Annex to the Accreditation Certificate D-EP according to DIN EN ISO/IEC 17043:2010
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1 Deutsche Akkreditierungsstelle GmbH Annex to the Accreditation Certificate D-EP according to DIN EN ISO/IEC 17043:2010 Period of validity: to Holder of certificate: ESfEQA GmbH Siemensstraße 38, Heidelberg testing in the following fields: Medical Laboratory Diagnostics Investigation Fields: Clinical Chemistry, Virology Using the proficiency testing materials: Whole blood, serum, plasma, urine, hemolysate and aqueous solution This document is a translation. The definitive version is the original German annex to the accreditation certificate. 1/5
2 Investigation Field: Clinical Chemistry Biochemistry Albumin, Alkaline phosphatase, ALT/GPT, Amylase, AST/GOT, Bilirubin direct, Bilirubin total, Calcium, Calcium (ionized), Chloride, Cholesterol, Creatinkinase, Creatinine, Gamma GT, Glucose, HDL-Cholesterol, Iron, Lactate, Lactate Dehydrogenase, LDL-Cholesterol, Lipase, Lithium, Magnesium, Phosphate, Potassium, Sodium, TIBC Total Iron Binding Capacity, Total Protein, Triglycerides, Urea, Uric acid Urine Chemistry Urine Albumin, Calcium, Chloride, Creatinine, Glucose, Magnesium, Phosphate, Potassium, Total protein, Sodium, Urea, Uric acid Cardiac marker BNP, CK-MB (mass), CK-MB (activity), Homocysteine, Myoglobin, NT-proBNP, Troponin I, Troponin T Glycated hemoglobin Whole blood Hemolysate HbA1c, Hemoglobin Ethanol Aqueous solution Ethanol, Ammonium hydroxide Therapeutic drug monitoring Amikacin, Carbamazepine, Chinidine, Chloramphenicol, Digoxin, Disopyramide, Ethosuximide, Gentamicin, Lidocain, NAPA, Paracetamol, Phenobarbital, Phenytoin, Primidone, Procainamide, Salicylate, Theophylline, Tobramycin, Valproic Acid, Vancomycin Clinical Chemistry, (CC4, CC12) Urine Chemistry (UC) Cardiac Marker (CM4, CM12) Glycated Hemoglobin (GHB) Ethanol (ETH) Therapeutic Drugs (TDM) Period of validity: to Translation - 2/5
3 Drugs of abuse Urine Acetylmorphine, Amphetamines, Benzodiazepines, Buprenorphine, Cannabinoids, Cocaine, Barbiturates, Methadone, Opiates, Tricyclic Antidepressants Urine rapid testing Urine Bilirubin, Glucose, Hemoglobin, Ketone bodies, Leucocytes, Nitrite, ph, Specific Gravity, Total Protein, Urobilinogen Blood gas Aqueous solution Calcium, Chloride, Glucose, Lactate, pco 2, ph, po 2, Potassium, Sodium, Urea Lipids Apolipoprotein A1, Apolipoprotein B, LDL- Cholesterol, Cholesterol, Triglycerides, HDL- Cholesterol, Lp (a), Total Protein Fecal occult blood Aqueous solution Human hemoglobin in faeces Coagulation aptt, Antithrombin III, D- Dimer, Fibrinogen, Prothrombin time, Protein C, Protein S Tumor marker Hormones AFP, CEA, CA 19-9, CA 125, CA 15-3, CA 72-4, Cyfra 21-1, Ferritin, PSA total, PSA free, PSA complex Aldosterone, AMH, Androstendione, Calcitonine, C-Peptide, Cortisol, DHEA-S, Estriol, Folate, FSH, hcg, hgh, human growths hormone, IgE, Insulin, LH, Estradiol, Progesterone, Prolactin, PTH, SHBG, Testosterone, Thyreoglobulin, T3 free T3 total, T4 free, T4 total, TSH, Vitamin B12, Vitamin D Drugs of Abuse (DAT) Qualitative Urine Analysis (US) Blood gas and electrolytes (BG) Lipids (LIP) Fecal Occult Blood (FOB) Coagulation (COA4, COA12) Tumor Marker (TM4, TM12, TMH4, TMH12) Hormones (HOR4, HOR12, TMH4, TMH12) Period of validity: to Translation - 3/5
4 Specific proteins Albumin, Alpha-1-acid glycoprotein, Alpha-1- antitrypsin, Alpha-2- macroglobulin, ASO, Beta- 2-microglobulin, C3, C4, Ceruloplasmin, CRP, Haptoglobin, IgA, IgE, IgG, IgM, Prealbumin, RF, Transferrin Hemogram Whole blood HGB, HCT, MCH, MCHC, MCV, PLT, RBC, WBC, RDW, MPV Investigation Field: Virology Virus immunology anti-cmv IgG + total, anti- CMV IgM Virus immunology anti-hav IgG + total, anti- HAV IgM Virus immunology anti-hbs, anti-hbc, anti- HBe, HBsAg (qual. and quant.), HBeAg, anti-hbc IgM Virus immunology anti-hiv 1/2, anti-hcv, anti-hbc, HBsAg Virus immunology anti-hsv 1/2 IgG + total, anti-hsv 1/2 IgM Virus immunology anti-toxoplasmosis IgG + total, anti-toxoplasmosis IgM Virus immunology anti-rubella IgG + total, anti-rubella IgM Virus immunology anti-vzv IgG + total, anti- VZV IgM Virus immunology anti-treponema pallidum antibodies Virus immunology anti-ebv VCA IgG +total, anti-ebv EBNA IgG + total, anti-ebv VCA IgM Specific Proteins (SP4, SP12) Hemogram (HEM4, HEM12) Cytomegalovirus (CMV) Hepatitis A Virus (HAV) Hepatitis B Virus (HBV) Infectious Disease Combination Control (INF) Herpes Simplex Virus (HSV) Toxoplasmosis (TOX) Rubella (RUB) Varicella Zoster Virus (VZV) Syphilis (SYP) Epstein-Barr Virus (EBV) Period of validity: to Translation - 4/5
5 Virus immunology anti-toxoplasmosis IgG + total, anti-toxoplasmosis IgM, anti-rubella IgG + total, anti-rubella IgM, anti-cmv IgG + total, anti- CMV IgM, anti-hsv 1/2 IgG + total, anti-hsv 1/2 IgM Virus immunology antibodies (IgG, IgM, and IgA) against Chlamydia pneumoniae Virus immunology antibodies (IgG, IgM, and IgA) against Chlamydia trachomatis Virus immunology antibodies (IgG and IgM) against Parvovirus B19 Virus immunology antibodies (IgG and IgM) against Measles virus Virus immunology antibodies (IgG and IgM) against Borrelia ToRCH (TORCH) Chlamydia pneumoniae (CHP) Chlamydia trachomatis (CHT) Parvovirus B19 (PAR) Measles (MEA) Borrelia (BOR) Statistical evaluation: ISO 13528:2015 (E): Statistical methods for use in proficiency testing by interlaboratory comparisons (second edition ) Period of validity: to Translation - 5/5
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