Additional Support

Directions

Allow the test cup, urine specimen, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the cup from the sealed pouch and use it as soon as possible.
2. Remove the key by twisting it from the center of the cup cap.
3. Collect specimen in the cup and secure cap tightly by pressing down on the pull tab until an audible click is heard.
4. Technician dates and initials the security seal and attaches the security seal over the cup cap.
5. Place the cup on a flat surface and push the key to a fully closed position to initiate the test. Start the timer.
6. Remove the peel off label covering the test results.
7. If adulteration is included on the test cup, read the adulteration strip(s) between 3 and 5 minutes. Compare the colors on the adulteration strip to the enclosed color chart. If the specimen indicates adulteration, refer to your Drug Free Policy for guidelines on adulterated specimens. We recommend not to interpret the drug test results and either retest the urine or collect another specimen.
8. Read the drug strip results at 5 minutes. The drug test results remain stable for up to sixty minutes.

 

Interpretation

NEGATIVE:* A colored line appears in the Control region (C) and a colored line appears in the Test region (Drug/T) next to a specific drug tested. This negative result means that the drug concentrations in the urine sample are below the designated cut-off levels for a particular drug tested.

*NOTE: The shade of the colored line(s) in the Test region may vary. The result should be considered negative whenever there is even a faint colored line.

POSITIVE: A colored line appears in the Control region (C) and NO line appears in the Test region (Drug/T) next to the name of a specific drug tested. The positive result means that the drug concentration in the urine sample is greater than the designated cut-off for a specific drug.

INVALID: No line appears in the Control region (C). Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Read the directions again and repeat the test with a new test cup. If the result is still invalid, contact your manufacturer.
Materials Provided And Unprovided

 

Materials Provided

• Integrated E-Z Split Key® Cup II [Note: A Fahrenheit temperature strip is affixed to aid in the determination of specimen validity. Please use this temperature strip in conjunction with your Drug Free Policy (if applicable)].
• Keys
• Security seals
• Package insert
• Procedure cards
• SVT/Adulterant color charts (Optional)

Materials Required But Not Provided

• Timer
• External controls

Product Limitations

1. The Integrated E-Z Split Key® Cup II provides only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.1,4,10
2. There is a possibility that technical or procedural errors, as well as interfering substances in the urine specimen may cause erroneous results.
3.  Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the analytical method used. If adulteration is suspected, the test should be repeated with another urine specimen.
4. A positive result does not indicate level or intoxication, administration route or concentration in urine.
5. A negative result may not necessarily indicate drug-free urine. Negative results can be obtained when drug is present but below the cut-off level of the test.
6. This test does not distinguish between drugs of abuse and certain medications.
7. A positive test result may be obtained from certain foods or food supplements.

 

SVT/Adulterant Limitations

1. The adulteration tests, if included with this product, are meant to aid in the determination of abnormal specimens. While comprehensive, these tests are not meant to be an all-inclusive representation of possible adulterants.
2. Oxidants/PCC: Normal human urine should not contain oxidants or PCC. The presence of high levels of antioxidants in the specimen, such as ascorbic acid, may result in false negative results for the oxidants/PCC pad.
3. Specific Gravity: Elevated levels of protein in urine may cause abnormally high specific gravity values.
4. Nitrite: Nitrite is not a normal component of human urine. However, nitrite found in urine may indicate urinary tract infections or bacterial infections. Nitrite levels of > 20 mg/dL may produce false positive glutaraldehyde results.
5. Glutaraldehyde: Is not normally found in urine. However certain metabolic abnormalities such as ketoacidosis (fasting, uncontrolled diabetes or high-protein diets) may interfere with the test results.
6. Creatinine: Normal creatinine levels are between 20 and 350 mg/dL. Under rare conditions, certain kidney diseases may show dilute urine.

 

Test Principles

The Integrated E-Z Split Key® Cup II is an immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against their respective drug conjugate for binding sites on their specific antibody. During testing, a urine specimen migrates upward by capillary action.

A drug, if present in the urine specimen below its cut-off concentration, will not saturate the binding sites of its specific antibody. The antibody will then react with the drug-protein conjugate and a visible colored line will show up in the test region of the specific drug strip. The presence of drug above the cut-off concentration will saturate all the binding sites of the antibody. Therefore, the colored line will not form in the test region.

A drug-positive urine specimen will not generate a colored line in the specific test region of the strip because of drug competition, while a drug-negative urine specimen will generate a line in the test region because of the absence of drug competition. To serve as a procedural control, a colored line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

 

What Is Adulterants?

Adulteration is the tampering of a urine specimen with the intention of altering the test results. The use of adulterants can cause false negative results in drug tests by either interfering with the screening test and/or destroying the drugs present in the urine. Dilution may also be employed in an attempt to produce false negative drug test results. One of the best ways to test for adulteration or dilution is to determine certain urinary characteristics such as pH and specific gravity and to detect the presence of oxidants/PCC, specific gravity, pH, nitrite, glutaraldehyde and creatinine in urine.

• Oxidants/PCC (Pyridinium chlorochromate) tests for the presence of oxidizing agents such as bleach and hydrogen peroxide. Pyridinium chlorochromate (sold under the brand name UrineLuck) is a commonly used adulterant.8 Normal human urine should not contain oxidants or PCC.
• Specific gravity tests for sample dilution. The normal range is from 1.003 to 1.030. Values outside this range may be the result of specimen dilution or adulteration.
• pH tests for the presence of acidic or alkaline adulterants in urine. Normal pH levels should be in the range of 4.0 to 9.0. Values outside of this range may indicate the sample has been altered.
• Nitrite tests for commonly used commercial adulterants such as Klear or Whizzies. They work by oxidizing the major cannabinoid metabolite THC-COOH.9 Normal urine should contain no trace of nitrite. Positive results generally indicate the presence of an adulterant.
• Glutaraldehyde tests for the presence of an aldehyde. Adulterants such as UrinAid and Clear Choice contain glutaraldehyde which may cause false negative screening results by disrupting the enzyme used in some immunoassay tests. 8 Glutaraldehyde is not normally found in urine; therefore, detection of glutaraldehyde in a urine specimen is generally an indicator of adulteration.
• Creatinine is a waste product of creatine; an amino-acid contained in muscle tissue and found in urine.2 A person may attempt to foil a test by drinking excessive amounts of water or diuretics such as herbal teas to “flush” the system. Creatinine and specific gravity are two ways to check for dilution and flushing, which are the most common mechanisms used in an attempt to circumvent drug testing. Low creatinine and specific gravity levels may indicate dilute urine. The absence of creatinine (< 5 mg/dl) is indicative of a specimen not consistent with human urine.

 

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