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The Roche Diagnostics Corporation OnTrak TesTstik™ for Morphine 2000 (M2K) is an in vitro t st intended for professional use for the qualitative detection of morphine in urine at or above a cutoff concentration of 2000 ng/mL OnTrak TesTstik provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.

The OnTrak TesTcup M2K is an in vitro test intended for professional use in the qualitative detection of d,l-amphetamines (1000ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL) and morphine (2000 ng/mL). The TesTcup assays are based on the principle of microparticle capture inhibition. The test relies on the competition between drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane in the test chamber. Urine is collected directly in the OnTrak TesTcup M2K. After closing the cap and moving it to the "TEST" position, the sample reservoir is filled by tilting the cup. Urine then flows through a membrane by capillary action and reacts with antibody-coated microparticles and drug conjugate present on the membrane. In the absence of drug, the antibody is free to interact with the drug conjugate, causing the formation of a blue band ("negative" sign). When drug is present in the specimen, it binds to the antibody-coated microparticles. If sufficient drug is present, the microparticles are inhibited from binding the drug conjugate, and no blue band is formed. A positive sample causes the membrane to remain white ("positive" sign). An additional antibody/antigen reaction occurs at the "TEST VALID" area for all assays. The "TEST VALID" blue band forms when antibodies, which are imbedded in the membrane, interact with, and bind to, the antigen on the blue-dyed microparticles.