(137 days)
The VIDAS Rotavirus (RTV) Assay detects the presence of rotavirus antigen in stool specimens.
The VIDAS RTV Assay detects the presence of rotavirus antigen in stool specimens. Assay specificity is conferred by the use of two antibodies. The rotavirus antigen is captured on the SPR by a polyclonal anti-rotavirus VP6 antibody, and the detector antibody conjugate is composed of a mouse monoclonal anti-rotavirus VP6 antibody.
Here's an analysis of the provided text, focusing on the acceptance criteria and study details for the VIDAS Rotavirus Assay:
Acceptance Criteria and Study Details for the VIDAS Rotavirus Assay
This submission describes the VIDAS Rotavirus Assay, a diagnostic device for detecting rotavirus antigen in stool specimens. The primary study presented here is a standalone performance evaluation comparing the VIDAS RTV Assay to a commercially available EIA, with discrepancies resolved by a second EIA and electron microscopy (EM).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pivotal Study-Based Acceptance Criteria: | |
| Relative Specificity (compared to primary EIA with discrepancy resolution) | 95.1% |
| Relative Sensitivity (compared to primary EIA with discrepancy resolution) | 96.4% |
| Overall Agreement (compared to primary EIA with discrepancy resolution) | 96.5% |
| Overall Agreement (after EM resolution of all discrepant samples) | 94.8% |
| Number of Equivocal Results (following package insert instructions) | 4 |
| Number of Invalid Results (following package insert instructions) | 0 |
| Cross-reactivity/Interference (with approx. 50 microorganisms) | No cross-reactivity or interference observed. |
| Intra-assay Precision (Coefficient of Variation) |
§ 866.3405 Poliovirus serological reagents.
(a)
Identification. Poliovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to poliovirus in serum. Additionally, some of these reagents consist of poliovirus antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify polioviruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of poliomyelitis (polio) and provides epidemiological information on this disease. Poliomyelitis is an acute infectious disease which in its serious form affects the central nervous system resulting in atrophy (wasting away) of groups of muscles, ending in contraction and permanent deformity.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.