Description
AFIAS
PSA Neo
Description
Fluorescence immunoassay (FIA) for the quantitative determination of PSA (prostate specific antigen) in human whole blood/serum/plasma. It is useful as an aid in the diagnosis of prostate cancer or other prostate diseases.
For in vitro diagnostic use only.
The test uses a capture (“sandwich”) immunodetection method.
How to use
The sample type for AFIAS PSA Neo is human whole blood/serum/plasma.
- It is recommended that the sample (whole blood, serum, plasma) be tested within 24 hours of collection, with the collected sample stored at room temperature.
- Samples (serum, plasma) must be separated from the clot by centrifugation within 3 hours of whole blood collection.
- Samples (whole blood, serum, plasma) may be stored for one week at 2 - 8°C before testing. If testing is delayed for more than one week, samples (serum, plasma) should be frozen at - 20°C.
- Samples (serum, plasma) stored frozen at -20°C for 3 months showed no differences in performance.
- However, the whole blood sample should not be stored in the freezer under any circumstances.
- Since repeated freezing-thawing cycles may affect the test result, do not refreeze previously frozen specimens.
- Collect whole blood sample using C-tip.
- Hold the C-tip horizontally and touch the tip of the C-tip to the surface of the blood.
- Capillary action will automatically draw the blood sample to the C-tip and stop.
- Wipe away excess blood around the tip.
- Double check that whole blood is filled accurately into the C-tip and that the AFIAS test instrument is ready for a test in “C-tip mode”.
Components
Composed of "cartridges".
- Each sealed aluminum pouch contains two cartridges.
- Each cartridge packaged in an aluminum pouch consists of three components, including a cartridge part, a detector part and a diluent part.
- The cartridge part contains a membrane called a test strip containing anti-PSA on the test line and rabbit IgG on the control line.
- The detector part has a granule containing anti-PSA-biotin conjugate, streptavidin-fluorescence conjugate and anti-rabbit IgG-fluorescence conjugate, as well as sodium azide as a preservative in phosphate buffered saline (PBS).
- The diluent part contains polysorbate 20 as a detergent and sodium azide as a preservative in Tris-HCl buffer.
General mode
1) Insert a cartridge into the cartridge holder.
2) Insert a tip into the tip hole of the cartridge.
3) Select "General mode" in the AFIAS test tool.
4) Collect 100 mcL of sample (whole blood/serum/plasma/control) using a pipette and dispense it into the sample well of the cartridge.
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" 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 "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 analyte name 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 [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
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 tip hole of the cartridge.
4) Press the "Load" button of the cartridge slot with a tip to read the cartridge barcode and confirm the item name written on the cartridge.
5) Switch to "Emergency mode" in AFIAS-10.
6) Select the tip 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 “Instructions for Use”.
- Handle all specimens as if they contain infectious agents.
- Due to the risk of infection, it is recommended to wear protective clothing, including a mask and gloves, and handle specimens and models with utmost care during testing.
- Use only fresh samples and avoid direct sunlight.
- The lot numbers of all test components (cartridge and ID chip) must match each other.
- Do not interchange test components between different lots or use test components after the expiration date, as both actions may produce incorrect test results.
- Do not reuse cartridges and C-tips. All cartridges and C-tips must be used to analyze only one sample.
- Do not reuse pipette tips. Reusing pipette tips may lead to cross-contamination, resulting in incorrect test results.
- The cartridge must remain sealed in its original pouch until use. Do not use a cartridge if the pouch is damaged or has already been opened.
- Frozen specimens can be thawed only once. Specimens must be packaged in accordance with local regulations for shipment. Specimens with severe hemolysis and/or hyperlipidemia should not be used.
- If the test components and/or sample are stored in the refrigerator, allow the cartridge and sample to reach room temperature for approximately 30 minutes before use.
- The AFIAS test instrument may generate slight vibrations during use.
- Used cartridges, C-tips and pipette tips must be handled with care and disposed of in an appropriate manner in accordance with relevant local regulations.
- The cartridge contains sodium azide (NaN3) and may cause some health problems such as convulsions, hypotension, bradycardia, loss of consciousness, lung damage and respiratory failure. Avoid contact with skin, eyes and clothing. In case of contact, rinse immediately with running water.
- No interference with biotin was observed in AFIAS PSA Neo when the biotin concentration 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 stopping biotin intake.
- AFIAS PSA Neo will provide accurate and reliable results if the following conditions are met.
- AFIAS PSA Neo must only be used in conjunction with the AFIAS testing instrument.
- The recommended anticoagulant must be used.
- Use the C-tip when the following conditions apply.
- The C-tip provided with the kit is recommended to obtain a correct test result.
- Whole blood should be tested immediately after collection.
- Do not perform a C-tip test in “General mode”. This may cause an incorrect result.
- Excess whole blood around the C-tip should be removed. To avoid cross-contamination, do not reuse the C-tip for multiple specimens.
- The AFIAS cartridge must be inserted and placed in the cartridge holder before collecting the blood sample.
- When drawing blood, be careful not to create air bubbles in the C-tip.
- The test is intended for use by healthcare professionals in a laboratory setting, not intended for point-of-care testing.
- The test may produce false positive results due to cross-reactions and/or non-specific binding of some specimen components to the capture/detection antibodies.
- The test may produce false negative results due to the non-reactivity of antigens to antibodies, the most common situation is if the epitope is masked by some unknown components, and therefore cannot be detected or captured by antibodies. Instability or degradation of antigens with time and/or temperature may also cause false negative results as it makes antigens unrecognizable by antibodies.
- Other factors may interfere with the test and cause erroneous results, such as technical/procedural errors, degradation of test components/reagents, or the presence of interfering substances in test samples.
- Any clinical diagnosis based on the test result must be supported by a general judgment of the referring physician together with the clinical symptoms and other relevant test results.
Conservation
Store at a temperature between 2-30°C.
Validity with intact packaging: 20 months.
Cod. 5N2793U00PE02
Cod. 5N2793U00PE03
Cod. 5N2793U00PE04
Cod. 5N2793U00PE05
Cod. 5N2793U00PE06
Fluorescence immunoassay (FIA) for the quantitative determination of PSA (prostate specific antigen) in human whole blood/serum/plasma. It is useful as an aid in the diagnosis of prostate cancer or other prostate diseases.
For in vitro diagnostic use only.
The test uses a capture (“sandwich”) immunodetection method.
How to use
The sample type for AFIAS PSA Neo is human whole blood/serum/plasma.
- It is recommended that the sample (whole blood, serum, plasma) be tested within 24 hours of collection, with the collected sample stored at room temperature.
- Samples (serum, plasma) must be separated from the clot by centrifugation within 3 hours of whole blood collection.
- Samples (whole blood, serum, plasma) may be stored for one week at 2 - 8°C before testing. If testing is delayed for more than one week, samples (serum, plasma) should be frozen at - 20°C.
- Samples (serum, plasma) stored frozen at -20°C for 3 months showed no differences in performance.
- However, the whole blood sample should not be stored in the freezer under any circumstances.
- Since repeated freezing-thawing cycles may affect the test result, do not refreeze previously frozen specimens.
- Collect whole blood sample using C-tip.
- Hold the C-tip horizontally and touch the tip of the C-tip to the surface of the blood.
- Capillary action will automatically draw the blood sample to the C-tip and stop.
- Wipe away excess blood around the tip.
- Double check that whole blood is filled accurately into the C-tip and that the AFIAS test instrument is ready for a test in “C-tip mode”.
Components
Composed of "cartridges".
- Each sealed aluminum pouch contains two cartridges.
- Each cartridge packaged in an aluminum pouch consists of three components, including a cartridge part, a detector part and a diluent part.
- The cartridge part contains a membrane called a test strip containing anti-PSA on the test line and rabbit IgG on the control line.
- The detector part has a granule containing anti-PSA-biotin conjugate, streptavidin-fluorescence conjugate and anti-rabbit IgG-fluorescence conjugate, as well as sodium azide as a preservative in phosphate buffered saline (PBS).
- The diluent part contains polysorbate 20 as a detergent and sodium azide as a preservative in Tris-HCl buffer.
General mode
1) Insert a cartridge into the cartridge holder.
2) Insert a tip into the tip hole of the cartridge.
3) Select "General mode" in the AFIAS test tool.
4) Collect 100 mcL of sample (whole blood/serum/plasma/control) using a pipette and dispense it into the sample well of the cartridge.
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" 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 "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 analyte name 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 [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
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 tip hole of the cartridge.
4) Press the "Load" button of the cartridge slot with a tip to read the cartridge barcode and confirm the item name written on the cartridge.
5) Switch to "Emergency mode" in AFIAS-10.
6) Select the tip 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 “Instructions for Use”.
- Handle all specimens as if they contain infectious agents.
- Due to the risk of infection, it is recommended to wear protective clothing, including a mask and gloves, and handle specimens and models with utmost care during testing.
- Use only fresh samples and avoid direct sunlight.
- The lot numbers of all test components (cartridge and ID chip) must match each other.
- Do not interchange test components between different lots or use test components after the expiration date, as both actions may produce incorrect test results.
- Do not reuse cartridges and C-tips. All cartridges and C-tips must be used to analyze only one sample.
- Do not reuse pipette tips. Reusing pipette tips may lead to cross-contamination, resulting in incorrect test results.
- The cartridge must remain sealed in its original pouch until use. Do not use a cartridge if the pouch is damaged or has already been opened.
- Frozen specimens can be thawed only once. Specimens must be packaged in accordance with local regulations for shipment. Specimens with severe hemolysis and/or hyperlipidemia should not be used.
- If the test components and/or sample are stored in the refrigerator, allow the cartridge and sample to reach room temperature for approximately 30 minutes before use.
- The AFIAS test instrument may generate slight vibrations during use.
- Used cartridges, C-tips and pipette tips must be handled with care and disposed of in an appropriate manner in accordance with relevant local regulations.
- The cartridge contains sodium azide (NaN3) and may cause some health problems such as convulsions, hypotension, bradycardia, loss of consciousness, lung damage and respiratory failure. Avoid contact with skin, eyes and clothing. In case of contact, rinse immediately with running water.
- No interference with biotin was observed in AFIAS PSA Neo when the biotin concentration 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 stopping biotin intake.
- AFIAS PSA Neo will provide accurate and reliable results if the following conditions are met.
- AFIAS PSA Neo must only be used in conjunction with the AFIAS testing instrument.
- The recommended anticoagulant must be used.
- Use the C-tip when the following conditions apply.
- The C-tip provided with the kit is recommended to obtain a correct test result.
- Whole blood should be tested immediately after collection.
- Do not perform a C-tip test in “General mode”. This may cause an incorrect result.
- Excess whole blood around the C-tip should be removed. To avoid cross-contamination, do not reuse the C-tip for multiple specimens.
- The AFIAS cartridge must be inserted and placed in the cartridge holder before collecting the blood sample.
- When drawing blood, be careful not to create air bubbles in the C-tip.
- The test is intended for use by healthcare professionals in a laboratory setting, not intended for point-of-care testing.
- The test may produce false positive results due to cross-reactions and/or non-specific binding of some specimen components to the capture/detection antibodies.
- The test may produce false negative results due to the non-reactivity of antigens to antibodies, the most common situation is if the epitope is masked by some unknown components, and therefore cannot be detected or captured by antibodies. Instability or degradation of antigens with time and/or temperature may also cause false negative results as it makes antigens unrecognizable by antibodies.
- Other factors may interfere with the test and cause erroneous results, such as technical/procedural errors, degradation of test components/reagents, or the presence of interfering substances in test samples.
- Any clinical diagnosis based on the test result must be supported by a general judgment of the referring physician together with the clinical symptoms and other relevant test results.
Conservation
Store at a temperature between 2-30°C.
Validity with intact packaging: 20 months.
Cod. 5N2793U00PE02
Cod. 5N2793U00PE03
Cod. 5N2793U00PE04
Cod. 5N2793U00PE05
Cod. 5N2793U00PE06
