COVID-19 rapid test FRCOA 020

IgGIgMSARS-COV-2

The FREND™ COVID-19 total Ab is a fluorescence immunoassay (FIA) which can be used to aid in identifying individuals with an adaptive immune response to SARS-CoV-2 using human plasma. KEY FEATURES & BENEFITS - U.S. FDA EUA approved - 2 steps | Easy to use - Microfluidic Qualitative Immunoassay - LIS connectivity (data management) Microfluidic Qualitative Immunoassay FREND™ COVID-19 total Ab The FREND COVID-19 Neutralization Ab is a point-of-care testing (POCT) which can be used to check whether a patient has developed the immune response to SARS-CoV-2 using human serum or plasma (EDTA). The FREND COVID-19 Neutralization Ab is a fluorescence immunoassay (FIA) using the FREND System intended for the qualitative detection of neutralization antibodies to SARS-CoV-2. The FREND COVID-19 Neutralization Ab is intended for use as an aid in identifying individuals with neutralizing antibodies to SARS-CoV-2 after vaccination or prior infection. Instructions for Use Fast and simple test steps Using small amount of sample, the FREND System provides accurate results. Performance evaluation Clinical Performance Evaluation A total of 41 clinical samples (28 positive and 13 negative) confirmed with PRNT50 were tested with the FREND COVID-19 Neutralization Ab, demonstrating 92.9% PPA* and 100% NPA* as shown below. Effective Data Management Laboratory Information System Connectivity In the event of a pandemic, the management of a vast amount of clinical results is important. As many laboratories face challenges in effective arrangement of the essential information, the FREND System provides the following advantages: Paperless Time-saving Automatic Data Transfer & Collect