In the absence of the drug in the urine, the colored antibody-colloid gold conjugate moves with the sample fluid by capillary action along the membrane until it reaches the immobilized drug conjugate in the test band PCP PHENCICLIDINE region. At this point, the antibody-colloid gold conjugate reacts with the ® MonlabTest pre-coated drug conjugate to produce a visible pink colored line as the antibodies form complexes with the drug conjugate. The formation of a visible color line on the test band region indicates the urine sample tested is negative for phencyclidine. When the drug is present in the urine, the drug/metabolite antigen will Product code: compete with the drug conjugate coated in the test band region for the PRESENTATIO N limited antibody sites. When a sufficient concentration of drug is present, it MO-806018 20 strips MonlabTest will fill the limited antibody binding sites, and thus preventing the REF attachment of the colored antibody-colloid gold conjugate to drug Only for in vitro diagnostic use conjugates pre-coated in the test band region. An absence of the color band on the test region indicates a positive result . INTENDED USE A control band with a different antigen/antibody reaction is also added to The PCP Phencyclidine MonlabTest ® is a simple, one-step membrane strip to indicate that the test is performed properly. This control immunochromatographic assay intended for professional use only in the line should always be seen. A negative urine sample produces two distinct qualitative detection of Phencyclidine (PCP) and its metabolites in human color bands. A positive sample produces only one color band in the control urine with a cutoff at 25ng/ml. zone. If insufficient sample volume is used, there may not be a Control line, indicating the test is invalid. Note: This test provides only a preliminary analytical result which should be confirmed by a more specific method. Gas chromatography/mass MATERIALS PROVIDED spectrometry (GC/MS) has been established as the preferred confirmatory method by the National Institute on Drug Abuse (NIDA). 1) PCP Phencyclidine MonlabTest ® Clinical consideration and professional judgment should be applied to any 2) Instructions for use drug of abuse test result, particularly when preliminary positive results are indicated. MATERIALS NEEDED BUT NOT PROVIDED SUMMARY & EXPLANATION 1) Clean glass or plastic container for specimens collection 2) Timer Phencyclidine, commonly known as PCP or “angel dust,” is a sympathomimetic dissociative anesthetic whose biological effects include REAGENTS false feelings of invincibility, flashbacks, and even psychosis. It is used primarily as a recreational drug for its hallucinogenic effects. It is 1) Coated Antibodies/Antigens: usually taken orally, by inhalation, insufflation or intravenously. It is a. Control region (C): Goat anti-mouse (IgG) polyclonal antibody well absorbed by the body following all routes of administration b. Test region (T): Phencyclidine-BSA conjugate concentrating fastest in the fatty tissues and the brain. PCP is 2) Labeled Antibodies: metabolized by the liver via hydroxylation, which produces metabolites Colloidal gold conjugate of mouse monoclonal anti- Phencyclidine that are excreted by the kidneys. About 9% of phencyclidines are antibody excreted in the urine in unchanged form. The effects of phencyclidines generally last 4–6 hours following use and the drug has a half-life from SPECIMEN COLLECTION 8-55 hours depending on quantity consumed, body size, metabolic rate and other factors unique to the user. Statistically, the average half-life A fresh urine specimen should be used, no special pre-treatment is is 18 hours. necessary. Specimens should be collected in a clean glass or plastic container. The specimen may be refrigerated (2-8°C) and stored up to 2 The PCP Phencyclidine MonlabTest ® is a fast, qualitative, and visually days. For longer storage, freeze samples at -20°C or below. Refrigerated or read, immunoassay for screening without the use of an instrument. The frozen samples should be allowed to come to room temperature before method employs a unique monoclonal antibody to selectively identify assaying. Urine samples exhibiting visible precipitates should be filtered, Phencyclidine in test urine at or above the concentration of 25ng/mL. centrifuged or allowed to settle, so that clear aliquots can be obtained for This product is not intended to monitor drug levels, but only to screen testing. Urine samples within the normal urine pH range (4.5-8.0) do not urine for the presence of Phencyclidine. require prior adjustment. Adulteration of the urine sample may cause erroneous results. If adulteration is suspected, obtain another sample. PRINCIPLE OF THE TEST TEST PROCEDURE The PCP Phencyclidine MonlabTest ® is based on the principle of a competitive inhibition immunoassay, in which a chemically labeled drug 1. When you are ready to begin testing, open the sealed pouch by (drug conjugate) competes with the drug which may be present in urine tearing along the notch. Remove the test kit from the pouch and for the limited number of antibody binding sites. The test device consists use it as soon as possible. of a membrane strip, which is pre-coated with phencyclidine-BSA conjugate on the test band region, and a colored anti- phencyclidine 2. Immerse the strip into the urine sample with the arrow end monoclonal antibody-colloid gold conjugate pad placed at the end of the pointing towards the urine. Do not immerse past the Mark line. membrane. Take the strip out after 10-15 seconds and lay the strip flat on a clean, dry, non-absorbent surface (e.g., mouth of the urine container). Code: MO-806018 Monlab SL Selva de Mar 48 08019 BCN +34 93 433 58 60 Fax +34 93 436 38 94 [email protected] www.monlab.es Rev: december 2012 4. This test has been developed for testing urine samples only. The 3. Wait for colored bands to appear. Read results in 5 minutes. It performance of this test using other specimens has not been substantiated. is important that the background is clear before the result is 5. Adulterated urine samples may produce erroneous results. Strong read. Results obtained after more than 10 minutes are not oxidizing agents such as bleach (hypochlorite) can oxidize drug analytes. If considered valid. a sample is suspected of being adulterated, obtain a new sample. 6. As the PCP Phencyclidine MonlabTest ® for phencyclidine is a competitive assay, no prozone effect is present. 7. Samples containing target drug concentrations below the cutoff sensitivity for the test may produce a positive result occasionally. 8. Result read after 10 minutes may not be consistence with the original reading obtain within the result window within 5-10 minutes. PERFORMANCE CHARACTERISTICS ® Do not exceed the Sensitivity – PCP Phencyclidine MonlabTest has been shown to detect Mark li ne 25ng/ml of Phencyclidine (PCP) in urine at 10-15 minutes. The cutoff was determined by three people performed using the purchased controls (Cerilliant). Controls were diluted in drug-free urine to give concentrations INTERPRETATION OF RESULTS at 0%, 50%, 75%, 100%, 125% and 150% of the cutoff listed. A total of 15 samples were made at each concentration for Phencyclidine (PCP). The Negative: In addition to one pink colored control (C) line in the following results were tabulated in Table 1. control region, a distinct pink colored line will also appear in the test (T) region. The color intensity of the test line may be weaker or stronger than Table 1- Sensitivity Study on Phencyclidine (PCP) Test Kit that of the control line. Phencyclidine (PCP) 0 12.5 18.75 25 31.25 37.5 Positive: Only one pink colored line appears in the control (C) region. (ng/mL) No apparent line in the test (T) region. This indicates the presence phencyclidine at a level of 25ng/mL or above. Positive 0 0 1 14 14 15 Invalid: No line appears in the control zone “C”, the test should be Negative 15 15 14 1 1 0 voided since an improper test procedure may have been performed or deterioration of reagents may have occurred. This is due o the internal control built in which a distinct control region (C) line always appears. Specificity - The specificity of the PCP Phencyclidine MonlabTest ® was Repeat the test using a new device. If the problem persists, discontinue determined by adding various drugs and drug metabolites to drug-free using the test kit immediately and contact your local distributor. control urine specimens and tested with the kit. The results are expressed in terms of the concentration required to produce a positive result. Note : A faint line on the test region indicates the phencyclidine in sample is near the cut-off level for the test. These samples should be re-tested or Interfering Substances - The following compounds exhibited no confirmed with a more specific method before a clinical determination is interference when dissolved in drug-free control urine at 100µg/ml (Table made. 2). PH and specific gravity studies completed concurrently on the spiked drug-free control urine specimens also showed that there was no interference between the intended results. Table 2 Non-Cross Reacting Compounds (100µg/ml) Ac etaminophen (+) -Naproxen Pentazocaine Control Line Acetone (+/ -)-Ephedrine Pentermine Acetylsalicylic Acid (+/ -)-Isoproterenol Phenothiazine Albumin (+/ -)-Norephedrine Procaine Test Line Aminopyrine Ecgonine Promethazine Amitriptyline Ecgonine Methyl Ester Propanol Amoxici llin Erythromycin Quinidine Ampicillin Estradiol Quinine Aspartame Ethanol Raboflavin Aspirin Fenoprofen Ranitidine Mark Line Atropine Furosemide Salicylic acid Benzoic acid Glucose Serotonin Bilirubin Graiacol glycery ether Sodium Chloride LIMITATIONS Negative Positive Invalid Caffeine Hemoglobi n Sulfamethazine Cannabidiol Histamine Sulfate Benzocaine 1. This test is a qualitative, competitive screening assay. It is not Chloroquine Hydrocortisone Sulindac Chlorpromazine Ibuprofen Temazepam designed to determine the quantitative concentration of drugs or the Clonazepam Imipramine Tetracycline level of intoxication.