<p> OneStep Phencyclidine InstaStrip, Cat. # 121080-50, Page 1 A NEGATIVE specimen produces two distinct color bands, Atlas Link one the test zone and one in the control zone. A POSITIVE OneStep Phencyclidine InstaStrip specimen produces one color band in the control zone only .</p><p>Cat. No 121080-50 (50 tests)</p><p>INTENDED USE The Atlas Link. OneStep Phencyclidine InstaStrip is a rapid, qualitative, competitive binding immunoassay for determination of phencyclidine and its metabolites in urine at REAGENTS AND MATERIALS PROVIDED or above the cut-off level of 25 ng/ml. OneStep Phencyclidine 1. Test Dipstick. The test device contains InstaStrip is not intended to monitor drug levels, but only to membrane-immobilized screen for the presence of phencyclidine and its major reagents in a protein matrix metabolites. containing sodium azide. Note: The test provides only preliminary data, which should be confirmed 2. Urine Cups (optional). by other methods such as gas chromatography/mass spectrometry (GC/MS). 3. Positive Control. Contains PCP at 100 ng/ml in Clinical considerations and professional judgement should be applied to a buffered protein solution any drugs of abuse test result, particularly when preliminary positive results are indicated. with sodium azide. SUMMARY AND EXPLANATION OF THE TEST 4. Negative Control I. Contains of buffered protein solution with sodium azide. The OneStep Phencyclidine InstaStrip is an easy, fast, and 5. Test Instructions. visually read screening method without the need for instrumentation to arrive at determination. The test system MATERIALS REQUIRED BUT NOT PROVIDED employs unique monoclonal and polyclonal antibodies to 1. Clock or timer. selectively identify phencyclidine in urine samples with a high 2. Sample collection container. degree of sensitivity. Phencyclidine, commonly known as PCP or "angel dust," is WARNINGS AND PRECAUTIONS used primarily as a recreational drug for its hallucinogenic 1. For in vitro diagnostic and professional use only. effects. It is generally self-administered by intravenous 2. Do not use the test strip beyond the expiration date. injection or by inhalation and concentrates fastest in fatty 3. Use a new specimen container and dropper for each test to tissues and the brain.6 Excretion patterns vary widely with the avoid cross- contamination of urine samples. individual. 4. Urine specimens may be infectious; properly handle and Methods historically used for detecting phencyclidine in dispose of all used reaction devices in a biohazard biological fluids include thin-layer chromatography, gas container. chromatography, ultraviolet spectroscopy, enzyme 5. Visually inspect the foil package to insure it is intact. If immunoassay and radioimmunoassay.4-5 While confirmation the package is not intact, discard the device. techniques other than GC/MS may be adequate for some drugs of abuse, GC/MS is generally accepted as a vigorous STORAGE AND STABILITY confirmation technique for all drugs since it provides the best Store test kit below 28C; do not freeze. Refer to the level of confidence in the result. 1-3 expiration date for stability. PRINCIPLE OF THE TEST SAMPLE COLLECTION AND PREPARATION The OneStep Phencyclidine InstaStrip consists of a Samples must be collected in a clean, dry container, either chromatographic absorbent device in which the drug or drug plastic or glass, without any preservatives. If not analyzed metabolites in the sample compete with a drug conjugate immediately, urine specimens may be refrigerated (2-8C) immobilized on a porous membrane for limited antibody sites. and stored up to forty-eight hours, or frozen (-20C or below) As the test sample flows up through the absorbent device, the prior to assaying. If samples are refrigerated or frozen, they free drug in the specimen competes with immobilized antigen should be allowed to come to room temperature before testing. conjugate in the test zone by binding to the antibody-dye Urine samples exhibiting visible precipitates should be conjugate forming an antibody-antigen complex and filtered, centrifuged or allowed to settle, so that clear aliquots preventing the formation of a rose-pink color band when the can be obtained for testing. drug is at or above the detection level of 25 ng/ml. Urine samples within the normal urine pH range (4.5-8.0) do In the case where free drug in the sample is below the not require prior adjustment of pH. Adulteration of the urine detection level of 25 ng/ml, antibody-dye conjugate is free to samplemay cause erroneous results. If adulteration is bind to the immobilized antigen in the test zone, producing a suspected, obtain another sample. rose-pink color band. Furthermore, unbound dye conjugate TEST PROCEDURE binds to the reagent in the control zone, producing a rose-pink 1. Bring test components and the urine sample specimen to color band in said zone, demonstrating that the reagents and room temperature (15-28C). device are functioning correctly.</p><p>Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA Phone: (703) 266-5667, FAX: (703) 266-5664 http://www.atlaslink-inc.com, [email protected] OneStep Phencyclidine InstaStrip, Cat. # 121080-50, Page 2 2. Do not break the seal of the pouch until ready to begin urine of people using or abusing them. No cross-reactivity testing. was detected with the substances listed in Table-II. 3. Open the foil pouch at the notch and remove the test Table-I: Concentration of phencyclidine-related compounds dipstick. Place the dipstick into the urine sample. Do not showing a positive response approximately equivalent to the allow the urine level to exceed the maximum-level line phencyclidine cut off set for the test. indicated by the arrows. Compound Concentration (ng/ml) 4. Read the test result at five minutes. Phencyclidine 25 IMPORTANT: Do not interpret a test result after more than five N-Acetylprocainamide 10,000 Codeine 5,000 minutes. Waiting longer than five minutes may cause inaccurate p-Hydroxymethamphetamine 50,000 interpretation. To avoid confusion, discard the test device after reading Thebaine 10,000 the result at five minutes. 1-(1-phenylcyclohexyl)-morphine (PCM) 600 N,N-Diethyl-1-phenyl-Cyclohexylamine (PCDE) 2.0 INTERPRETATION OF RESULTS 1{1-(2-thienyl)cyclohexyl]-morphine (TCM) 200</p><p>Table-II: Compounds tested and found not to cross-react with the test at a 1 mg/ml concentration in urine:</p><p>Acetaminophen Ecgonine HC1 Pendimetrazine Acetylsalicylic Acid Ecgonine Methyl Ester Penicillin G Amikacin Glucose Pentobarbital Amitriptyline Histamine d-Propoxyphene Ampicillin Hydrocodone Hydrochlorothiazide Arterenol Hydromorphone Propanol Aspartame Indomathacin Phenobarbital Atropine Sulfate Ketoprofen Phentermine Benzoic Acid Levorphanol Phenylpropanolamine Benzoylecgonine HC1 D-9-THC L-Phenylephrine Caffeine 11-nor-D-9-carboxy-THC- Quinine Chlorpheniramine 9-COOH Ranitidine Chlorpropmazine HC1 Meperidine Sodium Salicylate Cimetidine Methylphenidate Tryptophan Deoxyephedrine Methadone Tetracycline Dextromethorphan Methaqualone Tetrahydrozoline Diethylpropion Morp. Glucuronide Theophylline Diphenylhydantoin Morphine Sulfate Thioridazine 1. Positive. One rose-pink band appears in the Control Zone, with Doxylamine Oxycodone Trifluoperazine no apparent band in the Test Zone. A positive result indicates that the phencyclidine level is at or above 25 ng/ml. 3. Accuracy. The accuracy of the OneStep Phencyclidine 2. Negative. Two rose-pink bands appear -- one in the Control InstaStrip was first tested through an in-house study by Zone and one in the Test Zone. A negative result indicates that Syntron and subsequently in a clinical trial submitted to a the phencyclidine level is below 25 ng/ml. NIDA certified laboratory. Each urine specimen was 3. Invalid. No rose-pink bands appear, or a band in the Test Zone, tested with the OneStep Phencyclidine InstaStrip and a but not in the Control Zone. An invalid result may be due to improper testing procedures or deterioration of the kit commercially available test (Syva EMIT II). Positive components. Repeat the assay sequence by using a new device. results were confirmed by GC/MS. The results are Note: There is no meaning attributed to line color intensity or width. summarized as follows: Syva EMIT II Positive Syva EMIT II Negative QUALITY CONTROL InstaStrip Positive 223 0 An internal procedure control has been incorporated into the InstaStrip Negative 0 290 test to ensure proper kit performance and reliability. When compared to EMIT II the relative sensitivity was 100%. The use of an external control is recommended to verify The relative specificity was 100%. The concordance of the proper kit performance. Quality control samples should be combined data with respect to EMIT II was 100%. When tested according to quality control requirements established by compared to GC/MS both screening methods reported 2 false the testing laboratory. positives and no false negatives.</p><p>PERFORMANCE CHARACTERISTICS 4. Precision. The precision was determined by replicate 1. Sensitivity. The OneStep Phencyclidine InstaStrip assays of three different patient urine samples with kits detects phencyclidine and its major metabolites in urine at from three different production lots. The resultant data concentrations equal to or greater than 25 ng/ml, which is indicated 100% precision for the duplicates within each suggested by NIDA for the immunoassay method. lot and no appreciable interlot variation when testing both 2. Specificity. A study was conducted to determine the positive and negative spiked samples across three (3) cross-reactivity of phencyclidine-related compounds with different lots of devices. the test. Substances listed in Table-I produced results approximately equivalent to the cut-off level for phencyclidine. A separate study was conducted with the OneStep Phencyclidine InstaStrip to determine the cross-reactivity LIMITATIONS OF THE TEST of non-phencyclidine related compounds with the test at 1. This product is designed for use with human urine only. concentrations much higher than normally found in the</p><p>Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA Phone: (703) 266-5667, FAX: (703) 266-5664 http://www.atlaslink-inc.com, [email protected] OneStep Phencyclidine InstaStrip, Cat. # 121080-50, Page 3 2. Although the test is very accurate in detecting phencyclidine in urine, there is a possibility false results will occur due to the presence of interfering substances in the urine and/or factors beyond the control of the manufacturer, e.g. technical or procedural errors associated with the testing. 3. The test is a qualitative screening assay and is not for determining quantitative concentration levels or the level of intoxication. 4. Adulterants such as bleach or other strong oxidizing agents, when added to urine specimens, may produce erroneous test results regardless of the analysis method used. If adulteration is suspected, obtain another urine specimen and retest. BIBLIOGRAPHY 1. Baselt, R.C., Disposition of Toxic Drugs and Chemicals in Man, 2nd Ed., Biomedical Publ., Davis, CA, p 488 (1982). 2. Cody, J.T., and Schwarzhoff, R., J. Anal. Toxicol., 17:2630 (1993). 3. Urine Testing for Drugs of Abuse. National Institute on Drug Abuse (NIDA) Research Monograph 73. 1986. 4. Federal Register, Department of Health and Human Services. Mandatory Guidelinesfor Federal Workplace Drug Test Programs, 69, 11970- 11979, 1988, Federal Register 59, 110, 29908-29931, 1994. 5. Dasgupta, A., Saldana, S., Kinnaman, G., Smith, M., and Johansen, K., Clin. Chem., 39 (1):104-108 (1993). 6. FDA Guidance for Labeling Urine Drugs of Abuse Screening Testing, Kshitij Mohan, 7/21/1987. 7. Froelich, P.E., Gross, G.: Separation and Detection of Phencyclidine in Urine by Gas Chromatography. J. Chromatograph 1977;137;135-143. 8. Gupta R.C. et al: Determination of Phencyclidine in Urine and Illicit Street Drug Samples. Clin. Toxicol 1975; 8:611-621. 9. Oellerich, M.: Enzyme Immunoassays In Clinical Chemistry:Present Status and Trends. J. Clin. Chem. Biochem., 1980;18:197-208. 10. Anilineo, Pitts, F.N.: Phencyclidine (PCP): A Review and Perspectives. CRC Crit. Rev. Toxicol 1982;10:145-177.</p><p>Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA Phone: (703) 266-5667, FAX: (703) 266-5664 http://www.atlaslink-inc.com, [email protected]</p>