Thirteen Panel Drug Screen Cup IV Drug Test with Adulterants (CLIA Waived)

PERFORMING THE TEST

Before testing:

Step 1: Donor dates and initials body label.

Step 2: Donor provides a urine specimen in the cup and screws cap on to it. Start timer immediately. 

Step 3: Operator checks the cap for tightness.

Step 4: Remove the peel-off label.

Step 5: Check the temperature strip label at 2-4 minutes after specimen collection for the fresh urine specimen. A green color will appear to indicate the temperature of the urine specimen. The proper range for an unadulterated specimen is 90-100°F (32-38°C).

Step 6: Drug test results are indicated by the presence or absence of colored band(s) in the result area of the test strips. The result should be read at 5 minutes. Do not interpret the result after 10 minutes. 

Step 7: Positive test results must be confirmed by another test method. Send the cup and urine specimen intact to a toxicology laboratory for confirmation.

Step 8: For the adulteration, compared with the color card, and the results should be read at 2 minutes，do not interpret the result after 5 minutes.

Step 9: For alcohol test, read results at 2 minutes by visually comparing the color of the reaction pad to the corresponding color blocks printed on the pouch to determine the alcohol concentration. Do not interpret the result after 3 minutes. For the adulteration, compared with the color card and the results should be read at 2 minutes, do not interpret the result after 5 minutes. 

INTERPRETATION OF RESULTS

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.