Quidel Corporation announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market its Solana Bordetella Complete Assay, a molecular diagnostic assay to be used with the Solana molecular diagnostic instrument for the qualitative detection and differentiation of Bordetella pertussis and Bordetella parapertussis nucleic acids isolated from nasopharyngeal swab specimens obtained from patients suspected of having a respiratory tract infection attributable to Bordetella pertussis and Bordetella parapertussis. Pertussis, or whooping cough, is a very contagious disease caused by the Bordetella pertussis bacteria, which attach to the cilia that line part of the upper respiratory tract, causing inflammation through the release of toxins, which cause airways to swell.1 Pertussis is spread from person to person through the inhalation of bacteria from an infected person’s cough or sneeze. Symptoms, such as a runny nose, low-grade fever, or mild cough usually develop within 5–10 days after exposure, but sometimes appear as long as 3 weeks later. Although whooping cough can cause serious illness in children and adults, it is most dangerous for infants and babies. According to the Centers for Disease Control and Prevention (CDC), about half of infants younger than 1 year of age who get this disease require hospitalization. The incidence of pertussis has risen steadily over the last few years. Factors that have likely contributed to the increased incidence of pertussis include a decline in vaccine use, waning vaccine-induced immunity in adolescent and adult populations, failure to receive booster shots later in life, and continued circulation of B. pertussis in the population. The Solana molecular diagnostic instrument can process up to 12 patient samples in each batched run, and provides time-saving workflow advantages to healthcare professionals in moderately complex settings. Solana also comes connected to Virena®, Quidel’s data management system, which provides aggregated, de-identified testing data in near real-time. The Solana instrumented system offers a comprehensive set of 510(k)-cleared assays that allows laboratories to quickly process multiple patient samples to diagnose many diseases such as Influenza A+B, Strep Complete (Groups A+C/G), RSV+hMPV, HSV 1+2/VZV, Trichomonas, Group B Strep, and C. difficile.