Descrizione Clinica
Diagnostics - diagnostics Screen nicotine test
SCREEN
CHECK TEST
NicotineDescription
Quick test for qualitative detection of cotinine (nicotine metabolite) in human urine.
Only for the determination of smoking status.
Product not intended for medical or diagnostic purposes.
The test contains monoclonal antibody particles coupled with anti-cotinin of rat and conjugated protein of cotinina. A goat antibody is used in the control line system.
Precautions
- In vitro diagnostic device for individual use. Do not use beyond the expiry date.
- The test must remain in the sealed package until use.
- All the samples must be considered potentially dangerous and manipulated as infectious agents.
- The tests used must be thrown according to local legislation.
Sample collection and preparation
Urine test: urine sample should be collected in a dry and clean container. You can use urine collected at any time of the day. The urine samples showing visible precipitates should be left to deposit to get a clear sample to test.
Mode of use
Bring the urine test and sample to room temperature (15-30°C) before testing.
1. Remove the test from sealed packaging and use it within an hour.
2. Remove the hood.
3. With the arrow to the urine sample, immerse the test support vertically in the urine sample for at least 10-15 seconds. Dip the strip at least to the level indicated by the undulating lines, but do not touch the plastic support.
4. Reposition the cappuccino and place the test support on a flat non-absorbent surface.
5. Start the timer and wait for the appearance of the colored line/e.
6. The result should be read at 5 minutes. The results can remain stable up to an hour after the start of the test.
Interpretation of results
NEGATIVE*: two lines appear. A coloured line should be in the control area (C) and one in the test zone (T). A negative result indicates that the concentration of cotinina is below the detection level (200 ng/mL).
POSITIVO: a line appears in the control area (C). No line appears in the test zone (T). A positive result indicates that the concentration of cotinina exceeds the detection level (200 ng/mL).
NULLO: no control line appears. An insufficient volume of sample or incorrect procedural techniques are the most likely causes of the failure of the control line. Review the procedure and repeat the test with a new device. If the problem persists, stop the use of the lot immediately and contact the distributor.
*The color shade in the test area (T) may vary, but it will have to be considered negative every time a colored line appears even just perceptible.
Limitation
1. The COT (Urine) rapid test provides only a qualitative preliminary analytical result. It is necessary to use a secondary analytical method to confirm the result. The recommended confirmation method is mass gaschromatography/spectrometry (GC/MS).
2. It is possible that procedural technical errors occur, as well as that other substances in the urine sample interfere causing incorrect results.
3. Adulterrants, such as bleach and/or alum, in urine samples can produce erroneous results regardless of the used analytical method. If you suspect adulteration, the test must be repeated with another urine sample.
4. A positive result indicates the presence of cotinina or its metabolites but does not indicate the level of intoxication, the way of administration or concentration in urine.
5. A negative result does not necessarily indicate that urine is devoid of cotinine. A negative result can appear when the cotinina is present but below the limit threshold of the test.
6. The test does not distinguish between cotinina from abuse and some drugs.
Conservation
Store wrapped in sealed packaging at room temperature (2-30°C). The test is stable until the expiry date printed on the sealed package or on the closed container label. The test must remain in the sealed package or in the closed container until use. Do not use beyond the expiry date.
Format
Pack of 1 piece.
Quick test for qualitative detection of cotinine (nicotine metabolite) in human urine.
Only for the determination of smoking status.
Product not intended for medical or diagnostic purposes.
The test contains monoclonal antibody particles coupled with anti-cotinin of rat and conjugated protein of cotinina. A goat antibody is used in the control line system.
Precautions
- In vitro diagnostic device for individual use. Do not use beyond the expiry date.
- The test must remain in the sealed package until use.
- All the samples must be considered potentially dangerous and manipulated as infectious agents.
- The tests used must be thrown according to local legislation.
Sample collection and preparation
Urine test: urine sample should be collected in a dry and clean container. You can use urine collected at any time of the day. The urine samples showing visible precipitates should be left to deposit to get a clear sample to test.
Mode of use
Bring the urine test and sample to room temperature (15-30°C) before testing.
1. Remove the test from sealed packaging and use it within an hour.
2. Remove the hood.
3. With the arrow to the urine sample, immerse the test support vertically in the urine sample for at least 10-15 seconds. Dip the strip at least to the level indicated by the undulating lines, but do not touch the plastic support.
4. Reposition the cappuccino and place the test support on a flat non-absorbent surface.
5. Start the timer and wait for the appearance of the colored line/e.
6. The result should be read at 5 minutes. The results can remain stable up to an hour after the start of the test.
Interpretation of results
NEGATIVE*: two lines appear. A coloured line should be in the control area (C) and one in the test zone (T). A negative result indicates that the concentration of cotinina is below the detection level (200 ng/mL).
POSITIVO: a line appears in the control area (C). No line appears in the test zone (T). A positive result indicates that the concentration of cotinina exceeds the detection level (200 ng/mL).
NULLO: no control line appears. An insufficient volume of sample or incorrect procedural techniques are the most likely causes of the failure of the control line. Review the procedure and repeat the test with a new device. If the problem persists, stop the use of the lot immediately and contact the distributor.
*The color shade in the test area (T) may vary, but it will have to be considered negative every time a colored line appears even just perceptible.
Limitation
1. The COT (Urine) rapid test provides only a qualitative preliminary analytical result. It is necessary to use a secondary analytical method to confirm the result. The recommended confirmation method is mass gaschromatography/spectrometry (GC/MS).
2. It is possible that procedural technical errors occur, as well as that other substances in the urine sample interfere causing incorrect results.
3. Adulterrants, such as bleach and/or alum, in urine samples can produce erroneous results regardless of the used analytical method. If you suspect adulteration, the test must be repeated with another urine sample.
4. A positive result indicates the presence of cotinina or its metabolites but does not indicate the level of intoxication, the way of administration or concentration in urine.
5. A negative result does not necessarily indicate that urine is devoid of cotinine. A negative result can appear when the cotinina is present but below the limit threshold of the test.
6. The test does not distinguish between cotinina from abuse and some drugs.
Conservation
Store wrapped in sealed packaging at room temperature (2-30°C). The test is stable until the expiry date printed on the sealed package or on the closed container label. The test must remain in the sealed package or in the closed container until use. Do not use beyond the expiry date.
Format
Pack of 1 piece.
