Nortriptyline TCA Multi Panel Drug Test Kits Urine Sample 3mm Strip Accurate Result

Drug Test Kit TCA Rapid Diagnostic Test strip, Gold colloidal method, detecting Nortriptyline in urine, 1000ng/ml

Product Name

One Step TCA Rapid Diagnostic Test Strip

Specimen: Urine

Intended Use

The TCA Rapid Test Strip (Urine) is a lateral flow chromatographic immunoassay for the detection of Nortriptyline in human urine at a cut-off concentration of 1,000 ng/mL. This test will detect other related compounds, please refer to the Analytical Specificity table in this package insert. This assay provides only a 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) or high performance liquid chromatography (HPLC) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

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 and 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. The TCA Rapid Test Dipstick (Urine) is a rapid urine-screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of nortriptyline in urine. The TCA Rapid Test Dipstick (Urine) yields a positive result when the Nortriptyline in urine exceeds 1,000 ng/mL.

DIRECTIONS FOR USE

1. Bring the pouch to room temperature before opening it. Remove the Test Dipstick from the sealed pouch and use it within one hour.
2. With arrows pointing towards the urine specimen, immerse the Test Dipstick vertically in the urine specimen in such a way that urine does not cross MAX line on the Test Dipstick for 10-15 seconds. See the illustration below.
3. Wait for the color line(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 10 minutes.

INTERPRETATION OF RESULTS

NEGATIVE:* A colored line appears in the Control region (C) and colored lines appears in the Test region (T). This negative result means that the concentrations in the urine sample are below the designated cut-off levels for a particular drug tested.

*NOTE: The shade of the colored lines(s) in the Test region (T) may vary. The result should be considered negative whenever there is even a faint line.

POSITIVE: A colored line appears in the Control region (C) and NO line appears in the Test region (T). The positive result means that the drug concentration in the urine sample is greater than the designated cut-off for a specific drug.

INVALID: No line appears in the Control region (C). Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for Control line failure. Read the directions again and repeat the test with a new test card. If the result is still invalid, contact your manufacturer.

LIMITATION

1. The TCA Rapid Test Dipstick (Urine) provides only a preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography/mass spectrometry (GC/MS) or high performance liquid chromatography (HPLC) are the preferred confirmatory methods.
2. The TCA Rapid Test Dipstick (Urine) is a qualitative screening assay and can not determine either the drug concentration in the urine or the level of intoxication.
3. It is possible that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results.
4. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the analytical method used. If adulteration is suspected, the test should be repeated with another urine specimen.
5. A positive result indicates presence of the drug or its metabolites but does not indicate level or intoxication, administration route or concentration in urine.
6. A negative result may not necessarily indicate drug-free urine. Negative results can be obtained when drug is present but below the cut-off level of the test.

PERFORMANCE

Accuracy

A comparison was conducted using the TCA Rapid Test Dipstick (Urine) and GC/MS. The following results were tabulated:

Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnostic test and endoscopic medical device respectively. Our products ranged in the following specialties: drug of abuse tests, fertility tests, infectious diseases tests, sexual transmitted diseases tests, tumor markers tests, cardiac markers tests, veterinary tests, and surgical stapler series.

NEW LIFE have 3 wholly-owned and joint stock subsidiary companies, including Orient New Life Medical Co., Ltd., Orient Gene Biotech Co., Ltd., Qianjing Medical Equipment Co., Ltd.

Company's core technical team with more than 35 employees，3 doctors and 25 masters. They have many years of famous universities in the United States and pharmaceutical companies engaged in the project research and development, production and marketing, business management experience.Company owns hundreds of grade purification workshop and all level of quality checkout room, equipped with various production and testing equipment.