The Serology Task Force of the National Coordination Centre for Testing Capacity – a partnership between RIVM, hospitals and laboratories – has collected research results on rapid diagnostic tests from independent Medical Microbiology Laboratories. The preliminary conclusions show that none of the rapid diagnostic tests (‘point-of-care tests’ or POCT) that were examined meets the requirements for individual patient diagnostics.
Based on the WHO advice not to use serological rapid diagnostic tests for human testing, and on the preliminary data collected in medical microbiology labs in the Netherlands, the Task Force advises against the use of rapid diagnostic tests. The test results are not reliable. The percentage of false positive and false negative results is too high.
Sixteen rapid diagnostic tests assessed for reliability
These ‘point-of-care tests’ (POCT) are based on antigen detection, and many different options are being sold. At this time, 168 rapid diagnostic tests are available worldwide. In the Netherlands, 23 rapid tests for COVID-19 are currently in various phases of research and validation. For this study, the data from research by 14 different independent labs were assessed to evaluate 16 rapid tests.
The providers claim that these tests can determine within 10 to 30 minutes whether:
1. The person being tested is currently infected with COVID-19;
2. The person being tested has previously had a COVID-19 infection.
WHO discourages use of rapid diagnostic tests
On 8 April 2020, the World Health Organization published a scientific brief on the use of point-of-care immunodiagnostic tests for COVID-19 stating that rapid diagnostic tests are not useful unless they have been extensively approved in the appropriate context (certain groups in combination with specific questions). For that reason, WHO recommends only using them for research purposes, and not for testing people. The WHO warns that the use of unreliable rapid diagnostic tests may impede containment and control of the COVID-19 pandemic. The European Centre for Disease Prevention and Control (ECDC) has warned that there are rapid diagnostic tests currently being marketed with falsified CE markings*, accompanied by falsified documentation, incomplete technical validation and unsubstantiated performance claims.
*CE certification marking indicates conformity with EU European Union (European Union) health, safety and environmental protection standards for products, according to the manufacturer. More information
Advice of the Serology Task Force of the National Coordination Centre for Testing Capacity
The Task Force advises against the use of rapid diagnostic tests or self-tests. Users may become unnecessarily worried, or they may be wrongly reassured. The Health and Youth Care Inspectorate (IGJ) has also published a report about this.