Methodology:
The COVID-19 ELISA IgG/IgM Antibody Test is an enzyme-linked immunosorbent assay (ELISA). It was developed to detect the presence of human antibodies targeting the viral Nucleocapsid (N) protein.
Specimen and Transport:
Serum whole blood via red top venipuncture draw, capillary blood collected using TAP Blood Collection or capillary blood collected using Mitra Microsampling Devices may be used for this test. Capillary devices are self-administrable, eliminating need for specialized training and minimizing risk due to close contact. After collection, the specimen is shipped to Phosphorus using included packaging and envelope at ambient temperature.
Turnaround Time:
Within 72 hours from date of receipt at the laboratory
Performance:
Sensitivity: 97.1%
Specificity: 98.2%
Positive Predictive Value: 97.1%
Negative Predictive Value: 98.2%
Clinical & Stability Study:
Clinical Performance: 146 Samples (62 positives and 84 negatives - confirmed by clinical assessment and qPCR testing by 3rd party EUA approved laboratories).
Stability: 10 representative samples were analyzed across 3 collection methods for both IgG and IgM proficiency through simulated temperatures between 22°C and 40°C for up to 72 hours.