- Condition: Factory New
- Weight: 2.5 lb
- QuickVue At-Home OTC COVID-19 test kit is intended for the qualitative detection of the nucleocapsid proteins from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over 2 – 3 days with at least 24 hours and no more than 36 ho
- Works for symptomatic and asymptomatic individuals
- Kit contains pre-filled vials – no counting of drops or errors in dispensing too much or too little of the liquid reagent solution.
- Positive results indicate the presence of viral foreign agent, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status.
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Learn more:
- MFR: Quidel Ships from MFI Medical
- MPN: 20451
Frequently asked questions
How quickly does this test provide results?
The QuickVue COVID-19 Test is designed for efficiency, delivering clear, visual results in just 10 minutes.
Is this test reliable and FDA-cleared?
Yes, this product features 510(k) clearance from the U.S. Food and Drug Administration, ensuring it meets rigorous diagnostic standards for non-prescription, at-home use.
Can this test be used on young children?
The test offers broad age suitability:
- Self-testing: Individuals aged 14 and older.
- Assisted testing: Adults can perform the test on children as young as 2 years old.
What is the recommended timeframe for testing?
For optimal accuracy, this test is specifically indicated for use within the first 5 days of symptom onset.
Does the kit contain everything needed for testing?
Yes, each kit is a complete diagnostic solution and includes:
- 2 COVID-19 Test Strips
- 2 Pre-Filled Reagent Tubes
- 2 Strip Replacement Cards
- 2 Swabs
- Comprehensive User Instructions
Is the testing process invasive?
The test utilizes a simple anterior nasal (nares) swab method, which is designed to be straightforward and non-invasive compared to deep nasopharyngeal procedures.
Are negative results definitive?
While the test is highly effective, it is important to note that all negative results are considered presumptive. It is always recommended to consult with a healthcare provider if symptoms persist.
Can I use this to rule out other infections?
No. Please be aware that positive results do not rule out co-infection with other respiratory pathogens, as this test is specific to the SARS-CoV-2 nucleocapsid protein antigen.
Is this test compliant with federal standards?
Yes, this product is both CLIA Waived and BAA/TAA compliant, reflecting its high quality and suitability for various professional and home health environments.
Where is this test manufactured?
This product is manufactured in the United States, adhering to strict quality control standards for medical diagnostic equipment.