New Drug Abuse Test Kit TCA (Nortriptyline) Rapid Diagnostic Test dipcard, urine drug test, 1000ng/ml cut-off , professional use

Product Name

One Step TCA Rapid Diagnostic Test Cassette

Specimen: Urine

Intended Use

The TCA Rapid Test Cassette (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.

Test Principle

The TCA Rapid Test Cassette (Urine) 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. Tricyclic Antidepressants, if present in the urine specimen below the cut-off level, will not saturate the binding sites of the antibody coated particles in the test. The antibodies coated particles will then be 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 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 that proper volume of specimen has been added and membrane wicking has occurred

DIRECTIONS FOR USE

1. Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.

Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. For best results, the assay should be performed within one hour.

2. Using the provided disposable pipette, transfer 3 drops of specimen (approximately 120 µL) to the specimen well (S) of the device and start the timer.

3. Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.

4. As the test begins to work, color will migrate across the membrane.

5. Wait for the colored band(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 8 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.

QUALITY CONTROL

A procedural control is included in the test. A line appearing in the control region

(C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

Control standards are not supplied with this kit. However, it is recommended that positive and negative controls be tested as good laboratory practice to confirm the test procedure and to verify proper test performance.