Orient New Life Medical Co.,Ltd. |
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Drug Abuse Test Kit PCP (Phencyclidine) Rapid Diagnostic Test
strip, 25ng/ml cut-off urine drug test, professional use
Product Name
PCP Rapid Diagnostic Test/ Phencyclidine Rapid Diagnostic Test
Specimen: Urine
Intended Use
Phencyclidine, also known as PCP, is a hallucinogen that was first
marketed as a surgical anesthetic in the 1950’s. It was removed
from the market because patients receiving it became delirious and
experienced hallucinations.Phencyclidine is used in powder,
capsule, and tablet form. The powder is either snorted or smoked
after mixing it with marijuana or vegetable matter. PCP is most
commonly administered by inhalation but can be used intravenously,
intra-nasally, and orally. After low doses, the user thinks and
acts swiftly and experiences mood swings from euphoria to
depression. Self-injurious behavior is one of the devastating
effects of PCP.PCP can be found in urine within 4 to 6 hours after
use and will remain in urine for 7 to 14 days, depending on factors
such as metabolic rate, user’s age, weight, activity, and diet. PCP
is excreted in the urine as unchanged drug (4% to 19%) and
conjugated metabolites (25% to 30%).The PCP One Step Phencyclidine
Test Strip (Urine) is a rapid urine screening test that can be
performed without the use of an instrument. The test utilizes a
monoclonal antibody to selectively detect elevated levels of
Phencyclidine metabolite in urine. The PCP One Step Phencyclidine
Test Strip (Urine) yields a positive result when the Phencyclidine
metabolite in urine exceeds 25 ng/mL.
Parameter | Calibrator | Cut-off (ng/mL) |
PCP (Phencyclidine) | Phencyclidine | 25 |
Test Principle
The PCP One Step Phencyclidine Test Strip (Urine) is a rapid chromatographic immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody.
During testing, a urine specimen migrates upward by capillary action. Phencyclidine, if present in the urine specimen below 25 ng/mL, will not saturate the binding sites of antibody-coated particles in the test strip. The antibody-coated particles will then be captured by immobilized Phencyclidine conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the Phencyclidine level exceeds 25ng/mL because it will saturate all the binding sites of antibodies.
A drug-positive urine specimen will not generate a colored line in
the test line region, while a drug-negative urine specimen or a
specimen containing a drug in a concentration less than the cut-off
will generate a colored line in the test line region. To serve as a
procedural control, a colored line will always appear at the
control line region, indicating that proper volume of specimen has
been added and membrane wicking has occurred.
DIRECTIONS FOR USE
Bring tests, specimens, and/or controls to room temperature
(15-30°C) before use.
Remove the test from its sealed pouch, and place it on a clean,
level surface. Label the test with patient or control
identification. For best results, the assay should be performed
within one hour.
Using the provided disposable pipette, transfer 3 drops of specimen
(approximately 120 µL) to the specimen well (S) of the device and
start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add
any solution to the result area.
As the test begins to work, color will migrate across the membrane.
Wait for the colored band(s) to appear. The result should be read
at 5 minutes. Do not interpret the result after 8 minutes
INTERPRETATION OF RESULTS
NEGATIVE:* A colored line appears in the Control region (C) and colored lines
appears in the Test region (T). This negative result means that the
concentrations in the urine sample are below the designated cut-off
levels for a particular drug tested.
*NOTE: The shade of the colored lines(s) in the Test region (T) may
vary. The result should be considered negative whenever there is
even a faint line.
POSITIVE: A colored line appears in the Control region (C) and NO line
appears in the Test region (T). 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 card. If the result is still
invalid, contact your manufacturer.
QUALITY CONTROL
A procedural control is included in the test. A 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.
Performance characteristics
Analytical Sensitivity
A drug-free urine pool was spiked with Phencyclidine at the
following concentrations: 0 ng/mL, 12.5 ng/mL, 18.75 ng/mL, 25
ng/mL, 31.25 ng/mL, 37.5ng/mL and 50ng/mL. The result demonstrates
> 99% accuracy at 50% above and 50% below the cut-off
concentration. Results are presented in Table 2 below.
Table 2: Analytical Sensitivity Summary
PCP Concentration (ng/mL) | Percent of Cut-off | n | Visual Result | |
Negative | Positive | |||
0 | 0 | 30 | 30 | 0 |
12.5 | -50% | 30 | 30 | 0 |
18.75 | -25% | 30 | 19 | 11 |
25 | Cut-off | 30 | 16 | 14 |
31.25 | +25% | 30 | 6 | 24 |
37.5 | +50% | 30 | 0 | 30 |
50 | +100% | 30 | 0 | 30 |
Conclusion: As indicated in table above: all specimens with PCP concentration
equal to or lower than 12.5ng/mL show negative results, all
specimens with PCP concentration of 25ng/mL are identified as
“+/-”, and all specimens with PCP concentration equal to or higher
than 37.5ng/mL showed positive results. Therefore, the cut-off
concentration of the PCP One Step Phencyclidine Test Strip (Urine)
is determined to be 25ng/mL PCP.
Analytical Specificity
Table 3 lists the compounds that are positively detected in urine by the PCP One Step Phencyclidine Test Strip (Urine) at 5 minutes and the concentrations at which they are detected.
Table 3: Analytical Specificity
Compound | Concentration (ng/mL) |
4-Hydroxyphencyclidine | 12,500 |
Phencyclidine | 25 |
ORIENT NEW LIFE MEDICAL CO., LTD. | |
Contact: | Jerry Meng |
Email: | Jerry @ newlifebiotest .com |
Tel. | +86 18657312116 |
SKYPE | enetjerry |