Products
COVID-19 Antibody
The LightDeck COVID-19 Total Antibody Test detects antibodies to the SARS-CoV-2 virus.
How it works
Simple procedure.
Results in 5 minutes.
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Results in 5 minutes
Lab-Quality Performance
Sensitivity = 98.2%
Sensitivity, or positive percent agreement (PPA), describes how well an assay correctly detects antibodies when the sample is positive. The LightDeck COVID-19 Total Antibody Test detected 56 of 57 positive samples.
Specificity = 99.4%
Specificity, or negative percent agreement (NPA), was evaluated in a study with 320 samples. This high NPA leads to low false positive rates, allowing clinicians to deliver highly accurate results about immune response to the SARS-CoV-2 virus.
Summary Statistics
| Measure | Point Estimate | 95% CL |
|---|---|---|
| Sensitivity (PPA) | 98.2% (56/57) | (90.7% – 99.8%) |
| Specificity (NPA) | 99.4% (318/320) | (97.8% – 99.8%) |
| Positive Predictive Value† | 89.6% | (76.5% – 100.0%)* |
| Negative Predictive Value† | 99.9% | (99.7% – 100.0%)* |
Critical Role of Antibody Testing
Determine past infection
Identify whether a person had been infected by SARS-CoV-2 and mounted an immune response.
Assess seroprevalence
Test for antibodies to determine the percentage of people in a community had a prior infection.
Assess immune response
Help identify adaptive immune response.
Testing in Hot Spots
Hospitals
Doctors, nurses, paraprofessionals
Nursing homes, assisted living
Residents and staff
Prisons and jails
Staff and inmates
Essential Workplaces
Food processing plants and grocery stores
Community Testing
Areas with outbreaks, universities, schools
Regulatory Disclaimers
- For prescription use only.
- For in vitro diagnostic use only.
- The LightDeck COVID-19 Total Antibody Test has completed the Section IV.D notification process under FDA’s “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised).”
- For use by laboratories that meet the CLIA requirements for high complexity testing
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