Annex to the Accreditation Certificate D-ML according to ISO 15189:2012
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1 Deutsche Akkreditierungsstelle GmbH according to ISO 15189:2012 Period of validity: to Date of issue: Holder of certificate: Medlab Ghana Limited 17 Ridge Road, Roman Ridge, (+233) Accra, Ghana Examinations in the field: Medical Laboratory Diagnosis Analytical Fields: Clinical Chemistry Immunology Microbiology Virology Transfusion medicine/immunhematology Type of Tests: Chromatography (Immunchromatography) Coagulometry Cultural tests Electrochemical Tests Electrophoresis Flow cytometry Germ differentiation/identification/typing Molecular biological tests (amplification methods) Sedimentation tests Sensitivity testing of bacteria Spectrometry (UV- /VIS-photometry) Page 1 of 5
2 Test area: Clinical Chemistry Flow cytometry Full Blood Count (FBC) Whole blood Flow cytometry CD4/CD8 Count Whole blood Flow cytometry Electrophoresis Haemoglobin Electrophoresis Whole blood Cellulose Acetate electrophoresis G6PD (Reduction) EDTA whole blood Methemoglobin reduction Coagulometry INR/PT Plasma Turbodensitometry APTT Plasma Turbodensitometry White blood cells, Red blood cells, Plts EDTA Blood smear film commenting Serum Pregancy test Serum Chromatography Sedimentation tests Erythrocyte Sedimentation Rate (ESR) Whole blood Observation / Westergreen Spectrometry (UV- /VIS-photometry) Total Bilirubin Serum DPD Direct Bilirubin Serum DPD Alkaline Phosphatease (ALP) Serum IFCC Gamma Glutamyl Transferase (GGT) Serum IFCC Aspartate Aminotransferase (AST) Serum IFCC without Pyridoxal-5-Phos Alanine Aminotransferase (ALT) Serum ALTIF-Tris buffer with pyridoxal-5- phosphate Lactate Dehydrogenase (LDH) Serum LDIF, Lactate to Pyruvate Period of validity: to Date of issue: Page 2 of 5
3 Total Protein Serum Prep,Biuret Reagent, end point Albumin Serum ALB1,Bromocresol Green Amylase Serum IFCC Urea Serum URUK, Urease, kinetic Creatinine Serum CRERB,Jaffe rate blanked Sodium Serum ISE Indirect Potassium Serum ISE Indirect Chloride Serum ISE Indirect Magnesium Serum MGXY, Xylidyl blue Phosphate Serum PHMD, Phosphomolybdate UV Uric acid Serum Uricase/POD Cholesterol (Total) Serum CHO-POD Triglycerides Serum GPO-POD HDL- Cholesterol Serum POD Glucose NAF-Plasma Hexokinase Calcium Serum Arsenazo lll HbA1c Whole blood Latex Agglutination Inhibition C-reactive protein (CRP) Serum Turbidimetric Assays (IFCC) Iron Serum TPTZ Total Iron Binding Capacity (IBCT) Serum TIBC, Removal of excess free iron Creatine Kinase (CK) Serum IFCC Reference Test area: Immunology Rheumatoid Factor (RF) Serum Agglutination Luteinising Hormone (LH) Serum ELISA Follicle Stimulating Hormone (FSH) Serum ELISA Prolactin Serum ELISA Progesteron Serum ELISA Estradiol (E2) Serum ELISA Beta Human Chorionic Gonadotrophin Serum (BHCG), quantitative ELISA Troponin T Serum ELISA D-dimer Heparinized blood Chromatography CKMB-Mass Serum ELISA Free Triiodothyronine (F-T4) Serum ELISA Thyroid Stimulating Hormone (TSH) Serum ELISA Free Thyroxine (F-T3) Serum ELISA Testosterone (total) Serum ELISA Ferritin Serum ELISA Period of validity: to Date of issue: Page 3 of 5
4 Prostate Specific Antigen (PSA) Serum ELISA Test area: Microbiology Bacteria from pure culture Culture bacteria Agglutination (Streptococci, Staphylococci) Cardiolipin-AK Serum Agglutination/RPR Treponema Pallidum Serum Agglutination Haemagglutination (TPHA) Salmonella-AK Serum Agglutination/Widal Chromatography (Immunochromatography (IC)) Helicobacter pylori Faeces Immunochromatography Faecal Occult Blood (FOB) Faeces Immunochromatography Sensitivity testing of bacteria Aerobic bacteria Culture Agar diffusion test, Kirby Bauer method Germ differentiation/identification/typing Anaerobic bacteria Culture growth Biochemical Gardnerella vaginalis Culture growth Enterobacteriaceae Culture growth Biochemical Neisseria Species Culture growth Culture growth behaviour Yeast Culture growth, Biochemical Streptococci Culture growth Culture growth behaviour Staphylococci Culture growth Culture growth behavoiur MRSA Culture growth Biochemical Cultural tests Bacteria Smears of all types, aspirates, saliva, CSF, Body fluids, blood cultures, Urine, faeces Culture growth Period of validity: to Date of issue: Page 4 of 5
5 Mycobacterium tuberculosis (TB Micro) Sputum Parasites Faeces Sediments Urine Urogenitale bacteriae Culture Bacteria Urine Sediments Urine Plasmodium spec. (Malaria Quick test) Whole blood film commenting Blood Parasites (Plasmodium spp etc) EDTA Blood smear Chlamydia - Ag Serum Chromatography Analytical Field: Virology Hepatitis BsAg Serum ELISA Hepatitis BsAb Serum ELISA Hepatitis BC IgG Serum ELISA Hepatitis Bc IgM Serum ELISA Hepatitis Be Ag Serum ELISA Hepatitis Be Ab Serum ELISA Hepatitis C Ab Serum ELISA HIV Serum ELISA Molecular biological tests (amplification methods) Hepatitis B Viral Load Serum RealTime PCR Test area: Transfusion medicine/immunhematology AB0 Rhesus factor (Blood group) Whole blood Agglutination Direct coombs Whole blood Agglutination Indirect coombs Serum Agglutination Period of validity: to Date of issue: Page 5 of 5
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