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.

Phenylalanine

IS

Tyrosine

Tyrptophan

1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5

-0.005

0.000

0.005

0.010

0.015

minutes