Novir INSTA COVID-19 Antigen Test
Novir is proud to introduce its INSTA COVID-19 Antigen Test Kit, a lateral flow immunoassay that detects the surface protein of the virus, providing a preliminary test result to aid in the diagnosis of infection with novel coronavirus.
The rapid diagnostic test can be performed by minimally skilled personnel without the use of laboratory equipment. Samples are collected with a nasal swab, with results in 15 minutes.
The tests are a tool to help slow the spread of COVID-19, manage risk, and instill confidence, comfort and trust as your business, school, camp, or other organization looks to reopen, and stay open, safely and responsibly. Novir has received the CE Mark for its INSTA Antigen Tests, and they are being manufactured by MPE-INC of Milwaukee, a leading provider of medical devices.
The tests are not cleared nor authorized by the United States Food and Drug Administration, and they are not available in the U.S.
Description
The INSTA COVID-19 Antigen Assay Kit is a lateral flow immunoassay for the qualitative detection of nucleocapsid protein from SARS-CoV-2 in nasal swab. It is intended to be used by professionals as a test and provides a preliminary test result to aid in the diagnosis of infection with novel Coronavirus.
- Includes:
- Sealed pouch with test cassette and desiccant
- Sterile swab
- Extraction buffer tube with integrated dropper
- Buffer holder; and
- Package insert
Note: Not approved for sale in the United States.
Specifications
| Sample Type | Nasal swab |
| Storage Requirements | Ambient |
| Kit Size | 20 tests/kit and 5 tests/kit |
| Test Time | 15 minutes |
| CE Mark | Yes |
| Disposable | Yes |
| Type | COVID-19 antigen |
| Control Sets | Yes, available on demand |
| Shelf Life | 12 months |
| Specificity | 99.5% |
| Sensitivity | 90% |
| PPV (Positive Predictive Value at 15% prevalence) | 96.9% |
| NPV (Negative Predictive Value at 15% prevalence) | 98.3% |
| Detectable Analytes | This test is used for detection of SARS-CoV-2 nucleocapsid protein antigen |
Ordering Information
To learn more about and order Novir INSTA Antigen Tests, please email sales@novir-usa.com.
Tests are not yet approved for sale or use in the United States.
