【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 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 2 days, below for -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】
Refer to Automatic Chemiluminescence Immunoassay Analyzer User Manual for the complete instructions for use of the analyzer.
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:
Add 500 μL of purified water to each Calibrator/Control for reconstitution.
Dissolved calibrators /controls are stable for 1 week when stored at 2-8 °C.
3) Input reagent information
Before using a new batch of reagents, the reagent information should be entered.
Run the analyzer software, enter the adding reagent interface and scan the reagent information QR code in the information card to input the test information.
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 100-150uL 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
1) Input Quality control information
2) Follow control procedures according to the user manual of the analyzer.
3) Load the reagent strips and add 100-150 uL of corresponding dissolved control materials, then tap the start button to perform the control tests.
The recommended control requirement for the MYO 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.)
5. Dilution
Specimens with a Myo value exceeding 1000ng/mL are flagged with the code “>1000” and may be diluted manually and test again.
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.
