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A rapid, one step screen test for the simultameous, qualitative detection of multiple drugs and metabolites in human urine For professional in vitor diagnostic use only.

INTENDED USE

The Muilti-Drugs One Step Screen Test Panel(Urine) is a lateral flow chromatographic immunoassay for the qualitative detection of , , Benzodiazepines, , , , Mathadone, , Tricyclic Antidepressants and in human urine.

SUMMARY

Urine based screen tests for multiple drugs of abuse range from simple immunoassay tests to complex analytical procedures. The speed and sensitivity of immunoassays have made them the most widely accepted method to screen urine for multiple drugs of abuse.

The Multi-drugs One step Screen Test Panel (Urine) is a rapid urine visual, competitive screen immunoassay that can be used for the simultaneous, qualitative detection of , , Benzodiazepines, , , , Mathadone, , Tricyclic Antidepressants and in human urine at the following cut-off concentrations: 1000 gn/mL , 300ng/mL, ( metabolite), 300 ng.mL (Benzodiazepines metabolite), 300ng/mL Benzoylecgonine( metabolite),1000ng/mL , 300 ng/mL , 300 ng.mL , 25 ng/mL , 1000 ng.mL Tricyclic Antidepressants, 50ng/mL 11-nor=Δ9-THC-9 COOH(THC) without the need of instrument.

PRINCIPLE

The Multi-Drug One Step Screen Test Panel(Urine) is an immunoassay hased on the principle of competitive binding.Drugs which may be present in the urine specimen compete against their respective drug conjugate for binding sites of its cut-off concentration. Will not saturate the binding sites of its specific antibody coated on the particles. The antibody coated particles will then be captured by the immobilized drug conjugate and a visible colored line will show up in the test line region of the specific drug level is at or above its cut-off concentration because it will saturate all the binding sites of the antibody coated on the particles.

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.

PRECAUTIONS

For in vitro diagnostic use only. Do not use after the expiration date.

The test panel should remain in the sealed pouch until use.

All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.

Then used test device should be discarded according to federal, state and local regulations.

Humidity and temperature can adversely affect results.

STORAGE AND STABILITY

Store as packaged in the sealed pouch at 2-30℃, The test panel is stable through the expiration date printed on the scaled pouch.The test panel must remain in the scaled pouch until use.DO NOT FREEZE.

Do not use beyond the expiration date.

SPECIMEN COLLECTION AND PREPARATION

Urine Assay

The urine specimen must be collected in a clean and dry container. Urine collected at any time of the day may be used. Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed settle to obtain a clear supernatant for testing.

Specimen Storage

Urine specimens may be stored at 2-8℃ for up to 48 hours prior to assay. For prolonged storage, specimens may be frozen and stored below -20℃. Frozen specimens should be thawed and mixed before testing.

MATERIALS

Materials Provided

Test panels

Package insert

Materials Required But Not Provided

Specimen collection container

Timer

DIRECTIONS FOR USE

Allow the test panel, urine specimen and /or controls to equilibrate to room temperature(10-30℃) prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the test panel form the sealed pouch and use it as soon as possible.
2. Take off the cap outside of the test end. With arrows pointing toward the urine specimen for at least 10-15 seconds. Do not pass the arrows on the test panel when immersing the panel.See the illustration below.
3. Place the test panel on a non-absorbent flat surface, start the timer and wait for the red line(s) to appear. The results should be read at 5 minutes. Do not iinterpret results after 10 minutes.