【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 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 5 days,
below -20 °C stable for 3 months.
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 Operation Manual for the complete instructions on use of the analyzer.
1. Preparation
1) Take the test kit from the refrigerated environment and use it after equilibrating to room temperature.
2) 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 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 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:
Once a calibration is accepted and stored, all subsequent samples may be tested without further calibration unless:
A reagent kit with a new lot number is used.
Reagents of the same batch number have been used for more than 4 weeks. As required: For example, controls testing are out of range
