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PCP test Cassette
Description
The Drug Screen PCP is a lateral flow, one-step immunoassay for the qualitative detection of phencyclidine in human urine at a cut-off of 25 ng/ml. This product is used to obtain a visual, qualitative...
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Drug Screen PCP

One-Step Phencyclidine Test
INTENDED USE

 

The Drug Screen PCP is a lateral flow, one-step immunoassay for the qualitative detection of phencyclidine in human urine at a cut-off of 25 ng/ml. This product is used to obtain a visual, qualitative result and is intended for use by drug testing professionals in drug testing programs. The assay should not be used without proper supervision and is not intended for over the counter sale to lay persons.

This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the National Institute on Drug Abuse (NIDA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

SUMMARY

Phencyclidine is an arylcyclohexylamine that was originally used as an anesthetic agent and a veterinary tranquilizer. Phencyclidine can produce hallucinations, lethargy, disorientation, loss of coordination, trance-like ecstatic states, a sense of euphoria and visual distortions. It has many street names, such as “angel dust” and “crystal cyclone”, etc. phencyclidine can be administered orally, by nasal ingestion, smoking, or intravenous injection. It is metabolized in the liver and excreted through the kidneys. The half-life of phencyclidine in the body is around three days. Suction and urinary acidification in the treatment of overdose typically reduces its half-life from three days to one day.

Urine based screening tests for drugs of abuse range from simple immunoassay tests to complex analytical procedures. The speed and sensitivity of immunoassays have made them the most widely accepted method for screening urine for drugs of abuse. The Drug Screen PCP is based on the principle of the highly specific immunochemical reactions of antigens and antibodies which are used for the analysis of specific compounds in biological fluids. This test is a rapid, visual, competitive immunoassay that can be used for the qualitative detection of phencyclidine in human urine at a 25 ng/ml cut-off concentration.

PRINCIPLE

The Drug Screen PCP is a one-step immunoassay in which a chemically labeled drug (drug conjugate) competes with the drug which may be present in urine for limited antibody binding sites. The test device contains a membrane strip which was pre-coated with drug conjugate on the test band region. A colored anti-phencyclidine monoclonal antibody-colloidal gold conjugate pad is placed at the end of the membrane. The colored antibody-colloidal gold conjugate moves along with urine, chromatographically by the capillary action, across the membrane, in the absence of drug in the urine, the colored antibody colloidal gold conjugate attaches to the drug conjugate on the test band region to form a visible line as the antibody/drug conjugate complexes. Therefore, the formation of a visible precipitant in the test band region occurs when the test urine is negative for the drug. When the drug is present in the urine, the drug/metabolite antigen competes with the drug conjugate on the test band region for the limited antibody sites. When a sufficient amount of drug is present, it will fill the limited antibody  binding sites. This will prevent attachment of the colored antibody-colloidal gold conjugate to the drug conjugate zone on the test band region. Therefore, absence of the color band on the test region indicates a positive result.

A control or reference band with a different antigen/antibody reaction is also added to the immunochromatographic membrane strip to indicate that the test is performed properly. This control line should always appear regardless of the presence of drug or metabolite. This means that negative urine will produce two colored bands, and positive urine will produce only one band. The presence of this colored band in the control region also serves as verification that 1) sufficient volume has been added, and 2) that proper flow was obtained.

MATERIALS SUPPLIED

·        25 individually wrapped test devices which include one disposable pipette each.

·        One instruction sheet.

MATERIALS REQUIRED BUT NOT PROVIDED

·        Specimen collection container.

·        Timer

STORAGE AND STABILITY

The test kit should be stored refrigerated or at room temperature (2-30℃). Each device should remain in its sealed pouch for the duration of the shelf-life.

PRECAUTIONS

·  FOR IN VITRO DIAGNOSTIC USE.

·  For professional use only.

· Urine specimens may be potentially infectious. Proper handing and disposal methods should be established.

·   Avoid cross-contamination of urine samples by using a new specimen collection container and specimen pipette for each urine sample.

SPECIMEN COLLECTION AND HANDLING

The Drug Screen PCP is formulated for use with urine specimens. Fresh urine does not require any special handing or pretreatment. Urine samples should be collected such that testing can be performed as soon as possible after the specimen collection, preferably during the same day. The specimen may be refrigerated at 2-8℃ for 2 days or frozen at -20℃ for a longer period of time. Specimens that have been refrigerated must be equilibrated to room temperature prior to testing. Specimens previously frozen must be thawed, equilibrated to room temperature, and mixed thoroughly prior to testing.

Note: Urine specimens and all materials coming in contact with them should be handled and disposed of as if capable of transmitting infection. Avoid contact with skin by wearing gloves and proper laboratory attire.

TEST PROCEDURE

Review “Specimen collection” instructions. Test device, patient’s samples, and controls should be brought to room temperature (20-30℃) prior to testing. Do not open pouches until ready to perform the assay.

·        Remove the test device from its protective pouch (bring the device to room temperature before opening the pouch to avoid condensation of moisture on the membrane). Label the device with patient or control number.

·        Hold the dropper vertically and transfer 3 full drops of urine (approx. 0.15ml) to the specimen well (S) of the test device, and then start the timer. Use a separate pipette and device for each sample or control.

·        Read result between 3 to 8 minutes after the addition of samples. Do not read result after 8 minutes.

INTERPRETATION OF RESULTS

Negative

Two pink-rose lines (bands) are visible in the control ("C") and test ("T") areas of the test window. The intensity of the test line may be less than that of the control line; this still means negative result.

Positive

The control line appears in the test window, but the test line is not visible.

Invalid

The test is invalid if the control line is not visible at five minutes. The test failed, or the test procedure was not followed properly. Verify the test procedure and repeat the test with a new testing device.

Note: A very faint line on the test region indicates that the phencyclidine in the sample is near the cut-off level for the test. These samples should be re-tested or confirmed with a more specific method before a positive determination is made.

LIMITATIONS OF PROCEDURE

1.    The assay is designed for use with human urine only.

2.   A positive result with any of the tests indicates the presence of a drug/metabolite only and does not indicate or measure intoxication.

3.    There is a possibility that technical or procedural errors as well other substances or factors not listed may interfere with the test and cause false results. See SPECIFICITY for lists of substances that will produce positive results, or that do not interfere with test performance.

4.     If it is suspected that the samples have been mislabeled or tampered with, a new specimen should be collected and the test should be repeated.

QUALITY CONTROL

Good laboratory practice recommends the use of control materials to ensure proper kit performance. Quality control specimens are available from commercial sources. When testing the positive and negative controls, use the same assay procedure as with a urine specimen.

PERFORMANCE CHARACTERISTICS

A.      Accuracy

The accuracy of ChemtrueTM Drug Screen PCP was evaluated in comparison to a commercially available immunoassay at a cut-off of 25 ng/ml for phencyclidine. One hundred twenty two (122) urine samples, collected from presumed non-user volunteers, have been tested by both procedures with 100% agreement.

In a separate study, fifty (50) urine samples, obtained from a clinical laboratory where they were screened and confirmed as positives by the commercially available immunoassay and GC/MS, were tested with the ChemtrueTM Drug Screen PCP. Of the 50 samples with phencyclidine concentration from 34.6 ng/ml to 1846 ng/ml, all were found positive by both methods (100% agreement).

B.      Reproducibility

The reproducibility of the ChemtrueTM Drug Screen PCP was evaluated at four different sites using blind controls. Of the 60 samples without phencyclidine all were determined negative. Of the (60) samples with phencyclidine concentration of 50 ng/ml, all were determined positive.

C.      Precision

The precision of the ChemtrueTM Drug Screen PCP was determined by conducting the test with spiked controls. The control at the 50 ng/ml should give a positive result.

Concentration

(ng/ml)

Number Tested

Correct Result

Correct Result

%

0

50

50

100

50

50

50

100

D.      Specificity

The specificity for the ChemtrueTM Drug Screen PCP was tested by adding various drugs, drug metabolites, and other compounds that are likely to be present in urine. All compounds were prepared in drug-free normal human urine.

The following structurally related compounds produced positive results when tested at levels equal to or greater than the concentrations listed below.

Compound                                                                              Concentration (ng/ml)

Tenocyclidine                                                                                              2,000

The following compounds were found not to cross-react when tested at concentrations up to 100 ug/ml.

Acetaminophen                                                                                        (+/-)-Ephedrine

Acetone                                                                                                      (+)-Epinephrine

Albumin                                                                                                     Erythromycin

Amitriptyline                                                                                               Ethanol

D-Amphetamine                                                                                      Flurosemide

L-Aphetamine                                                                                          Glucose

Ampillicin                                                                                                  Guaiacol glyceryl ether

Aspartame                                                                                                 Hemoglobin

Aspirinatropine                                                                                         Hydrocodone

Benzocaine                                                                                               Hydromaphone

Benzoylecgonine                                                                                      Imipramine

Bilirubin                                                                                                     Lidocaine

(+)-Brompheniramine                                                                             Meperidine

Caffeine                                                                                                     Methadone

Chloroquine                                                                                              Methadone

(+)-Chlorpheniramine                                                                              Methaqualone

(+/-)-Chlorpheniramine                                                                           (1R,2S)-(-)-N-Methyl-ephedrine

Chlorpromazine                                                                                       Methylphenidate

Cocaine                                                                                                      Morphine

Creatine                                                                                                     Morphine-3-β-d-glucuronide

(-)-Deoxyephedrine                                                                                 Dextromethorphan

Methylenedioxymethamphetamine                                                      4-Dimethylaminoantipyrine   

Naloxone                                                                                                   Dopamine

Naltrexone                                                                                                 Doxylamine

(+)-Naproxen                                                                                            Ecgonine

(+/-)-Norephedrine                                                                                  Ecgonine methyl ester

Oxalic Acid                                                                                                (-)-Ephedrine   

Oxazepam                                                                                                Oxycodone

Penicillin-G                                                                                              Pentermine

Pentobarbital                                                                                           Pheniramine

Phenobarbital                                                                                         Phenothiazine

L-Phenylephrine                                                                                    β-Phencylethylamine

Procaine                                                                                                 d-Propoxyphene

Quinidine                                                                                                Ranitidine

Secobarbital                                                                                          Sodium Chloride

Sulindac                                                                                                 Thioridazine

Trifluoperazine                                                                                      Trimethobenzamide

Tyramine                                                                                                Vitamin C

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