HOTGEN 2019-NCOV AG AUTOTEST

Coronavirus (2019-nCoV) Antigentest Hotgen Self-Diagnostic Kit

KIT for in vitro self-diagnostic use for the qualitative determination of the SARS-CoV-2 antigen in human samples obtained from a nasal swab.

The test can be used for rapid detection of SARS-CoV-2 antigen from individuals with suspected COVID-19 infection within the first 7 days of the onset of symptoms.
Children and minors must be supported by an adult to carry out the test.

Instructions for use

Wash and dry your hands thoroughly before carrying out the test and read the instructions for use carefully.
Remove the swab from the package, trying not to touch the cotton tip with your hands.
Gently insert the swab 1.5cm into the nostril until you feel resistance. With moderate pressure, rotate the swab 4-6 times in the nostril for at least 15 seconds. Repeat the procedure with the same swab also in the other nostril.
After sampling, remove the purple cap of 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, squeezing the flexible tube several times from the outside with your fingers. Close the tube with the appropriate 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 into the well (S) of the test card.
Read the results after 15 minutes. Results read after 30 minutes are no longer valid.
After performing the test, seal all used components in the appropriate biowaste bag.
Wash or disinfect your hands again.

Interpretation of results

POSITIVE: two red bands appear in the reading window. A red or purple band appears in the control area (C) and the other near the test area (T), thus indicating a positive test and a suspected COVID-19 infection.

NEGATIVE: in the reading window only one red-purple band is visible in the control area (C), thus indicating the absence of the SARS-CoV-2 virus in the analyzed sample or that the concentration of the virus is lower than the detection limit of the kit.

INVALID: No red-purple lines appear in the reading window. The test is therefore invalid. It is recommended to review the procedure and repeat the test with a new kit.

Warnings

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

storage

Store at a temperature ranging from 4°C to 30°C.
Validity with intact packaging: 24 months.

The kit contains

- test card
- extraction tube with buffer
- sterile disposable swab
- biohazard waste bag
- instruction leaflet for use

Format

Pack of 1 Self-Diagnostic Kit.