IRIS Technologies International, Ltd.
   Reference Materials and Complete Kits for Medical Diagnostics
 
   

North America
1615 Branch Valley Drive
Roswell, GA 30076, USA
Phone:  404-348-4130, Fax:  404-806-9525

Europe
3 Manse Brae
Longridge, EH47 8NZ, Scotland, UK
Phone:  ++44-(0)1501-771970

Please CLICK to e-mail IRIS

e-mail

    IRIS Technologies: Diagnostic Kits (Matrix Calibrators and Controls), ChromSword Auto (Automated HPLC Method Development), CHIRIS:  Chiral Stationary Phases

 
 

 

 

  

 

 

 

 

  
HOME
   
 
   Diagnostic Kits

 
 

 

Chiral Stationary Phases | CHIRIS


 
   

 

 
    
  
 

 

 

  

 

 

 

 

 

   

 

 

  
 
   
 

 

 

 

 

 

 

 

 
   
   
   
   




























































 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

© 2008 IRIS Technologies International, Ltd.

 

 
Diagnostics:  HPLC Complete Kits

ClinRep® Diagnostics

Parameters of clinical chemistry may be categorized according to their clinical purpose: for

Diagnostic parameters are endogenous substances that show a specific relationship to altered metabolic processes.  Therefore they are used for the diagnosis of specific diseases and affections.


Alcoholism
CDT (Carbohydrate-Deficient Tansferrin) in Serum 
CDT (Carbohydrate-Deficient Transferrin) in Serum – 
    On-Line Analysis

Tumor Diseases (Biogenic Amines)
Catecholamines in Plasma
Catecholamines in Urine 
Catecholamines in Urine – On-Line Analysis with Fluorescence Detection
Metanephrines in Urine
Serotonin in Plasma
Serotonin in Urine
VMA, HVA, 5-HIAA in Urine


Diabetes, Hemoglobin Testing
Hemoglobin A1c (HbA1c) in Whole Blood with DiamatTM
Hemoglobin A1c (HbA1c) in Whole Blood with VariantTM


Metabolic Diseases (Biogenic Amines)
5-Aminolevulinic Acid / Porphobilinogen in Urine 
Homocysteine in Plasma
Hydroxyproline in Urine
Phenylalanine (Tyr, Phe, Trp) in Whole Blood, Plasma and 
    from Filterspots
 
Porphyrins Differentiated in Urine
Total Porphyrins in Urine

Oxidative Stress
Malondialdehyde in Plasma/Serum


Vitamin Status
Vitamins A and E in Plasma
Vitamin B1 in Whole Blood
Vitamin B2 in Whole Blood
Vitamin B6 in Plasma / Whole Blood 
Vitamins B1, B2 in Whole Blood and Vitamin B6 in Plasma / Whole Blood (Combikit)
Vitamin C in Plasma

25-OH-Vitamin D3 in Plasma/Serum

 
ClinRep® Therapeutic Drug Monitoring
ClinTox® Human Biomonitoring
Parameters for TDM are drugs (and drug metabolites) 
which are measured in order to control the appropriate clinical
medication with the respective drug.
Parameters for HBM serve for the assessment of an occupational or environmental 
related exposure towards harmful substances.
  
ClinRep® and ClinTox® complete kits are designed for a fast, simple and accurate analysis of these parameters under routine conditions. 
The kits contain all reagents required for sample preparation, system testing, calibration and analysis.
 
Antiarrhythmics

Amiodarone in Plasma
Antiasthmatics

Theophylline, Theobromine and Caffeine in Plasma
Antiepileptic
Drugs

Antiepileptics in Serum
Lamotrigine and Sulthiame in Plasma

Antipsychiotics
Atypical Neuroleptics (Olanzapine, Clozapine, Quetiapine)
    in Plasma/Serum - On-Line Analysis

Immunosuppressants
Cyclosporine A in Whole Blood
Mycophenolic Acid in Plasma

 
Benzene and Benzene Derivatives

  ortho-Cresol and Phenol in Urine 
  Hippuric Acid and Methylhippuric Acids in Urine
  t,t-Muconic Acid in Urine

Polycyclic Aromatic Hydrocarbons (PAH)

1-Hydroxypyrene in Urine – On-Line Analysis

 

  Back to top Request Quote

Alcoholism
CDT (Carbohydrate-Deficient Tansferrin) in Serum

  Quantification of all transferrin isoforms
  Detection of genetic variants
  Screening for CDG syndromes

CDT (carbohydrate-deficient transferrin) is the Native sample, pathological range most specific parameter for chronic alcohol abuse. The present reagent kit can be applied for routine diagnostics as well as for confirmation analysis in case of unplausible diagnostic findings. The test allows the identification of genetic variants and can be used for the screening of CDG syndromes. The present application may also be performed as a fully automated method with on-line sample preparation.

Test Data
Lower detection limit: 0.4 %*
Lower determination limit: 0.6 %*
Intra-assay precision: 4.2 %
Interassay precision: 4.3 %
*depends on the amount on total transferrin

HPLC Parameters
Pump: ternary gradient pump, Flow rates: 1.2, 2.0 ml/min
Injection volume: 400 - 500 μl
, Injection interval: 20 min
UV/VIS-Detector: 460 nm 
HPLC-Thermostat: 40 °C

Sample Preparation

  Back to top  
Alcoholism
CDT (Carbohydrate-Deficient Tansferrin) in Serum –
On-Line

  Fully automated method
  Run time: 9.5 min

The present on-line test kit is designed as a fast Native sample, pathological range (injection interval: 9.5 min) and fully automated method for CDT analysis. A manual sample preparation is not required, but is performed on-line within the HPLC system. The pretreatment step (see below) serves for the iron saturation of the samples and is performed automatically by a barcode sampling system.

Test Data
Lower detection limit: 0.4 %*
Lower determination limit: 0.6 %*
Intraassay precision: 4.5 %
Interassay precision: 3.9 %
*depends on the amount on total transferrin

HPLC Parameters
Pump 1: binary gradient pump,
flow rate: 1.4 ml/min
Pump 2: isocratic pump,
flow rate: 0.4 ml/min
Injection volume: 400 - 500 μl
Injection interval: 9.5 min
UV/VIS-Detector: 460 nm
HPLC-Thermostat: 40 °C

Sample Pretreatment

  Back to top  
Diabetes, Hemoglobin Testing
Hemoglobin A1c (HbA1c) in Whole
Blood 
(for DiamatTM
and Modulary HPLC)


  Reliable and cost-efficient analysis
  “Gold standard” for HbA1c analysis
  Column lifetime:  > 1000 analyses

Diabetes mellitus is a chronic disease that is associated with abnormally high blood glucose levels. The determination of HbA1c is an important diagnostic tool for monitoring the efficiency of dietary control and therapy during treatment of diabetes mellitus. Due to the excellent specificity and reproducibility, HPLC is still considered as the “gold standard” method for the adjustment of the blood glucose concentration in diabetes patients. The HbA1c values, obtained with the present method, are in accordance with the value level of the DCCT (Diabetes Control and Comparison Trial). The kit can be applied on the BioRad analyzer DiamatTM or any conventional modular HPLC system and features in robustness and cost efficiency (column lifetime > 1000 analyses).

Test Data
Linearity: The test is linear over the whole range of physiologically occurring HbA1c values (approx. 3 -16 % HbA1c).
Intraassay precision: 1 - 2 %
Interassay precision: 2 - 3 %

Dependence on the amount of total hemoglobin:
The HbA1c value is independent on the amount of total
hemoglobin in a range from 6 - 24 g/dl total
hemoglobin.

HPLC Parameters for Modular HPLC Systems / for DiamatTM
Pump: Ternary Gradient Pump / Ternary Gradient Pump
Flow rate: 1.5 ml/min / 1.1, 1.5 or 1.8 ml/min
Injection volume: 20 μl / 20 μl
Injection interval: 5 min / 8-, 5- or 3 min programe
UV/VIS-Detector: 415 nm / 415 nm
HPLC-Thermostat: 23 °C / 23 °C

Sample Preparation

 

  Back to top  
Diabetes, Hemoglobin Testing
Hemoglobin A1c ( HbA1c) in Whole
Blood (for VariantTM and Modulary HPLC)

  Reliable and cost-efficient analysis
  “Gold standard” for HbA1c analysis
  Column lifetime:  > 1000 analyses


This HbA1c test kit is designed for the application on the BioRad analyzer VariantTM. However, the kit can also be used with any conventional modular HPLC system.

Test Data
Linearity: The test is linear over the whole range of
physiologically occurring HbA1c values (approx. 3 - 16 % HbA1c). 
Intraassay precision: 1 - 2 %
Interassay precision: 2 - 3 %

Dependence on the amount of total hemoglobin:
The HbA1c value is independent on the amount of
total hemoglobin in a range from 6 - 24 g/dl total hemoglobin. 

HPLC Parameters

Pump: binary gradient pump, Flow rate: 2.0 ml/min
Injection volume: 20 μl
Injection interval: 3 min
UV/VIS-Detector: 415 nm
HPLC-Thermostat: 28 °C

Sample Preparation

  Back to top  
Metabolic Diseases
5-Aminolevulinic Acid /
Porphobilinogen in Urine

  Easy to handle
  Cost-efficient
  Reliable test results


5-Aminolevulinic acid (5-ALA) and porphobilinogen (PBG) are intermediates in the biosynthesis of heme and hemoglobin. In certain diseases, called porphyrias, an accumulation of 5-ALA and PBG is observed due to abnormalities in the heme production. Besides to a genetic disposition (hereditary porphyrias), porphyrias may also be induced by several external factors, mostly by lead intoxication.  Here, an intoxication leads to an accumulation of 5-ALA by inhibition of the enzyme PBG synthase.  In contrast to the highly variable lead level in whole blood, the urinary 5-ALA level remains increased for at least one year after intoxication.

Test Data
Linearity: 0.8 - 80 mg/l
Recovery: > 90 %
Lower detection limit: 0.6 mg/l
Lower determination limit: 0.8 mg/l
Intraassay precision: 5-ALA: 3.4 %
PBG: 5.2 %
Interassay precision: 5-ALA: 4.6 %
PBG: 6.4 %

Sample Preparation

  Back to top  
Metabolic Diseases
Homocysteine in Plasma

  High specific derivatization
  Run time:  5 min.
  Sampling System for pre-analytics available

Homocysteine is an established marker to estimate the risk towards atherosclerosis and coronary heart disease. An elevated plasma homocysteine level (hyperhomocysteinemia), whether due to nutrient deficiencies or by genetic defects, can be reduced by intake of folic acid, vitamin B6 and B12. Therefore, the determination of homocysteine does not only serve for the risk assessment towards atherosclerotic affections but also to ensure the proper combination and dosage of a nutrition supplement therapy. The present test kit allows the simultaneous analysis of total homocysteine (tHcys) and total cysteine (tCys). For preanalytics a special sampling system is available.

Test Data
Linearity: 1 - 100 μmol/l
Recovery: 95 - 105 %
Lower detection limit: 0.5 μmol/l
Lower determination limit: 1 μmol/l
Intraassay precision: 3.9 %
Interassay precision: 5.8 %

HPLC Parameters
Pump: isocratic pump, flow rate:
1.0 ml/min
Injection volume: 20 μl
Injection interval: 5 min
Fluorescence
detector: 385 nm (exc.), 515 nm (em.)
HPLC-Thermostat: 30 °C

Sample Preparation

  Back to top  
Metabolic Diseases
Hydroxyproline in Urine


  High analytical selectivity
  Run time:  8 min.
  Reliable determination


Osteoporosis is a metabolic bone disease that is characterized by an abnormally low bone density and therefore is associated with an increased risk of fracture. The bone degradation goes along with an increased formation of the amino acid hydroxyproline, which is released into blood circulation and is excreted with urine. The present test kit guarantees an accurate hydroxyproline measurement. By a special sample preparation, hydroxyproline is turned into a derivative and can be quantified without interferences from other amino acids.

Test Data
 
Linearity: 5 - 170 mg/l
Recovery: 90 - 100 %
Lower detection limit: 3 mg/l
Lower determination limit: 5 mg/l
Intraassay precision: 3.5 %
Interassay precision: 4.5 %

HPLC Parameters
Pump: binary gradient pump,
flow rates: 1.2, 1.4 ml/min
Injection volume: 20 μl
Injection interval: 8 min
UV/VIS-Detector: 471 nm
HPLC-Thermostat: 60 °C

Sample Preparation

  Back to top  
Metabolic Diseases
Phenylalanine (Phe, Tyr Trp) in Whole Blood, Plasma and from Filterspots


  Easy sample preparation
  High analytical sensitivity
  Reliable monitoring


Several metabolic disorders (e.g. phenylketonuria, tyrosinemia) result from an impaired amino acid metabolism. Also, some forms of depression seem to be connected with alterations of the metabolism of tyrosine and tryptophane, being the precursors of the brain neurotransmitters epinephrine, norepinephrine, dopamine and serotonin. The present ClinRep® complete kit serves for the monitoring of the amino acids phenylalanine, tyrosine and tryptophane and may be performed from whole blood, plasma and filterspots (filter testcards).

Test Data
Linearity: 0.2 - 50 mg/dl
Recovery: 90 - 100 %
Lower detection limit: 0.1 mg/dl
Lower determination limit: 0.2 mg/dl
Intraassay precision:
Whole Blood: 5.2 %,
Plasma: 2.9 %, Filterspots: 3.8 %
Interassay precision:
Whole Blood: 6.8 %,
Plasma: 4.5 %, Filterspots: 5.4 %

HPLC Parameters
Pump: isocratic pump, flow rate: 1.0 ml/min
Injection volume: 20 μl
Injection interval: 12 min
UV/VIS-Detector: 214 nm
HPLC-Thermostat: 30 °C

Sample Preparation

  Back to top  
Metabolic Diseases
Prophyrins Differentiated in Urine


  High resolution of the prophyrin profile
  No interferences
  High analytical sensitivity


Metabolic diseases that lead to an accumulation of porphyrins in blood and tissues are summarized in the term “porphyrias”. The particular type of porphyria is diagnosed by the investigation of the specific porphyrin excretion profile. For this purpose, the present ClinRep® complete kit allows to separate (differentiate) the diverse porphyrins with high resolution (in different porphyrin-isomers!) and enables an exact quantification. As quick tests for the detection of porphyrias a column test for the determination of the total porphyrins as well as a column test for the determination of 5-aminolevulinic acid and porphobilinogen are available.

Test Data
 
Linearity: 1 - 5000 μg/l
Lower detection limit: 0.5 μg/l
Lower determination limit: 1 μg/l
Intraassay precision: 2.5 %
Interassay precision: 2.9 %

HPLC Parameters
Pump: binary gradient pump,flow rate: 1.0 ml/min
Injection volume: 20 μl
Injection interval: 20 min
Fluorescence
detector: 394 nm (exc.), 624 nm (em.)
Temperature: 25 °C (or ambient)

Sample Preparation

  Back to top  
Metabolic Diseases
Total Porphyrins in Urine


  Quick performance
  Easy handling
  Low price per test

The determination of the urinary total porphyrins serves for the basic diagnostics at suspicion on porphyrias. For further investigation in case of increased total porphyrin levels, the urinary excretion profile should be determined by HPLC. The present test kit features in quick performance, easy handling and a low price per analysis.

Test Data
Linearity: 20 - 4000 μg/l
Recovery: ~ 70 %
Lower detection limit: 15 μg/l
Lower determination limit: 20 μg/l
Intraassay precision: 5.5 %
Interassay precision: 7.2 %

Sample Preparation

  Back to top  
Tumor Diseases (Biogenic Amines)
Catecholamines in Plasma


  High sensitivity
  Extraordinary low detection limit
  Specific sample preparation


Epinephrine, norepinephrine and dopamine are termed as catecholamines. The determination of catecholamines is primarily used in order to help detect and rule out pheochromocytomas in symptomatic patients, i.e. in patients with persistent hypertension. It is also used in order to help monitor for recurrence when a pheochromocytoma has been discovered and removed. For these purposes, the present ClinRep® complete kit allows a quick and safe quantification of the catecholamines. The kit is easy to use and is characterized by an extraordinary good lower detection limit.

Test Data 
Linearity: 10 - 2500 ng/l 
Recovery: 70 - 90 %
Lower detection limit: 5 ng/l
Lower determination limit: 10 ng/l
Intraassay precision: 
6.7 % (norepinephr.),
7.6 % (epinephrine), 6.1 % (dopamine)
Interassay precision: 
5.3 % (norepinephr.),
4.2 % (epinephrine), 3.9 % (dopamine)

HPLC Parameters 
Pump: isocratic pump,
flow rate: 1.0 ml/min
Injection volume: 40 μl
Injection interval: 15 min
EC-Detector: potential: 500 mV,
Temperature: 25 °C (or ambient)

Sample Preparation

  Back to top  
Tumor Diseases (Biogenic Amines)
Catecholamines in Urine


  Easy test handling
  Reliable sample preparation
  High analytical specificity


With this HPLC application, the determination of the catecholamines is performed from urine. Whereas the determination from plasma is most useful for patients with persistent hypertension, the determination from urine gives the amount that is excreted over a 24-hours period. Since the catecholamine levels may fluctuate significantly during this period, the determination from urine may detect excess production that is missed with the plasma testing. Here, the test kit ensures a chromatography without interference due to an optimized sample clean up.

Test Data
Linearity: 2 - 1000 μg/l
Recovery: 70 - 85 %
Lower detection limit: 1 μg/l
Lower determination limit: 2 μg/l
Intraassay precision: 
3.8 % (norepinephr.),
5.6 % (epinephrine), 5.8 % (dopamine)
Interassay precision: 
5.6 % (norepinephr.),
4.9 % (epinephrine), 4.7 % (dopamine)

HPLC Parameters
Pump: isocratic pump,
flow rate: 1.0 ml/min
Injection volume: 20 μl
Injection interval: 15 min
EC-Detector: potential: 500 mV
HPLC-Thermostat: 30 °C

Sample Preparation

  Back to top  
Tumor Diseases (Biogenic Amines)
Catecholamines in Urine-On-line Analysis with Fluorescence Detection


  Fully automated method
  On-line sample preparation
  Robust analysis


The present ClinRep® complete kit is a fully automated method for the catecholamine determination in urine. A manual sample preparation is not required, but is performed on-line within the HPLC system! 

Test Data

Linearity: 2 - 1000 μg/l
Recovery: 100 %
Lower detection limit: 1 μg/l
Lower determination limit: 2 μg/l
Intraassay precision: 
5.7 % (norepinephr.),
6.7 % (epinephrine), 2.6 % (dopamine)
Interassay precision: 
6.2 % (norepinephr.),
7.2 % (epinephrine), 3.1 % (dopamine)

HPLC Parameters
Pump 1(SPE buffer): isocratic pump,
flow rate: 0.5 ml/min
Pump 2
(mobile phase): isocratic pump, flow rate: 1.0 ml/min
Switching valves: 1 x switching valve 6-port /
3-channel
Injection volume: 100 μl
Injection interval: 28 min
Fluorescence
detector: 275 nm (exc.), 330 nm (em.)
HPLC-Thermostat: 30 °C

Sample Preparation
No manual sample preparation required.

  Back to top  
Tumor Diseases (Biogenic Amines)
Metanephrines in Urine


  Effective sample clean-up
  Sensitive determination
  Low cost per test


The term “metanephrines” is used for the primary metabolites of the catecholamines, namely metanephrine, normetanephrine, and 3-methoxytyramine. The determination of catecholamines and their metabolites serves for helping to detect or rule out tumors of the sympathoadrenal system (pheochromocytoma and other neuroendocrine tumors). The pattern and the periodicity of the secretion of these substances into the blood circulation and urine, respectively, depends on the particular tumor. The reliable kit components of the present test kit ensure a sensitive determination of the analytes and enable a safe diagnosis.

Test Data
Linearity: 5 - 7500 μg/l
Recovery: 70 - 85 %
Lower detection limit: 3 μg/l
Lower determination limit: 5 μg/l
Intraassay precision:  2.4 % (normetanephr.),
 
4.1 % (metanephrine),
4.1 % (3-methoxytyr.)
Interassay precision: 7.2 % (normetanephr.),
7.1 % (metanephrine),
5.3 % (3-methoxytyr.)

HPLC Parameters
Pump: isocratic pump,
flow rate: 1.0 ml/min
Injection volume: 20 μl
Injection interval: 17 min
EC-Detector: potential: 720 mV
HPLC-Thermostat: 30 °C

Sample Preparation

  Back to top  
Tumor Diseases (Biogenic Amines)
Serotonin in Plasma


  Quick sample preparation
  Run time:  10 min.
  High analytical sensitivity


Serotonin is a neurotransmitter in the central nervous system. Serotonin deficiencies are connected
with disorders such as depression, schizophrenia, and Parkinson's disease. Moreover, serotonin is produced in excess by carcinoid tumors. Here, the determination of serotonin, together with its metabolite 5-HIAA is used for confirming or ruling out this tumor. The present ClinRep® complete kit allows a quick and highly sensitive determination of the analyte. The sample preparation requires just a single precipitation step. For the determination from urine we offers an additional test kit.

Test Data
Linearity: 2 - 1000 μg/l
Recovery: 80 - 90 %
Lower detection limit: 1 μg/l
Lower determination limit: 2 μg/l
Intraassay precision: 3 %
Interassay precision: 4 %


HPLC Parameters

Pump: isocratic pump,
flow rate: 1.0 ml/min
Injection volume: 20 μl
Injection interval: 10 min
EC-Detector: potential: 450 mV
HPLC-Thermostat: 30 °C

Sample Preparation

  Back to top  
Tumor Diseases (Biogenic Amines)
Serotonin in Urine


  Easy sample preparation
  Highly selective sample clean up.
  Run time:  10 min.


Serotonin is an important neurotransmitter. The main metabolite of serotonin is 5-hydroxyindole
acetic acid (5-HIAA) which is excreted with urine. Patients with carcinoid tumors usually show increased levels of serotonin in plasma and urine as well as of 5-HIAA in urine.  As some tumors show a decreased serotonin turnover (e.g. AADC-deficient tumors), low 5-HIAA levels must be verified by the determination of serotonin. The present test kit provides a highly selective sample preparation and guarantees a reliable chromatography.

Test Data
Linearity: 5 - 1000 μg/l
Recovery: 70 - 85 %
Lower detection limit: 3 μg/l
Lower determination limit: 5 μg/l
Intraassay precision: 3 %
Interassay precision: 4 %

HPLC Parameters
Pump: isocratic pump,
flow rate: 1.0 ml/min
Injection volume: 20 μl
Injection interval: 10 min
EC-Detector: potential: 450 mV
HPLC-Thermostat: 30 °C

Sample Preparation

  Back to top  
Tumor Diseases (Biogenic Amines)
VMA, HVA and 5-HIAA in Urine


  Highly selective sample preparation
  Highly selective sample clean up.
  Run time: 10 min.


Vanillylmandelic acid (VMA) and homovanillic acid (HVA) are end-products of the catecholamine metabolism. The determination of VMA and HVA in urine serves as screening test for neuroblastoma, one of the most common solid tumors of early childhood. 5-hydroxyindoleacetic acid (5-HIAA) is a metabolite of serotonin and is used for the diagnosis of carcinoid tumors.  The test procedure allows a reliable determination of VMA, HVA and 5-HIAA in only 15 min time for analysis.

Test Data
Linearity: 0.1 - 300 mg/l
Recovery: 70 - 90 %
Lower detection limit: 0.07 mg/l
Lower determination limit: 0.1 mg/l
Intraassay precision: 3 - 4 %
Interassay precision: 3 - 5 %

HPLC Parameters
Pump: isocratic pump,
flow rate: 0.9 ml/min
Injection volume: 20 μl
Injection interval: 15 min
EC-Detector: potential: 800 mV
HPLC-Thermostat: 30 °C

Sample Preparation

  Back to top  
Oxidative Stress
Malondialdehyde in Plasma/Serum


  Robust chromatography
 
Injection interval: 5 min.

Malondialdehyde is formed by radical mediated ClinChek® Plasma Control, Level II lipid peroxidation (oxidative stress) and shows mutagenic and cytotoxics effects by further reaction with DNA. For this reason, malondialdehyde is considered as suitable biomarker to determine oxidative stress. The ClinRep® complete kit allows the reliable quantification of malondialdehyde from plasma and serum. For quality assurance a ClinCal® plasma calibrator and ClinChek® plasma controls in two levels are available.

Test Data
Linearity: 0.04 - 20 μmol/l
Recovery: 100 %
Lower detection limit: 0.02 μmol/l
Lower determination limit: 0.04 μmol/l
Intraassay precision: 4.5 %
Interassay precision: 8.7 %

HPLC Parameters

Pump: isocratic pump, flow rate: 0.8 ml/min
Injection volume: 20 μl
Injection interval: 5 min
Fluorescence detector: 515 nm (exc.), 553 nm (em.)
HPLC-Thermostat: 30 °C

Sample Preparation

Malondialdehyde in Plasma/Serum
Malondialdehyde in Plasma/Serum
  Back to top  
Vitamin-Status
Vitamin A and E in Plasma


  Quick sample preparation
  Run time: 8 min.
  Reference materials with excellent stability


Vitamin A (retinol) and vitamin E (a-tocopherol) belong to the fat- soluble class of vitamins. In contrast to water-soluble vitamins, an excessive administration may lead to hypervitaminosis. Vitamin A deficiency is the leading cause of preventable blindness in children and raises the risk of disease and death from severe infections. Vitamin E is an important antioxidant and is thought to have a role in preventing atherosclerosis by inhibiting oxidation of low-density lipoprotein (LDL). The present ClinRep® complete kit allows the simultaneous analysis of both vitamins within a run time of 8 min. For sample preparation just a single precipitation step is required.

Test Data
Linearity: 
Vitamin A:
10 - 5000 μg/l, Vitamin E: 0.4 - 150 mg/l
Recovery: 90 - 100 %
Lower detection limit: Vitamin A: 7 μg/l,
Vitamin E: 0.25 mg/l
Lower determination limit: Vitamin A: 10 μg/l,
Vitamin E: 0.4 mg/l
Intraassay precision: Vitamin A: 3.0 %,
Vitamin E: 2.4 %
Interassay precision: Vitamin A: 6.6 %,
Vitamin E: 4.4 %

HPLC Parameters
Pump: isocratic pump,
flow rate: 1.5 ml/min
Injection volume: 20 μl
Injection interval: 8 min
UV-Detector: 325 / 295 nm
HPLC-Thermostat: 30 °C

Sample Preparation

Vitamins A and E in Plasma

  Back to top  
Vitamin-Status
Vitamin B1 in Whole Blood


  Determination as TPP or total thiamine
  Excellent sensitivity: 0.5 / 0.2 mg/l
  Run time: 4 min. / 6 min.
  Combinable with B2 and B6 test kits


Vitamin B1 (thiamine, thiamine pyrophosphate (TPP)) acts as
coenzyme in the carbohydrate metabolism and is essential for the normal function of the organism.
Deficiency mainly occurs in undernourished people, alcoholics or in special clinical situations (e.g. hemodialysis). A fully developed deficiency syndrome is called “BeriBeri”. With the present test kit, vitamin B1 may be determined as TPP or alternatively, by enzymatic treatment within sample preparation, as total thiamine. The kit can be easily combined with the test kits for vitamin B2 and B6.

Test Data
Determination as TPP /
as Total Thiamine

Linearity: 1 - 200 μg/l /
0.5 - 160 μg/l
Recovery: 95 - 100 % /
95 - 100 %
Lower detection limit: 0.5 μg/l /
0.2 μg/l
Lower determination limit: 1 μg/l /
0.5 μg/l
Intraassay precision: 2.7 % /
2.8 %
Interassay precision: 4.2 % /
4.5 %

HPLC Parameters
Pump: isocratic pump,
flow rate: 1.0 ml/min
Pump (Reagent N): flow rate: 0.1 ml/min
Injection volume: 50 μl
Injection interval: 4 min (TPP) /
6 min (total thiamine)
Fluorescence
detector: 376 nm (exc.), 435 nm (em.)
HPLC-Thermostat: 35 °C

Sample Preparation

  Back to top  
Vitamin-Status
Vitamin B2 in Whole Blood


  Quick sample preparation
  Run time: 10 min.
  Combinable with B1 and B6 test kits


The term “vitamin B2” covers three vitamers: riboflavin, flavin mononucleotide (FMN) and flavin
adenine dinucleotide (FAD). FMN and FAD are the effective forms of vitamin B2 and are synthesized in vivo from riboflavin by phosphorylation. Vitamin B2 is important for energy production, enzyme function and normal fatty acid and amino acid synthesis. The undersupply with vitamin B2 is mostly attributed to a general malnutrition. It is often seen in persons with risk factors such as alcohol problems, advanced age and extreme dietary habits. The present test features in a short time for analysis (easy sample preparation, short run time) and can be easily combined with test kits for the vitamins B1 and B6.

Test Data
Determination as FAD
Linearity: 20 - 500 μg/l
Recovery: 95 - 100 %
Lower detection limit: 10 μg/l
Lower determination limit: 20 μg/l
Intraassay precision: 3.8 %
Interassay precision: 4.0 %

HPLC Parameters
Pump: isocratic pump,
flow rate: 1.0 ml/min
Injection volume: 50 μl
Injection interval: 10 min
Fluorescence
detector: 450 nm (exc.), 530 nm (em.)
HPLC-Thermostat: 40 °C

Sample Preparation

  Back to top  
Vitamin-Status
Vitamin B6 in Plasma/Whole Blood