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FAMILY DRUG
test
Description
Urine drug test, immunoassay, lateral flow, 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 must be used to obtain a confirmatory analytical result. The preferred confirmatory method is Gas Chromatography/Mass Spectrometry (GC/MS). Clinical consideration and professional judgment are required for any drug of abuse test result, especially if preliminary results are positive.
How to use
Specimen collection and preparation
• Wash 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. Cap the container.
Performing the test
The test must be at room temperature (10°C-30°C).
1. After urine collection, 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 results after 5 minutes.
Interpretation of results
POSITIVE (+) A pink band is visible in each control zone. No colored band appears in the appropriate test zone. This indicates a positive result for the drug corresponding to that specific zone.
NEGATIVE (-) A pink band is visible in each control zone in the appropriate test zone. This indicates that the concentration of the drug corresponding to that test zone is zero or below the detection limit of the test.
INVALID If no colored band is visible in any of the control zones or if it is only visible in the test zones, the test is invalid. Another test must be performed to re-evaluate the sample.
No meaning is attributed to the intensity of the color or the width of the line.
Limitations
1. This test has been developed exclusively for urine samples. The performance of this test using different samples has not been demonstrated.
2. Adulterated urine samples may produce erroneous results. Strong oxidizing agents such as bleach (hypochlorite) can oxidize drug analysis. 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. It is possible that 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 can also be obtained when the drug is present but below the test cut-off level.
6. The test result does not distinguish between drugs of abuse and some medications.
7. Some foods or supplements may cause positive results.
Warnings
This kit is for external use only. Do not swallow.
• Discard after use. The test cannot be used more than once.
• Do not use beyond the expiration date.
• Do not use the kit if the package is punctured or not properly sealed.
• Keep out of reach of children.
• Product not intended for diagnostic medical purposes.
Storage
Store at a temperature of 4°C-30°C until the expiration date. Keep away from light, humidity and heat. Do not freeze.
Format
Package containing: one test, one desiccant, one leaflet.
Urine drug test, immunoassay, lateral flow, for the qualitative detection of specific drugs and their metabolites in human urine, at the following cut-off concentrations:
| Test | Calibrator | Cut-off (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 must be used to obtain a confirmatory analytical result. The preferred confirmatory method is Gas Chromatography/Mass Spectrometry (GC/MS). Clinical consideration and professional judgment are required for any drug of abuse test result, especially if preliminary results are positive.
How to use
Specimen collection and preparation
• Wash 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. Cap the container.
Performing the test
The test must be at room temperature (10°C-30°C).
1. After urine collection, 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 results after 5 minutes.
Interpretation of results
POSITIVE (+) A pink band is visible in each control zone. No colored band appears in the appropriate test zone. This indicates a positive result for the drug corresponding to that specific zone.
NEGATIVE (-) A pink band is visible in each control zone in the appropriate test zone. This indicates that the concentration of the drug corresponding to that test zone is zero or below the detection limit of the test.
INVALID If no colored band is visible in any of the control zones or if it is only visible in the test zones, the test is invalid. Another test must be performed to re-evaluate the sample.
No meaning is attributed to the intensity of the color or the width of the line.
Limitations
1. This test has been developed exclusively for urine samples. The performance of this test using different samples has not been demonstrated.
2. Adulterated urine samples may produce erroneous results. Strong oxidizing agents such as bleach (hypochlorite) can oxidize drug analysis. 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. It is possible that 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 can also be obtained when the drug is present but below the test cut-off level.
6. The test result does not distinguish between drugs of abuse and some medications.
7. Some foods or supplements may cause positive results.
Warnings
This kit is for external use only. Do not swallow.
• Discard after use. The test cannot be used more than once.
• Do not use beyond the expiration date.
• Do not use the kit if the package is punctured or not properly sealed.
• Keep out of reach of children.
• Product not intended for diagnostic medical purposes.
Storage
Store at a temperature of 4°C-30°C until the expiration date. Keep away from light, humidity and heat. Do not freeze.
Format
Package containing: one test, one desiccant, one leaflet.

