15th March 2021 Product update: rapidvirology staff writer
FDA-EUA COVID-19 Rapid Antigen Test Now Available on Amazon Business
Intrivo has announced that it will offer its 10-minute COVID-19 rapid antigen test on Amazon Business in the U.S. The lateral-flow CareStart™ Antigen test is only available to registered businesses and professionals operating under a CLIA Certificate of Waiver issued by the U.S. Department of Health and Human Services (HHS).
As the exclusive commercialization partner for CareStart COVID-19 tests in the U.S., Intrivo will handle all orders and fulfillment of its CareStart Antigen kit for approved buyers.
Intrivo will be better able to provide healthcare practitioners with faster, streamlined access to accurate, quality COVID-19 rapid antigen tests at higher volumes by utilizing Amazon Business, which serves millions of customers worldwide and 84 of the top 100 health systems in the U.S.
Intrivo's work with Amazon Business is the latest in the testing provider's efforts to expand distribution to more customers in need.
In December 2020, Intrivo inked distribution deals with McKesson Medical-Surgical, Concordance Healthcare Solutions, and NDC, Inc. creating a robust network of channel partners to expand the CareStart supply chain for healthcare providers and patients across the country.
The CareStart Antigen kits -- which are manufactured in the U.S. by Access Bio -- can be administered in any point-of-care setting by a health care provider with a CLIA waiver.
A recent amendment to the CareStart Antigen test's Emergency Use Authorization (EUA) allows for the use of lower nasal swabs to collect viral protein samples without sacrificing the sensitivity and specificity associated with a nasopharyngeal (NP) collection method.
The result is a faster, less invasive testing process that also eases patient fears of discomfort and allows practitioners to turn around results on-site in 10 minutes without needing additional equipment or special instruments for analyses.
The test is a lateral-flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in nasal swab and nasopharyngeal specimens collected from individuals suspected of being infected with COVID-19 or exposed to COVID-19.
Clinical validations are showing results of 87.2% sensitivity and 100% specificity for anterior nares specimen collection. Each CareStart COVID-19 antigen test kit includes test devices, assay buffer, extraction vials and caps, specimen collection swabs, positive and negative control swabs, and instructions. Each kit can administer up to 20 antigen tests.
For more information about Intrivo and CareStart COVID-19 Antigen test, please click here or use the 'Request Information' button provided below.
Date Published: 15th March 2021
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Note: This content has been edited by a rapidvirology.com staff writer for style and content.
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