8 minutes analysis time Minimum sample preparation process Sensitive separation with Zivak® PKU HPLC column Approximately 1000 analysis with one column Suitable for any HPLC System NOW accurate, sensitive and quantitative HPLC analysis in 8 minutes Main methods and procedures that have been selected are based on EN ISO 13485 and 98/79/EC. HPLC-UV Analysis Kit for the in-vitro Diagnostic Quantitative Determination of Phenylketonuria in Human Serum & Plasma and Dried Blood Samples Properties of the analysis kit METABOLIC DISEASES
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in Human Serum & Plasma and Dried Blood Samples · Minimum sample preparation process Sensitive separation with Zivak® PKU HPLC column Approximately 1000 analysis with one column
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8 minutes analysis time
Minimum sample preparation process
Sensitive separation with Zivak® PKU HPLC column
Approximately 1000 analysis with one column
Suitable for anyHPLC System
NOW accurate, sensitive
and quantitativeHPLC analysis
in 8 minutes
Main methods and procedures that have beenselected are based on EN ISO 13485 and 98/79/EC.
HPLC-UV Analysis Kit for thein-vitro Diagnostic Quantitative Determination of Phenylketonuria in Human Serum & Plasma and Dried Blood Samples
Properties of the analysis kit
METABOLIC DISEASES
METABOLIC DISEASES
Sample Chromatogram and Validation ResultsSample chromatogram is for DBS calibrator of Zivak® PKU HPLC-UV Analysis Kit
HPLC-UV Analysis Kit for thein-vitro Diagnostic Quantitative Determination of Phenylketonuria in Human Serum & Plasma and Dried Blood Samples
Tyrosine (TYR)
LOD
LOQ
Accuracy
Precision Intra-Assay
Precision Inter-Assay
Linearity
(µmol/L)
(µmol/L)
(%)
(%CV)
(%CV)
(R2)
0.85
2.55
97
4.9
5.3
0.998
(µmol/L)
(µmol/L)
(%)
(%CV)
(%CV)
(R2)
0.60
1.80
98
3.4
3.8
0.996
Tryptophan (TRP)
LOD
LOQ
Accuracy
Precision Intra-Assay
Precision Inter-Assay
Linearity
(µmol/L)
(µmol/L)
(%)
(%CV)
(%CV)
(R2)
0.35
1.05
97
3.9
4.2
0.997
Phenylalanine (PHE)
LOD
LOQ
Accuracy
Precision Intra-Assay
Precision Inter-Assay
Linearity
The results have been validatedwith a Zivak® COMET- 4100 HPLC-UV systemin Nov. 2014.