References Symbols Key P-58109-F Principle 1. Fairlight Consulting. The Status DS TCA test uses solid-phase chromatographic http://www.fairlite.com/ocd/articles/ tricyclic.shtml DS membrane immunoassay technology for the qualitative Instructions For Use (Read) detection of tricyclic antidepressants. The test is based on 2. Bickel MH. Poisoning by Tricyclic Antidepressant the principle of the highly specific immunochemical Drugs. Int. J. Clinical Pharmacol. 11 (1975) 145-176 REF Item Number One-Step TCA Assay reactions between antigens and antibodies which are used (No. 2). For In Vitro Use Only for the analysis of specific substances in biological fluids. Store At The test relies on the competition between the drug 3. Baselt RC. Disposition of Toxic Drugs and Chemi- conjugates and the drugs which may be present in the urine cals in Man. 2nd ed., Davis, CA: Biomedical Simple One-Step Immunoassay for the Qualitative Detection of Tricyclic sample, for binding to antibodies. In the test procedure, a Publ.;1982;pp. 30-34, 223-225, 394-397, 568-571. Expiration Date sample of urine is placed in the Sample Well of the device Antidepressants in Urine and is allowed to migrate upward. If the drug is present in the CONT Contents urine sample, it competes with the drug conjugate bound to the dye, for the limited antibodies immobilized on the IFU Instructions For Use membrane. If the level of drug or drug metabolite is above the cutoff level, the drug will saturate the antibodies, thus inhibiting the binding of the dye coated with drug conjugates PIP Transfer Pipette LifeSign, LLC to the antibodies on the membrane. This prevents the formation of a line on the membrane. Therefore, a IVD For In Vitro Diagnostic Use Item No. 20910 10 Test Kit drug-positive urine sample will not generate a line at Test (T) Item No. 20935 35 Test Kit position in the Result Window, indicating a positive result LOT Lot Number from positive drug competition. A negative urine sample will generate a line at T position in the Result window, indicating Manufacturer a negative result from an absence of competition with free drugs.In addition to the Test line that may appear in the Result window, a Control line is present to confirm the MF Manufactured For viability of the test. This Control line (validation line) should Intended Use always appear if the test is conducted properly. Polyclonal EC REP Authorized Representative sheep anti-mouse IgG antibody is immobilized on the control Status DS TCA is a simple, one-step immuno- line. The monoclonal antibody-dye conjugates that pass the chromatographic assay for the rapid, qualitative detection of CE Mark line will be captured and produce a colored line at the tricyclic antidepressants (TCAs) . The test is standardized to Control position (C). This works as a procedural control, detect nortryptiline at a cutoff concentration of 1000 ng/mL in confirming that proper sample volume was used and the human urine. reagent system at the Control line and the conjugate-color The Status DS TCA test is a qualitative screening test, and indicator worked properly. If insufficient sample volume is provides only a preliminary analytical result. A negative result used, there may not be a Control line, indicating the test is does not eliminate the possibility of the presence of tricyclic invalid. antidepressants (TCAs) in the urine specimen at concentrations below the cutoff. A positive result may be due Materials Provided to the sum of the reactivities of more than one tricyclic The Status DS TCA test kit contains all the reagents antidepressant and/or their metabolites (see Table 2: necessary to perform the tests. Specificity). To obtain a confirmed analytical result, a more specific alternative method should be used, e.g., high • Status DS TCA device. The test device contains a performance liquid chromatography (HPLC) or gas membrane strip coated with polyclonal anti-nortryptiline chromatography, mass spectrometry (GC/MS). Clinical antibody and a pad containing drug-dye conjugate in a consideration and professional judgment should be applied protein matrix. to any drug test result, particularly when preliminary positive • Disposable specimen pipette. results are used. • Instructions for use. Summary and Explanation Precautions Tricyclic antidepressants (TCAs) are a type of prescription • For in vitro diagnostic use only. drug intended for clinically depressed patients. Unfortunately, they are becoming more frequently abused • Avoid cross contamination of urine samples by and are now one of the leading causes of death by drug using a new urine specimen container and pipette overdose in the United States. There are two broad chemical for each urine sample. classes of TCAs. The tertiary amines— amitryptiline, • The test kit does not contain any HIV or hepatitis imipramine, trimipramine and doxepin—boost serotonin infective components. levels and are prescribed for insomnia, irritability and overstimulation. The secondary amines—nortryptiline, • Urine specimens are potentially infectious. Proper desipramine and protryptiline—enhance nore- pinephrine handling and disposal methods should be levels and are prescribed for opposite types of symptoms, established according to good laboratory practices. such as excessive fatigue, withdrawal and inertness.1 Abuse • The Status DS device should remain in its original Printed in U.S.A. EC REP Manufactured by MF Manufactured for: of TCAs may lead to coma, respiratory depression, P-58109-F sealed pouch until ready for use. Do not use the test 232-9/13/12 MT Promedt Consulting GmbH convulsions, blood pressure deviations, hyperprexia and if the pouch is damaged or the seal is broken. Altenhofstrasse 80 severe cardiac conditions. TCAs are excreted in urine mostly 66386 St. Ingbert Princeton BioMeditech Corporation in the form of metabolites for up to ten days.2,3 • Do not use the test kit after the expiration date. Germany 4242 U.S. Hwy 1, Monmouth Jct. A PBM Group Company +49-68 94-58 10 20 New Jersey 08852, U.S.A. 85 Orchard Road, 1-732-274–1000 www.pbmc.com Skillman, NJ 08558 800-526-2125, 732-246-3366 www.lifesignmed.com 4 1 Storage and Stability Performance Characteristics The following compounds show no cross-reactivity when Invalid: A distinct Control line (C) should always appear. The tested with Status DS TCA at a concentration of 100 µg/mL The Status DS TCA test kit should be stored at 2–30°C test is invalid if no Control line forms at the C position. Such The Status DS TCA test has been shown to detect nortryptiline (Table 3). (35–86°F) in the original sealed pouch. The expiration dating tests should be repeated with a new Status DS test device. at an average cutoff of 1000 ng/mL in urine. The accuracy of was established under these storage conditions. There are other possible redults depending on the Status DS TCA was evaluated in comparison to commercially Table 3. Non Cross-Reacting Compounds: combination of drugs in the urine sample. available immunoassay, Triage®. A total of 203 samples was tested by both procedures. Complete agreement was 4-Acetamidophenol Meperidine Specimen Collection and Preparation observed in 99% of the samples as shown below (Table 1). Acetophenetidin Meprobamate Limitations (Phenacetin) Methadone Approximately 110 µL of urine sample is required for each N-Acetylprocainamide p-Hydroxymethamphetamine test. Fresh urine specimens do not require any special • If inadequate sample is dispensed into the sample well Table 1. Accuracy: Comparison of Status DS TCA with Acetylsalicylic acid Methaqualone handling or pretreatment. Specimens should be collected in (less than 3 full drops or 110 µL), the sample may not Triage® Aminopyrine Methoxyphenamine migrate in the device. Should no migration be observed Amitryptyline (±) 3,4-Methylenedioxyamphetamine a clean glass or plastic container. If testing will not be Triage® Amobarbital (±) 3,4-Methylenedioxymethamphetamine performed within 2 hours, specimens should be refrigerated within the first minute after addition of the sample, the user Amoxapine Methylphenidate may dispense another drop of the urine sample into the (2–8°C) for up to 48 hours. If longer storage is required, Positive Negative TOTAL Amoxicillin Methyprylon specimen may be stored frozen (-20°C or colder). Specimens device. This process may be repeated a second time. If D,L-Amphetamine Morphine-3-ß-Dglucuronide migration does not occur after the second sample addition Status DS Positive 103 2 105 l-Amphetamine Nalidixic acid should be brought to room temperature before testing. Apomorphine Nalorphine Specimens containing a large amount of particulate matter the test should be repeated with a new device. (TCA) Negative 0 98 98 Aspartame Naloxone may give inconsistent test results. Such specimens should TOTAL 103 100 203 Atropine Naltrexone be clarified by centrifuging or allowing to settle before • The test is designed for use with unadulterated urine only. Benzilic acid Naproxen Benzoic acid Niacinamide testing. Benzphetamine Nifedipine • There is a possibility that factors such as technical or Butabarbital Norcodein procedural errors, as well as other substances in the urine Precision and Accuracy Cannabidiol Norethindrone Test Procedure The test procedure consists of adding the urine sample to sample which are not listed in Table 3 below, may interfere The precision of the Status DS TCA assay was determined by Chloralhydrate Noroxymorphone with the test and cause erroneous results. Chloramphenicol D-Norpropoxyphene the Sample Well of the device and watching for the carrying out the test with serially diluted standard drug solu- Chlordiazepoxide (–) Norpseudoephedrine appearance of colored lines in the Result Window. tions. About 95% of the samples containing nortryptiline Chlorothiazide Noscapine • Adulterants, such as bleach and/or alum, in urine concentrations 25% over the cutoff level consistently Chlorpromazine Nylidrin specimens may produce erroneous results regardless of showed positive results. The study also included over 40 Chlorquine D,L-Octopamine Test Protocol the method of analysis.