Reference Material and Control Material

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 1. Definition

1) Reference Material (RM)
Definition:the material with one or more uniform and stable enough features, which has been identified that it conform to the intended use of the measurement process.
Intended Use:calibrate equipment, evaluate measurement method, assign material , etc

2) Certified Reference Material (CRM)
   Definition:Reference Material adopting effective programs on metrology, with property values , uncertainty and traceability certificate.

3) Secondary Reference Material
   Secondary reference material comes from Primary reference material, used to measure the proporty value, with the State Council Approval
   
4) Control Material
   Control material is used to evaluate or verificate the measurement precision and measurement accuracy in in-vitro diagnosis, can be used for capacity verification and quality control in the laboratory.
   
5) Internal Quality Control (IQC)
   The laboratory staff adopt certain methods and steps to evaluate the reliability degree of the work in the laboratory continuously, in order to monitor and control the precision of the work in the laboratory, improve the consistency of the sample within and between batches, at last determine whether the results are reliable and can send out report.
   
6) Basic characteristics of refercence materails
Traceability, Interoperability, Stability, Uniformity, Accuracy

2. Classification of Reference Material
1) Primary reference material (national level)
2) Secondary reference material (ministerial level)

Reference Material and Control Material 1

 

3. The role of reference material
To guarantee the quality of products and the consistency of the test results, the reference material has the following important role.

1) Play an important role in the building, validation and implementation of product standards.
2) Play an important role in raw material inspection, production process control and product quality evaluation.
3) Institution of product inspection or certification use reference material for quality control and external quality assessment in inspection process for a long time.

4) Reference material plays an important role in the laboratory accreditation work and eliminating trade barriers.

. Whether to use reference material to calibrate instrument, verificate method and the accuracy of test results, keep the traceability of measurement test results, is also important in measuring and evaluating the laboratory detection ability.

4. roduct advantages and characters
1) Traceability: Reference material of all series can be traced back to WHO or national primary reference material
2) Accuracy: Use several different manufacturers' reagent at home and abroad to calibrate, highly reliable and accurate.
3) Stability: Use advanced production technology, strict production quality system to ensure product quality with high stability.
4) Uniformity: Reference material of all series have high uniformity between and within bottle.
5) Interoperability: All are liquid, do not need to dissolve, of simple operation and without matrix effect, of high product interoperability with fresh clinical sample .
6) Full coverage: Covers the most varieties

 

Product List

1.Secondary reference material with national certificate (5varieties and 16 items)
2.Reference material
3.Internal control material
4.External control material

1. List of secondary reference material with national certificate

Reference Material and Control Material 2

2. List of reference material

Reference Material and Control Material 3

3. List of internal control material

Reference Material and Control Material 4

Reference Material and Control Material 5

Reference Material and Control Material 6

4. List of external control material

Reference Material and Control Material 7

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