Frequently Asked Questions

What is ellume·lab?

The ellume·lab is a handheld diagnostic device that has been designed for healthcare professionals. In addition to it’s diagnostic capabilities, the ellumelab offers a suite of digital tools to support the healthcare professional at the point of care.

What is the intended use of the ellume·lab COVID Antigen test?

The ellume·lab COVID Antigen test uses a nasal swab to detect viral proteins of the SARS-CoV-2 that causes COVID-19. The test is for use in patients who are symptomatic for COVID-19 and have had symptoms for 6 days or less.

How long will the results take?

Positive results may be received from 3 minutes, with negative results received from 11 minutes. The average time to result is < 10 minutes and the maximum time to result is 15 minute.

How reliable and accurate are ellume·lab COVID Antigen test results?

In clinical trial conducted in the USA in early 2021, the ellume·lab COVID Antigen test had a sensitivity of 96.4% and a specificity of 100% when used in patients with signs and symptoms of COVID-19 when the test was taken within 6 days of onset of symptoms. This data was derived from subjects who had CT values of <33 on the comparator RT-PCR test used in the trials. CT values >30 are considered to be high and in studies this correlates with lower viral loads and potentially decreased infectivity for COVID-19. When samples with higher CT values (>33) were included the sensitivity of the ellume·lab COVID Antigen test was 81.8%.

1. Bullard et al. “Predicting Infectious Severe Acute Respiratory Syndrome Coronavirus 2 from Diagnostic Samples.” Clinical Infectious Diseases 2020;71(10):2663-6 2. La Scola et al. “Viral RNA load as determined by cell culture as a management tool for discharge of SARS-CoV-2 patients from infectious disease wards” European Journal of Clinical and Microbiology Diseases (2020) 39: 1059-1061 3. Basile et al. “Cell-based Culture Informs Infectivity and Safe De-Isolation Assessments in Patients with Coronavirus Disease 2019” Clinical Infectious Diseases 2021; XX(XX):1-8.

What type of patients can I use this product on?

The ellume·lab has been designed for use with all patients. It provides diagnostic testing for COVID-19 but provides other digital tools which may assist you in your day to day consultations with patients such as a drug dosage calculator and detailed medical diagrams.

How do I run more than one test at the same time?

The ellume·lab is designed with two eStick ports, allowing the user to perform two patient tests simultaneously or two control tests simultaneously. To perform two tests: Begin a single patient or a single control test, then once the testing screen has been launched, press the ‘Start second test’ button at any time to begin a second test. Do not perform a Patient Test and Control Test at the same time. While performing the two tests, you can toggle between them by pressing the eStick image next to the relevant eStick port.

Is the ellume·lab COVID Antigen test reimbursable?

Please check the AMA website for COVID-19 CPT coding and guidance in your state. https://www.ama-assn.org/practice-management/cpt/covid-19-cpt-coding-and-guidance

What is the cyber security policy for ellume·lab?

We make reasonable efforts to protect your information by using physical and electronic safeguards designed to improve the security of the information we maintain. For more details, visit https://www.ellumelab.com/privacypolicy