The INDICAID® COVID-19 IgM/IgG Rapid Test has been clinically validated reach a high detection accuracy, reaching a relative detection specificity of 99% and a relative detection sensitivity of 97.1%.In our clinical study, the INDICAID® COVID-19 IgM/IgG Rapid Test device was tested on clinical specimens from 60 healthy persons and 70 identified C OVID-19 patients, using PCR as the reference method. The results are summarized as below.
| INDICATOR | RESULT | INTERPRETATION | |
|---|---|---|---|
 | A line appears in regions (C), (IgG) and (IgM) | Positive | The presence of the control line (C) and both the IgM line (IgM) and IgG line (IgG) indicates the presence of both SARS-CoV-2 IgM and IgG antibodies. The result suggests current or recent COVID-19 infection. |
 | A line appears in regions (C) and (IgM) | Positive | The presence of the control line (C) and only the IgM line (IgM) indicates the presence of SARS-CoV-2 IgM antibodies. The result suggests an active or recent COVID-19 infection. |
 | A line appears in regions (C) and (IgG) | Positive | The presence of the control line (C) and only the IgG line (IgG) indicates the presence of SARS-CoV-2 IgG antibodies. The result suggests a recent or previous COVID-19 infection. |
 | A line appears in the region (C) | Negative | The presence of only the control line (C) and neither the IgM line (IgM) or the IgG line (IgG), indicates no detection of SARS-CoV-2 IgM or IgG antibodies. |
 | No line appears in the region (C) | Invalid | If the control line (C) does not appear, the result is invalid, regardless whether the IgM line (IgM) or the IgG line (IgG) is present. Repeat the test with a new test kit. |
25 INDICAID® COVID-19 Rapid Tests
