Antigen Detection Kit

APPROVED BY WHO

Our product is approved by WHO and is CE certified

RELIABLE RESULTS

Our tests are developed by experts and are >98% reliable

2 IN 1 SOLUTION

Our tests contain a SPUTUM and NASAL solution

QUICK RESULTS

You will get the results within 15 minutes

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Description

This product is suitable for the qualitative detection of a novel coronavirus in sputum samples. It provides an aid in the diagnosis of infection with the novel coronavirus.

SUMMARY

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease.  Based on the current epidemiological investigation, the incubation period is 1 to 14 days, but average 3 to 7 days. Asymptomatic virus carriers can also be infectious sources.

The main symptoms include fever, fatigue and a dry cough. In addition, you might experience nasal congestion, runny nose, sore throat, and/or diarrhea.

The detection kit includes

Test Card
Sample Extraction Tube
Tube Cap
Paper Cup

How to perform NASAL test

How to perform SPUTUM test

STORAGE AND STABILITY

Store the product package at temperatures 2-30°C or 38-86°F
Avoid exposure to sunlight.
The kit is stable within the expiration date printed on the labeling.
Once an aluminum foil pouch is opened, the test card should be used within one hour.
Prolonged exposure to hot and humid environments may cause inaccurate results.
The lot number and the expiration date are printed on the labeling.

WARNINGS AND PRECAUTIONS
Read the instructions for use carefully before using this product.
This product is for professional use.
Sputum rather than saliva is the type of sample recommended by WHO.
Sputum comes from the respiratory tract while saliva comes from the mouth.
Please make sure that the proper amount of sample is added for testing.
Too much or too little sample amount may cause inaccurate results.
If the test- or control-line is not visible in the result window, the test result is invalid – retests the sample with another test card.
This product is disposable. DO NOT recycle used components.
Dispose of used products, samples, and other consumables as medical wastes under relevant regulations.

How to read your results

Additional information

Weight .2 kg
Antigen Detection Kit

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A Novel Coronavirus Antigen test detects the virus itself by the specific spike proteins (i.e. Antigens) on its surface, in order to identify the existence of the virus in the sample.

An Antibody test is to detect the molecules (i.e. antibodies) that people produce after being infected with the virus. Antibodies may take several days to produce after infection and usually remain in the blood for a period after the patient recovers. There are two types, IgM Antibodies which are produced initially to fight the infection, but which disappear after several weeks, and IgG Antibodies which are produced later in the cycle and which generally remain in the body much longer. Therefore, whilst the antibody test has very limited use in the diagnosis of a new COVID-19 infection, it is essential to indicate potential immunity. However, at present, it unknown how long such immunity may subsist.

An Antigen test is based on an immune reaction, whilst the nucleic acid test is based on genetic information. Therefore, an Antigen test can be much faster than the nucleic acid test (15 minutes compared with 4 hours).The cost of speed is the sensitivity. That is, an Antigen test is not as sensitive as a nucleic acid test. The nucleic acid test can detect a microscopic amount of SARS-CoV-2 virus due to its sensitivity using the amplification process of virus genetic information. This is why a PCR test takes several hours and is capable of causing aerosol contamination.


It does not require any laboratory processing and hence are suitable for large scale general screening of the population. In North America & Europe all licensed Rapid-test Antigen products are currently required to only be used by qualified professionals. However, it appears likely that Antigen tests for home use, without professional supervision, will eventually be permitted.However, if the human body contains only a very low viral load, with no obvious clinical symptoms, then an Antigen test is likely to give a negative result, thus a false negative. Helpfully, the ability of people with a low viral load to spread the virus is correspondingly lower than heavily infected patients. The Antigen test is suitable as a triaging or screening test to determine whether or not a slow but accurate nucleic acid test should be obtained.An Antigen test will be efficient in quickly identifying people with high levels of infection, those who are most likely to infect others, and distinguishing those people from others with, for example, seasonal influenza. Therefore, Antigen tests can be effective in helping to limit the spread of the pandemic, by identifying those who are most likely to spread the disease and isolating them from others.


As an Antigen test detects the virus itself sample collection is very important because the virus is only present in some areas of the body. This is different from the collection of a blood sample for an Antibody test when we may expect the Antibodies to be present throughout the patient’s venous blood, although likely to be less present in capillary blood. Accordingly, we recommend the use of a sputum sample, because sputum is a secretion from the respiratory tract where the SARS-CoV-2 virus clusters the most.Hence using sputum provides a more certain method of successfully collecting a reasonable quantity of the virus in the sample, if it is present when compared with the back of the throat nasopharyngeal sample. Because the virus is unevenly distributed on the nasopharyngeal mucosa, it is not certain that a successful sample will be obtained from this area which may lead to a false-negative result. It is much more difficult and requires both expertise and some luck to obtain a truly representative sample from the back of the throat. Therefore, the nasopharyngeal sample accuracy will be lower than that of sputum. Studies have shown that after people are infected, the viruses survive, and thus can be detected, in the digestive tract, especially in the intestinal stool. Therefore, if convenient (e.g. in the hospital or at home), a stool sample is another option for testing; Saliva samples mixed with sputum also have a certain probability of detection, although the amount of virus contained is lower than pure sputum.


Sputum is the mucus that is coughed up from the lower airways (the trachea and bronchi). When taking a sample one should avoid its contamination / dilution with saliva so far as possible. Saliva (commonly referred to as spit) is an extracellular fluid produced and secreted by salivary glands in the mouth.

The WHO has always been a supporter of Antigen testing. Experts point out that compared with conducting an accurate test every two weeks, conducting a relatively insensitive quick test twice a week can more effectively contain the spread of SARS-CoV-2. The reason is that it is more helpful in containing the spread of the infection where the focus is on identifying those who are likely to spread SARS-CoV-2, rather than locating anyone who is infected in any way with SARS-CoV-2 – but with a low infection much less likely to spread it.

The first EASY-TO-USE COVID-19 tests are now CE certified and approved for distribution and sales across all Europe.

The HealthOx Biotech Ltd Antigen and Antibody tests are certified in the UK, Europe and Asia, and ready for medical use. They are approved by the MHRA and BSI and have earned the UK’s British Standards Institution (BSI) mark and the EU’s CE Certificate of Compliance.

All of our test kits can be ordered online via our website for delivery within 2-5 days. We also cater for telephone orders. Please contact Hi@healthoxbiotech.com