Test Kit Highlights
PortableCan be used anywhere without additional equipment or instruments required.
FlexibleWorks with fingertip blood, serum, plasma or whole blood samples.
SimpleEasy to use in four basic steps.
QuickClear results within ten minutes with high accuracy.
CertifiedCE-IVD marked and tried-and-tested in clinical trials.
The COVID-19 IgM/IgG test kit (fingertip blood, serum, plasma, whole blood) is a lateral flow immunochromatographic assay. The combination use of lgM and lgG testing can detect viral infection and immunity to the novel coronavirus effectively:
IgM/IgG positive indicates recent infection with COVID-19 and positive blood test for both antibodies.
IgM positive indicates recent infection with COVID-19, IgM has appeared in the blood.
IgG positive indicates that COVID-19 infection occurred, IgM has disappeared (potential immunity to the novel coronavirus).
Negative result indicates neither antibody is present.
Areas of Application
COVID-19 IgM/IgG Rapid Test Kit has different areas of application:
COVID-19 detection and screening in hospitals
Rapid testing at doctor's offices and pharmacies
COVID-19 tests at Immigration on borders
Widespread community testing for immunity to further COVID-19 infection
Self-testing at home for families
Screening at schools, universities and companies before reopening
How to use the Test Kit
Bring the test cassette to room temperature prior to testing. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Place the test cassette on a clean and level surface.
Venous blood collection: Add 10 μl of serum/plasma or 15 μl of whole blood sample to the sample well.
Add Diluent: Add two drops of diluent to the sample well. Avoid air bubbles.
The results can be interpreted in 10 minutes. Results measured after 20 minutes are invalid and should be discarded.
The COVID-19 IgM/IgG Rapid Test Kit (fingertip blood, serum, plasma or whole blood samples) is a lateral flow immunochromatographic assay. The burgundy coloured conjugate pad contains recombinant COVID-19 antigens conjugated with colloidal gold (COVID-19 conjugates) and rabbit IgG-gold conjugates.
When a specimen - followed by sample diluent - is added to the sample well, IgM and/or IgG antibodies - if present - will bind to COVID-19 conjugates to form an antigen antibody complex. This complex migrates through the nitrocellulose membrane by capillary action.
When the complex meets the line of the corresponding immobilized antibody (anti-human IgM and/or anti-human IgG), it is trapped to form a burgundy coloured band, which indicates a positive test result.
The absence of a coloured band in the test region indicates a negative test result. The test contains an internal control (C band) which should give a burgundy coloured band for the immunocomplex goat anti-rabbit IgG/rabbit IgG-gold conjugate, regardless of the colour development on any of the test bands.
Otherwise, the test result is invalid and the specimen must be retested with another device.
The World Health Organization (WHO) and governments around the world have called for urgent action to ramp up efforts to test for Covid-19 infection as a vital part of minimizing the scale of the outbreak and to track how it is evolving. In particular, a point-of contact test is needed that is simple and convenient to administer and can be done at home or at a doctor’s office without overloading hospitals and labs.
Immediately in the aftermath of the COVID-19 outbreak in Wuhan China. Xam-Med and its clinical partners in China began working closely with the Wuhan Third Hospital to develop and clinically test a rapid serology test, able to identify the COVID-19 infection in as little as 10 minutes.
It is Xam-Med’s primary goal to offer people around the world the ability to test with lab-level accuracy and speed without the need to send samples to a hospital or laboratory for results. Xam-Med, as a global company, is proud to bring this innovative and ground-breaking new rapid COVID-19 at-home testing capability to the world-wide fight to stop the Covid19 pandemic.
Xam-Med operates in over 20 countries to offer specialized health and wellness products to the hospital and at home medical industries.
What are IgM and IgG antibodies?
The immune system forms defensive substances called antibodies against COVID-19 (Coronavirus SARS-CoV-2). They belong to the classes of immunoglobulin M and immunoglobulin G (IgM and IgG). IgM antibodies develop when an infection is relatively recent. IgG antibodies only appear once the infection is already a bit older, however.
While the IgM antibodies only remain detectable in the blood for a short period, the IgG antibodies can be detected in the blood for longer. If IgG antibodies are detected, this does not mean that the individual has a COVID-19 infection that requires treatment. Antibodies only show that the immune system has been exposed to the pathogen.
In turn, a negative antibody test does not entirely rule out a COVID-19 infection in its early stages. If there are doubts about the results of the quick test (e.g. typical COVID-19 symptoms such as dry cough and high fever), it is essential to see a doctor.
Why are quick tests helpful?
Simple quick tests that provide reliable test results for an infection with COVID-19 symptoms are very useful in the current situation. They allow infected individuals to be identified and treated quickly and the risk of spread to other people can be minimised. In addition, these quick tests can reduce the strain on laboratory capacity for time-consuming PCR tests. In some countries, there is also limited capacity to perform the expensive PCR tests.
To be able to lift the significant measures to contain the COVID-19 pandemic (e.g. curfews, closing kindergartens, schools or universities, stopping production in factories), reliable information about who has already had contact with the virus and recovered from the infection is important. It is assumed that these individuals are immune against reinfection.
It would therefore mean that these people, after weighing up the risks, can return to their jobs, go back to kindergarten, take part in classes at school or attend lectures at universities. By testing staff in hospitals, doctors and nurses with positive antibody tests can be assigned to caring for patients with COVID-19.
Discharging patients that have the lung disease triggered by the COVID-19 virus can be made more efficient and safe for the population thanks to the quick antibody test. If a patient has no IgM but lots of IgG antibodies, it is believed that the patient has recovered from the disease and can be discharged.
How reliable is the test?
The test kit underwent a comprehensive clinical study at Wuhan Third Hospital. A total of 227 subject samples were tested in this clinical trial. The test results shall be summarized as follows: The examination results of 227 clinical stool samples showed that the total reagent (IgM + IgG) sensitivity was 93.13%, the total IgM sensitivity was 78.43% and the total IgG sensitivity was 84.31%.
The measurement results of the COVID-19 IgM/IgG Test Kit (Colloidal Gold) and the results of the "Pneumonia Diagnosis and Treatment Scheme for Printing and Distribution of New Coronavirus Infection" issued by the Chinese General Office of the National Health and Health Commission (PRC) are highly consistent. Given these results, the COVID-19 IgM/IgG Test Kit is equivalent to the clinically confirmed diagnosis standards.
In addition, the test kit is currently undergoing further clinical studies in Europe.
What must I bear in mind when using the test kit?
Simple rules should be followed to make sure the test kit is used correctly. First of all, the test kits can only be used for human serum samples, human plasma samples and venous human whole blood samples. For an accurate test result, the test procedure described in this package insert must be strictly observed. Deviations from the rules, such as the use of expired test kits, can lead to inaccurate results.
Incorrect procedures when taking, transferring and processing samples and the processing of blood samples with low concentrations can lead to incorrect results.
The test results of the test kit only serve as a guide and should not form the sole basis for diagnosis and treatment. The test kit should be used alongside recording clinical symptoms and confirmed by further traditional confirmation methods. It is not a suitable replacement for a diagnostic laboratory result.