Description
FAMILY DRUG
test
Description
A lateral-scrolling, immunological urine drug test for the qualitative detection of specific drugs and their metabolites in human urine at the following cut-off concentrations:
The test provides a preliminary result; a more specific alternative chemical method should be used to obtain a confirmatory analytical result. The preferred confirmatory method is Gas Chromatography/Mass Spectrometry (GC/MS). Clinical consideration and professional judgment should be used for each drug of abuse test result, especially if preliminary results are positive.
How to use
Sample collection and preparation
• Wash your hands with neutral soap and warm water. Open the sealed package and remove the test.
• Open the container cap and urinate directly into it. The sample volume must exceed the minimum urine level. Close the container.
Running the test
The test must be at room temperature (10°C-30°C).
1. After collecting urine, cap the container and place it on a flat surface.
2. Lift the label from right to left and read the result within 5 minutes. Do not read the results after 5 minutes.
Interpretation of results
POSITIVE (+) A pink band is visible in each control region. No colored band appears in the appropriate test region. This indicates a positive result for the drug corresponding to that specific region.
NEGATIVE (-) A pink band is visible in each control region in the appropriate test region. This indicates that the drug concentration corresponding to that test region is zero or below the detection limit of the test.
NULL If no colored band is visible in any of the control zones or if it is visible only in the test zones, the test is void. Another test should be performed to re-evaluate the sample.
No significance is attached to the intensity of the color or the width of the line.
Limits
1. This test is designed for urine specimens only. The performance of this test using other specimens has not been demonstrated.
2. Adulterated urine samples may produce erroneous results. Strong oxidizing agents such as bleach (hypochlorite) may oxidize the drug test. If a sample is suspected of being adulterated, collect a new sample.
3. This test is a qualitative control. It is not designed to determine the quantitative concentration of drugs or the level of intoxication.
4. Technical or procedural errors, as well as other substances that interfere with the urine sample, may cause erroneous results.
5. A negative result does not necessarily indicate drug-free urine. Negative results may also occur when drugs are present but below the cut-off level of the test.
6. The test result does not distinguish between drugs of abuse and some medicines.
7. Some foods or supplements can cause positive results.
Warnings
This kit is for external use only. Do not ingest.
• Discard after use. The test cannot be used more than once.
• Do not use beyond expiration date.
• Do not use the kit if the package is punctured or not sealed properly.
• Keep out of reach of children.
• Product not intended for medical diagnostic purposes.
Conservation
Store at 4°C-30°C until the expiry date. Keep away from light, moisture and heat. Do not freeze.
Format
Package containing: a test, a desiccant, an information leaflet.
A lateral-scrolling, immunological urine drug test for the qualitative detection of specific drugs and their metabolites in human urine at the following cut-off concentrations:
Test | Calibrator | Threshold Limit (ng/ml) |
Cocaine | Benzoylecgonine | 300 |
Marijuana | Marijuana | 50 |
Methamphetamine | Methamphetamine | 1000 |
Opiates | Morphine | 2000 |
Ketamine | Ketamine | 1000 |
The test provides a preliminary result; a more specific alternative chemical method should be used to obtain a confirmatory analytical result. The preferred confirmatory method is Gas Chromatography/Mass Spectrometry (GC/MS). Clinical consideration and professional judgment should be used for each drug of abuse test result, especially if preliminary results are positive.
How to use
Sample collection and preparation
• Wash your hands with neutral soap and warm water. Open the sealed package and remove the test.
• Open the container cap and urinate directly into it. The sample volume must exceed the minimum urine level. Close the container.
Running the test
The test must be at room temperature (10°C-30°C).
1. After collecting urine, cap the container and place it on a flat surface.
2. Lift the label from right to left and read the result within 5 minutes. Do not read the results after 5 minutes.
Interpretation of results
POSITIVE (+) A pink band is visible in each control region. No colored band appears in the appropriate test region. This indicates a positive result for the drug corresponding to that specific region.
NEGATIVE (-) A pink band is visible in each control region in the appropriate test region. This indicates that the drug concentration corresponding to that test region is zero or below the detection limit of the test.
NULL If no colored band is visible in any of the control zones or if it is visible only in the test zones, the test is void. Another test should be performed to re-evaluate the sample.
No significance is attached to the intensity of the color or the width of the line.
Limits
1. This test is designed for urine specimens only. The performance of this test using other specimens has not been demonstrated.
2. Adulterated urine samples may produce erroneous results. Strong oxidizing agents such as bleach (hypochlorite) may oxidize the drug test. If a sample is suspected of being adulterated, collect a new sample.
3. This test is a qualitative control. It is not designed to determine the quantitative concentration of drugs or the level of intoxication.
4. Technical or procedural errors, as well as other substances that interfere with the urine sample, may cause erroneous results.
5. A negative result does not necessarily indicate drug-free urine. Negative results may also occur when drugs are present but below the cut-off level of the test.
6. The test result does not distinguish between drugs of abuse and some medicines.
7. Some foods or supplements can cause positive results.
Warnings
This kit is for external use only. Do not ingest.
• Discard after use. The test cannot be used more than once.
• Do not use beyond expiration date.
• Do not use the kit if the package is punctured or not sealed properly.
• Keep out of reach of children.
• Product not intended for medical diagnostic purposes.
Conservation
Store at 4°C-30°C until the expiry date. Keep away from light, moisture and heat. Do not freeze.
Format
Package containing: a test, a desiccant, an information leaflet.