially critical to repeatedly insure the quality of these tests when they are put out there in the community. Dr. Miller pointed out that an US Food and Drug Administration (FDA) panel met a few years ago to recommend an annual review of the strains. These reviews will be enacted as the POC tests become publicly available.

Today, you have to wait for the doctor, then the laboratory clinician, then entry into the computer, and then for the doctor to get back to you, to learn test results. Dr. Patel, however, has previously set up a system at the Mayo Clinic where patients collect their own sample, which is then put into a machine at the laboratory. A result is obtained and left on a phone message in an automated fashion. This, along with a prescription and then the drug, is then retrievable starting with just a phone call from the patient. Currently they can do some of these tests in 15-20 minutes. This is so fast that they can decide whether or not to prescribe the antibiotics after the test. Dr. Patel believes this will not only improve the quality of care, but also the reduce risk of overuse of antibiotics, helping to control resistance. To confirm this, Dr. Patel recently completed a study that determined that patients can reliably do their own swab.

Drs. Miller and Patel believe that POC testing is going to revolutionize health care. We just need to be organize how to most reliably put this into action.

W. Todd Penberthy, PhD is a medical writer based in Orlando, Florida with over 4 years of experience. Prior to that, Todd was a professor directing biomedical research for 10 years including the use of zebrafish models of human disease with expertise in orthomolecular niacin-related science.