Taiwan's Bluesense Diagnostics, ViroTrack Sero COVID-19 IgA+IgM/IgG Ab is an in vitro immuno-magnetic (IMA) assay kit intended for the semi-quantitative detection of human IgA+IgM and IgG antibodies directed against SARS-CoV-2 in human whole blood, serum or plasma as an aid to the diagnosis of COVID-19 infection.

The ViroTrack Sero COVID-19 IgA+IgM/IgG Ab cartridge is a small test embedding nanoparticles and microfluidics structures, the two building blocks of BluSense’s  IMA technology.

All components of the ViroTrack Sero COVID-19 IgA+IgM/IgG Ab kit are single-use and intended to be used for analysis of human whole blood, serum and plasma samples, exclusively in combination with BluBox reader as an aid to the diagnosis of a COVID-19 infection.

ViroTrack Sero COVID-19 IgA+IgM/IgG Ab kit is intended to be used by healthcare professionals in clinical settings with the purpose of testing patients of both genders with clinical symptoms consistent with COVID-19.

ViroTrack Sero COVID-19 IgA+IgM/IgG Ab kit is a complete sample-to-result solution for testing the presence of human IgA+IgM and IgG antibodies against SARS-CoV-2 virus in whole blood, plasma and serum.

How does the ViroTrack Sero COVID-19 IgA+IgM/IgG Ab Kit work?

10 µL of sample is collected with the sample collection pipette and transferred to the sample dilution bu­er vial. The sample is diluted and mixed in the sample dilution bu­ffer vial by inversion. Subsequently, 50 µL of the diluted sample is dispensed using the loading pipette into the microfluidic cartridge sample loading inlet. The ViroTrack Sero COVID-19 IgA+IgM/IgG Ab cartridge is then inserted in the BluBox.

After the test is performed, the IgA+IgM and IgG results are displayed on the BluBox touch screen, indicating whether the sample is positive or negative for each antibody, as well as the resulting IMA units (the relative reactivity of the antibodies). The results are calculated using the LOT calibration and compared with the threshold values. LOT calibration and threshold values are stored in the QR code.

Portable Reader - BluBox

ViroTrack Sero COVID-19 IgA+IgM/IgG Ab is run with a portable (<3kg) optical reader based on Blu-ray technology components.