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  1.  Glutaraldehyde tests for the presence of aldehyde. Adulterants such as UrinAid and Clear Choice contain Glutaraldehyde and can cause false negative screening results by disrupting the test. Glutaraldehyde is not normally in urine and detection is generally an indicator of an adulterant.
  2.  Color - A clear color may indicate that the sample has been diluted. Unadulterated, normal urine should be pale to dark yellow or amber in color. However, a sample should not be considered positive by color alone, but should be suspect for closer examination.
  3.  Temperature - The temperature of a urine specimen should be between 91 and 98 degrees when checked within 4 minutes of collection. Urine that is submitted at body temperature will exceed 90.5 degrees Fahrenheit. A specimen that falls below that range is suspect.

ADULTERANT NTERPRETATION

(Please refer to the color chart for color comparison)

The test strips aid in the detection of urine adulteration for drugs of abuse test screens. The test is based on the chemical reaction to the reagents on the pads with components in the urine sample effecting color changes. Results are obtained by comparing the color on each of the test pads with a corresponding color chart.

Oxidants/PCC (Pyridinium chlorochromate): Tests for presence of oxidizing reagents and PCC. Normal Urine contains no trace of oxidants or PCC. A dark blue or green color may indicate their presence.

Specific gravity: Tests for sample dilution. Green to dark yellow indicates normal range. Blue and bright yellow indicate abnormal ranges. Normal range is between 1.003 and 1.030.

pH:  Tests for the presence of acidic or alkaline adulterants in urine. Normal pH will range from 4.0 to 9.0 and have an orange color. Colors outside the normal range will vary from pink (low pH) to dark brown (high pH).

Nitrites: Tests for the presence of nitrites which can cause discrepancies between the initial screening result and the GC/MS confirmation testing. Nitrites are not a normal component of urine. Abnormal nitrite levels (above 50mg/dl) will have red to dark red color.

Gtutaraldehyde: Tests for the presence of glutaraldehyde which can alter the test result and produce a false negative result. Normal urine should contain no Glutaraldehyde. A purple color indicates the presence of glutaraldehyde.

Creatinine: Normal urine samples contain Creatinine between 20 and 350 mg/dl (milligrams per deciliter). A specimen with a Creatinine level below 20 is considered dilute.

QUALITY CONTROL

A procedural control is included in the test. A red line appearing in the control region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

Control standards are not supplied with this kit. However, it is recommended that positive and negative controls be tested as good laboratory practice to confirm the test procedure and to verify proper test performance.

ADULTERATION LIMITATIONS

  1.  The adulteration tests 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.  Normal urine should contain no oxidants. The presence of high levels of antioxidants in the specimen, such as
    ascorbic acid, may result in false negative results for the oxidant pad.
  3.  Elevated levels of protein in urine may cause specific gravity values to be higher.
  4.  Normal creatinine levels are between 20 and 350 mg/dl. Under rare conditions, certain kidney diseases show
    dilute urine.
  5.  Normal urine should contain no trace of nitrite. However, nitrite found in urine may indicate urinary tract
    infections or bacterial infections.
  6.  Glutaraldehyde is not normally found in urine. However, certain metabolic abnormalities such as ketoacidosis
    (starvation) may interfere with the test result.

LIMITATIONS

  1.  The Split-Specimen Cup™ 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.
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  2.  There is a possibility that technical or procedural errors, as well as other 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,
  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.  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.

PERFORMANCE CHARACTERISTICS

Accuracy

A side-by-side comparison was conducted using the Split-Specimen Cup™ and commercially available drug rapid tests. Testing was performed on approximately 300 specimens per drug type previously collected from subjects presenting for Drug Screen Testing. Presumptive positive results were confirmed by GC/MS. The following compounds were quantified by GC/MS and contributed to the total amount of drugs found in presumptive positive urine samples tested.

Test

Compounds Contributed to the Totals of GC/MS

AMP

Amphetamine

BAR

Secobarbital, Butalbital, Phenobarbital, Pentobarbital

BZO

Oxazepam, Nordiazepam, a-OH-Aiprazolam, Desalkylflurazepam

COC

Benzoylecgonine

THC

11-nor-A -tetrahydrocannabinol-9-carboxylic acid

MTD

Methadone