Novir INSTA COVID-19 Antibody Test Device

Novir has begun production of its INSTA COVID-19 rapid antibody tests, which can help slow the spread of the virus and help schools, businesses, and other organizations reopen, and stay open, safely and responsibly. 

Novir has received the CE Mark, allowing for the tests’ sale and use in Europe and other markets that accept and recognize the CE Mark. MPE-INC is manufacturing the tests on behalf of Novir.

The INSTA antibody blood test detects if you have produced antibodies to COVID-19 and help determine if you’ve had the virus, even without symptoms. Results can be delivered in 15 minutes via the client’s smartphone or email, using Novir’s TRACK technology. 

Description

  • Highly accurate, easy-to-use, rapid point-of-care test kit provides results in 15 minutes
  • Includes:
    • 20 tests/kit
    • Disposable pipettes
    • Sterile safety lancets
    • Alcohol prep pads
    • Buffer
    • Package insert
  • Intended use:
    • Rapid lateral flow chromatographic immunoassay for qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood
    • Identify individuals with an adaptive immune response to SARS-CoV-2

Note: Device should not be used to diagnose acute SARS-CoV-2 infection. Not approved for sale in the United States.

Specifications

Sample Type Human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood
Storage Requirements Ambient
Kit Size 20 tests/kit
Test Time 15 minutes
CE Mark Yes
Disposable Yes
Type COVID-19 antibody
Control Sets Yes
Shelf Life 14 months
Specificity 99.24%
Sensitivity 90.44%
PPV (Positive Predictive Value at 15% prevalence) 95.5%
NPV (Negative Predictive Value at 15% prevalence) 98.3%
Detectable Analytes IgM and IgG antibodies to SARS-CoV-2
Includes 20 tests/kit, disposable pipettes, sterile safety lancets, alcohol prep pads, buffer, and a Pk. insert

Ordering Information

To learn more about and order Novir INSTA Antibody Tests, please email sales@novir-usa.com.

Tests are not yet approved for sale or use in the United States.

In Production: MPE-INC