CAse Studies

01 N1 Microdigital

The purpose of this study was to evaluate performance characteristics of the MicroDigital AB96-Covid-19 IgG N1 on the Mobi reader for the detection of N1 IgG related to the Covid-19 virus. This study compared Sunrise reader vs MRN Dx reader using and evaluated by MicroDigital AB96-Covid-19 IgG N1 kits with 300 contrived samples. A full validation plan and assessment was completed and approved by the Laboratory Director and Associate Director.

02 S1 microdigital

The purpose of this study was to evaluate the performance characteristics of detection of SARS-CoV2 antibodies utilizing AB96-Covid-19 IgG S1. This study compared 300 contrived samples with known S1 call using MicroDigital AB96-Covid-19 IgG N1 and cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit (FDA EUA) GenScript. A full validation plan and assessment was completed and approved by the Laboratory Director and Associate Director.

03 Noble bio V-capture Covid-19 S1 rbd igG/ Neutralizing AB Test

The purpose of this study was to evaluated the performance characteristics of detection of Noble Bio V-capture COVID-19 S1 RBD IgG/ Neutralizing Ab as a rapid chromatographic immunoassay for the qualitative detection of S1 RBD IgG/neutralizing antibodies to SARS-CoV-2 in human whole blood, serum, or plasma to evaluate individual immunity status. Study was performed using 300 contrived samples with known Neutralizing Antibody status. A full validation plan and assessment was completed and approved by the Laboratory Director and Associate Director.