As a part of EU efforts to offer steerage on using coronavirus exams, the JRC has created a database of COVID-19 in vitro diagnostic gadgets and check strategies that gathers info on accessible exams in a single place.
Testing for the presence of the SARS-CoV-2 virus or previous publicity to it’s a vital facet of combatting the COVID-19 outbreak, and for environment friendly methods for steadily lifting the confinement measures.
In the mean time, numerous exams exist already within the EU, and new exams are being developed.
Totally different exams are appropriate in several contexts. Data on their efficiency, i.e. how properly they work to realize their supposed objective, is necessary for making decisions, as an example as a part of nationwide methods.
As a observe up motion to the Communication “Pointers on in vitro diagnostic exams and their efficiency”, the JRC has developed a database, which gathers in a single place info on the at present accessible exams.
The database accommodates publicly accessible info on gadgets, together with parts of efficiency, and a collation of related scientific literature.
It doesn’t embrace producer technical documentation, which isn’t publicly accessible.
About COVID-19 exams
The COVID-19 exams fall broadly into two classes: these detecting the presence of the SARS-CoV-2 virus and people detecting previous publicity to the virus, i.e. the physique’s immune response to the an infection.
If an individual is contaminated, nasal or throat swabs can be utilized to disclose the presence of the virus.
This may be finished by both focussing on the particular genetic materials of the virus (in a so-called RT-PCR or reverse transcriptase polymerase chain response) or on sure particular molecules which are current on the floor of the virus (known as antigen exams).
The exams detecting previous publicity to the virus – additionally known as serological exams – reveal the presence of antibodies within the blood of an contaminated individual, produced in response to the virus.
Antibody exams are considerable on the EU market, however their effectiveness for the prognosis of COVID-19 is proscribed as a result of antibodies turn out to be detectable within the affected person’s blood solely a number of days after an infection.
Nonetheless, antibody exams may turn out to be important for performing large-scale inhabitants surveys and for guiding de-escalation methods when the pandemic is below management.
Making certain good check efficiency
EU legislation (Directive 98/79/EC) stipulates that CE-marked gadgets should be manufactured in order that they’re appropriate for the aim supposed by the producer, taking account the widely acknowledged state-of-the-art.
The producer is liable for evaluating the efficiency of the exams earlier than putting the gadget available on the market. This should be mirrored within the technical documentation of the gadget.
Nationwide competent authorities are liable for the surveillance of gadgets available on the market, and for taking acceptable motion in opposition to gadgets that don’t conform with the laws.
Given the fast improvement of the COVID-19 pandemic, the efficiency of the gadget within the medical observe could differ from the preliminary efficiency research carried out by the producer.
Due to this fact, the European Fee recommends finishing up extra validation of COVID-19 exams.
Validation refers to affirmation that the check achieves the efficiency ranges specified by the producer.
Such research are carried out by laboratories within the EU Member States.
The JRC has just lately developed a optimistic management materials for the validation of RT-PCR exams, which is out there to laboratories in Europe.