Use of On-Site Testing for Drugs of Abuse‪.‬

The use of on-site or near-patient testing (NPT) [1] devices as an aid in clinical diagnosis has long been recognized as a mechanism to allow rapid generation of biomedical results. NPT devices can be defined as any method that can be used to analyze specimens outside on the laboratory setting (1). The simplest of such devices are the dipstick tests and meters used in clinics and for routine measurement of chemistry analytes, ranging from the breath analyzers used at the roadside and in clinics to determine alcohol intoxication to the current spate of dipstick and cartridge tests for drugs-of-abuse screening. All of these NPT devices are classed by the Medical Devices Agency (an Executive Agency of the United Kingdom Department of Health that ensures that medical devices meet appropriate standards of safety, quality, and performance and comply with relevant Directives of the European Union) as in vitro diagnostic medical devices, defined under the In Vitro Diagnostic Medical Devices Directive 98/79/EC as "any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: