DOA TCA One Step Tricyclic Antidepressants Test with CE Certificate Urine uncut sheet

DOA TCA One Step Tricyclic Antidepressants Test with CE certificate urine uncut sheet

One Step Tricyclic Antidepressants Test is a rapid one step test for the qualitative detection of Tricyclic Antidepressants and its principal metabolites in human urine at specified cut-off level.

For in vitro diagnostic use only. For professional use only.

INTENDED USE

The One Step Tricyclic Antidepressants Test is a lateral flow chromatographic immunoassay for the detection of Tricyclic Antidepressants in human urine at the cut-off concentration of 1,000 ng/ml. This assay provides only a qualitative, preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

PERFORMANCE CHARACTERISTICS

A. Sensitivity

One Step Tricyclic Antidepressants Test has set the screen cut-off for positive specimens at 1,000 ng/mL for Notriptyline as a calibrator. The test device has been proved to detect above 1,000 ng/mL of Tricyclic Antidepressants in urine at 5 minutes.

B. Specificity and cross reactivity

To test the specificity of the test, the test device was used to test TCA, drug metabolites and other components of the same class that are likely to be present in urine, All the components were added to drug-free normal human urine. These concentrations below also represent the limits of detection for the specified drugs or metabolites.

Component Concentration (ng/ml)

Notriptyline 1,000

Nordoxepine 1,000

Trimipramiine 3,000

Amitriptyline 1,500

Promazine 1,500

Desipramine 200

Imipramine 400

Clomipramine 12,500

Doxepine 2,000

Maprotiline 2,000

Promethazine 25,000

C. Interfering substances

Considering the complexity of clinical urine specimens and the possibility that various urine specimens contain potentially interfering substances, for example Acetoacetic Aci, Acetone, Albumin etc., we simulated above situations by adding the potentially interfering substances to a certain concentration as specimen. The following components show no cross-reactivity when tested with One Step Tricyclic Antidepressants Test at a concentration of 100 mg/ml.

SUMMARY

TCA (Tricyclic Antidepressants) are commonly used for the treatment of depressive disorders. TCA overdoses can result in profound central nervous system depression, cardiotoxicity and anticholinergic effects. TCA overdose is the most common cause of death from prescription drugs. TCAs are taken orally or sometimes by injection. TCAs are metabolized in the liver. Both TCAs and their metabolites are excreted in urine mostly in the form of metabolites for up to ten days.

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