Respiratory Test Kit Advin COVID-19 Antigen Test 24 Tests

Product Information

Specifications for Respiratory Test Kit Advin COVID-19 Antigen Test 24 Tests

Manufacturer	Chembio Diagnostic
Part Number	66-9990-4
Application	Respiratory Test Kit
Brand	Advin
Contents 1	Each Test Kit Contains: Test Cassette, Extraction Buffer Tube, Disposal Bag, Disposable Nasal Swab, Quick Ref Guide
Contract Type	Customer
Number of Tests	24 Tests
Purchase Program Type	Standard Purchase
Reading Type	Visual Read
Sample Type	Anterior Nasal Swab Sample
Specialty	Immunoassay
Test Format	Test Device Format
Test Kit Type	Rapid
Test Method	Lateral Flow
Test Name	COVID-19 Antigen Test
Test Type	Home Test Device
Time to Results	10 Minute Results
UNSPSC Code	41116144

Product Properties:

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
All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed
Negative Percent Agreement (NPA) - 100%
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 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
Easy to use - simple 4-step process from sample collection to results
Non-Invasive - anterior nasal swab specimens; no need to swab deep in the nasal cavity for sample collection
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
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
Positive Percent Agreement (PPA) - 82.5%
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

Respiratory Test Kit Advin COVID-19 Antigen Test 24 Tests

Respiratory Test Kit Advin COVID-19 Antigen Test 24 Tests

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Brand

Contents 1

Contract Type

Country of Origin

Number of Tests

Product Dating

Purchase Program Type

Reading Type

Sample Type

Specialty

Test Format

Test Kit Type

Test Method

Test Name

Test Type

Time to Results

UNSPSC Code

Specifications for Respiratory Test Kit Advin COVID-19 Antigen Test 24 Tests

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