Product Overview
The Nano-Check™ RSV Test is a rapid immunochromatographic assay designed for the qualitative detection of respiratory syncytial virus (RSV) nucleoprotein antigen in anterior nasal swab specimens. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in infants and pediatric patients aged 6 months to 6 years, and adults over 60 years of age. It provides results in just 15 minutes, making it suitable for point-of-care settings.
Product Features
- Rapid Results: Delivers qualitative results in 15 minutes, facilitating timely clinical decision-making.
- High Accuracy: Demonstrates a relative sensitivity of 83.8% and a relative specificity of 99.6%, ensuring reliable detection of RSV infections.
- FDA Cleared & CLIA Waived: Approved under FDA 510(k) clearance (K240280) and CLIA waived (CW240005), allowing for use in various healthcare settings.
- Comprehensive Kit Contents: Each kit includes 25 test devices, reagent tubes with prefilled extraction buffer, sample collection swabs, positive and negative controls, and detailed instructions for use.
- User-Friendly Design: Features a simple one-step procedure with no additional equipment required, making it easy for healthcare providers to administer and interpret results.
Product Specifications
| Catalog Number/SKU | MF-MD8152 |
| Test Type | Rapid Immunochromatographic Assay |
| Target | Respiratory Syncytial Virus (RSV) Nucleoprotein Antigen |
| Sample Type | Anterior Nasal Swab |
| Time to result | 15 minutes |
| Sensitivity | 83.8% (Relative Sensitivity) |
| Specificity | 99.6% (Relative Specificity) |
| Intended Use | In vitro diagnostic use in individuals aged 6 months–6 years and 60+ years |
| Regulatory Status | FDA 510(k) Cleared (K240280), CLIA Waived (CW240005) |
| Kit Contents | 25 test devices, extraction tubes with buffer, swabs, positive/negative controls, IFU |
| Storage Conditions | Store at 2°C – 30°C (36°F – 86°F) |
| Shelf Life | As indicated on product packaging |
| CLIA Waived | Yes |
