directory of services - excorlab gmbh · 2020. 2. 27. · infomed cf-100-+-determination of...

DIRECTORY OF SERVICES

Area of analysis: Evaluation of medical devices

Mode of analysis: Biocompatibility tests

Analyte (measured variable) Sample material (Matrix) Method SOP/Standard Equipment AccreditedIn house-

Procedure

Research use

only

Evaluation of biocompatibility of dialyzers and

other medical devices according to DIN EN ISO

10993-4 (C5a, TAT, Cell count, Heparin,

Hemolysis, and others)

Medical devices

1) Ex vivo recirculation with heparinized

human blood

2) In vivo clinical testing

AA-001Ismatec MCP, Ismatec MCP-

Process - + -

Pyrogenretention (ex vivo) Hemodialyzers Ex vivo Hemodialysis, Cytokine induction AA-011Ismatec MCP, Ismatec MCP-

Process - + -

Evaluation of biocompatibility of flat sheets and

particles according to DIN EN ISO 10993-4 (ex

vivo)

Flat sheets, Flat sheet membranes,

Particles

Ex vivo incubation with heparinized

human bloodAA-010 Certomat U - + -

Evaluation of biocompatibility of adsorbers in

contact with blood according to DIN EN ISO

10993-4 (ex vivo)

Adsorber devices

1) Ex vivo recirculation with heparinized

human blood

2) In vivo clinical testing

AA-050Ismatec MCP, Ismatec MCP-

Process - + -

Evaluation of biocompatibility of miniaturized

dialyzers according to DIN EN ISO 10993-4 (ex

vivo)

Miniaturized dialyzersRecirculation model with heparinized

human bloodAA-058

Ismatec MCP, Ismatec MCP-

Process - + -

Determination of hemolysis, void volume and

pressure drop of plasmafiltersPlasmafilter

Ex vivo recirculation model with

heparinized human blood

AA-091,

DIN EN ISO 13960Dialysis machine DBB-05 - + -

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Mode of analysis: Biological evaluation of materials and medical devices


Procedure

Research use

only

Evaluation of skin irritation using epidermal

skin cultures

Aqueous solutions, Particulate

matter, Powder, ect.Determination of vitality of cultered cells

AA-081,

ISO 10993-10,

ISO 10993-12

Biotek Reader - + -

Area of analysis: Sterility testing of medical devices

Mode of analysis: Inspection of cultures (non specific)


Procedure

Research use

only

Determination of endotoxins/pyrogens Aqueous sample/Extract Turbidometry AA-013 Biotek Reader + + -

Determination of colony forming units (CFU) Aqueous sample/Extract Determination of cell count

AA-082

DIN EN ISO 6222

DIN EN ISO 8199

Heraeus BK600, Binder B28 - +

Evaluation of Bioburden Aqueous sample/Extract Determination of cell count DIN EN ISO 11737-1 Heraeus BK600, Binder B28 - + -

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Mode of analysis: Quality testing


Procedure

Research use

only

Evaluation of redness in clinically used

hemodilalyzersHemodialyzer

1) Recirculation model with heparinized

human blood; Image analysis

2) Clinical testing; Image analysis

AA-067Minolta Chroma-Meter CR-

310- + -

Particle Count in hemodialyzers (ex vivo) Hemodialyzer Particel count in rinsing solution AA-079 Ismatec MCP - + -

Gravity driven plasmaseparation Loop module Plasmaseparation AA-087 Test Rig, Plasmafilter - + -

Leak test of hemodialyzers and other

membrane devices

Hemodialyzers, Plasmafilters and

other membrane devicesPressure hold test

AA-094; DIN EN ISO 8637

or

AA-091; DIN EN ISO 13960

Pressure hold equipment,

vacuum pump- + -

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Mode of analysis: Determination of performance parameters


Procedure

Research use

only

Low molecular weight solute clearance

according to DIN EN ISO 8637 (ex vivo )

Hemodialyzers and other membrane

devicesEx vivo Hemodialyse AA-039 Dialysis monitor - + -

Plasma (blood) clearance of middle molecules

according to DIN EN ISO 8637 (ex vivo)

Hemodialyzers and other membrane

devicesEx vivo Hemodialyse AA-039 Dialysis monitor - + -

Determination of sieving coefficients according

to DIN EN ISO 8637 (ex vivo )


other membrane devicesEx vivo Hemodialyse AA-040 Dialysis monitor - + -

Determination of TMP according to DIN EN ISO

8637


other membrane devices

1) Hemodialysis; Recirculation model

with heparinized human blood

2) Hemodialysis; Clinical testing

AA-042 Dialysis monitor - + -

Determination dialysis parameters (Clearance,

Sieving Coefficient, Albumin Loss) of

miniaturized dialyzers

Miniaturized dialyzersEx vivo Hemodialysis with miniaturized

dialyzersAA-059 Ismatec IPC - + -

Determination of pressure drop, Volume of

blood compartment, UFR and KUF according to

DIN EN ISO 8637


other membrane devices

1) Hemodialyzis; Recirculation model

with heparinized human blood

2) Hemodialysis; Clinical testing

AA-065 Dialysis monitor - + -

Isolation of proteins from hemofiltrate of

patients with Kidney Failure (ex vivo)Hemofiltrate Ultrafiltration, Chromatography AA-037

Ismatec MCP, Ismatec MCP-

Process- + -

Determination of performance parameters of

plasmafractionation devices (Sieving

Coefficients, ex vivo )

Plasmafractionation devices ex vivo Plasmafractionation AA-077Plasmafractionation monitor

Infomed CF-100- + -

Determination of performance parameters of

plasmafilters (Sieving coefficients, TMP)Plasmafilter

ex vivo Recirculation model with

heparinized human blood

AA-091,

DIN EN ISO 13960Dialysis monitor - + -

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Area of analysis: Biochemistry/Clinical chemistry

Mode of analysis: Spectrometry (UV-/ VIS-Photometry/ Nephelometry)


Procedure

Research use

only

a-AmylaseHeparinized or EDTA plasma, Serum,

Dialysate, FiltratePhotometry AA-057 Roche cobas c111 - - -

α1-AntitrypsinHeparinized or EDTA plasma, Serum,

Dialysate, FiltrateNephelometry AA-014 Siemens BN ProSpec + - -

α1-acidic GlycoproteinHeparinized plasma, Serum,


α1-MicroglobulinHeparinized or EDTA plasma, Serum,

Dialysate, Filtrate, UrineNephelometry AA-014 Siemens BN ProSpec + - -

α2-MacroglobulinHeparinized plasma, Serum,


ADNase B Serum, Dialysate, Filtrate Nephelometry AA-014 Siemens BN ProSpec + - -

Alanine aminotransferaseHeparinized or EDTA plasma, Serum,


AlbuminHeparinized or EDTA plasma, Serum,


AlbuminHeparinized or EDTA plasma, Serum,


Alkaline phosphataseHeparinized plasma, Serum,


Ammonia EDTA plasma, Dialysate, Filtrate Photometry AA-057 Roche cobas c111 - - -

Antistreptolysin (ASL)Heparinized or EDTA plasma, Serum,


Apolipoprotein A-IHeparinized plasma, Serum,


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Procedure

Research use

only

Antithrombin IIIEDTA and citrated plasma, Dialysate,

FiltrateNephelometry AA-014 Siemens BN ProSpec + - -

Apolipoprotein A-II Serum, Dialysate, Filtrate Nephelometry AA-014 Siemens BN ProSpec + - -

Apolipoprotein BHeparinized plasma, Serum,


Apolipoprotein E Serum, Dialysate, Filtrate Nephelometry AA-014 Siemens BN ProSpec + - -

Aspartate aminotransferaseHeparinized or EDTA plasma, Serum,


ß2-MicroglobulinPlasma (EDTA or Heparinized),

Serum, Dialysate, FiltrateNephelometry AA-014 Siemens BN ProSpec + - -

BCA, Protein determinationPlasma, aqueous solutions,

Dialysate, FiltratePhotometry AA-074 Biotek reader + + +

BicarbonateHeparinized plasma, Dialysate,

FiltratePhotometry AA-057 Roche cobas c111 - - -

Bilirubin DirectHeparinized or EDTA plasma, Serum,


Bilirubin TotalHeparinized or EDTA plasma, Serum,


C1-InhibitorEDTA and citrated plasma, Serum,


CalciumHeparinized plasma, Serum,

Dialysate, FiltratePhotometry AA-057 Roche cobas c111 + - -

Carbohydrate-Deficient TransferrinHaparinzed or EDTA plasma, Serum,


CholesterolHaparinzed or EDTA plasma, Serum,


CoeruloplasminHeparinized plasma, Serum,


C-reactive Protein (CRP) Haparinzed or EDTA plasma, Serum,


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Procedure

Research use

only

C-reactive Protein (CRP) Heparinized or EDTA plasma, Serum,


C-reactive Protein (CRP) High SensitiveHaparinzed or EDTA plasma, Serum,


CreatinineHaparinzed or EDTA plasma, Serum,


Creatinine (Jaffé)Haparinzed or EDTA plasma, Serum,


Creatine kinaseHeparinized plasma, Serum,


Cystatin CHeparinized or EDTA plasma, Serum,


DEHP equivalents Aqueous solutions Photometry AA-099 Shimadzu UV-1650PC + + -

D-DimerHeparinized, EDTA or Citrated

plasma, Dialysate, FiltratePhotometry AA-057 Roche cobas c111 - - -

FerrumHeparinized plasma, Serum,


Endotoxin Dialysate, Filtrate Turbidimetry AA-013 Biotek reader + + -

Factor VIII Coatest Citrated plasma Photometrie AA-093 Biotek reader + - -

FerritinHeparinized plasma, Serum,

Dialysate, FiltrateNephelometry AA-014 Siemens BN ProSpec - - -

FibrinogenEDTA and citrated plasma, Serum,


FibronectinEDTA and citrated plasma, Serum,


GlucoseHeparinized or EDTA plasma, Serum,


Hemoglobin Plasma, Serum Photometry AA-056 Shimadzu UV-1650PC + + -

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Procedure

Research use

only

HemopexinHeparinized plasma, Serum,


HaptoglobinHeparinized or EDTA plasma, Serum,


HbA1cHeparinized or EDTA plasma,


HDL CholesterolHeparinized or EDTA plasma, Serum,


Heparin Citrated plasma, Dialysate, Filtrate Photometry AA-002 Biotek reader + - -

HomocysteineHeparinized or EDTA plasma, Serum,


Ig/L Chain, Type kappaHeparinized or EDTA plasma, Serum,


Ig/L Chain, Type lambdaHeparinized or EDTA plasma, Serum,


Immunoglobulin A (IgA)Heparinized plasma, Serum,


Immunoglobulin E (IgE)Heparinized plasma, Serum,


Immunoglobulin G (IgG)Heparinized plasma, Serum,


Immunoglobulin G (IgG) Subclass 1Heparinized plasma, Serum,


Immunoglobulin G (IgG) subclass 2Heparinized plasma, Serum,






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Procedure

Research use

only

Immunoglobulin M (IgM)Heparinized plasma, Serum,


InulinCPD, Citrated or Heparinized plasma,

Dialysat, FiltratPhotometry AA-048 Shimadzu UV-1650PC + + -

IronHeparinized plasma, Serum,


Complement factor C3cHeparinized or EDTA plasma, Serum,


Complement factor C4Heparinized or EDTA plasma, Serum,


LactateHeparinized plasma, Dialysate,

FiltratePhotometry AA-057 Roche cobas c111 + - -

LDHHeparinized plasma, Serum,


LDL-CholesterolHeparinized plasma, Serum,

Dialysate, FiltratePhotometrie AA-057 Roche cobas c111 + - -

LipaseHeparinized plasma, Serum,


Lipoprotein (a)Heparinized plasma, Serum,


MagnesiumHeparinized plasma, Serum,


MyoglobinHeparinized or EDTA plasma, Serum,


Pancreatic a-AmylaseHeparinized plasma, Serum,


Peroxide (PerOX)EDTA plasma, Serum and cell culture

supernatantsPhotometry AA-019 Biotek reader + - -

PhosphateHeparinized and EDTA plasma,

Serum, Dialysate, FiltratePhotometry AA-057 Roche cobas c111 + - -

PlasminogenEDTA and citrated plasma, Dialysate,

FiltrateNephelometry AA-014 Siemens BN ProSpec + - -

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Procedure

Research use

only

Pre albuminHeparinized or EDTA plasma, Serum,


Retinol binding Protein (RBP)Heparinized or EDTA plasma, Serum,


Rheumatoid factor (RF)Heparinized or EDTA plasma, Serum,


Serum Amyloid A Protein (SAA)Heparinized plasma, Serum,


Soluble Transferrin ReceptorHeparinized plasma, Serum,


Total proteinHeparinized or EDTA plasma, Serum,


TransferrinHeparinized or EDTA plasma, Serum,


TriglycerideHeparinized or EDTA plasma, Serum,


UreaHeparinized or EDTA plasma, Serum,


Uric AcidHeparinized or EDTA plasma, Serum,


Vitamin B12Aqueous solutions, Dialysate,

Heparinized or EDTA plasmaPhotometry AA-047 Shimadzu UV-1650PC + + -

γ‑GlutamyltransferaseHeparinized or EDTA plasma, Serum,


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Mode of analysis: Flow cytometry


Procedure

Research use

only

Apoptose / Annexin V Heparinized blood, Cell culture Flow cytometry AA-020 BD FACSVerse + + -

Characterisation MSC Cell culture Flow cytometry AA-095 BD FACSVerse - + +

CR3 (CD11b/CD18) EDTA blood Flow cytometry AA-006 BD FACSVerse + + -

Oxidative Burst Heparinized blood Flow cytometry AA-021 BD FACSVerse + + -

Granulocyte Activation EDTA blood Flow cytometry AA-075 BD FACSVerse + + -

Monocyte Subpopulations EDTA blood Flow cytometry AA-080 BD FACSVerse + + -

BD LeucocountHeparinized, Citrated or EDTA

plasma, Cell cultureFlow cytometry AA-083 BD FACSVerse + - -

TBNK-Lymphocyte Subpopulations EDTA blood Flow cytometry AA-084 BD FACSVerse + - -

BD Plasma CountHeparinized, Citrated or EDTA

plasmaFlow cytometry AA-085 BD FACSVerse + - -

Dentritic cells EDTA blood Flow cytometry AA-086 BD FACSVerse + + -

Platelet activation PAC-1/CD62P Blood Flow cytometry AA-098 BD FACSVerse + - +

Bloodcells: Platelets, Erythrocytes, Leucocytes,

Hematocrit, Hemoglobin etc.

Heparinized, Citrated or EDTA

plasma, Cell cultureImpedance method AA-005 ABX Pentra 60 C+ + - -

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Mode of analysis: Ligand assays (ELISA)


Procedure

Research use

only

HMW-AdiponectinHeparinized or Citrated plasma,

SerumELISA Instructions from the supplier Biotek reader - + -

Total-AdiponectinHeparinized or Citrated plasma,

SerumELISA Instructions from the supplier Biotek reader - + -

Apolipoprotein C3 Heparinized or EDTA plasma, Serum ELISA Instructions from the supplier Biotek reader - + -

Bisphenol A (BPA)Heparinized or Citrated plasma,

SerumELSIA AA-030 Biotek reader + + +

BNP Plasma, Serum ELISA Instructions from the supplier Biotek reader - + -

Bradykinin EDTA plasma ELISA AA-017 Biotek reader + + +

Fetuin A Serum ELISA Instructions from the supplier Biotek reader - + -

FGF23 EDTA plasma, cell culture medium ELISA Instructions from the supplier Biotek reader - + -

Interleukin 1ß


plasma, Serum, cell culture

supernatant

ELISA AA-012 Biotek reader + + +

Interleukin 6


plasma, Serum, cell culture

supernatant

ELISA AA-038 Biotek reader + + +

Complementaktivation: C3a, C5a, sC5b-9 Citrated or EDTA plasma ELISA AA-004 Biotek reader + - -

LeptinHeparinized, Citrated or EDTA

plasma, SerumELISA Instructions from the supplier Biotek reader + - -

Myeloperoxidase (MPO) EDTA plasma ELISA AA-024 Biotek reader + - -

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Procedure

Research use

only

ox LDL Heparinized or EDTA plasma, Serum ELISA AA-036 Biotek reader + - -

Platelet factor 4 (PF4) CTAD plasma ELISA AA-015 Biotek reader + - -

PMN Elastase Citrated or EDTA plasma ELISA AA-022 Biotek reader + - -

Thrombin-Antithrombin III-Complex (TAT) Citrated plasma ELISA AA-003 Biotek reader + - -

TNF-αHeparinized, Citrated or EDTA

plasma, cell culture supernatantELISA AA-029 Biotek reader + + +

Factor V Citrated or EDTA plasma ELISA AA-069 Biotek reader + + +

Factor X Citrated or EDTA plasma ELISA AA-070 Biotek reader + + +

Protein C Citrated plasma ELISA AA-071 Biotek reader + - -


Mode of analysis: Chromatography

High Performance Liquid Chromatography (HPLC)


Procedure

Research use

only

Amino AcidsHeparinized, Citrated or EDTA

plasma, Serum, DialysateHPLC AA-016 Dionex Ultimate 3000 + + -

Indoxyl sulfateHeparinized, Citrated or EDTA


p-Cresyl sulfateHeparinized, Citrated or EDTA


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Mode of analysis: Elektrophoresis

Elektrophorese (SDS-Gelektrophorese)


Procedure

Research use

only

Relative molecular weight of proteinsHeparinized, Citrated or EDTA

plasma, Serum, HemofiltratSDS-Gel electrophoresis AA-051

Electrophoresis equipment

EPS 301+ + -

IEF / 2-D PAGEHeparinized, Citrated or EDTA

plasma, Serum, HemofiltratGel electrophoresis AA-073

Electrophoresis equipment

EPS 301+ + -

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Mode of analysis: Electrochemical measurements

Potentiometry


Procedure

Research use

only

Na+ Heparinized blood, Plasma, Serum,

DialysatePotentiometry APO-046 OPTI CCA-TS + - -

K+ Heparinized blood, Plasma, Serum,


Cl-Heparinized blood, Plasma, Serum,


Ca2+ Heparinized blood, Plasma, Serum,


pHHeparinized blood, Plasma, Serum,


PO 2 Heparinized blood Amperometry APO-046 OPTI CCA-TS + - -

PCO 2 Heparinized blood Potentiometry APO-046 OPTI CCA-TS + - -

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Mode of analysis: Fluorescence spektrometry


Procedure

Research use

only

Cytotoxicity ex vivo according to DIN EN ISO

10993-5Aqueous solutions Determination of vitality of cultered cells

AA-035,

ISO 10993-5,

ISO 10993-12

Biotek Reader + + -


Mode of analysis: Light microscopy


Procedure

Research use

only

Blood slides, Microscopic evaluation of blood

slidesBlood slide Microscopy AA-097

RAL Stainbox, HemaPrep,

Leitz, Laborlux 12+ + -

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directory of services - excorlab gmbh · 2020. 2. 27. · infomed cf-100-+-determination of...

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