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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 Lucira COVID-19 All-In-One 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.
Are you interested in going to Japan for the Tokyo games? If so, Meenta is proud to support you on your road to Tokyo as an official virtual testing site for COVID-19. To get the COVID-19 test results report for travel to Japan, you’ll have to purchase a *different product* (linked here, not the current one) (instructional video here).
The Lucira COVID-19 All-In-One Test Kit is for use under the Food and Drug Administration’s Emergency Use Authorization only.
Variant Detection Information (last updated July 1st, 2021)
The Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) have highlighted the emergence of four notable SARS-CoV-2 Variants of Concern (1,2):
- Alpha (also known as B.1.1.7) first detected in UK,
- Beta (also known as B.1.351) first detected in South Africa,
- Delta (also known as B.1.617.2) first detected in India,
- Gamma (also known as P.1) first detected in Japan/Brazil, Additionally, a Variant of Interest has been identified to be rising in prevalence:
- Lambda (also known as C.37) first detected in Peru
Lucira Health performs routine surveillance of emerging SARS-CoV-2 strains by periodically evaluating in silico reactivity against sequence databases. These evaluations have shown that these variants are reactive to the Lucira COVID-19 Check-It and All-In-One Test Kits. The Lucira Health assay targets two non-overlapping regions of the N gene. Hence the detection region is unaffected by the mutations in the spike protein of SARS-CoV-2 in the variant strains. As these particular viral strains become commercially available, Lucira Health intends to perform testing to confirm detection of these strains. Lucira Health will continue to monitor the situation with emerging variants of SARS-CoV-2. If you have any questions on the above, please reach out to Technical Support at firstname.lastname@example.org.
2) https://www.who.int/publications/m/item/weekly-epidemiological-update-on-covid-19—29-june- 2021
For Use with Provider-collected Nasal Swab Specimens in individuals aged 13 and under. Instructions for sample collection can be found in this video and in this document. The CDC also had some very useful instructions for nasal swab collections here. Feel free to contact us any time with questions at email@example.com, and we’d be happy to help you out!
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Note: These products and services are not returnable.