ToxScreen Integrated Split Key Cup

The ToxScreen Integrated Split Key Cup is a rapid, user-friendly, qualitative immunoassay test used to determine the presence of drugs. The device integrates a collection cup with the testing device but separates the sample well to split the urine for the device’s testing. The FDA-registered cup allows for easy, single-step urine collection and testing while keeping the device tamper-proof.

The device comes with a uniquely designed key that activates the testing procedure so that the test can be performed at the collector’s convenience. When the key is inserted into the side of the device cup, a portion of the urine is separated to perform the analysis, leaving the remaining urine unaffected by the testing procedure. The testing device draws urine from the bottom of the split sample well, eliminating the need to tip or shake the device.

The device has built-in controls that monitor the testing process, and the foil-wrapped test device can be stored at room temperature for 18 months. Each cup has a temperature strip affixed to its side to enable users to verify the validity of the specimen as the urine is provided. A large, clear viewing window allows for easy, accurate reading of results within three to eight minutes. An opaque sticker on the front of the device keeps results confidential until the authorized individual is ready to view them.

Alere offers several configurations of the ToxScreen Integrated Split Key Cup, including a combination of four to 10 drugs and specimen validity testing.

Device Features:

• Integrated collection cup and test cassette allows for easy urine collection and prevents tampering.
• Test results are kept confidential until the authorized individual is ready to view them.
• Collectors may record pertinent information regarding the specimen directly on the collection cup to aid in identification.
• Split specimen for the testing procedure ensures remaining specimen is unaffected in case it is needed for confirmatory testing.
• Test devices are self-contained and portable and can be sent directly to the laboratory if confirmation is required.
• Sealable collection cup eliminates the need to remove the test cassette after testing.
• Test controls are built into the device.
• Easy-to-read results are available in 3 to 8 minutes.
• The devices may be stored at room temperature for up to 18-months.
• Devices must be ordered in increments of 25.

These test devices utilize a similar technique for analyzing the concentration of drugs in the body as labs use, but any non-negative test results from a point of collection test should be considered preliminary. A more specific method should be used in order to obtain a confirmation. The Substance Abuse and Mental Health Services Administration (SAMHSA) has established Gas Chromatography/Mass Spectrometry (GC/MS) as the preferred confirmatory method. As users of Alere’s products, you may elect to forward specimens that screen suspect positive to one of Alere’s SAMHSA-certified laboratories for re-screen and confirmation.