Screening

1. SIEMENS Syva ® RapidTest d. a. u. ® TCA

Syva_Rapid_Test_ca6

http://www.gurmed.com/EN/?page_id=812

This rapid test for TCA can be used to detect ten drugs at the same time.

 Information

  • One-Step Tricyclic Antidepressants Test
  • Qualitative Detection
  • Provides only a preliminary analytical result (screening test)
  • Principle: Competitive (indirect) ImmunochromatographicTest
  • Specimen: Human Urine

Precautions

  • For in vitro use.
  • Avoid cross contamination of urine samples by using a new urine specimen container and dropper for each urine sample.
  • This device does not contain any human source material.
  • Urine specimens are potentially infectious. Proper handling and disposal methods should be established according to good laboratory practice.
  • The kit should remain in its original packaging until ready to use.
  • Do not use test kit after expiration date.
  • This device contains nonsterile bovine serum albumin.

Storage and Stability

  • The kit should be stored at temperatures ranging from 2-30⁰C.

Specimen Collection and Preparation

  • Approximately 110 µl (3 drops) of urine sample
  • If testing will not be performed immediately, specimens should be refrigerated up to 48 hours (2-8⁰C) or frozen.
  • Specimens should be brought to room temperature before testing.

Test Protocol

  • Read the result after 5 minutes, but within 10 minutes of sample addition.

Interpretation of Results

  • Negative: appearance of a reddish-purple Control line and a line at the TCA position, any faint line at the TCA zone, visible within 10 minutes
  • Positive: appearance of only a reddish-purple Control line and no line at the TCA position (ie, the specimen contains the drug at a concentration giving a response above the cutoff level)
  • Invalid: No Control line at the C position

Picture2

 

Cut-off Values of the “Big Five”

The Cut-off values are the values wherein the kit will yield a positive or negative results based of the amount of the drugs present in the sample (urine). The following are the cut-off values of the “Big Five”. Take note that once one of these drugs present in the urine had already reached beyond the cut-off value that test will yield a positive result even though other of the Big Five are absent. Therefore, this test kit is not specific for TCA drugs.

  • Amitryptiline: 800 ng/ml
  • Desipramine: 1500 ng/ml
  • Imipramine: 1000 ng/ml
  • Nortriptyline: 1000 ng/ml
  • Doxepin: 1500 ng/ml

 

2. iScreen Tricyclic Antidepressant Drug Test

IS1_BAR-2

 

Test Features:

•On-Site Testing
•Saves Time & Money
•Simple Dip and Read Procedure
•Room Temperature Storage
•Laboratory Accurate
•Results in Minutes
•12 to 18 Month Shelf-Life

The iScreen Tricyclic AntidepressantsDrug Test is an on-site (rapid) urine test offering low cost and convenient collection. The iScreen is used by removing the end cap and inserting the detection device into the collection cup. Once the detection device is inserted, the tests will begin to run. The test results will be visible in a few minutes and if no drugs are found the corresponding panel will develop a red line below the Control Line.

iScreen Urine drug test kits are the least expensive and most flexible (meaning it is possible to test for many different drugs in different combinations) in testing drugs. Results of an iScreen urine drug test detect the presence or absence of specific drugs in the urine. A positive urine test result does not necessarily mean that the donor was under the influence of drugs at the time of the test. iScreen can be defined as a rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine.

iScreen Tricyclic AntidepressantsDrug Test urine drug test is an immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against their respective drug conjugate for binding sites on their specific antibody. During testing, a urine specimen migrates upward by capillary action. A drug, if present in the urine specimen below its cut-off concentration, will not saturate the binding sites of its specific antibody. The antibody will then react with the drug-protein conjugate and a visible colored line will show up in the test line region of the specific drug strip. The presence of drug above the cut-off concentration will saturate all the binding sites of the antibody. Therefore, the colored line will not form in the test line region.

A drug-positive urine specimen will not generate a colored line in the specific test line region of the strip 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 that proper volume of specimen has been added and membrane wicking has occurred.

Drug Cut-Off Level Approximate Detection Time in Urine
Tricyclic Antidepressants (TCA) 1,000 ng/ml 7-10 Days

iScreen Urine Dip Card – Drug Test Procedure

 Remove iScreen test from foil pouch at room temperature. Take off the cap revealing the testing strips.


 Immerse test vertically in the urine sample for at least 10-15 seconds. Do NOT allow the specimen to touch the device housing.


 Read the results at five (5) minutes. Results are stable for up to four (4) hours.


Negative – 2 Lines – ANY indication of a line in both test and control fields
Positive (Non-Negative) – 1 Line
Invalid – No line(s) or no control line(s)
From: http://www.rapiddetect.com/iscreen-single-tricyclic-antidepressant-test-p/is1_tca.htm

3. Instant-View® Tricyclic Antidepressants (TCA) Urine Drug Test

DOA-Cassette-1

The Instant-View® TCA urine drug test is a one-step, lateral flow test intended to detect tricyclic antidepressants (TCA) in human urine at a cut-off level of 1000 ng/ml. The accuracy rate for this test is 97.5%. This analyte is US FDA Cleared, CE Marked and available in some OTC Cleared/CLIA-Waived formats.

TCA are a group of antidepressant drugs taken orally or intramuscularly. This test is capable of detecting amitriptyline, desipramine, Imipramine and nortriptyline. The Instant-View® TCA urine drug test provides qualitative screening results and is for use by healthcare professionals only. It is recommended that a more specific alternate chemical method (i.e. GC/MS) be used in order to obtain a confirmed analytical result.

Available in the following formats:DOA Strips

  • Cassette with pipette (packaged 25 per kit box)
  • Dip strip (packaged 50 per kit box)
  • Dip cassette (packaged 25 per kit box)
  • It also has the option of being included in the Instant-View® multi-drug screen test cards, panels or SplitScreen cups.
Definition Street Names Possible Cross Reactants for Tests
A class of drugs used to treat depression. TCAs are the older antidepressants. New antidepressants such as Prozac, Paxil and Zoloft are not TCAs and should not cross react with the TCA assay. N/A Some manufacturers see large doses of carbamazepine (Tegretol) metabolites showing positive. Other prescription drugs may also cross react.

From: http://www.alfascientific.com/alfa-products/drugs-of-abuse/single-drug-tests/tricyclic-antidepressants

4. DRI® Tricyclics Serum Tox Assay

Intended Use

The DRI® Tricyclics Serum Tox Assay is intended for the qualitative and semiquantitative determination of tricyclic antidepressants in human serum, plasma or urine.

Summary and Explanation of the Test

Amitriptyline, imipramine, and related compounds are tricyclic antidepressants that are widely used for the treatment of depression. Metabolites of amitriptyline and imipramine (nortriptyline and desimipramine, respectively) also possess antidepressant activity, but are less effective than the parent compounds. The most frequent side effects associated with the use of tricyclic antidepressants include dry mouth, constipation, dizziness, palpitations and urinary retention. Acute toxicity due to tricyclic antidepressants may lead to coma, cardiac arrhythmia, respiratory depression and death. 1,2 Tricyclics have become the most common drug overdose case admitted to intensive care units.3 Detecting the presence of the drugs anddetermining its concentration in serum or urine from patients suspected of drug overdose can assist the physician in diagnosing and treating the patient.

The DRI Tricyclics Serum Tox Assay is a homogeneous enzyme immunoassay using ready- to-use liquid reagents. Specific tricyclic antibodies were used to detect most tricyclic antidepressants in serum, plasma, or urine. The test is based on the competition of an enzyme, glucose-6-phosphate dehydrogenase (G6PDH), labeled-drug and the drug from the sample for a fixed amount of specific antibody binding sites. In the absence of the drug from the sample, the specific antibody binds the enzyme-labeled drug and the enzyme activity is inhibited. This phenomenon creates a direct relationship between drug concentration in the sample and the enzyme activity. The enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.

Reagents

Antibody/Substrate Reagent: Contains polyclonal anti-tricyclics antibodies, glucose-6- phosphate (G6P), and nicotinamide adenine dinucleotide (NAD) in Tris buffer with sodium azide
as a preservative.

Enzyme Conjugate Reagent: Contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with nortriptyline in Tris buffer with sodium azide as a preservative.

Qualitative analysis

For qualitative analysis of samples, use the 300 ng/mL calibrator as the cutoff level. The DRI Serum Tox Calibrator 2, which contains 300 ng/mL nortriptyline, is used as a cutoff for
distinguishing “positive” from “negative” samples.

Semiquantitative analysis

For semiquantitative analysis, use all calibrators.

Results and Expected Values

Qualitative results

A sample that exhibits a change in absorbance (ΔA) value equal to or greater than the cutoff calibrator is considered positive. A sample that exhibits a change in absorbance (ΔA) value
lower than the cutoff calibrator is considered negative.

Semiquantitative results

A rough estimate of drug concentration in the samples can be obtained by running a standard curve with all calibrators and measuring samples off the standard curve.
Immunoassays that produce only a single result in the presence of a class of drugs, such as tricyclic antidepressants, cannot accurately measure the concentration of each individual
component. For a qualitative application, a positive result indicates only the presence of tricyclics. For a semiquantitative application, the assay gives an approximate, cumulative
concentration of tricyclic antidepressants.

Limitations

1. A positive result from this assay indicates only the presence of tricyclics and does not necessarily correlate with the extent of physiological and psychological effects.
2. A positive result by this assay should be confirmed by another non-immunological method such as GC/MS.
3. The test is designed for use with human serum, plasma or urine only.
4. Other substances and/or factors, (e.g.,technical or procedural) other than those investigated in the specificity study may interfere with the test and cause false results.

Specificity

Tricyclic compounds and other structurally related compounds were tested for cross-reactivity in the assay. The following table lists the concentrations of the compounds that produce a positive result in the assay using 300 ng/mL nortriptyline as cutoff calibrator.

12

For a detailed information: DRI® Tricyclics Serum Tox Assay Insert

References:

1.Spiker DG, Weiss AN, Chang, SS, Ruwitch JF and JT Biggs: Tricyclic Antidepressant Overdose: Clinical Presentation and Plasma Levels. Clin Pharmacol Ther 18:539 (1975).

2. Simpson GM, Pi EH and K White: Plasma Drug Levels and Clinical Response to Antidepressants. J Clin Psychiatry 44:27 (1983).

3. Spector R: Tricyclic Antidepressant Overdose. J Iowa Med Soc 73:320 (1983).

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