Test Kit Rapid QuickVue® At-Home OTC COVID-19 Te .. . .

188-1-2042
      
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Test Kit Rapid QuickVue® At-Home OTC COVID-19 Test Nasal (NS) Swab Sample 2 Tests (2/KT)
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Rally #188-1-2042
Quidel #20402
Respiratory Test Kit QuickVue® At-Home OTC COVID-19 Test 2 Tests CLIA Waived
TEST KIT, COVID-19 QUICKVUE AT-HOME OTC (2/KT)

Features
  • Trusted manufacturer
  • Leading industry veteran
  • Convenient and easy use
  • Quick results
  • Serial testing
  • Sensitivity: 83.5%
  • Specificity: 99.2%

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 -
The test is for use under an Emergency Use Authorization (EUA) Only. For more information on EUA visit 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 -
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.

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.

Individuals should provide all results obtained with this product to their healthcare provider for public health reporting.


Product Specifications
Manufacturer #20402
BrandQuickVue®
ManufacturerQuidel
Country of OriginUnited States
ApplicationRespiratory Test Kit
CLIA ClassifiedCLIA Waived
Contents 1Individually 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 TypeNasal Swab Sample
SpecialtyImmunoassay
Test FormatTest Strip Format
Test Kit TypeRapid
Test MethodLateral Flow Immunoassay
Test NameAt-Home OTC COVID-19 Test
Time to Results10 Minute Results
UNSPSC Code41116205


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.



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