Table 2.
Attributes of Currently Available Point-of-Care Molecular Assays.
| Assay | Availability | Targets | Sensitivity | Time to Results | Ease of Use | Ability to link to electronic medical record |
|---|---|---|---|---|---|---|
| binx io | CE-IVD mark and FDA approval | CT/NG | Very Good | 30 min | Non-laboratorian | Yes |
| Cepheid GeneXpert | CE-IVD mark and FDA approval | CT/NG with separate TV available | Excellent | 90 min | Non-laboratorian* | Yes |
| Randox run on Bosch Healthcare Vivalytic | CE-IVD | CT/NG/TV/MG/UU/MH/HD/TP/HSV | Unknown | 30 min | Laboratorian | Unknown |
| Visby (formerly Click) | In FDA clearance process | CT/NG/TV Female specimen only | Very Good | 30 min | Non-laboratorian - may be appropriate for home-use eventually | Yes |
a
This test does not have US FDA clearance for use by non-laboratorians