SLI Medical Acceptable Dating: we will ship >= 30 days
Sample Type
Visual Read
Test Format
Nasal Swab Sample
Test Method
Nasal Swab Sample
Test Name
Cassette Format
Test Type
Lateral Flow Chromatographic Immunoassay
Time to Results
COVID-19 Antigen OTC
UNSPSC Code
Antigen Detection
15 Minute Results
41116205
Features
INDICAID® Covid-19 Antigen Home test is for use under an FDA EUA: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
Product ships with minimum 30 days dating
Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection
This test is authorized for non-prescription home use with self-collected anterior nasal swab specimens directly from individuals aged 14 years and older or with adult-collected anterior nasal samples directly from individuals aged 2 years or older
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
Individuals who test positive should self-isolate and consult their healthcare provider as additional testing may be necessary and for public health reporting
Negative results are presumptive
and confirmation with a molecular assay
if necessary for patient management
may be performed
Negative results should be considered in the context of an individual’s recent exposures
history and the presence of clinical signs and symptoms consistent with COVID-19
Clinical performance showed 93% sensitivity and 100% specificity
