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