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Getein Quality Control Solution

Quality Control Solution

Getein Biotech provides Controls Solution on Getein platforms, covering multiples fields including cardiovascular diseases, inflammation, kidney injury, diabetes mellitus, fertility, etc.

Quality Control Solution

 

Definition

Substance, material, or article intended by its manufacturer to be used to verify the performance characteristics of an IVD medical device.

 

Performance Characteristics

One of the parameters used to define the analytical or clinical performance of an IVD medical device.

 

Basic Features of Control Materials

  1. The composition of the quality control product shall be similar or identical to the substrate used to test the patient samples.
  2. Quality control products should be uniform and stable.
  3. Quality control products must be tested in the same manner as the patient sample.

 

Internal quality control

Internal Quality Control (IQC) is a function of quality control to monitor and evaluate the work quality of the laboratory.

  • A series of inspection and control measures are adopted by each laboratory.

  • IQC is important for improvement of the laboratory quality management system, as it is a measure of laboratory performance.

 

External quality assessment

External Quality Assessment (EQA) is used to describe a method that allows for comparison of a laboratory's testing to a source outside the laboratory.

  •  Allows comparison of performance and results among different test sites

  •  Provides early warning for systematic problems associated with kits or operations

  •  Provides objective evidence of testing quality

  •  Indicates areas that need improvement

  •  Identifies training needs

 

QC rules

Our quality control methods are based on Westgard rules.

Based on this rule system, two kinds of quality control methods are established: L-J quality control and X-B quality control. L-J quality control curve is a straight line in an ideal state, with a fluctuation no more than 2 SD.

 

Specifications

 

1 level x 6 vials x 1 mL 2 levels x 2 vials x 1 mL 3 levels x 2 vials x 1 mL
1 level x 3 vials x 1 mL 2 levels x 1 vial x 1 mL 3 levels x 1 vial x 1 mL

 

Operation Procedure

 

 

Applicable Devices

Getein 1100 lmmunofluorescence Quantitative Analyzer

Getein 1160 lmmunofluorescence Quantitative Analyzer

Getein 1180 lmmunofluorescence Quantitative Analyzer

Getein 1200 lmmunofluorescence Quantitative Analyzer

Getein 1600 Immunofluorescence Quantitative Analyzer

 

Getein QC Products

 

Classification Item
Cardiac Marker
cTnI 
TnT
CK-MB
H-FABP
NT-proBNP 
BNP
Myo
CK-MB/cTnI/Myo
CK-MB/cTnI/Myo/NT-proBNP/D-Dimer/CRP/HCY
Inflammation PCT
CRP
SAA
IL-6
Coagulation D-Dimer
Diabetes HbA1c
Fertility HCG+β
LH
FSH
Prog
PRL
AMH
Renal Function mAlb
NGAL
CysC
β2-MG
Tumor tPSA
fPSA
AFP
CEA
Infectious Disease HBsAg
Anti-HCV
Metabolic Marker 25-OH-VD
Thyroid Function TSH
T3
T4
COVID-19 SARS-CoV-2 Antigen
Other Ferritin

 

*Other items are coming soon.

 

 

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