Covid Antibody rapid testing
German manufactured MEXACARE COVID-19 IgG/IgM Antibody Test is a rapid, qualitative immunochromatographic assay for the differential detection of IgM & IgG antibodies against SARS CoV-2 virus in human serum, plasma or whole blood samples. The test is intended for the determination of a current or past infection with the SARS-CoV-2 virus and for monitoring the disease status after SARS-CoV-2 virus infection.
The MEXACARE COVID-19 IgG/IgM Rapid Test has a sensitivity of 94.55% and a specificity of 97.26%.
MEXACARE GmbH is an ISO 13485 certified manufacturer for rapid medical tests.
The advantages of Mexacare COVID-19 IgG/IgM Rapid Test:
- European CE Certified. In vitro diagnostic medical devices compliant
- 97.26% Accuracy
- Regulatory approved European manufacturers collaborating with Abbott, Siemens and Roche
- Test device for qualitative and selective detection
- Fast, easy, inexpensive – No lab equipment needed
- Safe point of care test with result within 15-20 minutes √ High Specificity (>97%) allows fast detection of infected people
- Detection of antibodies even in patients without symptoms
- Complements RT-PCR as a powerful tool to broadly assess spread of virus
- Proven reliability through comprehensive clinical study (more than 700 test subjects)
- Important diagnostic gap for the detection of an earlier immune reaction is closed
- Proof of immunity of patients, and to lift quarantine measures
- Offers the possibility of effective screening of large parts of the population
- Compared to competitive products, the MEXACARE COVID-19 IgG/IgM Antibody Test has clearer bands, which makes it easier to read
Why are antibody tests useful?
Antibody tests can fill a diagnostic gap. In the earlier phases of the disease after the onset of symptoms the IgM antibody test can be used to screen for active infections with SARS-CoV-2 and help to distinguish between COVID-19 and other respiratory diseases such as influenza or RSV.
In the later stages, the IgG antibody test can help to detect previously undetected infections and screen the serological immunity of large numbers of the population. In addition, the IgG antibodies remain in the body for a long time after the patient has recovered. Therefore, the result is a marker for successful convalescence in ONLY IgG-positive patients.
Since antibody tests are much faster and easier to perform, the extended use of these tests could relieve the laboratories and help to keep capacity at the same level.
When should I test with the MEXACARE COVID-19 IgG/IgM Rapid Test?
The MEXACARE COVID-19 IgG/IgM Rapid Test is intended to complement the RT-PCR tests, which are currently performed in large numbers by doctors, laboratories and public health authorities throughout the world in the fight against the novel Corona-Virus SARS-CoV-2.
During the earliest stages of the disease – in the incubation period (according to WHO around 5-6 days on average) and on the first 2-3 days after the onset of symptoms – only RT-PCR can give you satisfactory test results as the body has not produced antibodies in detectable quantities.
3-5 days after the onset of the disease‘s symptoms (cough, light fever, sore throat) IgM antibodies can already be detected in the blood. At this point, testing with the MEXACARE COVID-19 IgG/IgM Rapid test is recommended as positive results can now be obtained. IgG antibodies are produced later by the immune system and are detectable in the body for a long time after recovery. In this way, undetected infections (e.g. infections that proceed without symptoms) or the serological protection of the test subject can be determined.
- C. Wedtner – Schwabing Hospital; C. Drosten – Charité; R. Wölfel – Microbiology of the German Armed Forces; RKI
- I. Eckert – University Hospital Geneva;
- Lauer, S. et al., 2020. The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application. Annals of Internal Medicine;
- National Health Commission of the People’s Republic of China, New Coronavirus Pneumonia Diagnosis and Treatment Program
Covid Testing FAQ’s
There are 3 main types of Covid tests available. These are split into 2 groups (1) laboratory tests (2) rapid tests.
The laboratory test or PCR test is mainly available through the National Healthcare provider (HSE or NHS) and can also be offered by some private healthcare providers. This is a very in-depth test and due to the need to return a sample to the laboratory can take several days for a result.
There are 2 rapid tests available which can be obtained more locally from your GP or other medical practitioner. These consist of the Antigen test and the Antibody test and can get you a result in 10-15 minutes.
You should get a test done if you are informed that you have been in contact with someone with Covid or have some symptoms which would indicate a possible infection. It is important not to get a test done too soon after encountering a Covid contact; leave 5-6 days or the testing will not detect the virus in your system; this is the incubation period a bit like measles. If you have symptoms the disease has progressed past the incubation period and testing can be done immediately.
Currently the main test used by Healthcare authorities is the PCR test and can be used to help detect an infection. The test can be done after 5-6 days incubation and in the early stages after the onset of symptoms. The PCR test is mirrored in time of use by the Antigen test for when it can be used to detect an infection. This test is gaining in popularity as it can be more accurate and give results in 10-15 minutes.
This is the best test to use 3-5 days after the onset of symptoms as the results are available in 10-15 minutes and it is the only test that can inform you where you are in the cycle of the disease. If you detect an IgM antibody only result you are in the 1st 7 days of symptoms and are infectious. If you detect an IgM and IgG antibody presence you are in the 7-14 day stage and still infectious. If you detect IgM only you are not infectious and ready to go back to work if you feel well enough.
Products that are made in Europe have higher manufacturer standards than other places in the world. For the individual tests, there are 2 main factors to look for when comparing tests. The Specificity (shows it only detects Covid and not other diseases like influenza etc) and the Sensitivity (shows how sensitive the test is to detect smaller quantities of the virus).
For the Mexacare products made in Germany the Antigen test has a Specificity of 99.38% and a Sensitivity of 95.65%. The Antibody test has Specificity of 97.26% and a Sensitivity of 94.55%
The Specificity and Sensitivity from different manufacturers tests all look similar so is there one better than another?
If you want to go more in depth you now need to look at the values obtained when comparing different Ct-values (Cycle threshold values). This will distinguish a quality test kit and will help you make the right decision. The Mexacare Antigen kit is 100% accurate for Ct values 20-30 but drops to 90.3% at 20-34 Ct values however this is usually 10-15% better than most of the well-known brands on the market which can range from 84-45%.