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QuickVue COVID-19 Antigen 10-min Rapid Test, Self-Administered, box/25

QuickVue COVID-19 Antigen 10-min Rapid Test, Self-Administered, box/25

$299.00
Part Number:
NDC-QUI-20387
Lead Time:
Call for availability
Shipping:
Free Shipping on most orders over $50*
Quantity:
25

Description

NOTE: QuickVue SARS Antigen Dipstick, 25 tests/kit (Short-Dated, Minimum Expiry Lead is 4 months) 

HIGH DEMAND ITEM. Call for current stock.

The QuickVue SARS Antigen Test detects SARS-CoV-2 antigens directly from anterior nares swab specimens. The QuickVue SARS Antigen Test provides accurate and reliable results in 10 minutes, allowing for testing of patients suspected of COVID-19/2019-nCoV in near-patient testing environments. Authorized for sale under the FDA Emergency Use Authorization EUA. The QuickVue SARS Antigen Test has not been FDA cleared or approved, but has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless authorization is terminated or revoked sooner.

Features & Benefits

Dipstick test format

Simple workflow follows a similar format to CLIA-waived QuickVue assays. No instrument necessary.

Results in 10 minutes

Test and treat in the same office visit.

Two-color result

Easy to read and interpret. Blue control line and red test line.

All components included in kit

Ready to use, no need for additional equipment.

Room temperature storage

No refrigerator space needed. No need to wait for reagents to warm up. Rapid SARS-CoV-2 tests can be run immediately as needed.

 

Product Specifications

Sample type

Anterior nares swab

Time to results

10 minutes

Kit storage conditions

Room temperature (15°C to 30°C/59°F to 86°F)

Internal controls

Included

External controls

Positive and negative included

PPA (Reference Extracted SARS-CoV-2 RT-PCR Assay)

96.6%

NPA (Reference Extracted SARS-CoV-2 RT-PCR Assay)

99.3%

Shelf life

24 months from date of manufacture

CLIA complexity

Waived*

*Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This test 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.

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Product Reviews

MPN:
20387