(88 days)
The RAMP RSV Assay is a qualitative immunochromatographic test for the detection of Respiratory Syncytial Virus (RSV) F-protein antigens in nasal wash/aspirate, nasopharyngeal aspirate and nasopharyngeal swab samples. It is an in vitro diagnostic assay that aids in the rapid diagnosis of RSV infections in symptomatic patients 21 years of age and younger. A negative test is presumptive and it is recommended that all negative results be confirmed by cell culture or direct specimen fluorescence assay (DSFA). Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional use.
The RAMP RSV Assay is a qualitative immunochromatographic test for the detection of Respiratory Syncytial Virus (RSV) in nasal wash/aspirate, nasopharyngeal aspirate, and nasopharyngeal swab samples from symptomatic patients 21 years of age and younger. A wash/aspirate or swab sample is mixed with Sample buffer and applied into the sample well of the Test Cartridge. The sample migrates along the strip. Fluorescent-dyed latex (test) particles. coated with anti-RSV antibodies bind to RSV antigens, if present in the sample. As the sample migrates along the strip, RSV-bound particles are captured at the RSV detection zone, and additional particles are captured at the internal standard zone.
This document describes the RAMP® RSV Assay, a qualitative immunochromatographic test for detecting Respiratory Syncytial Virus (RSV). The study presented focuses on its analytical and clinical performance.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Implied/Standard for Assay) | Reported Device Performance |
|---|---|---|
| Analytical Performance | ||
| Analytical Sensitivity (LoD) | Device should detect RSV at low concentrations | Ranged from 3.5x10^2 to >1.7x10^5 TCID50/mL depending on strain and sample matrix. Achieved 90-100% positivity for LoD samples. |
| Precision & Reproducibility | High agreement across sites and operators | 99.2% overall agreement with expected results. RAMP Ratio %CV 13-16%. |
| Interference | No interference from common substances | None of the tested interfering substances (whole blood, mucin, various medications/OTC products) interfered with negative or positive RSV results. |
| Analytical Specificity | No cross-reactivity with common viruses/bacteria | None of the 16 viruses and 17 bacteria tested gave a positive result. |
| Transport Media Compatibility | No interference with common transport media | None of the 7 transport media tested interfered with performance. |
| Swab Material Compatibility | No interference with common swab types | None of the 4 swab materials tested interfered with performance. |
| Clinical Performance | ||
| Overall Sensitivity | Reasonable sensitivity for RSV detection | 87.3% |
| Overall Specificity | High specificity for RSV detection | 95.6% |
| Sensitivity (NP Swab, All Ages) | 88.2% (95% CI: 81.4 - 92.7) | |
| Specificity (NP Swab, All Ages) | 97.4% (95% CI: 94.6 - 98.7) | |
| Sensitivity (NP Swab, Age |
§ 866.3480 Respiratory syncytial virus serological reagents.
(a)
Identification. Respiratory syncytial virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to respiratory syncytial virus in serum. Additionally, some of these reagents consist of respiratory syncytial virus antisera conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify respiratory syncytial viruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of respiratory syncytial virus infections and provides epidemiological information on diseases caused by these viruses. Respiratory syncytial viruses cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile bronchopneumonia.(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.