【SPECIMEN COLLECTION AND PREPARATION】
Collect and handle the specimen strictly as below:
1. Collect the specimen according to standard procedures.
2. Human serum collected using standard sampling tubes or tubes containing separating gel.
3. Human whole blood and plasma are collected using EDTA or Heparin sodium.
4. Separate human serum and plasma from blood as soon as possible to avoid hemolysis. Grossly hemolytic, lipidic or turbid samples should not be used. Specimen with extensive particulate should be clarified by centrifugation prior to use. Do not use specimens with fibrin particles or contaminated with microbial growth.
5. Do not leave specimens at room temperature for prolonged periods.
Serum and Plasma specimens may be stored at 2-8 °C for up to 3 days, below -20 °C stable for 3 months. Whole blood collected by venipuncture should be stored at 2 -8 °C if the test is to be used within 1 day of collection. Do not freeze whole blood specimens.
6. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.
7. If the patients had been treated by high dose of biotin (5 mg/day), blood collection must be done after at least 8 hours.
8. If specimens are to be shipped, pack them in compliance with local regulations covering the transportation of etiologic agents.
【DIRECTIONS FOR USE】
1. Preparation
1) Take the test kit from the refrigerated environment and use it after
equilibrating to room temperature.
2) Dissolution of the Calibrator and Control:
2. Calibration
1) When using a new batch of reagents, calibration must be priority performed after the reagent information is entered.
2) The system requires double parallel tests for calibrator 1 and calibrator 2 and will assign 2 test slots to calibrator 1 and calibrator 2 respectively by default and the four tests should be done in one time.
Follow calibration procedures according to the user manual of the analyzer.
Load the reagent strips, then add 100-150 μL of corresponding dissolved calibrator 1 and 2 to the corresponding sample well of the reagent strips, finally tap the start button to perform the calibration tests.
3) Calibration frequency
3. Quality Control
1) Input Quality control information
Input the QC information into the system by scanning the QR code of the quality control in the information card provided with the kit.
2) Follow control procedures according to the user manual of the analyzer.
3) Load the reagent strips and add 100-150 μL of corresponding dissolved control materials, then tap the start button to perform the control tests. The recommended control requirement for the SAA test is a single test of all control levels tested once every 24 hours in daily use. If the quality control procedures in your laboratory require more frequent use of controls to verify test results, follow your laboratory-specific procedures. Make sure the control values are within the defined ranges.
Each laboratory should establish corrective measures to be taken if control values fall outside the defined limits.
4. Sample test
Sample test can be performed on condition that the test results of calibration and quality control meet the requirements. (Calibration results indicate successful and Control results fall within the specified ranges in the information card.)
Dilution of the sample: pipette 2 μL of sample to the diluent provided with the kit, shake to mix thoroughly.
Tap [Analy] and select [SAA] item.
Load the reagent strips and add 100-150 μL of diluted sample to the sample well, and tap Start button. After the detection is finished, the concentration will be calculated by the software and displayed on the screen.
Note: the diluted sample should be used within 24 hours.
5. Dilution
Specimens with a SAA value exceeding 500 μg/mL are flagged with the code “>500.00” and may be diluted again and retest.
50mM Tris buffer is recommended as sample diluents. Note: After manual dilution, the dilution factor should be considered when calculate the final results. For detailed information, please refer to the User Manual of Automatic Chemiluminescence Immunoassay Analyzer
