QuickVue SARS Antigen FIA Dipstick thumbnail 1
Quidel QuickVue SARS Antigen FIA Dipstick $195.00/Kit of 25 CLIAwaived, Inc QDL-20387

* Image shown for reference purposes only. Actual product appearance may vary. Please read product description for full and accurate details.

- QuickVue SARS Antigen FIA Dipstick (QDL-20387)

By Quidel

$195.00 / Kit of 25

MSRP $273.00 You Save $78.00

Sold & Shipped by CLIAwaived, Inc
In Stock
See Product Warning Below
Typically Ships Within 2 day(s)
Price Match Guarantee
Calculate shipping
See Product Restrictions Below
Share this:

What you get:

  • Condition: New
  • Brand: Quidel
  • Product ID / Part Number: QDL-20387
  • Packages/Order: 1
  • Package Type: Test
  • Total Units: 25
  • Order Size: Kit
  • Unit Price: $7.8
Have a question ?

- Requires a CLIA Certificate Number
(25 Tests per Kit)
For use under the Emergency Use Authorization (EUA) only For in vitro diagnostic use

Specimen Collection
Anterior Nares Swab Sample: Use the swabs supplied in the kit.

QuickVue SARS Antigen FIA Dipstick, Nasal Swab.

The QuickVue SARS Antigen Test is a lateral flow immunoassay that allows for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nares (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.

The QuickVue SARS Antigen test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings. The QuickVue SARS Antigen test is only for use under the Food and Drug Administration's Emergency Use Authorization.

- For use under the Emergency Use Authorization (EUA) only
- For in vitro diagnostic use
- Rx Only

REAGENTS AND MATERIALS SUPPLIED
25-Test Kit:
- Individually Packaged Test Strips (25): Monoclonal anti-SARS antibodies
- Reagent Tubes (25): Lyophilized buffer with detergents and reducing agents
- Reagent Solution (25): Vials with 340 L salt solution
- Sterile Nasal Swabs (Kit #20387) (25)
- SARS Positive Control Swab (1): Swab is coated with non-infectious recombinant SARS antigens
- Negative Control Swab (1): Swab is coated with heat-inactivated, non-infectious Streptococcus C antigen
- Package Insert (1)
- Procedure Card (1)

MATERIALS NOT SUPPLIED
- Timer or watch
- QuickVue SARS Antigen Control Swab Set for additional QC (20389)
- Dry transport tube (SKU # 20385) (25). Store at room temperature.

All clinical specimens must be at room temperature before beginning the assay.
Performing the assay outside the time and temperature ranges provided may produce invalid results.
Assays not performed within the established time and temperature ranges must be repeated.

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.

The QuickVue SARS Antigen test does not differentiate between SARS-CoV and SARS-CoV-2.

Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nares specimens during the acute phase of infection.

INTENDED USE
The QuickVue SARS Antigen Test is a lateral flow immunoassay that allows for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nares (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms. 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.

The QuickVue SARS Antigen test does not differentiate between SARS-CoV and SARS-CoV-2.

Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nares specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.

Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.

Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed. Negative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient's recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.

The QuickVue SARS Antigen test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings. The QuickVue SARS Antigen test is only for use under the Food and Drug administration's Emergency Use Authorization.

SUMMARY AND EXPLANATION
SARS-CoV-2, also known as the COVID-19 virus, was first identified in Wuhan, Hubei Province, China in December 2019. This virus, as with the novel coronavirus SARS-1 and MERS, is thought to have originated in bats, however the SARS-CoV-2 may have had an intermediary host such as pangolins, pigs or civets.1 The WHO declared that COVID-19 was a pandemic on March 11, 2020, and human infection has spread globally, with hundreds of thousands of confirmed infections and deaths.2 The median incubation time is estimated to be 5.1 days with symptoms expected to be present within 12 days of infection.3 The symptoms of COVID-19 are similar to other viral respiratory diseases and include fever, cough and shortness of breath.4

PRINCIPLE OF THE PROCEDURE
The QuickVue SARS Antigen test employs lateral flow immunoassay technology. Using this test allows for the rapid detection of nucleocapsid protein from SARS-CoV and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2 but does not differentiate between the two viruses. To begin the test, a lyophilized reagent must be rehydrated in the Reagent Tube. This reagent facilitates exposure of the appropriate viral antigens to the antibodies used in the test. The Reagent is first rehydrated with the provided Reagent Solution, and the swab specimen is then inserted into the Reagent Tube. This Reagent interacts with the specimen and facilitates exposure of the appropriate viral antigens to the antibodies used in the test. The Test Strip is added to the Reagent Tube now containing the specimen and Reagent Solution. If the extracted specimen contains SARS-CoV or SARS-CoV-2 antigens, a pink-to-red Test Line, along with a blue procedural Control Line will appear on the Test Strip indicating a positive result. If SARS-CoV or SARS-CoV-2 is not present, or is present at very low levels, only a blue procedural Control Line will appear.

Covid Attributes:
Type: Antigen / Rapid
Use: Lab / Clinical
Certification: CLIA Certificate Required for purchase
Sample SpecimenType: Nasal Swab

SKU: QDL-20387

This product has the following special restrictions:

- Requires CLIA Certification
- Product is not returnable
- Product is not cancellable

$10.95 for first item, $2.50 for each additional item. Free shipping on 10 or more CliaWaived Inc products, GND (1-5 BUS DAYS) in continental USA. Exclusions may apply. Quote upon request: 2ND DAY, OVN, PRIO OVN (BEFORE NOON).

20% restocking fee, 10% administration fee. Shipping is paid for by the customer. Original packaging. No returns after 10 days. No Cancellations; No Returns on PPE or PPE-related products; All Sales Final. Not all products are eligible for returns. Exclusions may apply. Please refer to the "Restrictions" tab on the products listing page, i.e. where stated "Non-Returnable Item". All returns must be approved by our Returns Department. An e-mail notification will be issued regarding your return status and return instructions, should this apply. Any product returned for credit without an authorized RMA number clearly printed on the outside package or shipping label will be refused. Unauthorized returns will not be honored or accepted for credit.

Item is NOT for Resale and I must provide a valid CLIA License number in order to purchase the item.

CLIAwaived, Inc

CLIAwaived, Inc:
CLIAWaived Inc is wholesale medical distribution company based in San Diego, California; we specialize in marketing and distributing rapid point-of-care diagnostics.

CLIAWaived Inc has been distributing products throughout the world since 2003.

There are no reviews for this product yet.

Log in to write a review