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Quality Control Solution

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

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Product Detail

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

The composition of the quality control product shall be similar or identical to the substrate used to test the patient samples.
Quality control products should be uniform and stable.
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
Infectious Disease	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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