in the test strip. The antibody coated particles will then be specimen for testing. PCP captured by immobilized Phencyclidine conjugate and a visible Specimen Storage colored line will show up in the test line region. The colored line will not form in the test line region if the Phencyclidine Urine specimens may be stored at 2-8°C for up to 48 hours One Step level exceeds 25 ng/mL because it will saturate all the binding prior to testing. For prolonged storage, specimens may be sites of anti-Phencyclidine antibodies. frozen and stored below -20°C. Frozen specimens should be A drug-positive urine specimen will not generate a colored thawed and mixed before testing. Phencyclidine Test Strip (Urine) line in the test line region because of drug competition, while a drug-negative urine specimen or a specimen containing a A rapid, one step test for the qualitative detection of drug concentration less than the cut-off will generate a line in PROCEDURE Phencyclidine in human urine. the test line region. To serve as a procedural control, a Allow the test strip, urine specimen, and/or controls to colored line will always appear at the control line region reach room temperature (15-30C) prior to testing. indicating that proper volume of specimen has been added For in vitro diagnostic use only. and membrane wicking has occurred. 1. Bring the pouch to room temperature before opening it. Remove the test strip from the sealed Store at 2-30 °c pouch and use it as soon as possible. MATERIALS 2. With arrows pointing toward the urine specimen, Materials Provided immerse the test strip vertically in the urine INTENDED USE specimen for at least 10-15 seconds. Do not  Test strips(Contain mouse monoclonal pass the maximum line (MAX) on the test strip The PCP One Step Phencyclidine Test Strip (Urine) is a lateral anti-Phencyclidine antibody-coupled particles and flow chromatographic immunoassay for the detection of when immersing the strip. See the illustration Phencyclidine-protein conjugate. A goat antibody is below. Phencyclidine in urine at a cut-off concentration of 25 ng/mL. employed in the control line system). This assay provides only a preliminary analytical test result. A 3. Place the test strip on a non-absorbent flat surface,  Package insert start the timer and wait for the red line(s) to more specific alternate chemical method must be used in Materials Required But Not Provided order to obtain a confirmed analytical result. Gas appear. The result should be read at 5 minutes. Do chromatography/mass spectrometry (GC/MS) is the preferred  Specimen collection container not interpret the result after 10 minutes. confirmatory method. Clinical consideration and professional  Timer judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. PRECAUTIONS  For in vitro diagnostic use only. Do not use after the INTRODUCTION expiration date. Phencyclidine, also known as PCP, is a hallucinogen that was  The test strip should remain in the sealed pouch first marketed as a surgical anesthetic in the 1950’s. It was until use. removed from the market because patients receiving it  All specimens should be considered potentially became delirious and experienced hallucinations. hazardous and handled in the same manner as an Phencyclidine is used in powder, capsule, and tablet form. infectious agent. The powder is either snorted or smoked after mixing it with  The used test strip should be discarded according to marijuana or vegetable matter. PCP is most commonly federal, state and local regulations. 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 STORAGE AND STABILITY to depression. Self-injurious behavior is one of the Test Results devastating effects of PCP.  The kit can be stored at room temperature or PCP can be found in urine within 4 to 6 hours after use and refrigerated (2-30°C). will remain in urine for 7 to 14 days, depending on factors such as metabolic rate, user’s age, weight, activity, and diet.  The test Cassette is stable through the expiration date INTERPRETATION OF RESULTS PCP is excreted in the urine as unchanged drug (4% to 19%) printed on the label on the sealed pouch. (Please refer to the illustration above) and conjugated metabolites (25% to 30%).1 NEGATIVE: * Two lines appear. One red line should be in the  The test Cassette must remain in the sealed pouch control region (C), and another apparent red or pink line until use. Do not freeze. should be in the test region (T). This negative result indicates PRINCIPLE that the Phencyclidine concentration is below the detectable The PCP One Step Phencyclidine Test Strip (Urine) is an level (25 ng/mL). immunoassay based on the principle of competitive binding. SPECIMEN COLLECTION AND PREPARATION *NOTE: The shade of red in the test line region (T) may vary, but it should be considered negative whenever there is even Drugs that may be present in the urine specimen compete Urine Assay against the drug conjugate for binding sites on the antibody. a faint pink line. During testing, a urine specimen migrates upward by capillary The urine specimen must be collected in a clean and dry POSITIVE: One red line appears in the control region (C). No action. Phencyclidine, if present in the urine specimen below container. Urine collected at any time of the day may be used. line appears in the test region (T). This positive result 25 ng/mL, will not saturate the binding sites of the antibody Urine specimens exhibiting visible particles should be indicates that the Phencyclidine concentration exceeds the centrifuged, filtered, or allowed to settle to obtain a clear detectable level (25 ng/mL). results were tabulated: Effect of Urinary pH INVALID: Control line fails to appear. Insufficient specimen Method GC/MS Total The pH of an aliquoted negative urine pool was adjusted to a volume or incorrect procedural techniques are the most likely Results Positive Negative Results pH range of 5 to 9 in 1 pH unit increments and spiked with reasons for control line failure. Review the procedure and PCP One Step Positive 50 5 55 Phencyclidine to 12.5 ng/mL and 37.5ng/mL. The spiked, repeat the test with a new test strip. If the problem persists, Test Strip pH-adjusted urine was tested with the PCP One Step Negative 0 157 157 Phencyclidine Test Strip (Urine) in duplicate. The results discontinue using the test kit immediately and contact your Total Results 50 162 212 local distributor. demonstrate that varying ranges of pH do not interfere with % Agreement with 100% 97% 98% the performance of the test. GC/MS Analysis Cross-Reactivity QUALITY CONTROL Analytical Sensitivity A study was conducted to determine the cross-reactivity of A procedural control is included in the test. A red line A drug-free urine pool was spiked with Phencyclidine at the the test with compounds in either drug-free urine or appearing in the control region (C) is considered an internal following concentrations: 0 ng/mL, 12.5 ng/mL, 18.75 ng/mL, Phencyclidine positive urine. The following compounds show procedural control. It confirms sufficient specimen volume, 25 ng/mL, 31.25 ng/mL and 37.5 ng/mL. The result no cross-reactivity when tested with the PCP One Step adequate membrane wicking and correct procedural demonstrates >99% accuracy at 50% above and 50% below Phencyclidine Test Strip (Urine) at a concentration of 100 technique. the cut-off concentration. The data are summarized below: g/mL. Control standards are not supplied with this kit; however, it is PCP Non Cross-Reacting Compounds recommended that positive and negative controls be tested Percent of Visual Result Concentration n Acetaminophen -Estradiol Oxymetazoline as good laboratory testing practice to confirm the test Cut-off Acetophenetidin Estrone-3-sulfate Papaverine procedure and to verify proper test performance. (ng/mL) Negative Positive N-Acetylprocain Ethyl-p-aminobenzoa Penicillin-G 0 0 30 30 0 Acetylsalicylicamide Fenoprofente Pentazocine LIMITATIONS 12.5 -50% 30 30 0 Aminopyrineacid Furosemide Pentobarbitalhydrochloride 1. The PCP One Step Phencyclidine Test Strip (Urine) 18.75 -25% 30 19 11 Amitryptyline Gentisic acid Perphenazine provides only a qualitative, preliminary analytical result. 25 Cut-off 30 16 14 Amobarbital Hemoglobin Phenelzine A secondary analytical method must be used to obtain a 31.25 +25% 30 6 24 Amoxicillin Hydralazine Phenobarbital confirmed result. Gas chromatography/mass 37.5 +50% 30 0 30 Ampicillin Hydrochlorothiazide Phentermine spectrometry (GC/MS) is the preferred confirmatory Analytical Specificity L-Ascorbic acid Hydrocodone L-Phenylephrine method.2,3 2. It is possible that technical or procedural errors, as well The following table lists the compound that is positively D,L-Amphetami Hydrocortisone -Phenylethylamine as other interfering substances in the urine specimen detected in urine by the PCP One Step Phencyclidine Test Apomorphinene O-Hydroxyhippuric Phenylpropanolamine may cause erroneous results. Strip (Urine) at 5 minutes. Aspartame p-Hydroxy-methampacid Prednisolone 3. Adulterants, such as bleach and/or alum, in urine Compound Concentration (ng/mL) Atropine hetamine Prednisone specimens may produce erroneous results regardless of 4-HydroxyPhencyclidine 12,500 Benzilic acid 3-Hydroxytyramine Procaine the analytical method used. If adulteration is suspected, Benzoic acid Ibuprofen Promazine the test should be repeated with another urine Phencyclidine 25 specimen. Precision Benzoylecgonin Imipramine Promethazine 4. A positive result indicates presence of the drug or its A study was conducted at 3 physicians’ offices by untrained Benzphetaminee Iproniazid D,L-Propanolol metabolites but does not indicate level of intoxication, operators using 3 different lots of product to demonstrate the Bilirubin () - Isoproterenol D-Propoxyphene administration route or concentration in urine. within run, between run and between operator precision. An () - Isoxsuprine D-Pseudoephedrine 5. A negative result may not necessarily indicate drug-free identical panel of coded specimens containing, according to CaffeineBromphenirami Ketamine Quinidine urine. Negative results can be obtained when drug is GC/MS, no Phencyclidine, 25% Phencyclidine above and Cannabidiolne Ketoprofen Quinine present but below the cut-off level of the test. below the cut-off, and 50% Phencyclidine above and below Cannabinol Labetalol Ranitidine 6. Test does not distinguish between drugs of abuse and the 25 ng/mL cut-off was provided to each site. The following certain medications. results were tabulated: Chloralhydrate Loperamide Salicylic acid Chloramphenico Maprotiline Secobarbital Phencyclidin n per Site A Site B Site C Chlordiazepoxidl Meperidine Serotonin PERFORMANCE CHARACTERISTICS e conc. site - + - + - + Chlorothiazidee Meprobamate (5-Hydroxytyramine) Accuracy (ng/mL) () Methadone Sulfamethazine Chlorphenirami A side-by-side comparison was conducted using the PCP One 0 15 15 0 15 0 15 0 Chlorpromazine Methoxyphenamine Sulindac Step Phencyclidine Test Strip (Urine) and a leading Chlorquinene (+) Temazepam commercially available PCP rapid test. Testing was performed 12.5 15 15 0 14 1 14 1 Cholesterol 3,4-Methylenedioxy-a Tetracycline on 212 clinical specimens. Ten percent of the specimens 18.75 15 11 4 13 2 10 5 Clomipramine (+)mphetamine Tetrahydrocortisone, 3 employed were either at -25% or +25% level of the cut-off Clonidine 3,4-Methylenedioxy- acetate concentration of 25 ng/mL Phencyclidine. Presumptive 31.25 15 8 7 5 10 1 14 methamphetamine Cocaine Morphine-3--D Tetrahydrocortisone 3 positive results were confirmed by GC/MS. The following 37.5 15 4 11 0 15 0 15 results were tabulated: Codeinehydrochloride glucuronide (-D glucuronide) Method Other PCP Rapid Test Total Effect of Urinary Specific Gravity Cortisone Morphine Sulfate Tetrahydrozoline Results Positive Negative Results Fifteen (15) urine specimens with specific gravity ranging (-) Cotinine Nalidixic acid Thiamine PCP One Step from 1.001 to 1.032 were spiked with 12.5 ng/mL and 37.5 Creatinine Naloxone Thioridazine Test Strip Positive 56 0 56 Negative 1 155 156 ng/mL of Phencyclidine respectively. The PCP One Step Deoxycorticoste Naltrexone D, L-Tyrosine Total Results 57 155 212 Phencyclidine Test Strip (Urine) was tested in duplicate using Dextromethorphrone Naproxen Tolbutamide % Agreement with the fifteen neat and spiked urine specimens. The results Diazepaman Niacinamide Triamterene 98% 100% 99% this Rapid Test Kit demonstrate that varying ranges of urinary specific gravity do Diclofenac Nifedipine Trifluoperazine When compared at 25 ng/mL cut-off with GC/MS, the following not affect the test results. Diflunisal Norcodein Trimethoprim Digoxin Norethindrone Trimipramine Diphenhydramin D-Norpropoxyphene Tryptamine Doxylaminee Noscapine D, L-Tryptophan Ecgonine D,L-Octopamine Tyramine Ecgoninehydrochloride Oxalic acid Uric acid (-)methylesterY Ephedrine Oxazepam Verapamil Erythromycin Oxolinic acid Zomepirac Oxycodone

REFERENCES 1. Robert DeCresce. Drug Testing in the workplace. 114 2. Baselt RC. Disposition of Toxic Drugs and Chemicals in Man. 2nd Ed. Biomedical Publ., Davis, CA. 1982; 488 3. Hawks RL, CN Chiang. Urine Testing for Drugs of Abuse. National Institute for Drug Abuse (NIDA), Research Monograph 73, 1986

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Product For in-vitro Reference No. diagnostic use. Caution. Store at Read product Number of tests insert before in the pack. use. Lot (batch) Manufacturer. number. Manufacturer Expiry date. telephone number. Manufacturer fax number.