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Testing for COVID-19 just got easier

Covid-19 Antigentest package
NewGene Bioengineering, approved by Läkemedelsverket

A new normal

We are now offering the COVID-19 self test for companies and individuals. The test is quick, reliable and easy with given results in 15 minutes. The test is self-administered with a shallow swab in the nasal cavity and doesn’t require a health professional. The actual test causes minimal discomfort and can be taken 2-3 times per week, regardless of symptoms, at home or in the work place.

1.
Take nasal sample
2.
Mix with
fluid
3.
Dispense and
wait 15 min

An approved product

Gibson Medical is an authorized representative of the manufacturer NewGene Bioengineering in Sweden - the product is approved by Läkemedelsverket. Our self-tests are available in three different packaging quantities: 1-pack, 5-pack and 25-pack. Each testing kit contains four components: test swab, test tube, cork and test cartridge.

covid-19 antigentest package
  • Rapid test for COVID-19
  • Recommended test method
  • Uncomplicated testing
  • Minimal discomfort
  • High sensitivity (>95%)
  • Test regardless of symptoms
  • Test results within 15 minutes
  • Should be used 2-3 days per week

Quality and safety

The test is performed by collecting a nasal swab sample which detects the presence of SARS-CoV-2, the virus that causes covid-19, as well as it's common mutations. The test has a high reliability providing it is performed in accordance with the instructions for use; over 97% sensitivity (the probability of detecting infection in an infected patient) and over 99% specificity (the probability that a positive response is actually correct).

Products such as this self-test have to be reviewed by several agencies before they can be sold to the public. The CE marking guarantees that the product meets the required level of reliability and that the product is safe to use.

This product has been granted an exemption by the Läkemedelsverket for self-testing by the public. This exemption is valid until 31-7-2021 or until CE marking is obtained. It is fully expected to obtain a CE marking before this date. See the packaging leaflet and instructions for use for complete information. Always follow government restrictions and recommendations.

Test results

In the event of a positive result, you should contact 1177 or similar healthcare provider.  Additional tests may be required to confirm viral infection or to initiate contact tracing.

A negative result means the sample does not contain a sufficient amount of the virus, but infection cannot be completely ruled out.

PositivE

Line at both
C and T

NegativE

Only line
at C

INVALID

Without line
at C

Download files

Instructions

Questions & answers

Is it not enough that everyone will be vaccinated?

We have seen in Swedish studies that the protection against symptomatic disease after one shot of the vaccine is around 40%. It is not yet clear how long the vaccination protection will last and whether the vaccine, in addition to protecting against disease, will also lead to a reduction in the spread of infection. The majority of the population (Phase 4 of the vaccination program) is likely to receive their second injection at the earliest in September.

How reliable is the test?

It has approximately 97% sensitivity (probability of detecting infection in an infected patient) and over 99% specificity (probability that a positive response is actually correct). This is provided that the test is carried out in accordance with the instructions for use.

If I take the test in the morning and then travel to work on public transport, could I not be contagious at work then?

Virus levels needto be high for you to be contagious and it usually takes 3-7 days until viruslevels are so high that you are contagious (and get a positive test result).Therefore, sampling every 3 days is recommended.

How long is the exemption for the self-test valid?

The exemption is valid until 31/7 or until we have received the CE marking for self-test, this is expected to take place as early as June.

What should I do if I get a positive answer?

Contact your local healthcare provider or call 1177.

What can I do if it is negative?

A negative result indicates that there is no virus in the sample, or that the virus load is below the detection limit for this product. The possibility of a virus infection cannot be completely ruled out though, and we recommend that you follow current guidelines from the authorities.

Will restaurants etc. be able to offer the self-test to guests and thus stay open longer?

This remains to be seen in the future. Follow current recommendations on the Folkhälsomyndigheten’s website for the latest news.

Is it possible to travel if you show a negative result from a self-test?

A travel certificate currently requires a healthcare provider to certify your test result. Different countries have different requirements for test methods. Many countries accept antigen tests, but some countries require PCR tests.

How does it work with mutations?

Most mutations occur in the so-called spike protein and this product detects the presence of the nucleocapsid protein. The test can thus detect all currently known mutations including UK B.1.1.7, Brazilian P.1 and South African B.1.351.

If we test all staff every day, how big is the risk that we will still get someone with an infection?

It is not possible to give an exact figure on it, but the clinical data that is available suggest that if you have 100 people infected in the workforce, you will identify approximately 97 of these via correctly performed self-tests. Thus there is approximately a 3% risk of missing someone who is infected. However, testing should always be seen as a complement to other infection prevention measures and should not be regarded as a one hundred percent protection against infection.

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Contact

Ideon Science Park
SE-223 70 Lund
info@gibsonmedical.se

Sweden
tel +46 10 330 50 50
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