Quickvue at-home otc covid-19 test kit in Costa Rica is authorized for nonprescription home use with self-collected (unobserved) direct anterior nasal(NS) swab specimens from individuals aged 14 years and older or with adult-collected anterior NS samples from individuals aged 2 years or older
Positive results indicate the presence of virus-specific proteins, Quickvue at-home otc covid-19 test kit in Costa Rica but clinical correlation with past medical 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 and the agent detected may not be the definite cause of disease. Individuals who test positive with the QuickVue At-Home OTC COVID-19 Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary
Negative results should be treated as presumptive, do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions
Negative results should be considered in the context of an individuals 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
Individuals should provide all results obtained with this product to their healthcare provider for public health reporting
This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens
The test is intended to be read at 10 minutes; If the test is read before this or is read more than 5 minutes after the indicated read time, results may be inaccurate and the test should be repeated
Manufacturer #20402
BrandQuickVue
ManufacturerQuidel
Country of OriginUnknown
Application Quickvue at-home otc covid-19 test kit in Costa Rica
ContentsIndividually Wrapped Sterile Foam Swabs, Individually Packaged, (2) Single-Use Test Strips, Pre-Filled Tubes, Tube Holder, Instruction Sheet, Fact Sheet for Individuals
HCPCSU0004
Number of Tests2 Tests
Reading TypeVisual Read
Sample TypeDirect Anterior Nasal (NS) Swab Sample
Test FormatTest Strip Format
Test MethodLateral Flow Immunoassay
Test NameAt-Home OTC COVID-19 Test
Time To Results10 Minute Results