ESfEQA BIOCHEMISTRY PROGRAMS

BIOCHEMISTRY PROGRAMS

BILIRUBIN NEONATAL

Program: BILI-N: 4 surveys/year x 2 samples
Material: Lyophilized samples of human Serum (minimum 0,5mL)
Evaluation: Quantitative

Analytical parameters:

Bilirubin direct
Bilirubin conjugated
Bilirubin total
Bilirubin non-conjugated

BLOOD GAS AND ELECTROLYTES

Program: BG12: 12 surveys/year x 1 sample BG4: 4 surveys/year x 2 samples
Material: Liquid buffered aqueous solution or serum-based samples (minimum 2 mL)
Evaluation: Quantitative

Analytical parameters:

Bicarbonate (HCO -)
Calcium
Chloride
Creatinine
Glucose
Lactate
Magnesium
pCO2
pH
pO2
Potassium
Sodium
Urea

CARDIAC MARKER

Program: CM12: 12 surveys/year x 1 sample CM4: 4 surveys/year x 2 samples
CM2: 2 surveys/year x 2 samples
Material: Lyophilized samples of human sera with added analytes of human origin (minimum 1 mL)
Evaluation: Quantitative
Analytical devices that are intended for whole blood only are not suitable for these samples.

Analytical parameters:

BNP
CK-MB (mass)
CK-MB (activity)
Homocysteine
hsCRP
Myoglobin
NT-proBNP
Troponin I
Troponin T

CLINICAL CHEMISTRY

Program: CC12: 12 surveys/year x 1 sample CC4: 4 surveys/year x 2 samples
CC2: 2 surveys/year x 2 samples
Material: Lyophilized samples of human sera with added enzymes and proteins of human origin (5 mL)
Evaluation: Quantitative

Analytical parameters:

Albumin
ALP Alkaline phosphatase ALT/GPT
α-Amylase Amylase pancreatic AST/GOT
Bilirubin, direct Bilirubin, total Bilirubin conjugated
Bilirubin non-conjugated Calcium
Calcium (ionized)
Chloride
Cholesterol Cholinesterase CK Creatinkinase Creatinine Copper
Gamma GT Glucose
HDL Cholesterol Iron
Lactate
LDH Lactate Dehydrogenase LDL Cholesterol
Lipase
Lithium Magnesium Phosphate Potassium Sodium
TIBC Total Iron Binding Capacity Total protein
Triglycerides
UIBC Unsaturated Iron Binding Capacity Urea
Uric acid
Zinc

COAGULATION

Program: COA12: 12 surveys/year x 1 sample COA4: 4 surveys/year x 2 samples
COA2: 2 surveys/year x 2 samples
Material: Lyophilized samples of human plasma (1 mL)
Evaluation: Quantitative

Analytical parameters:

aPTT (activated Partial Thromboplastin Time)
Antithrombin III
D-Dimer
Fibrinogen
PT (prothrombin time)
Protein C
Protein S
Thrombin Time

CO-OXIMETRY

Program: OXI: 4 surveys/year x 2 samples
Material: Purified bovine hemoglobin solution treated with carbon monoxide (minimum 1,0 mL)
Evaluation: Quantitative
This program is not accredited according to DIN EN ISO/ IEC 17043

Analytical parameters:

Oxyhemoglobin
Desoxyhemoglobin
Carboxyhemoglobin
Methemoglobin
Total Hemoglobin

CSF DIAGNOSTICS

Program: CSF: 4 surveys/year x 2 samples
Material: Liquid samples made from human serum and other human and chemical components (minimum 1 mL)
Evaluation: Quantitative
This program is not accredited according to DIN EN ISO/ IEC 17043

Analytical parameters:

Albumin
Chloride
Glucose
IgA
IgG
IgM
Lactate
LDH
Sodium
Proteins

DRUGS OF ABUSE

Program: DAT12: 12 surveys/year x 1 sample DAT4: 4 surveys/year x 2 samples
Material: Liquid or lyophilized samples of filtered human urines with added drugs for qualitative analysis
(minimum 2 mL)
Evaluation: Qualitative

Analytical parameters:

Acetylmorphine
Amphetamines
Barbiturates
Benzodiazepines
Buprenorphine
Cannabinoids
Cocaine and metabolites
EDDP
Fentanyl
Ketamine
MDMA
Methadone
Metamphetamines
Opiates
Phencyclidine
Synthetic
Cannabinoids (K2/Spice)
Tramadol
Tricyclic
Antidepressants

ETHANOL, AMMONIA AND BICARBONATE

Program: ETH12: 12 surveys/year x 1 sample ETH4: 4 surveys/year x 2 samples
Material: Liquid samples with added compounds (minimum 1 mL)
Evaluation: Quantitative

Analytical parameters:

Ethanol
Ammonia
Bicarbonate

FECAL OCCULT BLOOD

Program: FOB: 2 surveys/year x 2 samples
Material: Liquid samples simulating extracted stool samples (minimum 0,5 mL)
Evaluation: Qualitative and quantitative

Analytical parameters:

Human Hemoglobin (qualitative and quantitative)

GLUCOSE POC - WHOLE BLOOD

Program: 4 surveys/year x 2 samples
GLUWB: Registration of 1-3 measuring systems
GLUWB 6 DEVICES: Registration of up to 6 measuring systems GLUWB 9 DEVICES: Registration of up to 9 measuring systems
Material: Simulated whole blood (minimum 1 mL)
Evaluation: Quantitative

Analytical parameters:

Glucose

GLYCATED HEMOGLOBIN (HbA1c)

Program: GHB12: 12 surveys/year x 1 sample GHB4: 4 surveys/year x 2 samples
Material: Lyophilized samples of hemolysate of human blood (minimum 0,5 mL)
Evaluation: Quantitative

Analytical parameters:

HbA1c

PROTHROMBIN TIME (INR)-POCT

Program: 4 surveys/year x 2 samples
INR-POCT: Registration of 1-3 measuring systems
INR-POCT 6 DEVICES: Registration of up to 6 measuring systems INR-POCT 9 DEVICES: Registration of up to 9 measuring systems
Material: Liquid samples (minimum 0,3 mL)
Evaluation: Quantitative
Suitable for POCT analyzers, e.g. Roche Coaguchek, Siemens Xprecia Stride, Abbott iStat.

Analytical parameters:

Prothrombin Time (INR)

QUALITATIVE URINE ANALYSIS (URINE STICK)

Program: US4: 4 surveys/year x 2 samples US2: 2 surveys/year x 2 samples
Material: Liquid or lyophilized samples of urine preparation of human origin with added preservatives and stabilizers (minimum 10 mL)
Evaluation: Semi-quantitative

Analytical parameters:

Bilirubin
Glucose
hCG
Hemoglobin
Ketone bodies
Leucocytes
Nitrite
pH
Specific Gravity
Total Protein
Urobilinogen

THERAPEUTIC DRUGS

Program: TDM: 4 surveys/year x 2 samples
Material: Liquid samples with added compounds (minimum 2 mL)
Evaluation: Quantitative

Analytical parameters:

Amikacin
Carbamazepine
Chinidine
Digoxin
Ethosuximide
Gentamicin
Lidocain
Paracetamol
Phenobarbital
Phenytoin
Primidone
Salicylate
Theophylline
Valproic Acid
Vancomycin

URINE CHEMISTRY

Program: UC: 4 surveys/year x 2 samples
Material: Liquid or lyophilized samples of human urine (minimum 5 mL)
Evaluation: Quantitative

Analytical parameters:

Microalbumin
Amylase
Calcium
Chloride
Creatinine
Glucose
Magnesium
Osmolality
Phosphate
Potassium
Total protein
Sodium
Urea
Uric acid

URINE SEDIMENT FOR LIGHT SCATTERING METHODS

Program: USEDL4: 4 surveys/year x 2 samples USEDL2: 2 surveys/year x 2 samples
Material: Liquid samples of human urine (minimum 5 mL)
Evaluation: Qualitative, quantitative and semi-quantitative
This program is suitable for light scattering methods, e.g. Sysmex UF-5000/4000/1500.

Analytical parameters:

Bacteria qual., semi-quant., quant.
Casts qual., semi-quant., quant.
Crystals qual., semi-quant., quant.
Red cells qual., semi-quant., quant.
White cells qual., semi-quant., quant.

URINE SEDIMENT FOR MICROSCOPIC METHODS

Program: USEDM4: 4 surveys/year x 2 samples USEDM2: 2 surveys/year x 2 samples
Material: Liquid samples of human urine (minimum 5 mL)
Evaluation: Qualitative, quantitative and semi-quantitative
This program is suitable for manual microscopy and automated microscopy, e.g. Siemens Atellica, Beckman Coulter Iris, Roche Cobas u 701, Menarini Sedimax, 77 Elektronika UriSed, Dirui FUS, Analyticon Urilyzer Cell, Mindray EH Series, Mindray EU series.

Analytical parameters:

Bacteria qual., semi-quant., quant.
Casts qual., semi-quant., quant.
Crystals qual., semi-quant., quant.
Red cells qual., semi-quant., quant.
White cells qual., semi-quant., quant.