I’ve written about waived point of care (POC) polymerase chain reaction (PCR) technology for several of my Contemporary Pediatrics Ped v2.0 articles. Alere and Roche market Clia waived devices that perform rapid office assays for strep, influenza and RSV. These bring state of the art diagnosis with state of the art accuracy to the physicians office via reasonably priced systems, that produce results in less than a half hour. Now BioFire expands the physician repertoire of tests to include 11 respiratory virus and bacteria. In 65 minutes the FilmArray RP EZ device tests for: Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus, Influenza A, , Influenza B, Parainfluenza Virus, Respiratory Syncytial Virus, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumonia. Sensitivities and Specificities are in the vicinity of 98% compared to viral culture or reference PCR methods.
Assuming that these tests are reimbursed by insurance companies, what patients would benefit from this assay? As a pediatrician, I see many children with fever and respiratory symptoms who may or may not have a sore throat. I can quickly rule out strep and influenza, as well as RSV in the infant with the Alere or Roche systems – but what about the child who tests negative who may or may not have pneumonia. I envision the FilmArray test proofing very useful – when it reveals an infection with coronavirus, or other respiratory viruses. It also may reveal patients with occult bacterial infections who would possibly benefit from treatment with antibiotics. It also lets us better advise patients regarding duration of symptoms, reducing spread in households, and how to treat the illness.
POC PCR tech is a truly game changing technology and as the market grows and becomes more competitive in the years to come.
The video features a product demonstration of the FilmArray RP EZ system by Bruce Applebaum from BioFire, and he answers many questions regarding the device, reimbursement, and the economics of integrating the system into your office practice.