Descrizione Clinica
SCREEN
CHECK TEST
FerritineDescription
CE 0123 in vitro diagnostic medical device.
The Ferritine rapid test is a test for the qualitative detection of ferritine in human blood from pricked for iron deficiency anemia.
Only for auto-diagnostic use in vitro.
Precautions
1. Only for auto-diagnostic use in vitro.
2. Do not eat, drink or smoke in the sample handling area or kits.
3. Store in a dry place at 2-30°C (36-86°F), avoiding areas with excessive humidity. If the sealed package is damaged or open, please do not use the test.
4. This kit is intended for use as a preliminary test and repeated abnormal results should be discussed with a doctor or specialist.
5. Strictly follow the indicated timings.
6. Use the test only once. Do not disassemble or touch the test window on the support.
7. The kit should not be frozen or used over the printed expiration date on the package.
8. Keep away from the reach of children.
9. The test used must be disposed of according to local regulations.
Procedure
1. Wash your hands with soap and rinse with warm clean water.
2. Bring the packaging to room temperature before opening it. Open the sealed package and extract the device.
3. Gently pull and throw the protective cap of the hand.
4. Use the tampon with alcohol provided to clean the tip of the middle finger, seat of the puncture.
5. Press the hand, on the side where the cap was removed, against the finger tip (we recommend the side of the ring). The tip is automatically and safely after use.
6. Keeping your hand turned down, massage the puncture seat to get a drop of blood.
7. Without pressing the capillary dropper bulb, put it in contact with the blood. The blood will migrate into the capillary dropper to the line indicated on the dropper. You can massage your finger again to get more blood if you do not reach the line. As far as possible, try to avoid the formation of air bubbles.
8. Put the blood collected in the well for device samples, pressing the dropper bulb.
9. Wait until the blood is completely poured into the well. Unscrew the buffer bottle cap and add 1 drop of buffer in the cockpit for device samples.
10. Wait for the appearance of the colored line/e. Read the results at 5 minutes.
Do not interpret the results after 10 minutes.
Interpretation of results
NORMAL: two lines appear, both the T (Test) and the C (Control). This result indicates that the concentration of ferritine in the blood is normal and that there is no shortage of potential iron.
ANOMALO: only one line appears, that of control (C). This result indicates that the concentration of ferritine in the blood is too low. You should consult a doctor because there may be a shortage of iron.
NULLO: no control line appears. The most probable reasons for the failure of the control line are an insufficient sample volume or incorrect procedural techniques. Review the procedure and repeat the test with a new kit. If the problem persists, stop using the kit immediately and contact your local distributor.
Limits
1. The Ferritina rapid test provides only a qualitative analytical result. You need to use an additional analytical method to get a confirmation result.
2. It is possible that technical or procedural errors occur, as well as interference of other substances in the blood sample that could lead to incorrect results.
3. As with all diagnostic tests, all results are to be evaluated together with other clinical information available to the doctor.
4. Other clinical trials are required if you get doubtful results.
Conservation
Store packed at room or refrigerated temperature (2-30°C). The test is stable until the expiry date printed on the sealed package or on the closed box. The test must remain in the sealed package until the time of use. DON'T CONGEL. Do not use beyond the expiry date.
Format
Pack containing 1 piece.
BIBLIOGRAPHY:
1. Kryger MH, Otake K, Foerster J (March 2002). "Low body stores of iron and restless legs syndrome: a correctable cause of insomnia in adolescents and teenagers". Sleep Med.3(2): 127–32.
2. Mizuno S, Mihara T, Miyaoka T, Inagaki T, Horiguchi J (14 March 2005). "CSF iron, ferritin and transferrin levels in restless legs syndrome". J Sleep Res1: 43–7.
CE 0123 in vitro diagnostic medical device.
The Ferritine rapid test is a test for the qualitative detection of ferritine in human blood from pricked for iron deficiency anemia.
Only for auto-diagnostic use in vitro.
Precautions
1. Only for auto-diagnostic use in vitro.
2. Do not eat, drink or smoke in the sample handling area or kits.
3. Store in a dry place at 2-30°C (36-86°F), avoiding areas with excessive humidity. If the sealed package is damaged or open, please do not use the test.
4. This kit is intended for use as a preliminary test and repeated abnormal results should be discussed with a doctor or specialist.
5. Strictly follow the indicated timings.
6. Use the test only once. Do not disassemble or touch the test window on the support.
7. The kit should not be frozen or used over the printed expiration date on the package.
8. Keep away from the reach of children.
9. The test used must be disposed of according to local regulations.
Procedure
1. Wash your hands with soap and rinse with warm clean water.
2. Bring the packaging to room temperature before opening it. Open the sealed package and extract the device.
3. Gently pull and throw the protective cap of the hand.
4. Use the tampon with alcohol provided to clean the tip of the middle finger, seat of the puncture.
5. Press the hand, on the side where the cap was removed, against the finger tip (we recommend the side of the ring). The tip is automatically and safely after use.
6. Keeping your hand turned down, massage the puncture seat to get a drop of blood.
7. Without pressing the capillary dropper bulb, put it in contact with the blood. The blood will migrate into the capillary dropper to the line indicated on the dropper. You can massage your finger again to get more blood if you do not reach the line. As far as possible, try to avoid the formation of air bubbles.
8. Put the blood collected in the well for device samples, pressing the dropper bulb.
9. Wait until the blood is completely poured into the well. Unscrew the buffer bottle cap and add 1 drop of buffer in the cockpit for device samples.
10. Wait for the appearance of the colored line/e. Read the results at 5 minutes.
Do not interpret the results after 10 minutes.
Interpretation of results
NORMAL: two lines appear, both the T (Test) and the C (Control). This result indicates that the concentration of ferritine in the blood is normal and that there is no shortage of potential iron.
ANOMALO: only one line appears, that of control (C). This result indicates that the concentration of ferritine in the blood is too low. You should consult a doctor because there may be a shortage of iron.
NULLO: no control line appears. The most probable reasons for the failure of the control line are an insufficient sample volume or incorrect procedural techniques. Review the procedure and repeat the test with a new kit. If the problem persists, stop using the kit immediately and contact your local distributor.
Limits
1. The Ferritina rapid test provides only a qualitative analytical result. You need to use an additional analytical method to get a confirmation result.
2. It is possible that technical or procedural errors occur, as well as interference of other substances in the blood sample that could lead to incorrect results.
3. As with all diagnostic tests, all results are to be evaluated together with other clinical information available to the doctor.
4. Other clinical trials are required if you get doubtful results.
Conservation
Store packed at room or refrigerated temperature (2-30°C). The test is stable until the expiry date printed on the sealed package or on the closed box. The test must remain in the sealed package until the time of use. DON'T CONGEL. Do not use beyond the expiry date.
Format
Pack containing 1 piece.
BIBLIOGRAPHY:
1. Kryger MH, Otake K, Foerster J (March 2002). "Low body stores of iron and restless legs syndrome: a correctable cause of insomnia in adolescents and teenagers". Sleep Med.3(2): 127–32.
2. Mizuno S, Mihara T, Miyaoka T, Inagaki T, Horiguchi J (14 March 2005). "CSF iron, ferritin and transferrin levels in restless legs syndrome". J Sleep Res1: 43–7.
