The novel coronavirus pandemic has ignited stupendous growth in the market for antibody tests for Covid-19 within just a few months with hundreds of products flooding the world market for those who want to know whether they had already had the disease or not.
However the issue is that many of the tests are not of the appropriate quality and do not work properly.
This has prompted authorities in Europe to implement stricter rules and regulations or this new and fast growing sector to fish out those tests that provide faulty and ‘inaccurate reports on a continuous basis and consequently take action against the companies that manufacture the tests and make false claims, said report quoting sources with knowledge of the matter.
Such inaccurate test results put a lot more than just possibility of fraud.
These tests have become critical for governments and companies to ascertain the how widely the virus has spread as countries start to reopen their economies and employees get back to work. All of these is to prevent the resurgence of a second wave of the virus.
But if the results are inaccurate, those efforts would be undermined.
These test kits, that are also known as serological or blood tests, have been used by many people at home or for personal checks in clinics.
According to a list compiled by the EU Commission, the EU executive, the number of antibody kits that have been marked with Europe’s CE mark of quality has doubled to touch 200 since April.
But according to reports quoting half a dozen national regulators and industry sources across Europe, some of these tests have proven to be unreliable. The United States has already banned the use of at least nine of those quality marked kits, according to reports based on analysis of public data available from the Food and Drug Administration of the US, The FDA had taken measure against spurious antibody test kits since last month.
The self-certification regime that allows manufacturers of antibody test kits to themselves label their products with the CE mark is now being considered to be changed by the EU Commission, said reports quoting information from EU officials and two European regulatory sources. One of the changes will be to make it mandatory for companies making such test kits to get the products reviewed by independent watchdogs prior to placing the CE mark on them.
Such a measure would be a major change in the current regulations which now allow manufacturers to simply certify their test kits themselves as being compliant with EU safety rules. Under the proposed changes, supervisors and reviewers of the test kits will be allowed to penalize companies if it is found out that the claims that manufacturers have made are false .
It was "currently considering the best way forward", said a spokesman for the Commission when asked about the plans. "We are assessing a number of different instruments available together with member states to see which action is the most appropriate," he added.
(Source:www.nasdaq.com)
However the issue is that many of the tests are not of the appropriate quality and do not work properly.
This has prompted authorities in Europe to implement stricter rules and regulations or this new and fast growing sector to fish out those tests that provide faulty and ‘inaccurate reports on a continuous basis and consequently take action against the companies that manufacture the tests and make false claims, said report quoting sources with knowledge of the matter.
Such inaccurate test results put a lot more than just possibility of fraud.
These tests have become critical for governments and companies to ascertain the how widely the virus has spread as countries start to reopen their economies and employees get back to work. All of these is to prevent the resurgence of a second wave of the virus.
But if the results are inaccurate, those efforts would be undermined.
These test kits, that are also known as serological or blood tests, have been used by many people at home or for personal checks in clinics.
According to a list compiled by the EU Commission, the EU executive, the number of antibody kits that have been marked with Europe’s CE mark of quality has doubled to touch 200 since April.
But according to reports quoting half a dozen national regulators and industry sources across Europe, some of these tests have proven to be unreliable. The United States has already banned the use of at least nine of those quality marked kits, according to reports based on analysis of public data available from the Food and Drug Administration of the US, The FDA had taken measure against spurious antibody test kits since last month.
The self-certification regime that allows manufacturers of antibody test kits to themselves label their products with the CE mark is now being considered to be changed by the EU Commission, said reports quoting information from EU officials and two European regulatory sources. One of the changes will be to make it mandatory for companies making such test kits to get the products reviewed by independent watchdogs prior to placing the CE mark on them.
Such a measure would be a major change in the current regulations which now allow manufacturers to simply certify their test kits themselves as being compliant with EU safety rules. Under the proposed changes, supervisors and reviewers of the test kits will be allowed to penalize companies if it is found out that the claims that manufacturers have made are false .
It was "currently considering the best way forward", said a spokesman for the Commission when asked about the plans. "We are assessing a number of different instruments available together with member states to see which action is the most appropriate," he added.
(Source:www.nasdaq.com)