Descrizione Clinica
AFIAS
P New
Description
immunological fluorescence (FIA) essay for quantitative determination of PSA (specific prostatic antigen) in whole blood/serum/plasm. It is useful as an aid in the diagnosis of prostate cancer or other prostate pathologies.
Only for in vitro diagnostic use.
The test uses a capturing immunorelevation method ("sandwich").
Mode of use
Sample type for AFIAS PSA Neo is whole blood/serum/human blood.
- It is recommended to analyze the sample (full blood, serum, plasma) within 24 hours of harvesting, with the sample collected at room temperature.
- Samples (serum, plasma) must be separated from the clot by centrifugation within 3 hours of the whole blood sampling.
- Samples (full blood, serum, plasma) can be stored for a week at 2 – 8°C before being analyzed. If the test is delayed for more than a week, the samples (serum, plasma) must be frozen at - 20°C.
- Samples (serum, plasma) kept frozen at -20°C for 3 months did not show any performance differences.
- However, the whole blood sample should not be kept in any case in the freezer.
- Since a repeated freezing-freezing cycle can affect the test result, do not refreeze previously frozen samples.
- Relief of the whole blood sample using the C-tip.
- Keep the C-tip in horizontal position and touch the surface of the blood with the tip of the same.
- The capillary action will automatically draw the blood sample to the C-tip and stop.
- Eliminate excess blood around the tip.
- Recheck that the whole blood is thoroughly filled in the C-tip and that the AFIAS test tool is ready for a "C-tip mode" test.
Components
Composed of "cartches".
- Each sealed aluminum envelope contains two cartridges.
- Each cartridge packaged in an aluminum envelope consists of three components, including a cartridge part, a detector part and a diluent part.
- The cartridge part contains a membrane called reactive strip containing the anti-PSA on the test line and IgG rabbit on the control line.
- The revealing part has a granulate contains conjugated anti PSA-biotin, conjugated streptavidina-fluorescence and conjugated anti-IgG rabbit-fluorescence, as well as sodium nitrogen as preservative in saline solution buffered with phosphate (PBS).
- The thin part contains polysorbate 20 as a sodium detergent and nitrogen as a preservative in the Tris- HCl buffer.
General mode (General mode)
1) Insert a cartridge into the special holder.
2) Insert a tip into the cartridge hole.
3) Select the "General mode (General mode)" in the AFIAS test tool.
4) Take 100 mcL of sample (full blood/serum/plasm/control) using a pipette and dispense it in the cartridge sample well.
5) Select the sample type (whole blood or serum/plasma) on the screen.
- If using control as sample, select "serum/plasma".
6) Tap the "Start (START)" button on the screen.
7) The test result will appear on the screen after 15 minutes.
C-tip mode
1) Insert a cartridge into the appropriate compartment.
2) Collect 30 mcL of whole blood using a C-tip.
3) Insert the C-tip filled with whole blood into the tip port of the cartridge.
4) Select the "C-tip mode (C-tip mode)" in the AFIAS test tool.
5) Press the "Start" icon on the display.
6) The test result will appear on the display after 15 minutes.
- AFIAS-10
Normal mode
1) Insert a cartridge into the appropriate compartment.
2) Insert a tip into the appropriate slot on the cartridge.
3) Press the “Load” icon on the compartment containing the cartridge with the tip to read the cartridge barcode and confirm the name of the analyte shown on the cartridge.
4) Insert the test tube into the test tube rack.
5) Insert the test tube rack into the loading compartment of the sampling station.
6) Select the sample type (whole blood or serum/plasma) on the screen.
7) Press the "Start" icon on the display.
8) The test result will appear on the display after 15 minutes.
Emergency mode – General tip
1) The procedure is the same as “Normal mode 1 – 3)”.Switch to “Emergency mode” in AFIAS-10.
2) Select the tip type [Puntale generico (General tip)] on the display.
3) Select the sample type (whole blood or serum/plasma) on the display.
4) Take 100 mcl of sample using a pipette and dispense it into the sample well of the cartridge.
5) Press the "Start" icon on the display.
6) The test result will appear on the display after 15 minutes.
Emergency mode – C-tip (Emergency mode – C-tip)
1) Insert a cartridge into the appropriate compartment.
2) Collect 30 mcL of whole blood using a C-tip.
3) Insert the C-tip with the sample into the cartridge point hole.
4) Press the "Load" button of the housing containing the cartridge with a tip to read the cartridge bar code and confirm the name of the item written on the cartridge.
5) Switch to the "Emergency mode" in AFIAS-10.
6) Select the point type (C-tip) on the display.
7) Press the "Start" icon on the display.
8) The test result will appear on the display after 15 minutes.
Warnings
- Follow the instructions and procedures described in these “Use Instructions”.
- Handle all the samples as if they contain infectious agents.
- Due to the risk of infection, it is recommended to wear protective clothing, including mask and gloves, and handle samples and models with maximum care during the test.
- Use only fresh samples and avoid direct sunlight.
- The batch numbers of all test components (cartridge and chip ID) must match between them.
- Do not exchange the test components between different batches or use the test components after the expiry date, since both actions could produce incorrect test results.
- Don't reuse the cartridges and C-tip. All cartridges and C-tip must be used to analyze only one sample.
- Don't reuse the pipette bits. The reuse of pipette tips can lead to cross contamination, resulting in incorrect test results.
- The cartridge must remain sealed in its original envelope until use. Do not use a cartridge if the envelope is damaged or has already been opened.
- Frozen sample can be thawed once. For shipping, samples must be packed in accordance with local regulations. Do not use samples with severe hemolysis and/or hyperlipidemia.
- If the test components and/or sample are stored in the refrigerator, let the cartridge and sample reach the ambient temperature for about 30 minutes before use.
- The AFIAS test tool can generate light vibration during use.
- The used cartridges, C-tip and pipette tips must be handled with care and disposed of using a suitable method in accordance with relevant local regulations.
- The cartridge contains sodium nitrogen (NaN3) and can cause some health problems such as seizures, hypotension, bradycardia, loss of consciousness, lung injuries and respiratory failure. Avoid contact with skin, eyes and clothing. In case of contact rinse immediately with running water.
- No interference with biotin in AFIAS PSA has been observed Neo when the concentration of biotin in the sample was less than 100 ng/mL. If a patient has taken biotin at a dose greater than 0.03 mg per day, it is recommended to repeat the test 24 hours after the interruption of taking biotin.
- AFIAS PSA Neo will provide accurate and reliable results if you comply with the following conditions.
- AFIAS PSA Neo should only be used together with the AFIAS test tool.
- The recommended anticoagulant must be used.
- Use the C-tip when the following conditions occur.
- We recommend the C-tip provided with the kit to obtain a correct test result.
- The whole blood must be analyzed immediately after the harvest.
- Do not test with C-tip in the “General Mode (General Mode)”. It could cause an incorrect result.
- The whole excess blood around the C-tip must be removed. To avoid cross contamination, do not reuse the C-tip for multiple samples.
- The AFIAS cartridge must be inserted and placed in the cartridge holder before the blood sample is taken.
- While taking blood, pay attention not to create air bubbles in the C-tip.
- The test is intended for use by health professionals in a laboratory environment, not intended for decentralized analysis.
- The test can produce false positive results due to cross-reactions and/or non-specific adhesion of some sample components to capture/relevance antibodies.
- The test can produce false negative results due to the non-reactivity of antibodies, the most common situation if the epitope is masked by some unknown components, and therefore cannot be detected or captured by antibodies. Even the instability or degradation of antigens with time and/or temperature can cause false negative results because it makes antigens unrecognizable by antibodies.
- Other factors may interfere with the test and cause incorrect results, such as technical/procedural errors, degradation of test components/reagents or presence of interfering substances in test samples.
- Any clinical diagnosis based on the result of the test must be supported by a general judgement of the reference doctor along with clinical symptoms and other relevant test results.
Conservation
Store at temperature between 2-30°C.
Validity of whole packaging: 20 months.
Cod. 5N2793U0002
Cod. 5N2793U00
Cod. 5N2793U00
Cod. 5N2793U00
Cod. 5N2793U00
immunological fluorescence (FIA) essay for quantitative determination of PSA (specific prostatic antigen) in whole blood/serum/plasm. It is useful as an aid in the diagnosis of prostate cancer or other prostate pathologies.
Only for in vitro diagnostic use.
The test uses a capturing immunorelevation method ("sandwich").
Mode of use
Sample type for AFIAS PSA Neo is whole blood/serum/human blood.
- It is recommended to analyze the sample (full blood, serum, plasma) within 24 hours of harvesting, with the sample collected at room temperature.
- Samples (serum, plasma) must be separated from the clot by centrifugation within 3 hours of the whole blood sampling.
- Samples (full blood, serum, plasma) can be stored for a week at 2 – 8°C before being analyzed. If the test is delayed for more than a week, the samples (serum, plasma) must be frozen at - 20°C.
- Samples (serum, plasma) kept frozen at -20°C for 3 months did not show any performance differences.
- However, the whole blood sample should not be kept in any case in the freezer.
- Since a repeated freezing-freezing cycle can affect the test result, do not refreeze previously frozen samples.
- Relief of the whole blood sample using the C-tip.
- Keep the C-tip in horizontal position and touch the surface of the blood with the tip of the same.
- The capillary action will automatically draw the blood sample to the C-tip and stop.
- Eliminate excess blood around the tip.
- Recheck that the whole blood is thoroughly filled in the C-tip and that the AFIAS test tool is ready for a "C-tip mode" test.
Components
Composed of "cartches".
- Each sealed aluminum envelope contains two cartridges.
- Each cartridge packaged in an aluminum envelope consists of three components, including a cartridge part, a detector part and a diluent part.
- The cartridge part contains a membrane called reactive strip containing the anti-PSA on the test line and IgG rabbit on the control line.
- The revealing part has a granulate contains conjugated anti PSA-biotin, conjugated streptavidina-fluorescence and conjugated anti-IgG rabbit-fluorescence, as well as sodium nitrogen as preservative in saline solution buffered with phosphate (PBS).
- The thin part contains polysorbate 20 as a sodium detergent and nitrogen as a preservative in the Tris- HCl buffer.
General mode (General mode)
1) Insert a cartridge into the special holder.
2) Insert a tip into the cartridge hole.
3) Select the "General mode (General mode)" in the AFIAS test tool.
4) Take 100 mcL of sample (full blood/serum/plasm/control) using a pipette and dispense it in the cartridge sample well.
5) Select the sample type (whole blood or serum/plasma) on the screen.
- If using control as sample, select "serum/plasma".
6) Tap the "Start (START)" button on the screen.
7) The test result will appear on the screen after 15 minutes.
C-tip mode
1) Insert a cartridge into the appropriate compartment.
2) Collect 30 mcL of whole blood using a C-tip.
3) Insert the C-tip filled with whole blood into the tip port of the cartridge.
4) Select the "C-tip mode (C-tip mode)" in the AFIAS test tool.
5) Press the "Start" icon on the display.
6) The test result will appear on the display after 15 minutes.
- AFIAS-10
Normal mode
1) Insert a cartridge into the appropriate compartment.
2) Insert a tip into the appropriate slot on the cartridge.
3) Press the “Load” icon on the compartment containing the cartridge with the tip to read the cartridge barcode and confirm the name of the analyte shown on the cartridge.
4) Insert the test tube into the test tube rack.
5) Insert the test tube rack into the loading compartment of the sampling station.
6) Select the sample type (whole blood or serum/plasma) on the screen.
7) Press the "Start" icon on the display.
8) The test result will appear on the display after 15 minutes.
Emergency mode – General tip
1) The procedure is the same as “Normal mode 1 – 3)”.Switch to “Emergency mode” in AFIAS-10.
2) Select the tip type [Puntale generico (General tip)] on the display.
3) Select the sample type (whole blood or serum/plasma) on the display.
4) Take 100 mcl of sample using a pipette and dispense it into the sample well of the cartridge.
5) Press the "Start" icon on the display.
6) The test result will appear on the display after 15 minutes.
Emergency mode – C-tip (Emergency mode – C-tip)
1) Insert a cartridge into the appropriate compartment.
2) Collect 30 mcL of whole blood using a C-tip.
3) Insert the C-tip with the sample into the cartridge point hole.
4) Press the "Load" button of the housing containing the cartridge with a tip to read the cartridge bar code and confirm the name of the item written on the cartridge.
5) Switch to the "Emergency mode" in AFIAS-10.
6) Select the point type (C-tip) on the display.
7) Press the "Start" icon on the display.
8) The test result will appear on the display after 15 minutes.
Warnings
- Follow the instructions and procedures described in these “Use Instructions”.
- Handle all the samples as if they contain infectious agents.
- Due to the risk of infection, it is recommended to wear protective clothing, including mask and gloves, and handle samples and models with maximum care during the test.
- Use only fresh samples and avoid direct sunlight.
- The batch numbers of all test components (cartridge and chip ID) must match between them.
- Do not exchange the test components between different batches or use the test components after the expiry date, since both actions could produce incorrect test results.
- Don't reuse the cartridges and C-tip. All cartridges and C-tip must be used to analyze only one sample.
- Don't reuse the pipette bits. The reuse of pipette tips can lead to cross contamination, resulting in incorrect test results.
- The cartridge must remain sealed in its original envelope until use. Do not use a cartridge if the envelope is damaged or has already been opened.
- Frozen sample can be thawed once. For shipping, samples must be packed in accordance with local regulations. Do not use samples with severe hemolysis and/or hyperlipidemia.
- If the test components and/or sample are stored in the refrigerator, let the cartridge and sample reach the ambient temperature for about 30 minutes before use.
- The AFIAS test tool can generate light vibration during use.
- The used cartridges, C-tip and pipette tips must be handled with care and disposed of using a suitable method in accordance with relevant local regulations.
- The cartridge contains sodium nitrogen (NaN3) and can cause some health problems such as seizures, hypotension, bradycardia, loss of consciousness, lung injuries and respiratory failure. Avoid contact with skin, eyes and clothing. In case of contact rinse immediately with running water.
- No interference with biotin in AFIAS PSA has been observed Neo when the concentration of biotin in the sample was less than 100 ng/mL. If a patient has taken biotin at a dose greater than 0.03 mg per day, it is recommended to repeat the test 24 hours after the interruption of taking biotin.
- AFIAS PSA Neo will provide accurate and reliable results if you comply with the following conditions.
- AFIAS PSA Neo should only be used together with the AFIAS test tool.
- The recommended anticoagulant must be used.
- Use the C-tip when the following conditions occur.
- We recommend the C-tip provided with the kit to obtain a correct test result.
- The whole blood must be analyzed immediately after the harvest.
- Do not test with C-tip in the “General Mode (General Mode)”. It could cause an incorrect result.
- The whole excess blood around the C-tip must be removed. To avoid cross contamination, do not reuse the C-tip for multiple samples.
- The AFIAS cartridge must be inserted and placed in the cartridge holder before the blood sample is taken.
- While taking blood, pay attention not to create air bubbles in the C-tip.
- The test is intended for use by health professionals in a laboratory environment, not intended for decentralized analysis.
- The test can produce false positive results due to cross-reactions and/or non-specific adhesion of some sample components to capture/relevance antibodies.
- The test can produce false negative results due to the non-reactivity of antibodies, the most common situation if the epitope is masked by some unknown components, and therefore cannot be detected or captured by antibodies. Even the instability or degradation of antigens with time and/or temperature can cause false negative results because it makes antigens unrecognizable by antibodies.
- Other factors may interfere with the test and cause incorrect results, such as technical/procedural errors, degradation of test components/reagents or presence of interfering substances in test samples.
- Any clinical diagnosis based on the result of the test must be supported by a general judgement of the reference doctor along with clinical symptoms and other relevant test results.
Conservation
Store at temperature between 2-30°C.
Validity of whole packaging: 20 months.
Cod. 5N2793U0002
Cod. 5N2793U00
Cod. 5N2793U00
Cod. 5N2793U00
Cod. 5N2793U00
