HOTGEN

HOTGEN Corona Covid 19 rapid test also usable for private persons (layman test), easy to use, result after 15 minutes, Bfarm listed


Item number HOTGENCOVID1915min-5

  • It only has to be moved up about 2-3 cm into the nose when taking a nasal swab. Very pleasant!
  • Result readable after 15 minutes
  • Very easy to perform painlessly and without taking blood by nasal swab. Easy to use.

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Hotgen Coronavirus (2019-nCoV) Antigen Test with Lay Approval
The Hotgen Coronavirus Antigen Self Test is for the qualitative in vitro determination of SARS-CoV-2 antigen in human anterior nasal specimens. This self-test is suitable for home use as a rapid test for suspected cases of novel coronavirus, but can also be used as a confirmatory method for nucleic acid detection in discharged cases.

Properties of the Hotgene Coronavirus Antigen Self-Test
A positive test result indicates that the specimens contain SARS-CoV-2 antigen.
A negative test result, on the other hand, does not exclude the possibility of infection.
It is recommended that a comprehensive analysis of the condition be performed based on the patient's clinical manifestations and other laboratory tests.
This kit is intended for home use by lay persons outside the laboratory (such as a person's home or certain non-traditional locations such as offices, sporting events, airports, schools, etc.).
Components of the Hotgen Coronavirus Antigen Self-Test Kit
SARS-CoV-2 antigen test cassette
Sample extraction buffer
Disposable viral sample swab
Biohazard sample bags
Note: Components from different lots cannot be mixed.

Application of the Hotgen Coronavirus Antigen Self Test
1st Sample Collection & Sample Handling:

Gently insert the entire soft tip of the swab into one nostril for 1.5 cm until you feel some resistance.
Using medium pressure, slowly rub the swab in a circular motion around the inner wall of your nose 4 times for a total time of 15 seconds. Repeat the same procedure with the same swab in the other nostril.
After sampling, soak the swab below the liquid level of the sample extraction buffer, rotate and squeeze 3 times, the soaking time of the swab is about 15 sec.
Squeeze the swab head, then remove the swab from the collection tube, scraping the liquid from the swab.
The liquid in the tube is the sample after treatment.
2. sample storage:

The treated sample should be tested within 1 hour.
3. test procedure:

Place the test cassette and sample extraction buffer at room temperature for 15~30 minutes and bring to room temperature (10~30℃).
Open the aluminium foil pouch of the test cassette and place the test cassette on a flat surface.
Add 4 drops of the treated sample to the sample hole of the test cassette (For chromatographic abnormalities, add an additional 1 to 2 drops of the treated sample). Incubate for 15 minutes at 10 ~ 30°C.
Observe results after incubation at 10 ~ 30°C for 15 minutes. The result obtained after 30 minutes is invalid.
Interpretation of the result of the Hotgene Coronavirus Antigen Self Test
Positive: Two colour bands appear in the observation window, i.e. a red or magenta line appears at the position of the quality control line (C line) and the detection line (T line), indicating that the test result of the SARS-CoV-2 antibody in the sample is positive.

Negative: A red or magenta line appears at the quality control line (C-line) position in the observation window and no line appears at the test line (T-line) position, indicating that the SARS-CoV-2 antibody test results in the sample are negative or the concentration is below the detection limit of the set.

Invalid: No line shows at the quality control line (C line) position in the observation window, indicating that the test is invalid and the sample should be recollected and retested.

Disposing of the Hotgene Coronavirus Antigen Self Test
Place the test cassette, sample extraction buffer and disposable virus sample swab in the Biohazard sample bag and seal the bag. Discard the remaining components of the sample kit. Reapply the hand disinfectant.

Frequently asked questions of the Hotgen Coronavirus Antigen Self-Test
When can I test myself? - You can test yourself at any time, whether you have symptoms or not. As a general rule, please note that the test result is a snapshot valid for that point in time. Tests should therefore be repeated as required by the relevant authorities.
What do I have to pay attention to in order to get the most accurate test result? - Always follow the instructions for use exactly. Perform the test immediately after taking the sample. Put the drops from the sample tube only into the designated well of the test cassette. Dispense four drops from the sample tube. Too many or too few drops can lead to a false or invalid test result.
The test strip is very discoloured. What is the reason for this or what am I doing wrong? - The reason for a clearly visible discolouration of the test strip is the release of too many drops from the test tube into the well of the test cassette. The indicator strip can only absorb a limited amount of liquid. If the control line does not appear or if the test strip is very discoloured, please repeat the test with a new test kit according to the instructions for use. 
What should I do if I have performed the test but do not see a control line? - In this case, the test result is to be considered invalid. Please repeat the test with a new test kit according to the instructions for use. I am unsure about the interpretation of the results. What should I do? If you cannot clearly determine the result of the test, contact the nearest medical facility using the regulations of your local authorities.
My result is positive. What should I do? - If both a horizontal coloured line is visible in the control area (C) and in the test area (T), your result is positive and you should contact the medical facility immediately according to the regulations of your local authorities. Your test result may be reviewed and the next steps will be explained to you. 
My result is negative. What should I do? - If only a horizontal coloured line is visible in the control area (C), this may mean that you are negative or that the viral load is too low to be detected by the test. If you experience symptoms such as headache, migraine, fever, loss of sense of smell and taste, contact your nearest medical facility in accordance with the regulations of your local authorities. In addition, you can repeat the test with a new test kit.
Can this test cassette be reused or used by more than one person? - This test cassette is intended for single use and cannot be reused or used by more than one person.
Principle of the Hotgene Coronavirus Antigen Self Test
This kit is based on immunochromatographic technology using colloidal gold. It uses a double antibody sandwich method to detect N-protein of SARS-CoV-2 antigen in human anterior nasal specimens. The detection line (T-line) of the SARS-CoV-2 antigen test cassette was coated with novel coronavirus antibody, and the quality control line (C-line) was coated with sheep antimouse. During the test, the sample is dropped into the test cassette and the liquid is chromatographed upwards under capillary action. The SARS-CoV-2 antigen in the sample first binds to the colloidal gold-labelled SARS-CoV-2 antibody, to form a solid-phase SARS-CoV-2 antibody - SARS-CoV-2 antigen-labelled SARS-CoV-2 antibody - colloidal gold complex at the T-line position and a solid-phase sheep antimouse-labelled SARS-CoV-2 antibody - colloidal gold complex at the C-line position. After completion of the assay, observe the colloidal gold colour reaction of the T-line and C-line to determine the SARS-CoV-2 antigen results in human anterior nasal samples.

Further notes
STORAGE AND SHELF LIFE

The kit should be stored at 4~ 30°C and the shelf life is fixed at 18 months.
After opening the foil bag, it should be used within 30 minutes (temperature 10~30℃, humidity ≤70%).
The sample extraction buffer should be used within 18 months after opening (temperature 10~30℃, humidity ≤70%).
See label for manufacturing and expiry dates.
LIMITATIONS

The test result of this kit is not the only confirmatory indicator for clinical indications. Infection should be confirmed by a specialist along with other experimental results, clinical symptoms, epidemiology and additional clinical data.
In the early stages of infection, low antigen expression may lead to negative results.
Specimen test results are related to the quality of specimen collection, processing, transport and storage. Any errors may cause inaccurate results. If cross-contamination is not controlled during specimen processing, false positive results may occur.
PRECAUTIONS

The kit is intended for in vitro diagnostic use only. Please read the instruction manual carefully before testing.
Please use the swab and sample extraction buffer included in this kit. Do not substitute the sample extraction in this kit with components in other kits.
The operation should be carried out strictly according to the instructions.
Positive and negative predictive values are highly dependent on prevalence rates. Positive test results are more likely to represent false positives during periods of low/no SARS-CoV-2 activity at low disease prevalence. False negative test results are more likely when the prevalence of disease caused by SARS-CoV-2 is high.
The sensitivity of the test after the first five days of symptom onset has been shown to decrease compared to an RT-PCR SARS-CoV-2 assay.
After opening, the test cassette must be used within 30 minutes (temperature 10~30 ℃ , humidity ≤ 70%), and they should be used immediately after opening at 30 ℃, and the unused test cassette must be sealed and stored in a dry place.
Waste or excess specimens generated during the test should be inactivated according to the infectious agents.


IMPORTANT: Corona rapid tests are sealed for health protection reasons. It is in the customer's best interest to receive completely unused goods. If the consumer has removed or tampered with the seal, the Corona rapid tests are excluded from the right of return.

Similar Face Masks

Respiratory protection masks are divided into different filter classes. The main differentiating criterion is how small the particles that prevent the masks from entering the airways may be and what the percentage retention rate actually is.



The European standard for PPE masks of class FFP2 is approximately equivalent to the international standard KN95. In the course of the corona crisis, it was decided to approve masks of the KN95 standard in a fast-track procedure for the European market for use against Covid 19 in order to have enough masks available to defend against corona. Please note that masks that carry the FFP2 standard and have a four-digit identification number behind the CE logo have been fully tested according to the EC standard and may therefore also be used for other applications such as in trade and industry.

KN 95 is a designation for a Chinese standard.


The Chinese standards GB 2626-2006 "Respiratory protective equipment. Non-powered air-purifying particle respirator" and GB 19083-2010 "Technical requirements for protective face mask for medical use" are from the Standardization Administration of the People's Republic of China (SAC)



There are currently many Chinese masks on the market that do not have FFP2 approval. The Chinese mask type KN95 essentially meets the requirements of the American N95 masks.


Attention: Please make sure that such masks are certified by the German DEKRA or TÜV for use as "Corona Masks"!

MNB stands for Oral-Nose-Covering as a mechanical barrier or "brake" for the transmission of breath droplets or saliva when breathing, coughing or sneezing. These coverings / masks are produced in a wide variety of variations. They are usually produced privately or by textile manufacturers.



Medical Oral and Nasal Protection Masks (MNS), so-called surgical masks, are mainly used in the medical sector such as doctors' surgeries, clinics or in the care sector. They can prevent the spread of saliva or breath droplets from the wearer and are primarily used to protect the other person. Surgical masks belong to the category of medical products and comply with the corresponding legal regulations.

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