Table 1. . Commercially available syndromic panel by manufacture and platform.
| Manufacturer | GenMark | BioFire | Luminex | BD | T2 Biosystems | ||
|---|---|---|---|---|---|---|---|
| Platform | ePlex | XT-8 | FilmArray | Verigene | xTAG/NxTAG | BD MAX | T2 |
| Respiratory US&CE IVD |
Respiratory US&CE IVD |
Respiratory† US&CE IVD |
Respiratory US&CE IVD |
Respiratory US&CE IVD |
– | – | |
| Syndromic panels | Blood CE IVD |
– | Blood US&CE IVD |
Blood US&CE IVD |
– | Blood‡ US&CE IVD |
|
| GI Development |
– | GI US&CE IVD |
GI US&CE IVD |
GI US&CE IVD |
GI US&CE IVD |
– | |
| CNS Development |
– | CNS US&CE IVD |
– | – | – | – | |
Summarized here are panels for the following major infectious syndromes: respiratory infections, bloodstream infections (e.g., bacteremia/fungemia), gastrointestinal (GI) infections (i.e. diarrheal illness) and CNS infections (e.g., meningitis and encephalitis). The regulatory status of each platform is denoted as: approved for clinical use (IVD) in the USA, approved for clinical use in the European Community (CE), or under development.
†The BioFire FilmArray currently includes an upper respiratory pathogen panel (for nasopharyngeal specimens) available for clinical use in the USA and Europe, as well as a separate pneumoniae panel (for bronchoalveolar lavage specimens) that currently remains under development.
‡With the exception of T2, all other manufacturer's bloodstream panels are performed on positive blood-culture media, whereas the T2 assay is performed directly on whole blood. A candidemia panel for the T2 is IVD-marked in both the USA and Europe, while a bacteremia panel presently remains CE IVD-marked only.
IVD: In vitro diagnostics.