Microbe&Lab and its affiliated partners conduct a great deal of scientific research themselves. Coronalab only offers certified CE-IVD tests that are performed in a laboratory. The tests are internally and externally validated on the target use.
“Short of a vaccine, testing is the only way out of lockdown”, Professor Ara Darzi, Imperial College London and Co-Director of the College’s Institute of Global Health Innovation.
With this test we want to see if you currently have the corona virus. We use the so-called polymerase chain reaction (PCR) technique to investigate whether you have the coronavirus. This is the gold standard in virus diagnostics. With a throat and/or nasal swab we remove some mucus or fluid from your throat and/or nose. In the laboratory we isolate the genetic material of this RNA virus. Then we copy this into DNA and make multiple copies so that there is a lot of it and a machine detects it. If sufficient virus material is recognized, we receive a signal. That way we can see if someone is infected with the virus.
Microbe&Lab has been validated by RIVM to perform this PCR test. This means that RIVM has assessed our test results as good quality and that we also use the test set-up indicated by them.
With this (blood) test we want to see whether you have (IgG) antibodies against SARS-CoV-2. The test has been shown to be suitable and reliable for people who have had symptoms consistent with SARS-CoV-2 at least 14 days ago. It is also possible that you have had an exposure risk because, for example, you have been in contact with someone who had the virus. On the basis of the questionnaire under ‘our tests’ we select the right target group for our test.
We currently use a validated ELISA test. This test shows good reliability in several internal and external evaluations (see references). The blood bank Sanquin also uses an ELISA test to detect SARS-CoV-2 antibodies. The reliability corresponds to what experts expect from an antibody test.
A test has two important properties: specificity and sensitivity. Very high specificity is crucial for the application for our antibody test. The test should give as few false positive results as possible. A false-positive result would mean that someone thinks he or she has had the disease, when in fact he or she has not. So this would give a false sense of security. You also want to have the highest possible sensitivity so that the test actually identifies the people who have had SARS-CoV-2 as ‘positive’. Our ELISA tests have a sensitivity and specificity between 96-100% for the detection of antibodies against SARS-CoV-2 in our target group. All positive results are confirmed by an independent ELISA, which is advised by experts in the field as well as the manufacturer in its guidelines. We also use an online questionnaire to advise people with complaints to test. As a result, we also have a high prevalence (22% in latest data) which further increases the reliability of the test.
What do we do next?
Coronalab evaluates many corona tests and new test methods. This is a complex task because each application has its own set of criteria. Various tests are evaluated in a study context. We do this because we want to know more about the reliability of new tests in different target groups (eg differences in degree of symptoms and prevalence). For example, we see that these IgG antibodies also arise in asymptomatic infections (Long, et. al., Nature Medicine 2020), but we are currently investigating the reliability of the ELISA test in this asymptomatic target group.
With this research we also want to contribute to the development of new tests. For this we work together with various laboratories at home and abroad and we are looking at other initiatives such as FIND. We also want to share our own data with the RIVM.
A good summary of the various tests can be found here: https://www.ntvg.nl/materialen/klinische-betekenis-van-laboratoriumtesten-sars-cov-2/complete
- Adams ER., et al. Evaluation of antibody testing for SARS-CoV-2 using ELISA and lateral flow immunoassays. https://www.medrxiv.org/content/10.1101/2020.04.15.20066407v1
- Long, Q., et al. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med (2020). https://doi.org/10.1038/s41591-020-0897-1
- GeurtsvanKessel et al., Towards the next phase: evaluation of serological assays for diagnostics and exposure assessment. https://www.medrxiv.org/content/10.1101/2020.04.23.20077156v1
- Lassaunière, et. al., Evaluation of nine commercial SARS-CoV-2 immunoassays. https://www.medrxiv.org/content/10.1101/2020.04.09.20056325v1.article-metrics
- RIVM https://lci.rivm.nl/richtlijnen/covid-19
- Slot, et al. (2020). Herd immunity is not a realistic exit strategy during a COVID-19 outbreak. 10.21203/rs.3.rs-25862/v1. https://www.researchsquare.com/article/rs-25862/v1
- Zhao, J., et al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clin Infect Dis. Preprint at doi: 10.1093/cid/ciaa344 (2020).