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LYHER® Urine Multi-Drug Test Kit (Cassette/DipCard/Cup)

A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs in human urine.

For prescription use only.

For in vitro diagnostic use only.

Detailed Description

The LYHER® Urine Multi-Drug Test Kit (Cup), LYHER® Urine Multi- Drug Test Kit (Cassette) and LYHER® Urine Multi-Drug Test Kit (Dipcard) are rapid lateral flow immunoassays for the qualitative detection of d-amp, d-met, bzo, Morphine, pcp and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

Test

Calibrator

Cut-off

amp (AMP)

d-amp

1000ng/ml

Cocaine (COC)

bzo

300ng/ml

Marijuana (THC)

11-nor-Δ9-THC-9-COOH

50ng/ml

met (MET)

d-met

1000ng/ml

Opiate (OPI)

Morphine

2000ng/ml

pcp (PCP)

pcp

25ng/ml

The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 6 analytes. The drug screen tests are intended for prescription use only.

The tests provide only a preliminary result. A more specific alternative chemical method should be used in order to obtain a confirmed presumptive Positive result.

Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary Positive results.

Certificate: CE/FDA 510K

Specimen: Urine

Product Format: 

Cassette (REF: DOA-101)

Dipcard (REF: DOA-102)

Cup (REF: DOA-103)

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

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

Cup:25/40Tests/Box

Materials Provided:

  • Test device (Cassette or DipCard or Cup)
  • Dropper(only for cassette)
  • Package insert

Directions for Use

Allow the test panel, urine specimen, and/or controls 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 Positivesible.
  1. Please choose the appropriate operation instructions depend on the actual product you have.

For Cassette:

1) Place the test device on a clean and level surface.

2) Hold the dropper vertically and transfer 3 full drops of urine (approx. 100ml) to the each 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.

3) Read results at 5 minutes.

DO NOT INTERPRET RESULT AFTER 10 MINUTES.

 

For Dip-card

1) Remove the test device from the foil pouch.

2) Remove the cap from the test device. Label the device with patient or control identifications.

3) Immerse the absorbent tip into the urine sample for about 10 seconds. Urine sample should not touch the plastic device.

4) Replace the cap over the absorbent tip and lay the device flatly on a non-absorptive clean surface.

5) Read results at 5 minutes.

DO NOT INTERPRET RESULT AFTER 10 MINUTES.

For Cup

1) Tear the foil bag open, remove test cup and disPositiveable gloves provided for donor. Label the device with donor information.

2) Open test cup lid. Urinate directly into the test cup. Be sure to fill up the test cup with the urine specimen between a minimum 30 ml to maximum 110 ml (marked on the cup).

3) After urine specimen has been collected, close the lid securely.

4) Peel off label to reveal test result. Wait for the colored line(C) to appear.

Read test result at 5 minutes.

DO NOT INTERPRET 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.

 

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