Coronavirus and COVID-19 testing FAQs
What is the coronavirus antibody test?
AlphaBiolabs rapid IgM-IgG combined antibody test for COVID-19 is a portable lateral flow immunoassay screening device which uses a finger-prick blood sample to detect your body’s immunological response to an active or recent exposure to the SARS CoV-2 virus (COVID-19).
How does the coronavirus antibody 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 for the presence of COVID-19 IgM and IgG antibodies is an effective method to detect your body’s immunological response to a COVID-19 infection.
- Detection of IgM antibodies tends to indicate a current ongoing infection.
- Detection of IgG antibodies indicates a later stage of infection.
Our immunoassay COVID-19 testing kits have a screening device containing 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 has been placed in the sample (S) well and the buffer has been placed in the buffer (B) well. There is no need to send your sample to our laboratory for confirmatory testing unless you need a ‘back to lab’ antibody or COVID-19 PCR test.
How accurate is the coronavirus antibody instant test?
We are pleased to confirm that the immunoassay screening devices contained within our kits are of a very high quality. Recently, our screening kits have been evaluated by the NHS who confirm that there is a high correlation between our antibody screening device results and hospital rt PCR samples obtained by patients. This has led to the NHS concluding that our COVID-19 screening kits are ‘Fit for Use’.
During the NHS evaluation, it was determined after 21 days from point of infection, that the diagnostic sensitivity of our immunoassay is 98.8% for IgM and 100% for IgG. Diagnostic specificity for IgM and IgG was also notified at 100%.
The performance data from our screening device manufacturers show the diagnostic sensitivity for IgG detection is 99.9%. In addition, the diagnostic sensitivity for IgM detection is 91.8%. Another important measure is the diagnostic specificity. The diagnostic specificity for IgG has been shown to be 99.5%, whereas the diagnostic specificity for IgM is 99.2%.
How much does a coronavirus test cost?
The AlphaBiolabs rapid IgM-IgG Combined Antibody Test is used to identify your employee’s response to a COVID-19 infection. The cost of the test varies depending on the quantities ordered and if you require the attendance of AlphaBiolabs trained personnel onsite to oversee the sample collection provision. Call 0333 600 1300 to speak to our expert team regarding your specific requirements.
How reliable is the coronavirus antibody test?
Our COVID-19 screening kit devices are CE-marked for professional use and have consistently demonstrated a high correlation with the results obtained from hospital-based rt PCR samples.
The performance data from our screening device manufacturers show the sensitivity is greater than 99.9% diagnostic sensitivity for IgG detection, with a 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 NHS has subsequently evaluated our COVID-19 screening kits and has deemed them ‘Fit for Use’.
As part of the NHS evaluation, it was determined after 21 days from point of infection or from 7 days from the onset of symptoms, that the diagnostic sensitivity of our immunoassay was shown to be 98.8% for IgM and 100% for IgG. Diagnostic specificity for IgM and IgG was also reported at 100%.
Will the coronavirus test tell me if I have a coronavirus infection?
The presence of COVID-19 IgM and IgG antibodies in your blood sample is an effective way to detect your body’s immunological response to a COVID-19 infection. The detection of IgM antibodies tends to indicate a current ongoing infection, with the detection of IgG antibodies indicating a later stage of infection.
What testing options are available for COVID-19?
At AlphaBiolabs, we can provide you with a complete range of testing options.
Option 1 – Real time PCR (rt PCR) testing in our new state-of-the-art Daresbury Sci Tech-located laboratories using a throat swab to detect the presence of the actual SARS CoV-2 virus (COVID-19) in your throat. This type of test is ideally collected by a healthcare professional but can be self-collected. Results are usually available within 24 hours once the samples arrive at our laboratory.
Option 2 – Laboratory Antibody Test – We can provide you with a government-approved ‘back to lab’ antibody test for IgG only with a very high degree of sensitivity and specificity. If required, due to the nature of the sample collection (intravenous blood), we provide the option of sending a fully trained phlebotomist (with the relevant PPE) to any location to collect the relevant samples and complete the documentation for all sample donors.
Option 3 – Instant Antibody Test – We are only one of a small handful of companies that can provide you with an NHS-evaluated rapid onsite IgM-IgG combined antibody test for COVID-19 to obtain an instant result.
Is the test specific to the COVID-19 infection?
Yes, our immunoassay screening devices are highly specific to antibodies produced by your body in response to the SARS CoV-2 (COVID-19) virus that gives rise to coronavirus disease.
What is the difference between the NHS coronavirus laboratory test (PCR) and the immunoassay antibody test?
There are two main ways to detect a COVID-19 infection.
One type of test detects the presence of the actual virus using a laboratory technique known as rt PCR. This is currently the main type of test utilised in hospitals.
PCR testing requires the use of a nasopharyngeal or throat swab to collect a sample from the back of the nose and / or throat. The rt PCR laboratory test result can take typically 2–3 days from sample collection to the production of a report containing the test results.
The other type of test deploys a technology known as immunoassay screening. This type of test searches for COVID-19-specific antibodies that your body will produce in the event of a SARS CoV-2 infection. Antibody testing can be separated further into two categories.
‘Back to Lab’ testing is performed in a laboratory setting by fully trained scientists on laboratory instrumentation such as chemical analysers. Results can typically take up to 3 days from sample collection for the generation of a result.
Instant immunoassay screening is usually slightly less powerful than laboratory testing; however, the sample collection procedure is less invasive and does not require a phlebotomist. Additionally, a result is typically generated within 15 minutes.
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.
- Select the middle finger and massage for 60 seconds. Clean thoroughly with the alcohol cleansing wipe and allow to dry.
- Apply the lancet with a small amount of pressure to the middle of 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. Fill the larger pipette with blood up to the point it widens and place 2 drops into the ‘S’ sample well on the screening device.
- Use the smaller pipette to collect all the pre-measured buffer solution in the small tube and add to the ‘B’ sample well on the screening device. The results will appear in the section window within the 10-15 minutes.
- The result will be invalid if the control line does not appear, or if the results take over 20 minutes to appear.
Is your COVID-19 portable antibody screening device CE-Marked?
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.
Is your COVID-19 device approved by the MHRA?
The MHRA does not approve devices but has issued guidance on the minimum performance criteria for COVID-19-specific immunoassay screening devices. This can be found at https://www.gov.uk/government/publications/how-tests-and-testing-kits-for-coronavirus-covid-19-work/target-product-profile-enzyme-immunoassay-eia-antibody-tests-to-help-determine-if-people-have-antibodies-to-sars-cov-2
We are pleased to confirm that the immunoassay screening devices contained within our kits exceeds the minimum standard.