Hotgen - covid 19 antigen test with nasal swab

Product Description

Rapid antigen test for self-diagnosis of Covid-19 via nasal swab.

Indications

Hotgen is the self-test for the recognition of the Sars-Cov-2 antigen which is performed using a swab in the anterior nasal region.
The test can be used be used for the rapid detection of the Sars-CoV-2 antigen from subjects with suspected Covid-19 infection within the first 7 days of the onset of symptoms.
The result is available after approximately 15 minutes: all currently known mutations/variants of the virus are detected.

Hotgen rapid nasal swab

• A safe self-diagnosis without the hassle of a nasopharyngeal swab
• They allow the identification of Sars-CoV-2 antigens with a simple nasal swab.

Rapid nasal swabs are antigen swabs used for the detection of Sars-CoV-2 virus antigens. The big difference with most antigen swabs currently on the market is that the test is carried out in self-diagnosis.
The sample is taken from the first part of the nasal canal with a short swab and the test is therefore non-invasive and non-annoying.
This represents a great advantage for the screening of children and sensitive subjects and allows qualified healthcare professionals to perform self-diagnosis.

The product is a CE Medical Device.

Directions for use and Dosage

Wash and dry your hands thoroughly before performing the test.
Read the instructions for use carefully before performing the test.
Remove the swab from the package, trying not to touch the cotton tip with your hands.
Gently insert the swab 1.5 cm into the nostril until it stops. no resistance is felt.
Using moderate pressure, rotate the swab 4-6 times in the nostril for at least 15 seconds.
Repeat the procedure with the same swab in the other nostril.
After sampling, remove the purple cap from the tube and immerse the swab in it.
Keep the swab immersed in the buffer solution for at least 15 seconds, rotating it several times and pressing the cotton tip towards the bottom of the tube at least 3 times.
Before removing the swab from the tube, squeeze the tip by squeezing more firmly. Twist the flexible tube from the outside with your fingers.
Close the tube with the purple cap.
Open the package and place the test card on a flat surface.
Remove the transparent cap and add 4 drops of the mixture to the well (S) of the test card.
Read the results after 15 minutes.
Results read after 30 minutes are no longer valid. valid.
After performing the test, seal all used components in the appropriate biohazard bag.
Do not reuse.
Wash or disinfect your hands again.

Interpretation of results:

• Positive: two red lines appear in the reading window.
  One red or purple line appears in the control region (C) and the other near the test region (T), thus indicating a positive test and a suspected COVID-19 infection.
• Negative: only one red-purple line is visible in the reading window in the control region (C), thus indicating a positive test and a suspected COVID-19 infection. the absence of the SARS-CoV-2 virus in the analyzed sample or that the concentration of the virus is below the detection limit of the kit.
• Invalid: no red-purple line appears in the reading window.
  The test is therefore invalid. It is recommended to review the procedure and repeat the test with a new kit.

Children and minors must be supported by an adult to perform the test.

Warnings

This kit is for in vitro diagnostic use only.
Please read the instructions carefully before performing the test.
Use only the components provided in the kit; do not replace the kit material.
Use only undamaged components.
Follow the instructions for use strictly and do not mix components from different lots.
Never drink the buffer solution.
If ingested, contact your doctor immediately.
The kit provides only a qualitative result; it is not able to quantify the concentration of the Sars-Cov-2 antigen in the sample.
The test result cannot be interpreted as a qualitative result. be used as the sole element to confirm the diagnosis.
Symptoms, medical history, other laboratory tests and patient information must be carefully considered before clinical management.
Children and minors must be supported by an adult.
The test cannot be used with non-human specimens.

Storage

Store at a temperature ranging from 4 °C to 30 °C.

Format

Single test sachet composed of:

• Sars-Cov-2 antigen test card.
• Extraction tube with buffer.
• Sterile disposable swab.
• Biological risk waste bag.
• Instructions for use.