COVID-19
The LightDeck COVID-19 Total Antibody Test detects antibodies to the SARS-CoV-2 virus to determine prior infection.
Simple Procedure. Results in 5 minutes.
1.
Enter data. Add sample.
2.
Insert cartridge.
3.
Results in 5 minutes.
Performance Data
Clinical Sensitivity
Sensitivity, or positive percent agreement (PPA), was determined by testing 95 samples from SARS-CoV-2 positive patients (PCR+ more than 14 days).
Clinical Specificity
Specificity, or negative percent agreement (NPA), was determined by testing 546 pre-COVID samples.
Summary Results
† 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.
Assess immune status
In the future, an antibody test along with other clinical data, may help identify individuals who may be less susceptible to infection and can return to work.
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