Intended Use

​

​ SGTI-Flex COVID-19 IgG is an antibody test intended to use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Detection is determined by a blood sample.

 

Key Highlights

 

• Run time: Read results after 10 to 15 minutes, after 30 minutes results are invalid

• Target Region: IgG

• Specificity: 99.15%

• Sensitivity: 92.43%

• LOD: 5.3 x 102 TCID50/mL

• 25 tests per box