COVID-19 rapid test

IgGIgMserum

SGTI-flex COVID-19 IgM/IgG is a immunochromatographic test kit that qualitatively measures the IgM and IgG antibodies of COVID-19 in whole blood (fingertip blood or venous blood), serum or plasma. This kit is accurate and easy to use - CE-IVD - ANVISA (Brazil) 7. Conclusion Comparison studies between the test device (SGTi-flex COVID19 IgM/lgG) and the predicate device (Reference method, real time RT-PCR) were conducted by lab professionals, using total 523 specimens. The results showed the accuracy (Overalll percent agreement) was 97.13%. The Séroconversion study confirmed that IgM was first generated in patients with negative results for IgM or IgG antibodies in the early stages of infection, and that IgG was also produced over time. When estimating the sensitivity of IgM and IgG over time from symptom onset for ail positive samples, the proportion of IgM positive patients reached a peak of 100.0% approximately 15-21 days after symptom onset, whereas the proportion of IgG positive patients reached 100% approximately 22 days after symptom onset.