Combined Antibody Assay
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.
Spring Health is proud to announce that we are one of the first company with a rapid test for COVID-19 lgG/lgM. Our product is made with CE mark in order to fulfill highest European standards. Now worldwide our product is being used to screen patients for the corona virus.
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Frequently Asked Questions
What are IgG and 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.
What do the results mean?
The test strip has three different lines; one for IgG, one for IgM and one control line. There are four different valid results:
IgM + Control – The sample is positive for IgM. This means the patient is in the early stages of an infection and combined with the common symptoms, is positive for COVID-19
IgG + IgM + Control – The sample is positive for both IgG and IgM and therefore positive for COVID-19
Control only – The sample is negative
If the control line does not appear, the test is void and should be repeated, irrespective of how many test lines are visible.
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.
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.
How accurate is the test?
We conducted a clinical study in Wuhan, China, where we compared the test cassette to conventional laboratory tests for COVID-19 diagnosis, which also detected the presence of IgG/IgM in 902 blood samples. We obtained the following results:
Sensitivity > 91%
Specificity > 99%
Accuracy > 97%
This clinical study is evidence of the usability and effectiveness of the test.
Is the product already on the market, e.g. in Great Britain?
This is a relatively new test but is now being used successfully in many countries around the world.
What should I do if I test positive?
If you test positive, you should follow your country’s government’s advice on COVID-19 infection. This usually means self-isolation for 7 days, avoiding contact with others and remaining hydrated. Most cases of COVID-19 are mild and recovery only takes a few days, so there’s no need to panic. Speak to your healthcare practitioner for further advice.
Can babies and young children be tested?
Yes, there are no issues with testing babies and young children.
What if I test negative?
A negative result means the biomarkers are not present in your blood, but you should still exercise caution, as you may still be in the early stages of infection (before IgM levels rise to a detectable level). If symptoms develop, follow the protocols as above and retest as necessary. If symptoms do not develop, it is unlikely you have COVID-19 but should still follow strict hygiene procedures. Ensure you wash your hands regularly, avoid social gatherings and work from home if possible. There’s no need to retest unless you suspect you have contracted the infection and are displaying symptoms.
What if I test positive but don’t display any symptoms?
In this case, there are two options. Either you are infected and may begin to display symptoms in the next few days, or you are infected but are asymptomatic (you won’t display symptoms). In both cases, you should treat it as though you are positive for the virus and should follow the appropriate healthcare guidelines. Speak to your healthcare practitioner for further advice.
So can the test 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.
What if I test negative but display symptoms?
If you have the common symptoms of COVID-19 (fever and cough), you likely have contracted the infection and should self-isolate. It is likely your IgG/IgM levels haven’t risen to a detectable level yet. You can be tested again 24 hours later for confirmation id required. Speak to your healthcare practitioner for further advice.
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.
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 pregnant or breast feeding women be tested?
Yes, there is no harm to the mother or baby when performing a test.
Is the test CE marked? Does it have IVD certification?
Yes, the COVID-19 test is CE marked for professional use and is therefore a registered IVD device.
Has the test been accredited by the NHS or Public Health England (PHE)?
The COVID-19 test is CE marked for professional use and is therefore suitable for use by a healthcare professional. This test is very new to the market and is an excellent and accurate way to quickly detect COVID-19.