Description
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Digy Personal Test
Description
Device suitable for the early diagnosis of pregnancy, which allows to perform rapid tests based on the quantitative determination of human chorionic gonadotropin ("hCG") in urine. It is an in vitro diagnostic device (IVD) for self-diagnosis.
The device allows to detect concentrations equal to or greater than 25 mIU/ml in urine.
Specificity was determined by cross-reactivity studies with known amounts of luteinizing hormone (LH), follicle-stimulating hormone (FSH), and thyroid-stimulating hormone (TSH). Negative results were obtained in all tests conducted with 500 mIU/ml LH, 1,000 mIU/ml FSH, and 1,000 mcIU/ml TSH.
How to use
Sample collection and preparation
To perform the test, you can hold the absorbent part directly under the urine stream, or collect the urine in a special disposable container or another clean container for later testing. The kit can be used with any urine sample. If the test cannot be performed immediately, the sample must be stored at 4°C, and brought back to room temperature before use. To perform the test correctly, urine must not be stored for periods longer than 2 days.
Test procedure
Do not remove the device from the pouch until you are ready to test. Read the instructions carefully before testing. The test should be performed at room temperature.
1. Remove a test device from the pouch by tearing it at the invitation. Grasping the handle with one hand, remove the cap with the other, to expose the absorbent tip. Never hold the device with the absorbent tip facing up, during the entire procedure.
2. You can choose whether to perform the test directly under the urine stream or to use a urine sample previously collected in a container.
- Urine jet test:
Hold the absorbent tip down under the urine stream. Do not urinate on any part other than the absorbent tip. The device should be held at an angle greater than 45 degrees during sample collection. The hourglass symbol will appear on the display. Within 10 seconds, you will hear a beep and the hourglass symbol will start to flash. Move the device away from the urine stream and hold the absorbent tip down, or place the device horizontally on a flat surface. If desired, you can close the cap.
- Test with sample collected in a container:
Collect urine in a clean, dry container. Completely immerse the absorbent tip in the urine. Be careful not to get the test device wet. The hourglass symbol will appear on the display. Within 10 seconds, you will hear a beep and the hourglass symbol will start to flash. Remove the device from the urine and keep the absorbent tip pointing down, or place the device horizontally on a surface. You can close the cap if desired.
3. The hourglass symbol will continue to flash to indicate that the test is in progress. Within 5 minutes, a second beep will be heard and the hourglass symbol will stop flashing. Then the result will appear on the display.
Possible results are: Not Pregnant, Pregnant and Error. In the latter case, the test was not performed correctly, the result is invalid or the device was used. Repeat the test with a new device.
If the hourglass symbol does not appear after using the test, consult the user manual.
Warnings
For in vitro diagnostic use only. For external use only. Do not ingest. Dispose of after first use. Cannot be reused for other tests. Do not use the test kit after the expiration date. Do not use the kit if the package is punctured or not hermetically sealed. Keep out of reach of children. Wash and dry your hands before performing the test. Keep your hands clean and dry throughout the procedure. Do not use the product outdoors. To obtain accurate results, it is necessary to follow the instructions carefully. The battery cannot be replaced. Follow local regulations for the disposal of used test devices. Do not freeze.
As with any diagnostic procedure, confirmation of pregnancy can only be made by a physician after evaluation of all required clinical and laboratory findings. The device is only suitable for use with human urine. If the urine sample is too diluted, the amount of hCG contained in it may be insufficient. If pregnancy is still suspected, collect another urine sample after at least 48 hours. Then perform the test again. A low hCG concentration at an early stage of pregnancy may lead to a negative result. In this case, repeat the test with a new urine sample after at least 48 hours. Medical procedures based on the use of hCG, such as fertility treatments, may lead to an incorrect result. Consult your physician. Please note that using an unclean container or performing the procedure incorrectly may also result in an incorrect result.
Conservation
Store at a temperature between 4°C and 30°C. Avoid direct exposure to sunlight, humidity and heat.
Format
1 piece.
Cod. 0202301200000
Device suitable for the early diagnosis of pregnancy, which allows to perform rapid tests based on the quantitative determination of human chorionic gonadotropin ("hCG") in urine. It is an in vitro diagnostic device (IVD) for self-diagnosis.
The device allows to detect concentrations equal to or greater than 25 mIU/ml in urine.
Specificity was determined by cross-reactivity studies with known amounts of luteinizing hormone (LH), follicle-stimulating hormone (FSH), and thyroid-stimulating hormone (TSH). Negative results were obtained in all tests conducted with 500 mIU/ml LH, 1,000 mIU/ml FSH, and 1,000 mcIU/ml TSH.
How to use
Sample collection and preparation
To perform the test, you can hold the absorbent part directly under the urine stream, or collect the urine in a special disposable container or another clean container for later testing. The kit can be used with any urine sample. If the test cannot be performed immediately, the sample must be stored at 4°C, and brought back to room temperature before use. To perform the test correctly, urine must not be stored for periods longer than 2 days.
Test procedure
Do not remove the device from the pouch until you are ready to test. Read the instructions carefully before testing. The test should be performed at room temperature.
1. Remove a test device from the pouch by tearing it at the invitation. Grasping the handle with one hand, remove the cap with the other, to expose the absorbent tip. Never hold the device with the absorbent tip facing up, during the entire procedure.
2. You can choose whether to perform the test directly under the urine stream or to use a urine sample previously collected in a container.
- Urine jet test:
Hold the absorbent tip down under the urine stream. Do not urinate on any part other than the absorbent tip. The device should be held at an angle greater than 45 degrees during sample collection. The hourglass symbol will appear on the display. Within 10 seconds, you will hear a beep and the hourglass symbol will start to flash. Move the device away from the urine stream and hold the absorbent tip down, or place the device horizontally on a flat surface. If desired, you can close the cap.
- Test with sample collected in a container:
Collect urine in a clean, dry container. Completely immerse the absorbent tip in the urine. Be careful not to get the test device wet. The hourglass symbol will appear on the display. Within 10 seconds, you will hear a beep and the hourglass symbol will start to flash. Remove the device from the urine and keep the absorbent tip pointing down, or place the device horizontally on a surface. You can close the cap if desired.
3. The hourglass symbol will continue to flash to indicate that the test is in progress. Within 5 minutes, a second beep will be heard and the hourglass symbol will stop flashing. Then the result will appear on the display.
Possible results are: Not Pregnant, Pregnant and Error. In the latter case, the test was not performed correctly, the result is invalid or the device was used. Repeat the test with a new device.
If the hourglass symbol does not appear after using the test, consult the user manual.
Warnings
For in vitro diagnostic use only. For external use only. Do not ingest. Dispose of after first use. Cannot be reused for other tests. Do not use the test kit after the expiration date. Do not use the kit if the package is punctured or not hermetically sealed. Keep out of reach of children. Wash and dry your hands before performing the test. Keep your hands clean and dry throughout the procedure. Do not use the product outdoors. To obtain accurate results, it is necessary to follow the instructions carefully. The battery cannot be replaced. Follow local regulations for the disposal of used test devices. Do not freeze.
As with any diagnostic procedure, confirmation of pregnancy can only be made by a physician after evaluation of all required clinical and laboratory findings. The device is only suitable for use with human urine. If the urine sample is too diluted, the amount of hCG contained in it may be insufficient. If pregnancy is still suspected, collect another urine sample after at least 48 hours. Then perform the test again. A low hCG concentration at an early stage of pregnancy may lead to a negative result. In this case, repeat the test with a new urine sample after at least 48 hours. Medical procedures based on the use of hCG, such as fertility treatments, may lead to an incorrect result. Consult your physician. Please note that using an unclean container or performing the procedure incorrectly may also result in an incorrect result.
Conservation
Store at a temperature between 4°C and 30°C. Avoid direct exposure to sunlight, humidity and heat.
Format
1 piece.
Cod. 0202301200000
