High Accuracy Drug Test Kit PCP Rapid Diagnostic Test Dipcard, 25ng/ml cut-off,

Product Specification

High Accuracy Drug Test Kit PCP Rapid Diagnostic Test Dipcard, 25ng/ml cut-off, detecting Phencyclidine in urine

Product Name

PCP Rapid Diagnostic Test/ Phencyclidine Rapid Diagnostic Test

Specimen: Urine

Intended Use

The PCP Rapid Test Device (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of Phencyclidine in human urine specimens at the cut-off concentrations listed below:

Test Principle

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%).

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

The specimen correlation study was performed on 212 urine specimens. 50 positive urine specimens and 162 negative urine specimens were confirmed by GC/MS. These specimens were randomized and tested using the PCP One Step Phencyclidine Test Strip (Urine). Specimens were rated as either positive or negative at 5minutes. The test results are shown in Table 1.

Table 1: Specimen Correlation

Positive agreement with GC/MS: 50/(50+0) > 99%

Negative agreement with GC/MS: 159/(157+5) = 97%

Total agreement with GC/MS: (50+157)/(50+0+5+157) = 98%