The ENNOLIFE COVID-19 Antigen Test employed magnetic beads and microfluidic technology in a sandwich immunoassay design that is used with ENNOLIFE Clinical Chemistry Analyzer for the detection of COVID-19 antigen (nucelocapsid protein or NP) producing 3 inspection reports in 30 minutes with accuracy up to 93.33%.
The ENNOLIFE COVID-19 Antigen Test was co-developed by ProtectLife International Biomedical and AnTaimmu BioMed. AnTaimmu BioMed discovered and developed novel monoclonal antibodies against COVID-19 antigen NP, ProtectLife International Biomedical design and developed the testing system based on microfluidic chip and precision spectroscopy technology. The ENNOLIFE COVID-19 Antigen Test had received the approval of Taiwan FDA.
CLINICAL PERFORMANCE and LIMIT OF DETECTION
The performance of the ENNOLIFE COVID-19 Antigen Test was established with 75 tests and the accuracy was 93.33%. The result was compared to FDA Emergency Use Authorized molecular (RT-PCR) test for detection of SARS-CoV-2. The overall sensitivity and specificity was 94.12% (PPV: 59.91% NPV: 98.47%)
The limit of detection (LoD) of the ENNOLIFE COVID-19 Antigen Test is 1.25×102 TCID50/mL for the CGMH virus strain (conducted at Chang Gung Memorial Hospital, Linkou, Taiwan)