QUIDEL QDL-20387 QuickVue SARS Antigen Test Instructions
- June 5, 2024
- QUIDEL
Table of Contents
QUIDEL QDL-20387 QuickVue SARS Antigen Test
For use under the Emergency Use Authorization (EUA) only
For in vitro diagnostic use
Rx Only
Refer to the Package Insert for complete instructions. Read the complete test procedure, including recommended Quality Control procedures, before performing the test.
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.
Expiration date: Check expiration on each individual test package or outer box
before using. Do not use any test past the expiration date on the label.
Test Procedure
-
Dispense all of the Reagent Solution into the Reagent Tube. Swirl the Reagent Tube to dissolve its contents.
NOTE: The Reagent Tube should remain in the tube holder for the entirety of the testing -
Place the patient swab sample into the Reagent Tube. Roll the swab at least 3 times while pressing the head against the bottom and side of the Reagent Tube.
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Express all liquid from the swab head by rolling the swab a minimum of three (3) times as the swab is being removed. Discard the swab in accordance with your biohazard waste disposal protocol.
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Place the Test Strip into the Reagent Tube with the arrows pointing down. Do not handle or move the Test Strip until the test is complete and ready for reading.
Quality Control
Built-in Control Features
The QuickVue SARS Antigen test contains built-in procedural control features.
The manufacturer’s recommendation for daily control is to document these
built-in procedural controls for the first sample tested each day.
The two-color result format provides a simple interpretation for positive and
negative results. The appearance of a blue procedural Control Line provides
positive control by demonstrating sufficient flow has occurred and the
functional integrity of the Test Strip was maintained. If a blue procedural
Control Line does not develop within 10 minutes on the Test Strip, then the
test result is invalid.
A built-in negative control is provided by the clearing of red background
color, verifying that the test has been performed correctly. Within 10
minutes, the result area should be white to light pink and allow the clear
interpretation of the test result. If background color remains and interferes
with interpretation of the test result, then the test result is invalid.
Should this occur, review the procedure and repeat the test with a new patient
sample and a new Test Strip. Patient samples or reagents cannot be reused.
External Quality Control
External Controls may also be used to demonstrate that the reagents and assay
procedure perform properly.
Quidel recommends that positive and negative controls be run once for each
untrained operator, once for each new shipment of kits — provided that each
different lot received in the shipment is tested — and as deemed additionally
necessary by your internal quality control procedures, and in accordance with
local, state and federal regulations or accreditation requirements.
The Test Procedure described in the Package Insert should be used when testing
the external controls.
If the controls do not perform as expected, repeat the test or contact Quidel
Technical Support before testing patient specimens.
Interpretation of Results
*Positive Result:**
At ten (10) minutes, the appearance of ANY shade of a pink-to-red Test Line
AND the appearance of a blue procedural Control Line indicates a positive
result for the presence of SARS antigen. Results will remain stable for five
(5) minutes after the recommended read time. Do not read the result beyond the
five minutes. False positive, false negative or invalid results may occur if
the strip is read outside of the recommended time period.
A positive result does not rule out co-infections with other pathogens.
Look closely! This is a positive result. Even if you see a very faint,
pink Test Line and a blue Control Line, you must report the result as
POSITIVE.
C = Control Line
T = Test Line
Negative Result:**
At ten (10) minutes, the appearance of ONLY the blue procedural Control Line
indicates SARS antigen was not detected. Results will remain stable for five
(5) minutes after the recommended read time. False positive, false negative or
invalid results may occur if the strip is read outside of the recommended time
period.
A negative result does not exclude SARS-CoV-2 infection. Negative results should be treated as presumptive may need to be confirmed with a molecular assay.
Invalid Result:
If at ten (10) minutes, the blue procedural Control Line does not appear, even
if any shade of a pink-to-red Test Line appears, the result is invalid.
If at ten (10) minutes, the background color does not clear and it interferes
with the reading of the test, the result is also invalid.
If the result is invalid, a new test should be performed with a new patient
sample and a new Test Strip.
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 COVID19 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.
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 upper respiratory 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.
Refer to the Package Insert for Warnings and Precautions, Specimen Collection and Handling, and Quality Control.
EMERGENCY USE AUTHORIZATION – WARNING AND PRECAUTIONS
In the USA, this product has not been FDA cleared or approved; but has been
authorized by FDA under an EUA for use by authorized laboratories; use by
laboratories certified under the CLIA, 42 U.S.C. §263a, that meet requirements
to perform moderate, high or waived complexity tests. This product 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. This product has been authorized only for the
detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
In the USA, – 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 the virus that causes
COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act,
21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or
authorization is revoked sooner.
ASSISTANCE
If you have any questions regarding the use of this product, please call
Quidel’s Technical Support Number 800.874.1517 (in the U.S.) or 858.552.1100,
Monday through Friday, from 7:00 a.m. to 5:00 p.m., Pacific Time. If outside
the U.S., contact your local distributor or
[email protected]. Test system
problems may also be reported to the FDA through the MedWatch medical products
reporting program (phone: 800.FDA.1088; fax: 800.FDA.0178;
http://www.fda.gov/medwatch).
Study the Package Insert thoroughly before using Quick Reference Instructions. This is not a complete Package Insert.
Quidel Corporation
San Diego, CA 92121 USA quidel.com
References
- English | QuidelOrtho
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program | FDA