The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device is very quick with a processing time of approximately 10 minutes.
The COVID-19 IgG/IgM his highly portable and does not require comlpex equipment making it ideal for testing nationwide.
The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for COVID-19. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals.
Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals and birds that cause respiratory, enteric, hepatic and neurologic diseases. Four viruses - 229E, OC43, NL63 and HKU1 are prevalent and typically cause common cold symptoms in immunocompromised individuals. Three other strains SARS-CoV, MERS-CoV and SARS-CoV-2 (COVID-19) are can be transmitted from between non-human vertebrates to humans.
The sensitivity of the IgM test is 87.9% and specificity 100% when compared to RT-PCR.
The sensitivity of the IgG test is 97.2% during the convalescence period, and specificity is 100%.
- Positive results may be detected in as little as 10 minutes
- Detection Window (IgM): 3-5 days after incubation
- Dual band results for simple interpretation
- Multivariable analysis of immunoglobin IgG & IgM
- Room temperature storage or refrigerated (2-30⁰C / 36-86⁰F)
- Procedural internal control included
- Buffer included
- Sensitivity: IgG 97.2%; IgM 87.9%
- Specificity: IgG 100%; IgM 100%
- DSpecimen: Whole Blood, Serum, Plasma
- Time to Results: 10 minutes
- Shelf Life: 24 months from the date of manufacture