Roche reported that its first point-of-care assay for diagnosing whooping cough and other Bordetella infections received US Food and Drug Administration 510(k) clearance with a Clinical Laboratory Improvement Amendments waiver, along with CE IVDR certification. The polymerase chain reaction–based test, designed for use on the cobas liat system, generates results in 15 minutes. This turnaround enables physicians to diagnose patients during the visit and take prompt action, including providing appropriate antibiotics.

Pertussis continues to pose a global health burden, with an estimated 24.1 million cases and 170,000 deaths annually in children younger than 5 years. Early manifestations often resemble other respiratory infections, leading to empiric treatment and delayed confirmation. Such delays may permit disease progression.

The assay identifies and differentiates three clinically relevant species: Bordetella pertussis, the primary cause of classic pertussis; Bordetella parapertussis, which produces a similar but often milder illness with variable response to standard therapy; and Bordetella holmesii, an emerging pathogen associated with pertussis-like presentations and diagnostic complexity. Rising case numbers have been reported, consistent with the disease’s 3- to 5-year cyclical pattern. Recent increases may be driven by disruptions in routine vaccination during the pandemic period, waning immunity, and vaccine hesitancy, contributing to broader age-range susceptibility and atypical symptom patterns in older patients.

The cobas liat system is already used in point-of-care settings worldwide for respiratory diagnostics. It delivers polymerase chain reaction–level accuracy in 20 minutes or less and supports assays for SARS-CoV-2, influenza A, influenza B, respiratory syncytial virus, and group A Streptococcus.

Source: Roche