Coronavirus and COVID-19 testing FAQs

What is the coronavirus test?

The AlphaBiolabs Rapid IgM-IgG Combined Antibody Test is designed to indicate a COVID-19 infection and 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?

The AlphaBiolabs IgM-IgG Combined Antibody Rapid Test works by detecting both early and late marker antibodies in human finger-prick blood samples informing you if you are experiencing a current or a recent coronavirus infection.

Immunoglobulin M (IgM) provides the first line of defence during viral infections, followed by 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. This indicates a current COVID-19 infection.
  • Detection of IgG antibodies indicates a later stage of infection. This indicates a previous COVID-19 infection, up to 6 weeks prior.

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 provided within 15 minutes after the blood sample and buffer have been combined in the testing device. There is no need to send the sample away to a laboratory for confirmatory testing.

How accurate is the coronavirus test?

The quality and accuracy of COVID-19 screening devices can vary dramatically between different manufacturers. It is therefore important to choose carefully when deciding on the immunoassay screen you wish to use.

It has been widely acknowledged that the accuracy demonstrated by German-made COVID-19 immunoassay devices are of the highest levels.

The sensitivity of our German-made immunoassay screens is greater than 99.9% diagnostic sensitivity for IgG detection, and 91.8% diagnostic sensitivity for IgM detection. The diagnostic specificity for IgG reaches 99.5%, whereas the diagnostic specificity for IgM is 99.2%.

The screening kit is CE Marked and certified for professional and business use only.

What does the coronavirus test entail?

The testing process is very simple and involves only four steps from taking the finger-prick blood sample to getting the results (within 15 minutes).

Collect blood sample

Add blood sample to sample well

Place 2–3 drops of buffer in sample well

Read results after 15 minutes

How do I understand the results?

Three detection lines can be seen in the detection window. The control (C) line appears when the sample flows through the cassette. This result indicates a negative result and no COVID-19 infection has been detected.

The IgM (M) line appears when the coronavirus immunoglobulin M antibody has been detected. This indicates a current COVID-19 infection.

If the IgG (G) line appears, then the coronavirus immunoglobulin G antibody has been detected. This result indicates you have previously had a COVID-19 infection.

Negative

IgM Positive

IgG Positive

IgM / IgG Positive

How much does a coronavirus test cost?

The AlphaBiolabs Rapid IgM-IgG Combined Antibody Test is used to identify COVID-19 infection. The cost of the test varies depending on the quantities required and if you need the attendance of AlphaBiolabs personnel onsite to oversee the sample provision. Call 0333 600 1300 to gain a quote.

How reliable is the coronavirus test?

The sensitivity of our German-made immunoassay is greater than 99.9% diagnostic sensitivity for IgG detection, and 91.8% diagnostic sensitivity for IgM detection. The diagnostic specificity for IgG reaches 99.5%, whereas the diagnostic specificity for IgM is 99.2%.

The coronavirus / COVID-19 screening kit is CE Marked and certified for professional / business use only.

Will the coronavirus test tell me if I have a coronavirus infection?

Yes, detection of IgM antibodies usually indicates a recent exposure to COVID-19, which indicates a current COVID-19 infection. Detection of IgG antibodies indicates a later stage of infection, which indicates you have previously had a COVID-19 infection.

Will the coronavirus test tell me if I have already had coronavirus?

If both the quality control line (C) and the detection line G appear in the detection window then the novel coronavirus IgG antibody has been detected. This indicates a later stage of infection. Therefore, you have previously had the COVID-19 infection, within the last 6 weeks of taking the test.

What is the difference between coronavirus and COVID-19?

Coronavirus disease and COVID-19 are both names for the disease caused by the virus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

What is in the coronavirus kit?

The coronavirus kit includes an immunoassay screening device, blood lancet, buffer solution, plastic pipette and an alcohol cleansing wipe.

Can the coronavirus screening kit be used at home?

The screening test is for business and professional use only and can be performed in any location by a trained individual, company nurse or Occupational Health personnel.

How long is the screening kit valid for?

The coronavirus screening kit is valid for at least 12 months. There is an expiry date on the protective foil wrapper containing the kit.

What testing options are available for COVID-19?

The AlphaBiolabs 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. If required, we provide the option of sending a fully trained sample collector to any location to demonstrate the use of the kits and to oversee the correct sample collection and document completion of all sample donors. The sample collector will have PPE and will also be able to provide PPE to all sample donors.

What is the technical data on the tests?

The technical data for the COVID-19 screening device is available on request.

What is the accuracy of the coronavirus antibody test?

The sensitivity of our immunoassay is greater than 99.9% diagnostic sensitivity for IgG detection, and 91.8% diagnostic sensitivity for IgM detection. The diagnostic specificity for IgG reaches 99.5%, whereas the diagnostic specificity for IgM is 99.2%.

The coronavirus antibody test is CE Marked and certified for professional / business use only.

What standards are the coronavirus tests manufactured to?

The German-made 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.

Can I buy the screening tests from you if I am outside of the UK?

Yes, we can sell the COVID-19 screening tests to businesses outside the UK. Courier fees will apply.

Is the test specific to the COVID-19 infection?

Yes, the test detects the novel coronavirus IgM antibody and the novel coronavirus IgG antibody.

What is the difference between the NHS coronavirus laboratory test (PCR) and the immunoassay antibody test?

There are two types of tests for COVID-19. One is to confirm if you are currently infected by the virus (SARS-CoV-2) using a laboratory technique known as PCR. The other type of test is an immunoassay antibody test.

The PCR test requires the use of a nasopharyngeal swab to collect a test sample from the back of the nose and throat. The sample collection procedure may be unpleasant and can lead to false negatives if the sample has not been collected properly. It has been recently reported that up to 30% of tests may have been affected in this way. The PCR laboratory test can take up to 2-3 days for results.

The immunoassay antibody test reveals if an individual has been exposed to the virus and their body has developed antibodies. IgM antibodies are present early in infection, IgG antibodies arise several days later. Coronavirus disease is new and therefore you will not have antibodies specific to it if you have not been infected.

Any reduction in the diagnostic sensitivity rate of the antibody test (which is at least 90%) is compensated by the easy sample collection procedure and simple use of the antibody screening kit. Caution should be exercised in relation to the quality of which immunoassay devices to use as this can vary significantly: choose a reputable provider and a high quality device.

How do I take the blood sample?

Full instructions are provided in the kit.

Do not open the foil packaging on the immunoassay screening device until you are ready to use it. It must be placed on a level surface at room temperature for the duration of the test. We highly recommend that you are sufficiently hydrated before commencing this test.

  • Wash your hands in warm water and dry. Massage and rub hands together for 60 seconds to encourage blood circulation.
  • Choose a finger (we recommend the middle finger). Massage the chosen middle finger and then wipe thoroughly with the alcohol cleansing wipe and allow to dry.
  • Apply the lancet with a small amount of pressure to the middle of the finger rather than the fingertip. Do not remove the blood lancet from the finger too soon as it may not pierce the skin.
  • Stand up and hold your hand below your waist and massage your finger towards the pin prick to encourage blood flow.

What if my test shows negative but then later on it changes to positive?

Once you apply your blood sample and buffer solution to the device, please wait for the coloured line(s) to appear.

Read the test results within 10-15 minutes.  Sometimes, lines can appear after 20 minutes however, do not interpret the result after more than 20 minutes as they will be deemed invalid.

How do I dispose of my screening kit after use?

Dispose of all used or damaged test cassettes, capillary samplers, or other kit component as biohazardous materials. To do this, place all components in a double sealed bag before putting into the waste. Sample results that are positive should be kept separate from normal waste for 72 hours.

You can buy coronavirus testing kits here. Alternatively you can call our Customer Services team on 0333 600 1300 or email info@alphabiolabs.com.