COVISELF COVID-19 RAPID ANTIGEN TEST

Short Description

COVISELF COVID-19 RAPID ANTIGEN TEST is an in-vitro diagnostic test designed to qualitatively detect SARS-CoV-2 antigen from a nasal swab sample. It is a rapid self-test that can provide a result within approximately 15–20 minutes when used according to the manufacturer's instructions.

What Is COVISELF COVID-19 RAPID ANTIGEN TEST?

COVISELF is a rapid antigen self-test that uses a nasal swab sample to detect proteins associated with SARS-CoV-2. It is an immunochromatographic test designed for home use.

The test is intended to provide a rapid indication of whether SARS-CoV-2 antigen is detected in the collected sample. Test results should always be interpreted according to the manufacturer's instructions and the clinical situation.

Uses

COVISELF COVID-19 RAPID ANTIGEN TEST may be used to:

• Detect SARS-CoV-2 antigen in a nasal swab sample.

• Perform a rapid COVID-19 self-test at home.

• Support COVID-19 testing in people with symptoms or other reasons to suspect infection, according to applicable local guidance.

  
  

The appropriate use of the test and interpretation of the result should follow the manufacturer's instructions and, where appropriate, guidance from a healthcare professional.

How Does COVISELF COVID-19 RAPID ANTIGEN TEST Work?

The test uses antibodies designed to detect SARS-CoV-2 antigen in a nasal sample. The collected sample is mixed with the supplied extraction buffer and applied to the test device. If the target antigen is detected, the corresponding test line appears on the device.

Results generally develop within about 10–15 minutes and should be read within the time specified in the product instructions. Results read outside the specified time may not be valid.

How to Take COVISELF COVID-19 RAPID ANTIGEN TEST

Use COVISELF COVID-19 RAPID ANTIGEN TEST exactly according to the manufacturer's instructions.

• Wash and dry your hands before beginning the test.

• Prepare the test components and extraction tube as instructed.

• Collect the nasal sample using the sterile swab supplied with the kit.

• Insert the swab carefully into the nostril as directed and collect the sample from both nostrils.

• Place the swab into the supplied extraction buffer and prepare the sample according to the instructions.

• Apply the specified amount of extracted sample to the test device.

• Wait for the specified time before interpreting the result.

• Do not reuse the test device, swab, or other single-use components.

• Follow the manufacturer's instructions for disposal of used materials. 

• If the test result is negative but symptoms or other concerns remain, further testing or medical advice may be appropriate because a negative rapid antigen result does not always exclude infection.

  
  

Important Safety Information

Tell your doctor or pharmacist about relevant medical circumstances and any medicines, supplements, or herbal products you use if you are seeking advice about interpreting a COVID-19 test result or managing symptoms.

Important precautions include:

• Read the manufacturer's instructions completely before using the test.

• Follow the specified sample-collection and result-reading times carefully.

• Do not use expired test devices or reagents.

• Do not freeze the test components.

• Keep the kit away from children.

• A negative rapid antigen result may occur despite infection, particularly when viral levels are low. Symptomatic individuals with a negative rapid antigen result may require additional testing according to local guidance. 

• If the control line does not appear, the test result should be considered invalid and the test should be repeated using a new kit. 

• If you are unsure how to interpret a result or whether additional testing is needed, speak with a doctor or pharmacist.

  
  

Pregnancy & Breastfeeding

COVISELF COVID-19 RAPID ANTIGEN TEST is a diagnostic test rather than a medicine, so pregnancy or breastfeeding does not generally determine whether the test itself can be used. However, pregnant or breastfeeding individuals who have symptoms, receive a positive result, or are concerned about COVID-19 should seek appropriate medical advice.

Recommendations for testing and follow-up may vary between countries and according to individual circumstances.

Side Effects

Like all diagnostic tests, COVISELF COVID-19 RAPID ANTIGEN TEST can cause some discomfort during sample collection, although not everyone experiences it.

• Temporary nasal discomfort or irritation

• Tickling or mild discomfort while collecting the nasal sample

  
  

The manufacturer advises stopping the procedure and seeking advice from a healthcare professional if the nasal swab causes significant pain. Incorrect sample collection or interpretation can also result in an incorrect test result.

This is not a complete list of possible problems or warnings. Please refer to the product packaging and instructions for use supplied with your test for complete information and speak with your doctor or pharmacist if you have concerns.

Storage

Store COVISELF COVID-19 RAPID ANTIGEN TEST according to the instructions shown on the original product packaging.

• Store the test kit at room temperature and away from direct sunlight.

• Do not freeze the test components.

• Keep the kit out of reach of children.

• Allow test reagents to reach room temperature before use when required by the manufacturer's instructions.

• Do not use the test device or reagents after the expiry date.