For Professional Use

In a controlled environment only: ( Doctors, Nurses, Pharmacies, Professionals )

Corona Virus Self Testing Kits For Professional use Only.

The COVID-19 rapid test identifies the body’s response to coronavirus after infection, and gives a qualitative yes/no result within 15 minutes.

The kit is CE marked and Europeon certified, produced by a BIOZEK Lab A Dutch Company. Implementing rapid screening for COVID-19 has huge time and cost savings when compared to laboratory...

  • Rapid finger-prick test for coronavirus
  • Identify COVID-19 infection before symptoms appear
  • Screen workforce and isolate carriers immediately
  • CE Marked and certified for professional use
  • Four simple steps with results in under 15 minutes
  • Each kit screens one person. Single use
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CORONA VIRUS COVID RAPID TEST

Biozek Covid-19 IgG/IgM Rapid Test

The COVID-19 IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to COVID-19 in human whole blood, serum or plasma specimen.

NEWS: BIOZEK COVID-19 IGG/IGM RAPID TEST CASSETTE.

The World Health Organization (WHO) on March 11 declared COVID-19 a pandemic, pointing to the over 118,000 cases of the corona virus illness in over 110 countries and territories around the world and the sustained risk of further global spread. To stop further global spread of the virus, the world needs a screening test that is fast and reliable. We started to develop a rapid test cassette against the COVID-19. Biozek is proud to announce that we are one of the first company with a rapid test for COVID-19 IgG/IgM (ref BNCP-402). Our product is Dutch made with CE mark and is SFDA approved. Now worldwide our product is being used to screen patients for the corona virus. The COVID-19 is being used by Dutch Ministry of Defence, Ministry of health of Andorra and Kuwait.


Cat. No Product Description Format Kit Size CE Status Specimen Cut-Off
BNCP-402 COVID-19 IgG/IgM Rapid Test Cassette Cassette 30 T CE WB/S/P


Content

Test Cassettes-30

Droppers-30

Buffer-2

Package Insert -1

Onsite CoronaVirus Test

The Corona Virus Self Testing Kits IgM-IgG Combined Antibody Rapid Test is one of the world’s first rapid screening tests for the identification of coronavirus infection. This accurate screening test is similar to the type that was used widely by the Chinese Centre for Disease Control and Prevention to identify COVID-19 infections and is now available from Corona Virus Self Testing Kits. The single-use qualitative test detects both early and late marker IgG/IgM antibodies in human finger-prick blood samples.

Certificate of COVID-19, 2019-nCoV Rapid Test Cassette

Click Here to Download.

Keep your workforce safe

Screening your workforce is vital. Recent studies suggest that a high percentage of patients show no or few clinical symptoms. This easy-to-administer test can be performed by the individual themselves or by a company nurse or Occupational Health personnel.

Collect blood sample
Add blood sample to sample well
Place 2–3 drops of buffer in sample well
Read results after 15 minutes

Please note: this test is for business / professional use only, not for members of the public.

IMPORTANT – FOR USE BY MEDICAL PROFESSIONALS

The Government is presently most concerned that these kits do not enter the open market and into the hands of those who do not have the medical knowledge to correctly interpret the results. At present we are therefore required to obtain, prior to dispatch, the name and role of the medical professional who will be responsible for their receipt, storage and use. All kits are serialised and will be registered to the professional to whom they are delivered.

These are NOT domestic “Home Test” kits – they are professional lateral flow tests, certified for use by GP’s, Nurses, Pharmacists and other suitably medically-trained staff

These COVID-19 test kits are professional, lateral-flow, pharmaceutical blood screening kits currently in use with hospitals worldwide and provide a result in just 15 minutes. Blood or Serum may be used and accuracy for detection of IgG/IgM antibodies is now in excess of 98.6%. They are certified for clinical use; at present they can only be supplied to, and used by, a medical professional.

By identifying probable positives through mass-screening, RT-PCR follow-up testing can be used more effectively and immediate action to isolate those potentially contagious and those with known contact. RT-PCR testing is time-consuming, labour-intensive and cannot provide enough capacity to resolve this crisis by itself.

Corona Virus Test Kit Product Analysis and Reports.


Results

A total of three detection lines are possible. The control (C) line appears when the sample flows through the cassette.

Negative Result

If only the quality control (C) line appears, then no novel coronavirus antibody has been detected and the result is negative. If the control line doesn’t appear, the test has been unsuccessful and needs to be repeated.

Positive Result, M only

If both the quality control line (C) and the detection line M appears, then the novel coronavirus IgM antibody has been detected and the result is positive for the IgM antibody.

Positive Result, G only

If both the quality control line (C) and the detection line G appears, then the novel coronavirus IgG antibody has been detected and the result is positive for the IgG antibody.

Positive Result, G and M

If the quality control line (C) and both detection lines G and M appear, then the novel coronavirus IgG and IgM antibodies have been detected and the result is positive for both the IgG and IgM antibodies.



How does the coronavirus screening test work?

Immunoglobulin M (IgM) is the body’s largest antibody. It is also the first antibody to appear in response to an initial exposure to an antigen (a toxin or other foreign substance), which induces an immune response in the body. It is widely accepted that IgM provides the first line of defence during viral infections, followed by the generation of adaptive, high affinity IgG responses for long-term immunity and immunological memory. Therefore, testing of COVID-19 IgM and IgG antibodies is an effective method for the rapid identification of a current or recent COVID-19 infection.

  • Detection of IgM antibodies tends to indicate a recent exposure to COVID-19.
  • Detection of IgG antibodies indicates a later stage of infection.

Thus, this combined antibody test could also provide information on the stage of infection.

Diagnose a COVID-19 infection before symptoms appear

For Professional use


In a controlled environment only: ( Doctors, Nurses, Pharmacies, Professionals )

Frequently Asked Questions


What is the coronavirus test?

The Rapid IgM-IgG Combined Antibody Test for COVID-19 is a lateral flow immunoassay used to qualitatively detect both early and late marker IgG/IgM antibodies in human finger-prick blood samples.

How does the coronavirus test work?

It is widely accepted that Immunoglobulin M (IgM) provides the first line of defence during viral infections, followed by the generation of adaptive, high affinity Immunoglobulin G (IgG) responses for long-term immunity and immunological memory. Therefore, testing of COVID-19 IgM and IgG antibodies is an effective method for the rapid diagnosis of COVID-19 infection.

  • Detection of IgM antibodies tends to indicate a recent exposure to COVID-19.
  • Detection of IgG antibodies indicates a later stage of infection.

The testing device has a strip, which contains a colloidal gold-labelled recombinant novel coronavirus antigen and quality control antibody colloidal gold marker, two detection lines (G and M lines) and one quality control line (C) fixed on a nitrocellulose membrane. M is fixed with monoclonal anti-human IgM antibody for detecting the novel coronavirus IgM antibody. G is fixed with monoclonal antihuman IgG antibody for detecting the novel coronavirus IgG antibody.

How quickly can I get the results?

Results are within 15 minutes after the blood sample and buffer have been combined in the testing device’s sample well.

How accurate is the coronavirus test?

We can confirm that the quality of the immunoassay screen is very high. The medical device contained within our kits has an EC-Declaration of Conformity with the Essential Requirements Annex I of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. The sensitivity of our immunoassay is 86.8% (IgM), 97.4% (IgG), with a specificity of 98.6% (IgM), 99.3% (IgG).

How do I understand the results?

A total of three detection lines are possible. The control (C) line appears when the sample flows through the testing device cassette.

Negative Result

If only the quality control (C) line appears, then no novel coronavirus antibody has been detected and the result is negative.

Positive Result, M only

If both the quality control line (C) and the detection line M appears, then the novel coronavirus IgM antibody has been detected and the result is positive for the IgM antibody.

Positive Result, G only

If both the quality control line (C) and the detection line G appears, then the novel coronavirus IgG antibody has been detected and the result is positive for the IgG antibody.

Positive Result, G and M

If the quality control line (C) and both detection lines G and M appear, then the novel coronavirus IgG and IgM antibodies have been detected and the result is positive for both the IgG and IgM antibodies.