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Descripción
Descripción
- Non-Invasive - anterior nasal swab specimens; no need to swab deep in the nasal cavity for sample collection
- Easy to use - simple 4-step process from sample collection to results
- This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or with adult-collected anterior nasal (nares) samples from individuals aged 2 years or older
- This test is authorized for individuals with symptoms of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests
- Individuals should provide all results obtained with this product to their healthcare provider for public health reporting and to receive appropriate medical care
- Positive results indicate the presence of viral antigens, 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
- All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed
- Negative results 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 measures such as isolating from others and wearing masks; negative result 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
- The Advin COVID-19 Antigen Test @ Home is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2
- The Advin COVID-19 Antigen Test @Home is For FDA Emergency Use Authorization (EUA) only: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
- Positive Percent Agreement (PPA) - 82.5%
- Negative Percent Agreement (NPA) - 100%
Especificaciones
Especificaciones
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Product Document(s)
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ApplicationRespiratory Test Kit
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Contents 1Each Kit Contains: (2) Test Cassettes, (2) Extraction Buffer Tubes, (2) Disposal Bags, (2) Disposable Nasal Swabs, Quick Ref Guide
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Is_ECATN
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Is_GSAY
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Is_VAN
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Number of Tests2 Tests per Kit
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Purchase Program TypeStandard Purchase
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Reading TypeVisual Read
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Sample TypeAnterior Nasal Swab Sample
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SpecialtyImmunoassay
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Test FormatTest Device Format
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Test Kit TypeRapid
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Test MethodLateral Flow
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Test NameCOVID-19 Antigen Test
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Test TypeHome Test Device
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Time to Results10 Minute Results
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ApplicationRespiratory Test Kit
-
Contents 1Each Kit Contains: (2) Test Cassettes, (2) Extraction Buffer Tubes, (2) Disposal Bags, (2) Disposable Nasal Swabs, Quick Ref Guide
-
Is_ECATN
-
Is_GSAY
-
Is_VAN
-
Number of Tests2 Tests per Kit
-
Purchase Program TypeStandard Purchase
-
Reading TypeVisual Read
-
Sample TypeAnterior Nasal Swab Sample
-
SpecialtyImmunoassay
-
Test FormatTest Device Format
-
Test Kit TypeRapid
-
Test MethodLateral Flow
-
Test NameCOVID-19 Antigen Test
-
Test TypeHome Test Device
-
Time to Results10 Minute Results
Advin COVID-19 Ag @Home Sales Sheet
Advin COVID-19 Ag @Home Healthcare Provider IFU
Advin COVID-19 Ag @Home IFU
Advin COVID-19 Ag @Home Healthcare Providers Fact Sheet
Advin COVID-19 Ag @Home FDA EUA Letter
Advin COVID-19 Ag @Home Sales Sheet
Advin COVID-19 Ag @Home Healthcare Provider IFU
Advin COVID-19 Ag @Home IFU
Advin COVID-19 Ag @Home Healthcare Providers Fact Sheet
Advin COVID-19 Ag @Home FDA EUA Letter
Return policy
Return policy
Not loving it? We offer returns for most items within 30 days of delivery for a refund or store credit.
Advin COVID-19 Antigen Home Test Kit
