COVID-19
The LightDeck COVID-19 Total Antibody Test detects antibodies to the SARS-CoV-2 virus to determine prior infection.
An important tool to understand immune response
The LightDeck COVID-19 Total Antibody Test helps clinicians assess an individual‘s immune response. An antibody test can reveal if a person had COVID-19 even if they were asymptomatic or never diagnosed with the disease. The LightDeck assay is designed to detect the receptor-binding domain (RBD) of the S1 spike antigen to detect antibodies that block the virus entry into the cells. This assay design is aligned with the multiple vaccines that target or include the SARS-CoV-2 S1 RBD, with the goal to elicit antibodies in vaccinated subjects. The spike protein and particularly the RBD are the most common target of vaccine designs.
Simple Procedure. Results in 5 minutes.
1.
Enter data. Add sample.
2.
Insert cartridge.
3.
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
| Point Estimate | 95% CI | |
| 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%)* |
† Calculated based on 5% prevalence *Variance of predictors calculated using the delta method
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.
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).”
Package Insert
Fact Sheet for Providers
Fact Sheet for Recipients
Product Overview Flyer
LightDeck Diagnostics
5603 Arapahoe Avenue, Suite 1 | Boulder, CO | 80303 USA
Ph. (303) 952-2905 | info@LightDeckDx.com