TCA Tryciclic strip

CONTENTS TCA Tryciclic Antidepressants Tryciclic A rapid test for the qualitative detection of Tryciclic REF 4452250 50 tests Antidepressants Antidepressants (TCA) in human urine.

ONE STEP

For professional in vitro diagnostic use only

PRINCIPLE

LINEAR TCA Antidepressants strip is a rapid chromatographic immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody.

During testing, a urine specimen migrates upward by capillary action. TCA TCA TCA TCA TCA Tricyclic Antidepressants, if present in the urine specimen below the cut-off level, will not saturate the binding sites of the antibody coated C C C C C particles in the test. The antibodies coated particles will then be T T T T T captured by immobilized Tricyclic Antidepressants conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the Tricyclic Antidepressants level exceeds the cut-off level because it will saturate all the binding -MAX- -MAX -MAX- sites of anti-Tricyclic Antidepressants antibodies. A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen will generate a line in the test line region because of the absence of drug competition. To serve as a procedural control, a colored line will always appear at the control line region indicating Negative Positive Invalid that proper volume of specimen has been added and membrane wicking has occurred.

REAGENT COMPOSITION NEGATIVE:* Two lines appear. One colored line should be in the

The LINEAR TCA Tryciclic Antidepressants strip, contains anti-Tricyclic control line region (C), and another apparent colored line should be in Antidepressants particles and Tricyclic Antidepressants conjugate the test line region (T). This negative result indicates that the Tricyclic coated on the membrane. A goat antibody is employed in the control concentration is below the detectable level. li ne system. *NOTE: The shade of color in the test line region (T) will vary, but it should always be considered as negative whenever there is even a faint colored line. PACKAGING CONTENTS

REF 4452250 50 TCA Tryciclic Antidepressants test strip. POSITIVE: One colored line appears in the control line region (C). No line appears in the test line region (T). This positive result indicates that the concentration exceeds the detectable STORAGE AND STABILITY level.

Store at 2-30ºC. The test strip is stable through the expiration date printed on the sealed INVALID: Control line fails to appear. Insufficient specimen volume pouch. The test strip must remain in the sealed pouch until use. DO or incorrect procedural techniques are the most likely reasons for NOT FREEZE. Do not use beyond the expiration date. control line failure. Review the procedure and repeat the test using a new test. If the problem persists, discontinue using the lot immediately and contact your local distributor. SPECIMEN COLLECTION AND PREPARATION

The urine specimen must be collected in a clean and dry container. QUALITY CONTROL Urine collected at any time of the day may be used. Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed A procedural control is included in the test. A colored line appearing in to settle to obtain a clear supernatant for testing. the control line region (C) is considered an internal procedural control. It Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. confirms sufficient specimen volume, adequate membrane wicking and For long-term storage, specimens may be frozen and stored below -20°C. correct procedural technique. Control standards are not supplied with Frozen specimens should be thawed and mixed before testing. this kit; however, it is recommended that positive and negative controls be tested as good laboratory testing practice to confirm the test procedure and to verify proper test performance. MATERIAL REQUIRED

- Timer. CLINICAL SIGNIFICANCE - Specimen collection container . TCA (Tricyclic Antidepressants) are commonly used for the treatment

of depressive disorders. TCA overdoses can result in profound central PROCEDURE nervous system depression, cardiotoxicity and effects. TCA overdose is the most common cause of death from prescription Allow the test strip, urine specimen, and/or controls to reach room drugs. TCAs are taken orally and sometimes by injection. TCAs are temperature (15-30ºC) prior to testing. metabolized in the liver, both TCAs and their metabolites are excreted in urine mostly in the form of metabolites for up to ten days. 1. Bring the pouch to room temperature before opening it. Remove the The LINEAR TCA Tricyclic Antidepressants strip is a rapid urine- test strip from the sealed pouch and use it as soon as possible. screening test that can be performed without the use of an instrument. 2. With arrows pointing toward the urine specimen, immerse the test The test utilizes a monoclonal antibody to selectively detect elevated strip vertically in the urine specimen for at least 10-15 levels of in urine. The LINEAR TCA Tricyclic seconds. Do not pass the maximum line (MAX) on the test strip Antidepressants strip yields a positive result when the Nortriptyline in when immersing the strip. See the illustration below. urine exceeds 1,000 ng/mL. 3. Place the test strip on a non-absorbent flat surface, start the timer Test to monitor therapeutic measures related to the study and control of and wait for the red line(s) to appear. The result should be read at detoxification treatments of drug of abuse and its effects in laboratory 5 minutes. Do not interpret the result after 15 minutes. tests.

QUALITY SYSTEM CERTIFIED LINEAR CHEMICALS S.L. Joaquim Costa 18 2ª planta. 08390 Montgat, Barcelona, SPAIN ISO 9001 ISO 13485 Telf. (+34) 934 694 990 Fax. (+34) 934 693 435. website www.linear.es

ANALYTICAL PERFORMANCE Creatine Riboflavine A. Accuracy Dexbrompheniramine Sodium Chloride Sulindac The accuracy of the LINEAR TCA Tricyclic Antidepressants strip was 4-Dimethylaminoantipyrine compared and checked against a commercially available test with a threshold value of 1,000 ng/mL. 120 urine samples taken from volunteer Dopamine test persons who claim to be non-consumers was examined under both Erythromycin Trimethobenzamide tests. The results were 100% in agreement. Ethanol Tyramine Furosemide Vitamin C B. Reproducibility Glucose

The reproducibility of the LINEAR TCA Tricyclic Antidepressants strip was verified by blind tests performed at a four different locations. All 60 NOTES utilized samples with a TCA-concentration of 500 ng/mL yielded a negative result. All 60 samples with a TCA-concentration of 1,500 ng/mL 1. The LINEAR TCA Tricyclic Antidepressants strip provides only a yielded a positive result. No significant differences were observed qualitative, preliminary analytical result. A secondary analytical between test results of the different evaluation sites. method must be used to obtain a confirmed result. Gas chromatography/mass spectrometry (GC/MS) is the preferred 2,3 C. Precision confirmatory method. 2. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the analytical method used. Test precision was determined by blind tests with control solutions. If adulteration is suspected, the test should be repeated with Controls with a TCA-concentration of 500 ng/mL yield a negative result. another urine specimen. Controls with a TCA-concentration of 1,500 ng/mL provide a positive 3. A positive result indicates presence of the drug or its metabolites but result. does not indicate level of intoxication, administration route or concentration in urine. 4. A negative result may not necessarily indicate drug-free urine. D. Specificity Negative results can be obtained when drug is present but below the cut-off level of the test. The specificity of the LINEAR TCA Tricyclic Antidepressants strip was 5. Test does not distinguish between drugs of abuse and certain tested with the substances listed below, all of which can be found in a . normal urine specimen. These substances was added to normal drug free urine. REFERENCES The following compounds with a similar chemical structure yielded a positive result at the specified concentration: 1. Baselt, R.C. Disposition of Toxic Drugs and Chemicals in Man, Biomedical Publications, 1982 CONCENTRATION COMPOUND 2. Urine Testing for Drugs of Abuse. National Institute on Drug Abuse (ng/mL) (NIDA), Research Monograph 73, 1986 Nortriptyline 1,000 3. Thomas L. eds., Labor und Diagnose, 6. ed., TH-Books Verlags- gesellschaft, Frankfurt, 2005 1,000 4. Fed. Register, Department of Health and Human Services, 3,500 Mandatory Guidelines for Federal Workplace Drug Testing 10,000 Programs, 53, 69, 11970, 1988 5. McBay, A.J. Clin. Chem. 33, 33B-40B, 1987 Gilman, A.G., & 1,500 Goodman, L.S. The Pharmacological Basis of Therapeutics, eds. 500 MacMillan Publishing, New York, NY, 1980. Diphenyldramine 20,000

Doxepin 1,000 800

Nordoxepine 1,000 4,000

Perphenazine 25,000 200

Promethazine 40,000 Protryptyline 3,000

Trimipramine 2,500

All following listed compounds reacted negative up to a concentration of 100 µg/mL.

Acetamidophene Guaiacol Glyceryl Ether

Acetone Hemoglobin

Albumin Imipramine Amitriptyline (+/-)-Isoproterenol Ampicillin Lidocaine Aspartame (+)-Naproxen

Aspirin Oxalic Acid Penicillin-G Benzocaine Bilirubin

Caffeine Phenylethylamine Chloroquine Procaine (+/-)-Chlorpheniramine 44522-3/0903 Chlorpheniramine R1.ing

QUALITY SYSTEM CERTIFIED LINEAR CHEMICALS S.L. Joaquim Costa 18 2ª planta. 08390 Montgat, Barcelona, SPAIN ISO 9001 ISO 13485 Telf. (+34) 934 694 990 Fax. (+34) 934 693 435. website www.linear.es