clarity COVID-19 Antigen Rapid Test Cassette User Guide
- June 6, 2024
- Clarity
Table of Contents
clarity COVID-19 Antigen Rapid Test Cassette
For Use Under the Emergency Use Authorization Only (EUA). For professional in- vitro diagnostics use only. For prescription use only
A rapid test for the qualitative detection of novel coronavirus SARS-CoV-2
antigen in a nasopharyngeal swab.
Please refer to the package insert for detailed assay instructions, cautions,
limitations and warnings.
INTENDED USE
The Clarity COVID-19 Antigen Rapid Test Cassette is a rapid chromatographic immunoassay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal swab (NP) specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset.
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 complexity, high complexity, or waived 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 Clarity COVID-19 Antigen Rapid Test Cassette does not differentiate between SARS-CoV and SARS-CoV-2 viruses.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in nasopharyngeal swab 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 SARS-CoV-2 infection 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 Clarity COVID-19 Antigen Rapid Test Cassette is intended for use by trained clinical laboratory personnel and individuals trained in point of care. The Clarity COVID-19 Antigen Rapid Test Cassette is only for use under the Food and Drug Administration’s Emergency Use Authorization.
BEFORE YOU BEGIN
- If the test kit has been stored in the refrigerator, allow all kit component(s) to equilibrate to room temperature before use.
- Read through the entire User Quick Reference Guide before beginning a test. Refer to the Instruction for Use for more information.
Materials required for testing
SPECIMEN COLLECTION
Notes
- Collect the specimen immediately after opening the swab packaging.
- Do not touch the head of the swab.
- Process the test specimen immediately after collection.
- Tilt patient’s head back 70 degrees.
- Gently and slowly insert the swab with a flexible shaft (wire or plastic) through the nostril parallel to the palate (not upwards) until resistance is encountered or the distance is equivalent to that from the ear to the nostril of the patient, indicating contact with the nasopharynx.
- Gently rub and roll the swab.
- Leave swab in place for several seconds to absorb secretions.
- Slowly remove swab while rotating it. Specimens can be collected from both sides using the same swab, but it is not necessary to collect specimens from both sides if the minitip is saturated with fluid from the first collection.
- If a deviated septum or blockage create difficulty in obtaining the specimen from one nostril, use the same swab to obtain the specimen from the other nostril.
- Place swab, tip first, into a dry tube or directly into the extraction buffer tube.
For more info, please visit: https://www.cdc.gov/coronavirus/2019-ncov/downloads/lab/NP_Specimen_Collection_Infographic_FINAL_508.pdf
TEST PROCEDURE
Notes
- Allow test cassette, specimen, and extraction buffer to reach room temperature prior to testing.
- Remove the test cassette from the sealed pouch and use it within 1 hour. Best results will be obtained if the test is performed immediately after opening the pouch.
RESULT INTERPRETATION
Read result at 10 minutes. Do NOT interpret the result after 20 minutes.
Note: A negative result is presumptive and confirmation with a molecular
assay, if necessary, for patient management may be performed.
Note: Erroneous results can occur if the test results are read before or
after 10-20 minutes.
STORAGE AND STABILITY
The test kit should be stored as packaged at room temperature or refrigerated 2°C – 30°C (36°F – 86°F). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
EXTERNAL QUALITY CONTROL
Positive and Negative Control standards are supplied with this kit; it is
recommended that positive and negative controls be tested as a good laboratory
practice with every new lot, shipment, or a new operator.
To perform a control test, remove the control swabs from the packaging and
follow the instructions under “TEST PROCEDURE” and interpret the result as per
“INTERPRETATION OF RESULTS”. If the correct control results are not obtained,
do not perform patient testing or report patient results. Contact the US
Technical Support at 1-877-485-7877/
[email protected]
or email [email protected]
ASSISTANCE
For any enquiries regarding the Clarity COVID-19 Antigen Rapid Test Cassette,
please contact us at:
Email:
[email protected]
/Tel: 1-877-485-7877 (US)
OR
Email: [email protected]
In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA under a 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., inpatient 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; and in the USA, the emergency use of this product 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 declaration is terminated or the authorization is revoked sooner.
Marketed by:
Clarity Diagnostics LLC.
1060 Holland Drive, Suite A & D
Boca Raton FL 33487 USA
[email protected]
Tech Support: 1-877-485-7877
www.claritydiagnostics.com
US Technical Support Contact:
TECH SUPPORT: 1 -877- 485-7877
WWW.CLARITYDIAGNOSTICS.COM
[email protected]
Manufactured by: Salofa Oy Örninkatu 15, 24100 Salo, Finland,
www.salofa.com,
i[email protected]
US Technical Support: 1-877-485-7877,
[email protected]