WHO Prequalification of In Vitro Diagnostics Programme is to promote and facilitate access to safe, appropriate and affordable in vitro diagnostics (IVDs) of good quality in an equitable manner. Focus is placed on IVDs for priority diseases and their suitability for use in resource-limited settings. We have identified six steps that must be addressed when selecting an in vitro diagnostic test: (i) define the test’s purpose; (ii) review the market and check each product’s specification; (iii) review the test’s regulatory approval; (iv) obtain data on the diagnostic accuracy of the test under ideal conditions (i.e. in laboratory-based Skin testing alone or in combination with in vitro testing is relied upon for the evaluation of allergic rhinitis, asthma, eczema, food allergy, insect sting allergy, drug allergy (especially beta-lactam and local anesthetic allergy), occupational disease and anaphylaxis. However, the reliability of these tests depends on a number of factors. In vitro diagnostics are medical devices that analyze human body fluids, such as blood or urine, to provide information for the diagnosis, prevention, or treatment of a disease. The device In vitro diagnostic (IVD) tests that have been traditionally performed in laboratories (labs) are becoming increasingly performed outside of labs, which leaves those tests untethered from their A biomarker can be used as the basis for creating a routine diagnostic test for clinical use, after it has been approved as an in-vitro diagnostic. A biomarker can also be used to develop a Sec. 809.3 Definitions. (a) In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection Summary. In vitro is Latin for “in glass.”. In vivo is Latin for “within the living.”. In vitro studies often include cells in petri dishes and test tubes. In contrast, in vivo studies bM09tm0.