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

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