HEALGEN RAPID ANTIGEN SELF TEST - SINGLE

The Rapid COVID-19 Antigen Test is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasal swab from individuals who are suspected of COVID-19.
 It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections.

SINGLE USE ONLY

To obtain accurate results, do not use visually bloody or overly thick/sticky samples

Qualitative, visually read results in 15 minutes

No instrument required

Room temperature storage or refrigerated (2-30°C / 36-86°F)

Sterile Swabs, Extraction Buffer and Extraction Tubes included.

SPECIFICATIONS

Clinical Evaluation

• Positive Percent Agreement (PPA): 95.7%
• Negative Percent Agreement (NPA): 99.6%
• Overall Percent Agreement (OPA): 98.9%
• Specimen: Nasal
• Swab Time to Results: 15 minutes
• Shelf Life: 24 months from the date of manufacture

FAQ

What is antigen testing? ?

Antigen tests detect proteins specific to a virus that appears in infected individuals, which indicates active infection. Rapid antigen testing is beneficial because of their portability, ease-of-use, and swift time to result. 

What is the extraction buffer?

The extraction buffer includes components to dissociate viral proteins from their surfaces to be used as a target for the test. The method of the extraction buffer is used to prepare the test sample by dissolving the virus shell, which also deactivates the virus.

Does the test kit include transport media? 

The test kit includes an extraction buffer that is used to prepare the specimen for testing purposes. The extraction buffer IS NOT transport media and should not be used to preserve or transport specimens.

Can the test be used with alternative specimen types such as nasal swabs or any specimen contained in viral transport media?  

The Rapid COVID-19 Antigen Test is for direct nasal swab specimen only. The test can only be used with the swab provided in the kit.

Can I collect the specimen and test at a later time? ?

The specimen should be tested immediately after collection. The specimen can be retained up to 1 hour following collection if immediate testing of specimens is not possible. Dispose of the specimen and recollect if retained for more than 1 hour.

 Can I freeze the device for long-term storage?

The device should never be frozen. If refrigerated, allow the test kit components to reach room temperature before use.