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Lucira COVID-19 All-In-One Test Kit

Lucira COVID-19 All-In-One Test Kit

Condition: New product

The Lucira COVID-19 All-In-One Test Kit is a single use test kit.

This product is no longer in stock

$70.00

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The Lucira COVID-19 All-In-One Test Kit is a single use test kit intended to detect active infection with the novel coronavirus SARS-CoV-2 that causes COVID-19. This test is for prescription home use with self-collected nasal swab samples in individuals aged 14 and older who are suspected of COVID-19, and for use in point of care settings for all ages, limited to healthcare provider collection in individuals aged 13 and under.

This test may be prescribed for patient use at home with self-collected nasal swab samples in individuals aged 14 and older who are suspected of COVID-19. For individuals aged 13 and under, this test is limited to point of care use with healthcare provider collection.

• The LUCIRA COVID-19 All-In-One Test Kit contains everything needed to perform one (1) COVID-19 test. The test kit includes: Instructions, 1 test unit, 1 sample vial, 1 sterile nasal swab, 2 AA batteries and 1 disposal bag.

• When prescribing the LUCIRA COVID-19 All-In-One Test Kit for at home use, please make sure to advise patients to first read the Instructions for Use included in the test kit before performing the LUCIRA COVID-19 test. Following the instructions is important for the test to work properly.

• The LUCIRA COVID-19 All-In-One Test Kit is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

• In point of care settings, specimens may be selfcollected collected in individuals aged 14 and older. In individuals aged 13 and under, specimens should be collected by healthcare providers and should be collected with appropriate infection control precautions. Current guidance is available at the CDC’s website (see links provided in “Where can I go for updates and more information?” section).

When collecting and handling specimens from individuals suspected of being infected with COVID-19, appropriate personal protective equipment should be used as outlined in the CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). For additional information, refer to CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19) (see links provided in “Where can I go for updates and more information?” section).

The Lucira COVID-19 All-In-One Test Kit is the first FDA EUA authorized prescription at-home test for individuals 14 years and older.

1. Swab Your Nose
2. Stir Into Sample Vial
3. Get Results In 30 Minutes
4. Seek Treatment
What are the approved available alternatives? There are no approved available alternative tests. FDA has issued EUAs for other tests that can be found at:
https://www.fda.gov/emergency-preparedness-andresponse/mcm-legal-regulatory-and-policyframework/emergency-use-authorization
Where can I go for updates and more information?
CDC webpages:
General: https://www.cdc.gov/COVID19
Symptoms: https://www.cdc.gov/coronavirus/2019-ncov/symptomstesting/symptoms.html
Healthcare Professionals: https://www.cdc.gov/coronavirus/2019-nCoV/guidance-hcp.html
Information for Laboratories: https://www.cdc.gov/coronavirus/2019-nCoV/guidancelaboratories.html
Laboratory Biosafety: https://www.cdc.gov/coronavirus/2019- nCoV/lab-biosafety-guidelines.html
Isolation Precautions in Healthcare Settings: https://www.cdc.gov/coronavirus/2019-ncov/infectioncontrol/control-recommendations.html
Specimen Collection: https://www.cdc.gov/coronavirus/2019- nCoV/guidelines-clinical-specimens.html
Infection Control: https://www.cdc.gov/coronavirus/2019- ncov/infection-control/index.html
FDA webpages:
General: www.fda.gov/novelcoronavirus
EUAs:(includes links to patient fact sheet and manufacturer’s instructions) https://www.fda.gov/medical-devices/coronavirusdisease-2019-covid-19-emergency

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