Varian, Inc.
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Diagnostics
On-Site? CupKit™
OnTrak TesTcup?
OnTrak TesTcup? II
OnTrak TesTstik™
OnTrak TesTcard™ 9
On-Site? Alcohol
On-Site? OraLab?
OnTrak OraTube™
SMARTdata Solutions

The step-by-step OnTrak TesTcup? process


1. Open foil pouch to remove the cup. Record specimen ID in designated spot (a permanent marker works best).

 


2. Collect directly in cup (or add specimen to cup). A minimum sample of 30 mL is recommended. TesTcup can also deliver results with as little as 15 mL.

 


3. Close lid by lining notch up to the "TEST" position and gently pushing down on lid.

 


4. Tilt cup forward (toward the front label) until the specimen is covering 1/2 to 3/4 of the lid. Do not fully invert or shake the cup. Hold for a full count of 10 seconds (20 seconds if using less than a 30 mL sample).

 


5. Place on flat surface. Wait for all "TEST VALID" bands to appear. Timing is not required.

 


6. Remove the Results label and place it anywhere on the cup. Read each result.

 


7. Close lid by turning clockwise to "STOP" position for storage and shipment




Result interpretation


Test valid

A dark blue, light blue, or partial blue band in the "TEST VALID" window should be interpreted as valid.

If the "TEST VALID" bands do NOT appear, retilt the cup for an additional 10 seconds. Return cup to upright position and let sit for an additional 1 to 3 minutes.

The intensity of the blue bands in the "TEST VALID" and "TEST RESULT" windows will vary between different tests.

 


Negative

A dark blue, light blue, or partial blue band in the "TEST RESULT" window should be interpreted as negative.

 


Positive

No color present in the "TEST RESULT" window -- appears as a white plus (+) sign -- should be interpreted as a preliminary positive.




Temperature strip


The TesTcup design includes a built-in temperature strip to assess sample integrity. Normal temperature for fresh, unadulterated urine is 32-37 °C (90-99 °F).



Maximizing performance

? Store unused TesTcups at room temperature. Do not open the foil pouch unless it is at room temperature.
? Always review the expiration date and lot number prior to using a TesTcup. Do not use expired product.
? Run the TesTcup within 8 hours of removing it from its protective packaging. This time frame may be shorter in extremely humid climates.
? Run the test as soon as possible after sample collection.
? If the lid is in the "STOP" position (locked) prior to running a test, turn counter-clockwise to the "TEST" position for 1 full minute before tilting the cup.
? After performing a test, turn the lid to the extreme, clockwise position ("STOP") for secure transport or storage. Patented technology of the TesTcup design guarantees that no contamination of the urine sample will occur from the reagent system. Confirmation tests will be unaffected.

Proven performance

? Cleared by U.S. Food and Drug Administration (FDA) as both a medical device and a transportation device
? Meets all current established and legally defensible Substance Abuse and Mental Health Services Administration (SAMHSA) cutoff detection levels
? Performance data shows accuracy results compared to Gas Chromatography/Mass Spectrometry (GC/MS) methods
? Cutting-edge technology design delivers fast results which can be read without needing subjective interpretation
? Developed in compliance with all ISO 9001 procedures

Proven stability and easy storage

? 36-month shelf-life from date of manufacture
? Up to 8-hour stability after unused product is removed from protective foil pouch
? 30-minute stability of result (after performing a test)
? Room temperature storage -- no refrigeration required

Self-contained, integrated design for collection, testing, and transport

? No reagent mixing or handling
? Option to void sample directly into cup to eliminate urine handling
? Lid locks down for secure transport or storage

Simple to use

? No multiple steps to learn -- just fill, tilt, and read
? No timing devices required
? Results are ready to read in 3-5 minutes -- and remain stable for up to 30 minutes

Clear, easy-to-read results

? Built-in temperature strip helps you assess sample integrity
? Blue band confirms validity of test for each individual drug
? Blue band appears to indicate a "negative" result for each drug
? White plus sign (no blue band) indicates a "preliminary positive" result for each drug


Test your knowledge