Urine Kit Contents

The PROFILE-II A test kit (Catalog Number 600599) contains the following:

1. Twenty-five (25) test devices in individual foil packages containing a sample pipette.

2. One instructional package insert

3. One Color Comparator Chart

Storage Conditions

The kit, in its original packaging, should be stored at 2-25 °C (35-77°F) until the expiration date on the label.

READING THE TEST RESULTS

Negative: The appearance of both a reddish-purple Control (CTRL) line and a specific drug line indicates a negative test result. The color intensities of the Control line and a specific drug line may not be equal; any line of faint color intensity visible within 7 minutes indicates a negative test result.

Non-Negative: The appearance of a reddish-purple Control (CTRL) line and the absence of a line next to a specific drug name at 7 minutes indicates a preliminary positive test result for that drug.

Invalid: The absence of a reddish-purple Control (CTRL) line indicates the test is invalid. The urine sample should be retested on a new PROFILE-II device.

Precision

Performance of PROFILE-II around the specific cutoff for each drug was evaluated by testing standard drug solutions diluted in drug-free urine in replicates of 20 each on 3 different days by 3 operators. Twenty replicates of drug-free urine were also tested on each day. At 25% above the cutoff, the precision of each assay was as follows: THC=95%, COC=100%, OPI=96.7%, AMP=100%, and PCP = 98%.

LIMITED EXPRESS WARRANTIES

The manufacturer makes no express warranty other than the diagnostic test kit will measure certain drugs and/or drug metabolites and adulterants when used in accordance with the manufacturer's printed instructions. The use of the kit for any other purpose is outside the intended use of this product. The manufacturer gives no express warranty as to what the legal or clinical significance is of the levels of drug(s)/drug metabolites detected by the PROFILE-II A. The manufacturer disclaims any and all implied warranties of merchantability, fitness for use or implied utility for any other purposes. Any and all damages for failure of the kit to perform to its instructions are limited to the replacement value of the kit.

Covered by U.S. Patent No. 5,202,268.

P/N 101089

Rev. 7/01

Printed in USA