A procedural control (the control line [C]) is built into each test strip, indicating that the regents on the device are present and functioning properly.

For laboratory use it is good laboratory practice to use positive and negative controls to ensure proper test performance. Follow federal, state and local requirements for Qualilty Control testing. Control specimens are commercially available. Positive and negative controls should be used: 1) prior to using a new lot/shipment of test devices, 2) if the product has been stored outside the recommended storage conditions, or 3) as determined by your organization’s protocol.

Test results should be confirmed by an accepted reference method such as GC/MS.

A urine specimen collected in the Rapid TOX Cup II can be transported to a laboratory without the need to transfer to another container if shipped within nine (9) days. The specimen must be refrigerated and preferably shipped with cold packs.

Limitations of Procedure

Rapid TOX Cup II is designed for use with human urine only.

Rapid TOX Cup II provides only a preliminary qualitative test result. Use a more specific alternative quantitative analytical method to obtain a confirmed analytical result. Liquid chromatography Mass spectrometry (tandem MS) LC-MS/MS or gas chromatography/mass spectrometry (GC/MS) are the preferred confirmatory method. Use the best judgment to any Rapid TOX Cup II test result; particular when preliminary positive results are obtained.

Other substances and/or factors not listed may interfere with the test and cause erroneous results, such as adulterants, procedural errors or cross reactivity with other drugs or agents.

For troubleshooting tips and more information on cross reactivity with other drugs, please consult the Product Instructions from the Rapid TOX Cup II box.