Thirteen Panel PreScreen Plus Cup With Adulterants (CLIA Waived)

PERFORMING THE TEST

Before testing:

Read the instructions completely.
Check the expiration date on the box. Do not use the test if it is expired. Have a watch, clock or timer ready.

Step 1: Tear the foil bag open, remove the test cup and disposable gloves provided for donor. Label the device with donor information. (Fig. 1)

Step 2: Open test cup lid. Urinate directly into the test cup. Be sure to fill the test cup with the urine specimen provided between a minimum of 30ml to maximum 110ml (marked on the cup). (Fig. 2)

Step 3: After urine specimen has been collected, close the lid securely and return cup to collection official. (Fig. 3)

Step 4: Collection official should use the gloves provided. Peel off the label to reveal test result. Read the test result at 5 minutes. DO NOT INTERPRET RESULT AFTER 10 MINUTES. (Fig. 4&5) 

INTERPRETATION OF RESULTS

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Negative Result NEGATIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T). Certain lines may appear lighter or thinner than other lines. A line is to be considered a line whether it is faint, light or dark. *NOTE: The shade of red in the test line region (Drug/T) will vary, but it should be considered negative whenever there is even a faint pink line.
Preliminary Positive Result: POSITIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).
Invalid Result: INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specific read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

ADULTERATION TEST

Urine sample adulteration is usually achieved by substitution, dilution or the addition of adulterants including so-called "masking agents" sold commercially. The use of adulterants can cause false negative results in drug tests by either interfering with the test and/or destroying drugs present in the urine. Dilution may also be used in an attempt to produce false negative drug test results.

The Drug Tests In Bulk PreScreen Plus Test (CLIA Waived) adulteration test is based on the color response of chemical indicators in the presence of adulterants. pH (P), specific gravity (S), oxidant/PCC (O), creatinine (C), nitrite (N) and glutaraldehyde (G) are tested to determine the integrity of urine samples.

pH: The pH determination of urine samples is based on the color change of an indicator in an acidic or basic medium. Normal urine pH ranges from 4 to 9. Values outside of this range may indicate the sample has been altered.

Specific Gravity: The specific gravity test is based on the pKa change of certain pretreated polyelectrolytes in relation to the ionic concentration. In the presence of an indicator, the colors change from dark blue to blue-green in urine of low ionic concentration to green and yellow- green in urine of higher ionic concentration. The normal range for specific gravity is from 1.003 to 1.030. Values outside this range generally indicate specimen dilution or adulteration.

Oxidants/PCC (Pyridinium Chlorochromate): Bleach, hydrogen peroxide, pyridinium chlorochromate or other oxidizing agents react with an oxidant indicator to form a color complex. A blue-green, brown, or orange color indicates adulteration with bleach or other oxidizing agents. Normal human urine should not contain oxidants.

Creatinine: Creatinine reacts with an indicator in an alkaline medium to form a purplish-brown color complex. The normal range of creatinine is from 20 to 300 mg/dl. Values outside this range generally indicate a manipulated test.

Nitrite: Nitrite reacts with the reagents aromatic amine to form a diazonium salt which couples with an indicator to yield a pink-red/purple color complex. A urine sample containing nitrite at a level greater than 15 mg/dl is considered adulterated.

Glutaraldehyde: Adulterants such as "Clear Choice" contain glutaraldehyde which may cause disrupting the enzyme used in some immunoassay tests. Glutaraldehyde is not normally found in human urine.

What do the test results mean?

Q. The drug line is lighter than control line. Does it mean the drug is present in the urine?
A. No. The drug line may be darker or lighter than the control line. The line intensities of different drugs will vary for many reasons. No matter how faint the drug line appears on the test strip, it is considered a negative result. No further testing is required.

Q. What does a Negative Result mean?
A. If you get a negative result, the sample did not contain the drug being tested for. No further testing is required. However, it is possible to get a negative result even if a person has taken drugs. Some reasons why this might happen are:

• The urine sample was collected at wrong time. It was collected before the drug got into the urine or after it was no longer in the urine.
• The person took a drug other than the one tested for in this test; e.g. they might have taken LSD, when this test is for drugs other than LSD.

Q. What does an Invalid Result mean?
A. If any of the strips do not show a control, the result is invalid. We recommend that you re-test or call our toll-free help line at 1-866-465-2855 for technical help.

Other Questions:

Q. When is the best time to take the test?
A. The drug test can be used at any time of day. Approximate detection times using each drug are listed in the following table:

The Substance Abuse and Mental Health Services Agency (SAMHSA) has set cutoff levels when testing for marijuana, cocaine, amphetamine, opiates, PCP, Ecstasy and methamphetamine. Screening tests may not detect amounts of drugs in a urine sample that are below the cutoff level. Even if some drug is present in a urine sample, the sample would be considered negative if the drug level is below the cutoff level.

Q. How much urine do I need?
A. The Drug Tests In Bulk PreScreen Plus Test (CLIA Waived) requites just 30 ml of urine. Fill the collection cup of the minimum fill line on the side of the cup. This is enough urine for the initial test and confirmation testing if needed.

Q. Do I have to wait the full 5 minutes before reading the test?
A. Yes, we recommend that you wait the full 5 minutes before reading the result.

Q. Are there any factors that could affect the drug testing result?
A. Yes, certain factors may affect the drug testing result.

1. Certain over the counter medicines and prescription medicines may cause a preliminary positive result.
2. Urine can be adulterated (i.e. contaminated or tampered) by using bleach, cleaning supplies and other liquids. This may dilute the urine and the test may not be accurate.
3. Drinking large amount of liquids may dilute the urine so that the drug (if present) cannot be detected.
4. Failure to use the Drug Tests In Bulk PreScreen Plus Test (CLIA Waived) as directed may result in an inaccurate screening result.
5. The following compounds are detected positive in urine by the Drug Tests In Bulk PreScreen Plus Test (CLIA Waived). Concentrations are given in ng/ml; percent cross-reactivity is shown in parentheses.