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LYHER® Urine Marijuana (THC) Test Kit (Strip/Cassette)

A rapid, one step screening test for thequalitative detection of Marijuana (THC) in human urine. For prescription use only. For in vitro diagnostic use only.

Detailed Description

The Urine Marijuana (THC) Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of THC-COOH in urine at the cut-off concentrations:

Test

Calibrator

Cut-off

Marijuana (THC)

11-nor-Δ9-THC-9-COOH

50ng/ml

The test provides only a preliminary analytical test result. The test is not intended to be used in monitoring the drug levels. A more specific alternate method must be used in order to confirm the test result. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography/Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are obtained.

Certificate: CE/FDA 510K

Specimen: Urine

Product Format: 

Strip (REF: DTH-101)

Cassette (REF: DTH-102)

Specification: Strips:50/100Tests/Box;

Cassette: 10/15/20/25Tests/Box

Materials Provided:

lTest device (Strip or Cassette)

lDropper(only for cassette)

lPackage insert

Directions for Use

Allow the test panel, urine specimens to equilibrate to room temperature (15-30°C) prior to testing.

  1. Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.

For Strip

Remove the test Strip from the sealed pouch and use it as soon as possible.With arrows pointing toward the urine specimen, immerse the test strip vertically in the urine specimen for 15 seconds. Do not pass the maximum line (MAX) on the test strip when immersing the strip. See the illustration below. Place the test strip on a non-absorbent flat surface, start the timer and wait for the red line (s) to appear. Read results at 5 minutes.

DO NOT INTERPRET RESULT AFTER 10 MINUTES.

For Cassette

Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 100ml) to the specimen well (S) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well (S). See the illustration below.

DO NOT INTERPRET RESULT AFTER 10 MINUTES.

  1. Wait for the colored line(C) to appear. The result should be read at 5 minutes.

Do not interpret the result after 10 minutes.


NEGATIVE:* Two lines appear. One colored line should be in the control region (C), and another apparent colored line adjacent should be in the test region (T). This negative result indicates that the drug concentration is below the detectable level.

*NOTE: The shade of color in the test line region (T) will vary, but it should be considered negative whenever there is even a faint line.

POSITIVE: One colored line appears in the control region (C). No line appears in the test region (T). This positive result indicates that the drug concentration is above the detectable level.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test using a new test panel. If the problem persists, discontinue using the lot immediately and contact your manufacturer.

For strip:

Sensitivity: 96.7%

Specificity: 99.5%

For cassette:

Sensitivity: 97.5%

Specificity: 99.5%

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