FilmArray RP EZ
Pediatricians now have several Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88)-waived point-of care-(POC) polymerase chain reaction (PCR) systems that facilitate diagnosis of influenza A and B, strep pyogenes, and respiratory syncytial virus (RSV)—all with amazing accuracy. I’ve discussed these devices from Roche and Alere previously. FilmArray Respiratory Panel (RP) EZ from BioFire Diagnostics (Salt Lake City, Utah) expands the POC repertoire of PCR tests to include 14 respiratory viruses and bacteria. One obtains a nasopharyngeal swab, and the system processes the sample in 65 minutes. The tests include adenovirus, coronavirus, human metapneumovirus, human rhinovirus, influenza A, influenza A/H1, influenza A/H3, influenza A/H1-2009, influenza B, parainfluenza virus, RSV, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. The device is provided free of charge to practices who commit to performing 360 tests in a 1-year period. The cost per test is $130, and the reimbursement is usually 2 to 3 times the cost.
Alere Reader and BinaxNOW Influenza A and B Card
Although lateral flow POC assays for strep, RSV, and influenza A and B have been a mainstay of pediatric practices for decades, recent innovations have introduced optical readers that greatly improve their accuracy. Early in 2018, Abbott (Waltham, Massachusetts), who recently acquired Alere, will introduce a new Optical Reader that will be used in conjunction with its popular BinaxNOW Influenza A and B Card. The assay takes just 15 minutes to perform. The completed assay card is placed in the optical reader that interprets the results in seconds, eliminating operator subjectivity and improving sensitivity and specificity substantially. When purchased in quantity, each BinaxNOW Influenza A and B test costs about $16, with reimbursement typically twice that when one bills for both the A and B assays. The cost of the reader has not yet been announced.