Difference between revisions of "Team:Munich/Safety"

New Regulations on IVDDs

Technological advances of the last decade facilitate development of new in vitro diagnostic devices (IVDD). Since these tests may have a high impact on individual and public health, their safety is a major concern. To keep up with scientific and technological progress and with needs of society, European Parliament adopted new regulation on in vitro diagnostic medical devices just few months ago - on 5 April 2017. Australian Therapeutic Goods Administration issued a regulatory framework on 1 July 2010.

The general trend is the same - new policies are more strict and should promote safety of IVDDs. For example, while the previous directive in EU required only one out of five IVDD to be checked by a Notified Body before it was placed on the market, according to new regulation only safety class A tests (lowest risk) will be sole responsibility of the manfucaturer. All devices of higher risk classes will require involvement of Notified Body. This risk classification of IVDDs is new as well and scheme for performance evaluation during lifetime of a device was introduced. While U.S. system focuses on evidence of clinical efficiency, the FDA rarely requires clinical outcome studies (1); in contrast, new EU regulation introduces new requirements for clinical evidence including clinical data and continous performance evaluation including incident reporting.

Self-tests

Another big topic related to new IVDDs is usage of self-tests. There are several risks associated with them (13):

• Diagnostic sensitivity:
  1. False-negatives (device shows negative result, though the true result should be positive). Since self-testers often perform tests for reassurance, without considering the disadvantages (12), in the best case self-tests for high severity conditions should be available only false-negative ratio is in the similar range as for clinical tests. Poorly informed patient may be harmed in case of false-negative; treatment will postpone and condition worsen. Consumer information should promote more informed usage for self-testing (12).
  2. False-positives (device shows positive result, though the true result should be negative). Though this fault may seem to be less harmful, since in case of testing for severe disease like HIV most of patients are aware that positive result must be confirmed (3), in case of testing for milder conditions, patient may receive unnecessary and potentially harmful treatment.
• Analytical sensitivity
  1. False-negative between infection and seroconversion: this risk is related rather to immunoassays and is less relevant for tests like our which is based on detection of nucleic acids.
• Analytical sensitivity
• Analytical sensitivity
• Analytical sensitivity

Since our project’s ultimate goal is to diagnose infectious diseases, we thoroughly addressed safety aspects of our work. Originally we had an intention to work with saliva samples, but since our lab has S1 biosafety level, we had to find another solution. So we decided to obtain RNA of non-pathogenic parts of B.subtilis, Norwalk virus and Hepatitis virus by method of in vitro transcription. Besides that we work with E.coli only.

More details about regulations, law and safety aspects of our work can be found in our Safety Form.