COVID-19 Colloidal Gold Immunoassay Testing Kit,
IgG/IgM Combined

We have all the answeRs

Frequently Asked Questions

How does the test casette work?

The test is a lateral flow immunoassay test and operates in a similar way to a pregnancy test. Embedded into the test strip are antibodies that bind to a COVID-19 specific biomarker, Immunoglobulin G (IgG), and another infection biomarker, Immunoglobulin M (IgM). When a sample (blood, serum or plasma) is added to one end of the test, it flows along the test strip and interacts with these antibodies. If the patient has contracted COVID-19, the biomarkers in their blood will bind to the antibodies on the test strip, leaving a visible test line. If the patient doesn’t have COVID-19, no biomarkers should be present in their blood and no test line will be visible. There are separate test lines for IgG and IgM and only one needs to be visible for a positive result.

What are IgG & IgM?

Immunoglobulins are antibodies themselves and are part of our immune system. When we get an infection, such as COVID-19, immunoglobulins are produced, which attach to the virus and activate the rest of the immune system to attack and clear the virus. IgM is the first immunoglobulin to be produced and is a general antibody that can bind to many different types of pathogen. The presence of IgM is an indicator of early infection. IgG is a more specialised antibody that specifically binds to the SARS-CoV-2 virus. The presence of IgG is an indicator of later stage infection (usually 7 days or longer after infection).

Is the test specific for COVID-19?

The IgG that the test detects is specific to COVID-19, so a positive result would indicate COVID-19 infection. Although the IgM is a more generalised antibody, its presence, combined with IgG and/or the common symptoms of COVID-19, would also indicate infection with the novel SARS-CoV-2 virus. The test can be used for primary and secondary diagnosis of COVID-19.

What samples can I use?

The test cassette will work with whole blood, plasma or serum. Capillary blood is the easiest to obtain via a finger pinprick, however, venous blood obtained via venepuncture is also suitable. The type of sample will not affect the sensitivity or accuracy of the test.

What is the buffer solution for and can I use any buffer with the test?

The buffer solution has two functions. It acts as the carrier for the sample, allowing it to laterally flow along the test strip, and it maintains a constant sample pH as it flows, preventing degradation of the biomarkers and the antibodies. We recommend that you only use the buffer solution provided with the test kits, as other ones may affect the accuracy of the test.

So the test can detect asymptomatic patients?

Yes, the test will be able to detect IgM/IgG in asymptomatic people, as they will have an immune response even though they don’t display symptoms. The timeline of infection will be the same as someone displaying symptoms.

I didn't read the results after 10 minutes. What should I do?

For the result, the window of accuracy is 10-15 minutes after you add the sample and buffer solution. If you forget to read the results after this time, the test may not be accurate and you should repeat it.

What is the shelf-life of the test cassette?

The shelf-life is 18 months from the date of manufacture. The product expiry is printed onto the packaging for reference. Do not use after the expiry date.

How should I store the tests?

The recommended storage temperature is 2 – 30°C, however, we do not recommend you store them in the fridge, unless there is a risk of them overheating. Do not freeze the test cassettes or buffer solution. Tests should be performed at room temperature (15 – 30°C), so if you have stored tests in the fridge, you should allow them to reach room temperature before performing a test.

Do any medications, drugs or other proteins in the blood affect the test result?

To date we have tested numerous common pharmaceuticals, none of which have interfered with the test. Also, Rheumatoid Factor does not interfere with the test, hence we currently see no cross-reactivity issues. We are looking at more drugs and will update customers accordingly.

How accurate is the test?

The COVID-19 Colloidal Gold Immunoassay Testing Kit, IgG/IgM Combined had a positive coincidence rate of 100%, a negative coincidence rate of 98.65%, a positive predictive value of 98.41%, a negative predictive value of 100%, a total coincidence rate of 99.26%, a paired chi-square test P-value ≥0.05 and a Kappa value = 0.9852. The statistical results show that the two reagents are consistent, that is, the test reagent is equivalent to the reagents of the same species on the market. The results of simultaneous detection of homologous serum and plasma, whole blood, and peripheral blood samples using the test reagents show that the test reagent has a positive coincidence rate of 100%, a negative coincidence rate of 100%, a total coincidence rate of 100%, a paired chi-square test P-value ≥0.05 and. Kappa consistency test Kappa value = 1.0, indicating that the results of homologous serum and plasma, whole blood, peripheral blood test are consistent.

Will IgG and IgM remain in the blood after I’ve recovered from COVID-19?

There is some evidence that IgG/IgM remains in the blood after recovery to prevent reinfection. We have tested some patients and noticed that they still test positive for at least 33 days after first displaying symptoms. You won’t be infectious after you recover, even if you test positive, but you should still be cautious as long term immunity has not yet been confirmed and reinfection may still occur.

Can babies and young children be tested?

Yes, there are no issues with testing babies and young children.

Can pregnant or breast feeding women be tested?

Yes, there is no harm to the mother or baby when performing a test.

Is there anyone that shouldn’t be tested?

No, the more people that are tested, the better it will be to understand the spread of the virus, which will result in better measures being taken to prevent its spread. However, as the test requires a blood sample, anyone with a blood-related health condition (such as haemophilia) should discuss this with a healthcare professional before performing a test.

Is the test CE marked? Does it have IVD certification?

Yes, the COVID-19 Antibodies Rapid Test Kit, IgG/IgM Combined is CE marked for professional use and is therefore a registered IVD device, according to the requirements in the In Vitro Diagnostic Medical Device Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998. The test kit holds a Certificate of Free Sale issued by United Kingdom Medicines and Healthcare products Regulatory Agency (UK Medical Devices Regulations 2002 S.I. No. 618, as amended) and therefore may be freely sold in all member states of the European Economic Area including the United Kingdom.

Is the product already on the market, e.g. in Great Britain?

The test kit is sold throughout the United Kingdom, Europe, Africa and Euroasia.

Has the test been accredited?

The COVID-19 test is CE marked for professional use and is therefore suitable and ready for use by a healthcare professional. In addition to our clinical evaluations already completed on the product, we are currently working with a number of independent laboratories and Departments of Health across Europe to further validate the product and gain best practice approvals.

Do you have a confirmation lab test for Coronavirus to confirm positive samples?

This screening test is designed to be used alongside a robust screening protocol with laboratory confirmations. We would recommend you work within your healthcare institution to ensure the correct protocols are being followed when using this product.

We SHOW you how it's done!

Instructions for Use

Product Manual

View the COVID-19 Antibody Test Kit Instructions for Use.

View the Complete Whole Blood Collection Kit Instructions for Use.


  • Do not open pouch until ready to use.
  • Necessary materials: Test cassette, Buffer solution, Capillary Sampler, Lancet
  • Label Test cassette with patient ID.
  • Test on a level surface at room temperature. Always use appropriate PPE.
Phase 1. Whole Blood Collection
  1. Wear gloves and remove device(s) from packaging.
  2. Wash patient hands and sterilise finger with a disinfectant wipe.
  3. Prick fingertip with the lancet and gently press finger to produce blood.
  4. Use capillary sampler to obtain 20μL of blood. * For serum/plasma sample, take 20μL serum or plasma sample respectively,
  5. Add the sample into 60μL of buffer solution, recap and shake sample to mix thoroughly.
  6. Clean wound with cotton swab and cover with band-aid.
Phase 2. IgG & IgM Antibody Test
  1. Remove cap of the buffer solution and dispense 2-3 drops into the Test Cassette sample well using the capillary sampler.
  2. Allow test to run for 10 minutes. Read the results by viewing the detection window and comparing to the guidance below. Test results that have run over 15 minutes are invalid.
  3. NOTE: Cassette appearance below is indicative of final product. Please contact in the case of any uncertainty reading results.

Having issues/problems, watch the video here

We provide an overview of what is inside!

Kit Content

The COVID-19 Antibody Test Kit contains the following items:

- 1x COVID-19 test cassette
- 1x Retractable lancet
- 1x Capillary sampler
- 1x Buffer solution
- 1x Disinfectant wipe (not shown)
- 1x Cotton swab (not shown)
- 1x Band aid (not shown)

COVID-19 test cassette

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