Testing laboratory

The analytical performance validation of the automatic devices and diagnostic reagents is a critical step in registration process and routine laboratory use.
Performances, technical properties of reagents, automatons and of the reagent/ device couple have to be tested, qualified and validated. The use of a thrid party for the expertise bring the transparency guaranty to notified bodies.

That quality process is required during the entire life of the product and for each evolution.

Biological reagents validation

Reagents are the heart of every biological tests, to perform analysis or induce physiological reaction. These reagents have to be qualified when developed and each time they evolve for their:

  • Stability
  • Specificity
  • Detection range
  • Interferences
  • Cross reactions

Diagnostic systems validation

Most of routine techniques are now automatized. As reagents have to, analyzers run under certification process before access to the market. Each update of the system may also require an evaluation for its agreement. The tests we realized are similar to those for reagents as we validate a couple : analyzer and reagent. Parameters tested are:

  • Within run precision
  • Within Laboratory precision
  • Detection range
  • Interferences
  • Cross contaminations

Amarok Biotechnologies perform these tests according to European and CLSI rules or under specific protocols that you wanted to apply.

These studies are strictly confidential.

In association with our partners we can also :

  • Help you with regulation submission forms
  • help you in clinical validation of your analytical parameters

Our test lab is certified ISO 9001:2015.