Rally #188-1-2398
Quidel #20398
Rapid Test Kit QuickVue® At-Home OTC COVID-19 Test Direct Anterior Nasal (NS) Swab Sample 25 Tests
TEST KIT, COVID-19 QUICKVUE AT-HOME OTC (25 TEST/KT 10 KT/CS)
Features
- Works for symptomatic and asymptomatic individuals
- Detects SARS-CoV-2 antigens directly from anterior nares swab specimens
- Provides accurate and reliable results in 10 minutes, allowing for COVID-19 testing of symptomatic patients within the first five days of symptoms and asymptomatic patients when tested serially
- Contains pre-filled vials
The QuickVue At-Home OTC COVID-19 Test is intended for the qualitative detection of nucleocapsid proteins from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 36 hours between tests.
- Authorization -
For Use Under an Emergency Use Authorization (EUA) Only: 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.
This test 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.
This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
- Results -
Positive results indicate the presence of virus-specific proteins, 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 individual’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.
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. Individuals should provide all results obtained with this product to their healthcare provider for public health reporting.
Product Specifications
| Manufacturer # | 20398 |
| Brand | QuickVue® |
| Manufacturer | Quidel |
| Country of Origin | United States |
| Application | Respiratory Test Kit |
| CLIA Classified | CLIA Waived |
| Contents 1 | Individually Wrapped Sterile Foam Swabs, (25) Test Strips, Pre-filled Tubes, Tube Holder, Instruction Sheet, Fact Sheet for Individuals |
| Number of Tests | 25 Tests |
| Reading Type | Visual Read |
| Sample Type | Nasal Swab Sample |
| Specialty | Immunoassay |
| Test Format | Test Strip Format |
| Test Kit Type | Rapid |
| Test Method | Lateral Flow Immunoassay |
| Test Name | At-Home OTC COVID-19 Test |
| Time to Results | 10 Minute Results |
| UNSPSC Code | 41116144 |
| Weight (pounds) | 0.55 |
WARNING: This product can expose you to chemicals which are known to the State of California to cause cancer and birth defects or other reproductive harm. For more information, go to www.p65Warnings.ca.gov.
More Information
- QuickVue At-Home OTC COVID-19 Test FDA EUA Letter
- QuickVue At-Home OTC COVID-19 Test Fact Sheet
- QuickVue At-Home OTC COVID-19 Test Healthcare Providers Fact Sheet
- QuickVue At-Home OTC COVID-19 Test Patients Fact Sheet
- QuickVue At-Home OTC COVID-19 Healthcare Provider IFU
- Quidel Quick Vue At-Home OTC COVID-19 Test Dating Extension Letter
- QuickVue At-Home OTC COVID-19 Test User Instructions
- Quidel 12.28.21 Omicron Variant Letter
