Testing for COVID-19 just got easier

NewGene Bioengineering

For professional use

A quick test for COVID-19 to be used by healthcare professionals. The test is quick, reliable and easy with given results in 15 minutes. The test is administered with a shallow swab in the nasal cavity or with sputum sample. The nasal test causes minimal discomfort and can be taken regardless of symptoms to make sure a person is not contagious.

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. Our self-tests are available in three different packaging quantities: 1-pack, 5-pack and 25-pack.

  • Rapid test for COVID-19
  • Recommended test method
  • Uncomplicated testing
  • Minimal discomfort
  • High sensitivity (>95%)
  • Test regardless of symptoms
  • Test results within 15 minutes
  • Complement to PCR test

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).

Test results

In the event of a positive result isolate the patient, 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

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.

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. Studies conducted so far (June 2021) suggest the product performance is reliable also when tested against the following variants: B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma) and B.1.617 (Delta).

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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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