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Lucira COVID-19 All-In-One Test Kit
$65.00 per Test Kit
The Point of Care Lucira COVID-19 All-In-One Test provides PCR quality molecular accuracy in 30 minutes or less. This test is authorized for use in specific patient care settings, and includes Meenta medical oversight services, including a full results report.
The Lucira COVID-19 All-In-One Test Kit is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. This test is authorized for prescription home use with self-collected nasal swab samples in individuals aged 14 and older who are suspected of COVID-19 by their healthcare provider. This test is authorized for use at the Point of Care (POC), in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation, for individuals aged 14 and older, and in individuals aged 13 and under when the specimen is collected by a healthcare provider at the POC. This test utilizes a molecular amplification technology for the detection of SARS-CoV-2 RNA in individuals with known or suspected COVID-19. This product does not include the LUCI Pass software.
- FDA/EUA: First and only FDA EUA authorized single-use molecular POC test.
- Accuracy: In clinical evaluation, the Positive Percent Agreement (PPA) was 94.1% and the Negative Percent Agreement (NPA) was 98.0%.
- Fast Results: Results in as fast as 11 minutes for a positive result and 30 minutes for a negative result.
- Medical Oversight: This test includes use of the Meenta Testing platform to handle test logistics, including results reporting.
The Lucira COVID-19 All-In-One Test Kit is for use under the Food and Drug Administration’s Emergency Use Authorization only.
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