Product Description
CoviDx™ SARS-CoV-2 Rapid Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2
in nasal (NS) swabs and nasopharyngeal (NP) swabs from patients suspected of a Coronavirus-19 (COVID-19) infection by their healthcare
provider within the first 5 days of symptoms.
CoviDx is intended for use by trained laboratory personnel and healthcare professionals.
Results in 15 minutes.
CoviDx is intended for use by trained laboratory personnel and healthcare professionals.
Results in 15 minutes.
- CoviDx allows for optimal disease management and immediate patient isolation
- Detects UK, South African, and Danish COVID-19 variant strains1
- Pre-filled extraction vials and individually wrapped swabs enable multiple independent workstations for increased test distribution
- Facilitates professionally administered testing at the point of need, such as workplace testing and airport screening
- Room temperature storage
- 25 test kit
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.
The FDA has concluded that SARS CoV-2 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 detection of SARS-CoV-2, CoviDx is able to optimize patient isolation decisions and enable accurate cohorting.
Intended Use Statement
CoviDx SARS-CoV-2 Rapid Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal (NS) swabs and nasopharyngeal (NP) swabs from patients suspected of a Coronavirus-19 (COVID-19) infection by their healthcare provider within the first 5 days of symptoms.
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. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate complexity, high complexity, or waived tests. This test is authorized for use at the point of care (POC) in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in NS and NP during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
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, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management.
CoviDx SARS-CoV-2 Rapid Antigen Test does not differentiate between SARS-CoV and SARS-CoV-2.
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. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate complexity, high complexity, or waived tests. This test is authorized for use at the point of care (POC) in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in NS and NP during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
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, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management.
CoviDx SARS-CoV-2 Rapid Antigen Test does not differentiate between SARS-CoV and SARS-CoV-2.
- Within the U.S., CoviDx is only for use under the Food and Drug Administration’s Emergency Use Authorization.
- Please contact Lumos for specific product details that align with U.S. FDA notification procedures.
Contact us to order or learn more about the CoviDx SARS-CoV-2 Rapid Antigen Test.
