When the specimen reaches the reagent position of the plate, the BNP test is performed automatically by the instrument's built-in program. The test takes approximately 15 minutes.
The instrument measures BNP based on the amount of fluorescence detected in the measurement zone of the plate, with more fluorescence detected indicating a higher concentration of BNP in the specimen. The reagent brand and packaging specifications are based on the Triage BNP test plate manufactured by Biosite, which is provided by Invaris Medical Devices (Beijing) Co.
2.1 Reagent components: monoclonal and polyclonal antibodies to murine BNP labeled with fluorescent pigments. These antibodies are immobilized on a solid phase stabilizer.
2.2. Reagent Specifications: Test Plate 25T 25T Reagent Crypto Chip Product Test Parameter Triage BNP Detection Range: 5-5,000 pg/mL Sample Collection and Handling Requirements Specimens that meet the test requirements of the product are EDTA Blood or plasma specimens may be tested immediately or within 24 hours of collection. Blood and plasma specimens may be stored at room temperature or refrigerated for up to 24 hours. If testing is not possible within 24 hours, plasma should be separated and stored at -20 until tested. If severe hemolysis occurs in the specimen, repeat the test with a new specimen.
Test Reagent Requirements 5.1 Unopened test panels are stable to the expiration date when stored in a 2-8°C refrigerator.
5.2 Plates are stable at room temperature for 14 days, but do not exceed the expiration date on the package. Write the date of removal from the refrigerator on the package, check off the manufacturer's printed expiration date, and carefully record the time the product was stored at room temperature.
5.3 Allow a minimum of 15 minutes for single-packed plates to come to room temperature before using refrigerated (2-8) plates, and a minimum of 1 hour for kits containing multiple plates removed from the refrigerator.
5.4 Remove the plate from the package before use and discard after use. Procedure 6.1 Sample Preparation It is recommended that the tubes be shaken to mix the plasma before testing 6.2 Quality Control Plates The Quality Control Plates verify the correct functioning of the Triage instrument.
When running a new Plate on the Triage instrument, the Plate Password Chip must be installed first. Once installed, the information on the QP chip is stored in the Triage's memory and does not need to be reinstalled. See Triage Inserting the QPC chip into the front of the Triage in the lower left corner of the Triage
Remove the QPC chip from the Triage when the data transfer is complete
2) Select <Run Trial> from the main screen and press the Enter key.
3) Select <QC Board> and press enter.
4) Insert the QC plate and press enter.
5) When the test is complete the pass or fail result will be displayed or printed. All parameters should be passed before testing the patient. 6) Remove the QC plate from the Triage instrument and place it in the special QC plate box. Do not throw away the plates. See the Triage Triage User Manual for complete instructions on the use of QC plates. 6.3 Batch Calibration with Reagent Crypto Chips When opening a new batch of plates, the calibration and expiration information for that batch of plates should be loaded into the Triage prior to testing.
Transfer this information into the Triage using the Reagent Code Chip that was placed with the new lot of plates. Place the Reagent Code Chip into the front of the Triage in the lower left corner of the instrument and follow the on-screen prompts. When data transfer is complete, remove the reagent PIN chip from the instrument. See the Triage instrument user manual for complete instructions on password chip installation 6.4 Patient Specimen Testing 6.4.1 Place the pipette nozzle into the sample port of the test plate and squeeze the large bulb portion so that all of the liquid in the barrel portion of the pipette will flow into the sample port and none of the sample in the small bulb portion will be discharged. Throw away the pipette 6.4.2 Running the test Press <Confirm Patient Code> to confirm that the number is entered correctly, and press the Enter key. If the number is not entered correctly, select <Modify Patient Code> press the Enter key and repeat the previous steps Insert the test plate into the Triage instrument and press the Enter key. The number of analytes in the specimen will be displayed at the end of the test. Note: The test plate should be inserted into the instrument within 30 minutes of adding the sample, as more than 30 minutes will invalidate the result and block the printout. 6.4.3 Reading a Result No result output indicates that the result is not valid. 7. Clinical Applications The Triage BNP test is a fluorescent immunoassay that provides rapid quantitative detection of EDTA-type urinary natriuretic peptide (BNP) on the Triage instrument for bedside diagnostic purposes. The test can be used to assist in the diagnosis of congestive heart failure (also known as heart failure) and to assess the severity of heart failure, as well as to assess the risk of patients with acute coronary artery disease and heart failure. 8.1 The instrument's performance should be checked by running a quality control test panel each day that a patient sample is tested. 8.2 The QC test panel should be run when the instrument is set up, and QC should be run according to your laboratory's QC requirements. 8.3 Run the QC test panel under the following conditions: 8.3.1 Initial installation of the Triage instrument. 8.3.2 Before daily patient sample testing. 8.3.3 When the instrument has been transported or moved. 8.3.4 Anytime you are unsure of the instrument's performance. NOTE: If the QC test panel or external QC does not run as expected, then read the tips above to check that the test is running correctly. Repeat the test, or contact Biosite or your local Biosite representative. 9. Precautions for Use 9.1 The Triage BNP test is not the sole basis for the diagnosis of congestive heart failure, and the results should be interpreted in conjunction with clinical examinations and other laboratory findings. 9.2 Blood BNP concentrations may be elevated in patients with cardiac disease, in patients who are to undergo renal dialysis, and in patients who have undergone renal dialysis.