The blood cell analyzer calibration
Blood cell analyzer is one of the most common analytical instruments in clinical laboratory, on the premise of good instrument precision, calibration instruments correctly is the key to guarantee the accuracy of the clinical test results. Therefore, network perlong medical equipment combined with domestic actual situation, the national hematology, humoral committee summarized below Suggestions on blood cell analyzer calibration issues.
(a) the general requirements of calibration
1. In order to ensure the accuracy of the test results, requirements of each blood cell analyzer calibration. Instrument installation must be provided by the manufacturer for calibration and records, otherwise cannot be used for the detection of clinical specimens.
2. The laboratory shall be set up according to the requirement of the "recommended" blood cell analyzer calibration procedures for use in the lab and written document. Traceability include: use the calibration item, source, name and save method; Calibration of the specific methods and steps; When asked for calibration, by whom is responsible for the implementation, etc.
3. The blood cell analyzer calibration, must carry out the indoor test results of the quality control in monitoring instrument is shifting.
(a) the general requirements of calibration
1. In order to ensure the accuracy of the test results, requirements of each blood cell analyzer calibration. Instrument installation must be provided by the manufacturer for calibration and records, otherwise cannot be used for the detection of clinical specimens.
2. The laboratory shall be set up according to the requirement of the "recommended" blood cell analyzer calibration procedures for use in the lab and written document. Traceability include: use the calibration item, source, name and save method; Calibration of the specific methods and steps; When asked for calibration, by whom is responsible for the implementation, etc.
3. The blood cell analyzer calibration, must carry out the indoor test results of the quality control in monitoring instrument is shifting.
(perlong medical brand - XFA6000Intelligent intelligent automatic blood cell analyzer)
(2) of the calibration object
1. The source of the calibration object is a instrument of form a complete set of calibration; Second, from the fresh blood, but constant value requirements, directly or indirectly, traceability to international standards.
2. The calibration item (1) the choice of using Chinese drug administration registration, internationally recognized quality and reliable detection system of laboratory, the calibration of form a complete set of objects should be chosen manufacturers. (2) use the new blood as calibration item but must emphasize its traceability. (3) for use with no necessary calibration test system of laboratory, must use the new blood for calibration.
3. Quality control content and calibration content (1) the difference between a theoretically different concept; (2) from the nature, the characteristics of calibration objects closer to the new blood; (3) from the point of setting value accuracy, both have differences, but not significantly; (4) from the point of view of function, quality content used in routine work, with sample to be tested, only change the condition of instrument calibration item and need to be calibrated when using; (5) from the point of view of use, calibration object must form a complete set, and the supporting manufacturers of calibration, the calibration of the same series, different types of instruments used target value, but not necessarily exactly the same, and quality content is general commonly, and differences between different types of blood cell analyzer, it is important to note when using; 6. Said method is different, the calibration content determination results expressed in deviation, quality content determination results expressed in CV.
(3) the calibration method
The use of Chinese drug supervision and administration of registration of internationally recognized quality and reliable detection system of laboratory, set by the use of manufacturers supporting the calibration item, strictly according to the procedures prescribed by the instrument manual calibration. Use other detection system of laboratory, available fresh blood for calibration as follows.
Instrument is ready to use cleaner first processing and channel of the instrument internal testing room 30 min. Confirm, the background count of instruments, precision and carry pollution rate within the scope of the specification, shall be calibrated, otherwise must find the reason, if necessary, please maintenance personnel for maintenance.
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