Visby Medical Respiratory Health Test

The Visby Medical Respiratory Health Test is a single-use, fully integrated, automated RT-PCR device that detects and differentiates SARS-CoV-2, influenza A, and influenza B RNA in nasopharyngeal or anterior nasal swab specimens from patients with respiratory symptoms. Results are available in approximately 30 minutes and are intended to aid in differential diagnosis when used with other clinical information.

Both the Visby device and predicate use real-time RT-PCR qualitative detection technology with automated sample extraction and internal process controls. The key difference is that Visby is a fully self-contained, disposable device requiring no separate instrument, while the predicate (DiaSorin Simplexa) requires use of the LIAISON MDX instrument. Visby accepts both nasopharyngeal and anterior nasal swabs, whereas the predicate accepts only nasopharyngeal swabs. Visby achieves results in ~30 minutes versus ~90 minutes for the predicate.

Not stated in this summary. The document references clinical specimens, CLIA Waived testing settings, and comparator assays but does not cite specific ISO, IEC, or ASTM standards.

Both devices target the same three viruses (SARS-CoV-2, influenza A, B) using the same RT-PCR technology platform with qualitative results and internal controls. Clinical performance data from 1,501 prospectively enrolled subjects demonstrated high positive and negative percentage agreement (96.3–100% PPA; 99.0–99.8% NPA) across all three targets compared to FDA-cleared comparator assays. Analytical studies confirmed comparable limit of detection, broad strain inclusivity, absence of cross-reactivity with 43 non-target microorganisms, and no competitive interference between targets. The intended use, specimen types, assay targets, and regulatory classification are substantially the same; differences in instrument format and turnaround time do not create new clinical risks or alter the fundamental diagnostic function.