One-Step Urine Drug Test 1 Panel For Opiates (OPI) Gold Rapid Screen Test

The Opiates Drug Test/Single Panel Opiates (OPI) Drug Test Dip Card is a one-step urine drug screen that provides a rapid, one step screening for the simultaneous, qualitative detection of one drug in human urine. The single dipstick screens for the presence of Opiates in human urine, which is qualitatively analyzed to indicate a positive or negative test result. Results are produced in minutes making this test a quick, precise and practical solution for on-site drug screening.

INTENDED USE
Opiate (OPI) Rapid Test is an immuno-chromatographic assay for the qualitative determination of the presence of Opiate 1000 (OPI) listed in the table below

This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to Opiate 1000 (OPI) of abuse test result, particularly when preliminary positive results are indicated.

WARNINGS AND PRECAUTIONS
• Immunoassay for in vitro diagnostic use only.
• Do not use after expiration date.
• The test should remain in the sealed pouch until use.
• The used test should be discarded according to local regulations.

CONTENTS
• Drug Test.
• Desiccant
• Leaflet with instruction for use

STORAGE AND STABILITY

• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.

• The test must remain in the sealed pouch until use.

• Keep away from direct sunlight, moisture and heat.

• Do not freeze.

• Care should be taken to protect the components of the kit from contamination.

Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.

FEATURES
• Up to 24 month shelf life
• Up to 99% accurate
• One-step urine drug screen
• Easy dipstick card format
• Results in 5 to 8 minutes
• No reagents needed
• Stores at room temperature
• Built-in controls for each analyte to validate results.

OPERATION
Test must be in room temperature (15ºC to 30ºC)
1. Donor collects urine specimen in a urine cup.
2. Cassette and Strip Operation:
2.1 Cassette: Remove test device/cassette from the sealed pouch. Lay the cassette flat, add 2 drops of urine specimen by sample dropper into the sample well.
2.2 Distick Panel or Strip: Remove test strip from the sealed pouch. Dip the arrowed end of the test strip into the container with urine sample, take it out in 10 seconds and lay flat.
3. The result should be read at 5 minutes.
Do not interpret the result after 10 minutes.

INTERPRETATION OF RESULTS
Preliminary positive (+) Only one colored band appears, in the control region (C). No colored band appears in the test region(T).
Negative (-) Two colored bands appear on the membrane. Onebandappears in the control region (C) and another bandappearsinthe test region (T). Invalid Control band fails to appear. Results from any test which has not produced a control band at the specified readtimemustbediscarded. Please review the procedure and repeat withanewtest. If the problem persists, discontinue usingthekitimmediately and contact your local distributor.

NOTE:

1. The intensity of color in the test region(T) mayvarydepending on the concentration of analytes present inthespecimen. Therefore, any shade of color inthetest regionshould be considered negative. note that this is aqualitativetest only, and cannot determine the concentrationofanalytesin the specimen.

2. External controls are not supplied withthiskit. Itisrecommended that positive and negative controlsbetestedas a good laboratory practice to confirmthe test procedureand to verify proper test performance. 

TEST LIMITATIONS

1. This test has been developed for testing urine samplesonly.No other fluids have been evaluated. DONOTusethisdeviceto test substances other than urine.

2. There is a possibility that technical or procedural errors,aswell as interfering substances in the urine specimenmaycauseerroneous results.

3. Adulterated urine samples may produce erroneousresults.Strong oxidizing agents such as bleach (hypochlorite)canoxidize drug analyte. If a sample is suspectedofbeingadulterated, obtain a new sample in a different, unused, cup.

4. This test is a qualitative screening assay. It is not designedtodetermine the quantitative concentration of drugs or thelevelofintoxication.

5. A positive result does not indicate level or intoxication,administration route or concentration in urine.

6. A negative result may not necessarily indicatedrug-freeurine. Negative results can be obtained whendrugispresentbut below the cut-off level of the test.

QUALITY CONTROL

Users should follow the appropriate federal state, andlocalguidelines concerning the frequency of assayingexternalquality control materials. Though there is an internal procedural control lineinthetestdevice of Control region, the use of external controlsisstrongly recommended as good laboratory testingpracticetoconfirm the test procedure and to verifypropertest