Lumos CoviDx - SARS-CoV-2 Rapid Antigen Test
CoviDx™ SARS-CoV-2 Rapid Antigen Test is a lateral flow assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swabs and nasopharyngeal swabs from patients suspected of a Coronavirus-19 (COVID-19) infection by their healthcare provider within the first 5 days of symptoms.
Background Information
SARS-CoV-2 is a new coronavirus that was identified in December 2019 and can cause mild to severe illness—COVID-19. Due to its highly contagious nature and global health crises, SARS-CoV-2 was designated as a pandemic by the World Health Organization (WHO) in March 2020. The ability to rapidly identify COVID-19 patients to enable effective cohorting and prevent the spread of infection is a critical component of combatting the pandemic.
Rapid antigen tests are an important tool in the overall response against COVID-19 and to benefit public health. The main advantages of antigen testing are the speed and simplicity of the test, which can provide results in minutes. Through rapid detection of SARS-CoV-2, CoviDx is able to optimise patient isolation decisions and enable accurate cohorting.
Intended Use Statement
CoviDx SARS-CoV-2 Rapid Antigen Test is a rapid immunoassay for the qualitative detection of the nucleocapsid protein in nasal swabs (NS), oropharyngeal swabs (OP), and nasopharyngeal swabs (NP) from patients suspected of a Coronavirus-19 (COVID-19) infection.
CoviDx SARS-CoV-2 Rapid Antigen Test aids in the clinical diagnosis of patients suspected of COVID-19. The test is intended for professional use and should be used in conjunction with other clinical evidence.
Negative results should be considered presumptive and do not preclude infection. Negative results should not be used as the sole basis for diagnosis, treatment, or other clinical and patient management decisions and should be confirmed with a molecular test for SARS-CoV-2.
CoviDx SARS-CoV-2 Rapid Antigen Test does not differentiate between SARS-CoV and SARS-CoV-2.
CoviDx SARS-CoV-2 Rapid Antigen Test is CE marked and is in process of regulatory registration as required in various markets.
- Results within 20 minutes: facilitate immediate patient isolation
- Flexible workflow: pre-filled extraction vials and individually packaged reagents enable multiple independent workstations for increased test distribution
- Easy-to-use: instrument-free, user-friendly test procedure for non-lab settings
- Convenient: all materials included in the kit for hassle-free logistics
- Accurate: 100% Positive Percent Agreement (PPA) with PCR for samples with Ct values ≤ 30