As an accredited laboratory, this laboratory is entitled to use the following accreditation symbol. Valid from 15 December 2018 to 14 December 2021 Issued on 29 July 2019 ISO 15189 ML 006-01 Schedule of Accreditation Accreditation Scheme for Medical/Clinical Laboratories Sri Lanka Accreditation Board for Conformity Assessment Accreditation Number: ML 006-01 Lanka Hospitals Diagnostics (Pvt) Ltd. No. 578, Elvitigala Mawatha, Narahenpita Colombo-05. Scope of Accreditation: Performing Medical tests on Clinical Biochemistry/Chemical Pathology, Haematology, Clinical Pathology and Microbiology/Serology, Histopathology The laboratory is accredited for the following tests. Field of Sl Test Test Method Test Instrument Detection Limit Testing 01 Cobas C501 2-750 mg/dl Clinical Glucose (fasting, Random, Post Cobas c311 2-750 mg/dl Biochemistry/ prandial, Glucose Hexokinase/NADP Chemical challenge test, Glucose Dimension Pathology tolerance test, Glucose 0-500 mg/dl RXL Max series) Urea - BUN Urease - GLDH Cobas C501 1.4-112 mg/dL (Serum) Cobas c311 1.4-112 mg/dL Cobas C501 0.06-20.5 mg/dl Enzymatic colorimetric Creatinine Cobas c311 0.06-20.5 mg/dl (Serum) Jaffé method, rate-blanked and Dimension 0-20 mg/dl compensated RXL Max Cholesterol CHO-PAP Cobas C501 3.86-800 mg/dl (Serum) 3.86-800 mg/dl Cobas C501 3-120 mg/dl HDL- Cholesterol Direct HDL – PEGME (Serum) Cobas c311 3-120 mg/dl LDL –Cholesterol Clearance Method Cobas c311 3.86-548 mg/dl (Serum) Page 1 of 15 Triglycerides Lipase/GPO-PAP without Cobas C501 glycerol correction 8.85-885 mg/dl (Serum) Cobas c311 Total Bilirubin Dichlorophenyl Diazonium Cobas c311 0-25 mg/dl (Serum) Cobas C501 0-25 mg/dl Direct Bilirubin Cobas c311 0.09-17mg/dl Diazo with Sulphanilic acid (Serum) Cobas C501 0.09-17mg/dl Cobas c311 Sodium ISE(Indirect) 60-180 mmol/l Cobas C501 (Serum) ISE(direct) Roche 9180 40-205mmol/l ISE(direct) Roche 9180 1.5-15 mmol/l Potassium Cobas c311 1.5-10 mmol/l (Serum) ISE(Indirect) Cobas C501 1.5-10 mmol/l Chloride Cobas c311 60-140 mmol/l ISE (Indirect) (Serum) Cobas C501 60-140 mmol/l Cobas e411 0.004-100 BL-AA-18 ulU/ml TSH electrochemiluminscence Cobas e411 0.004-100 BL-AA-18 ulU/ml 0.01-15000 β-HCG electrochemiluminscence Cobas e411 mlU/ml Particle enhanced immune Dimension CRP 0.5-250 mg/l turbidimetricimmuno assay RXL Max Cobas C501 5-700 U/L SGPT Photometry AST IFCC (Serum) without pyridoxal activation Cobas c311 5-700 U/L SGOT Photometry AST IFCC Cobas C501 5-700 U/L (Serum) without pyridoxal activation Cobas c311 5-700 U/L Alkaline Phosphatase Cobas c311 5-1200 U/L Photometry (Serum) Cobas C501 5-1200 U/L Photometry Gamma-3- Cobas C501 3 - 1200 U/L Gamma GT Carboxy-4 -nitroanilide (Serum) (IFCC) Cobas c311 3 - 1200 U/L Total protein Cobas C501 2-120 g/L Photometry Biuret Reaction (Serum) Cobas c311 2-120 g/L Albumin Photometry Bromocresol Cobas C501 2.0-60 g/L (Serum) Green Cobas c311 2.0-60 g/L Total Calcium Cobas c311 0.8-20.1 mg/dL NM-BAPTA complex (Serum) Cobas c501 0.8-20.1 mg/dL Phosphorus Photometry Cobas C501 0.31-20.0 mg/dL (Serum) Phosphomolybdate UV Cobas c311 0.31-20.0 mg/dL Photometry Uricase Cobas C501 0.2-25 mg/dL Uric acid Peroxidase with Ascorbate (Serum) Oxidase @ 546 nm Cobas c311 0.2-25 mg/dL Cobas c311 7-2000 U/L CK Photometry IFCC substrate Cobas c501 7-2000 U/L (Serum) start Dimension 7-1000 U/L RXL Max HbA1C BioRad D10 HPLC 3.8-18.5 % (whole blood) BL-AA-07 Page 2 of 15 BioRad D10 3.8-18.5 % BL-AA-8 FSH 0.1-200 mlU/mL (Serum) LH 0.1-200 mlU/ml (Serum) PROLACTIN 0.047-470 (Serum) ng/mL FT3 0.26-32.55 (Serum) pg/mL FT4 0.023-7.77 (Serum) ng/mL Electrochemiluminscence Cobas e411 Cortisol 0.5-1750 nmol/L (Serum) Ferritin 0.5-2000 ng/mL (Serum) Total PSA 0.002-100 (Serum) ng/mL AFP 0.5-1000 IU/mL (Serum) Testosterone (Total) 0.25-15 ng/mL (Serum) Jaffe method, rate blanked and Dimension Creatinin (Urine) compensated RXL Max 0.5-400 mg/dl Lipase (Serum) Enzymatic colorimetric Cobas c311 3-300U/I Colorimetric Methylthymol Dimension Magnesium (Serum) 0-20 mg/dl blue RXL Max Microalbumin Particle-enhanced Dimension turbidimetric inhibition 1.3-100 mg/l (Urine albumin) immunoassay RXL Max TIBC measured 0-1000 µg/dl (Serum) Spectrophotometric Dimension RXL Max CA 125 Electrochemiluminscence Cobas C411 0.6-5000 u/l CEA Electrochemiluminscence Cobas C411 0.2-1000 ng/ml Complement C3 (Serum) 0-500 mg/dl Immunoturbidometric Complement C4 Cobas c 311 0-100 mg/dl (Serum) Vitamin B12 Electrochemiluminscence Cobas C411 50-2000 pg/ml (Serum) Nitrtetrazodium Colorimetric Fuctosamine assay Cobas c501 4-800 mg/dl (serum) IgE, quantitative Electrochemiluminscence Cobas C411 0.1-2500 u/ml Urine full report Physical Examination Clinical Pathology Colour Visual examination Manual - 02 Specific Gravity Dip Strip Manual 1.000-1.030 Appearance Visual examination Manual - Page 3 of 15 pH Dip Strip Manual 5.0 - 9.0 Chemical Examination Protein Dip Strip, sulphosalicylic acid Manual 10-1000 mg/dl Glucose Dip Strip, Benedict's method Manual 1000-2000mg/dl Ketone Dip Strip Manual 5-100 mg/dl Bile salts Dip Strip, HAY's test Manual - Bilirubin Dip Strip Manual 0.5 - 3 mg/dl Urobilinogen Dip Strip, Ehrlich Test Manual 1 - 12 mg/dl Microscopic Examination Dip Strip, Microscopic Pus Cells Manual 25-500WBCs/µl Examination Dip Strip, Microscopic Red Cells Manual 10-250RBCs/µl Examination Epithelial Cells Microscopic Examination Manual - Casts Microscopic Examination Manual - Crystals Microscopic Examination Manual - Organisms Microscopic Examination Manual - Guaiac paper test, Occult blood, fecal Manual Pseudoperoxidase - hCG Immunochromatography - - (Urine) 03 Sysmex XN1000, 0.1-30 g/dl Heamatology Hb (Haemoglobin) SLS – Heamoglobin Method Sysmex XT 4000i 0.1-30 g/dl Sysmex XN1000, 0-100 % RBC Cumulative pulse height PCV detection Sysmex XT 4000i 0-100 % 0.00-99.9 × Sysmex XN1000, Pulse count –DC method 106µL RBC Count (impedance) 0.00-99.9 × Sysmex XT 4000i 6 10 µL 3 Sysmex XN1000, 0-9999 × 10 µL Pulse height Platelets 3 DC method(impedance) Sysmex XT 4000i 0-9999 × 10 µL Computed from PCV & RBC- Sysmex XN1000, MCV µL Sysmex XT 4000i Sysmex XN1000, MCH Computed from Hb& RBC-pg Sysmex XT 4000i Computed from Hb& PCV- Sysmex XN1000, MCHC g/dl Sysmex XT 4000i Sysmex XN1000, RDW Computed - % Sysmex XT 4000i 0.3-999.9 x103 Sysmex XN1000, Flow cytometry by µL TLC semiconductor laser 0.3-999.9 x103 Sysmex XT 4000i µL Flow cytometry by semiconductor laser & manual Sysmex XN1000, DLC -Neutrophil (microscope) Sysmex XT 4000i Page 4 of 15 Sysmex XN1000, DLC -Lymphocyte Sysmex XT 4000i Sysmex XN1000, Flow cytometry by DLC - Eosinophil semiconductor laser & manual (microscope) Sysmex XT 4000i Sysmex XN1000, DLC -Monocyte Sysmex XT 4000i Sysmex XN1000, DLC - Eosinophil Sysmex XT 4000i Westergren Electra lab 100 ESR (Mechanical/optimal precision 1-140 mm of detection) Florescence ANA IFA - microscope RF (Rheumatoid Factor) Latex Agglutination Votex mixture 8-512 IU/ml Stago art-semi PT Clot Based Study 100sec automated Electromagnetic Stago Compact Max- PTT 190 sec fully automated D-dimer Latex agglutination Manual 0.2 mg/l Fibrinogen Stago Compact Max- 100-800mg/dl Clot Based Thrombin time fully automated - Abnormal Hemoglobin detection by capillary electrophoresis HbA Abnormal Hemoglobin Sebia capillary detection by capillary Capillary electrophoresis electrophoresis electrophoresis Hb A2 -- Abnormal Hemoglobin detection by capillary electrophoresis Hb F Abnormal Hemoglobin detection by capillary electrophoresis Hb S Abnormal Hemoglobin detection by capillary - electrophoresis Hb C Page 5 of 15 04 Microbiology/ Dengue rapid Ab Immunochromatography manual Serology 16.1 Pg/ml of ELFA VIDAS HIV-1 antigen HIV I & II (Ag + Ab) ELISA ELISA reader - ELISA CMIA (chemiluminescent 50pg/ml to HIV- Architect i1000 SR microparticle immunoassay) 1 p24Ag ELFA VIDAS 0.12 ng/ml ELISA ELISA reader - HBsAg CMIA (chemiluminescent Architect 1000i _<0.130IU/ml microparticle immunoassay) Microscope Gram staining Gram stain Microscope - method TPPA Particle agglutination - - Anti HBc CMIA (chemiluminescent Architect i1000SR 0.4-0.5PEIU/ml Anti HCV microparticle immunoassay) Architect i1000 SR HIV 1 & 2 Ab (Rapid) manual - Immunochromatography HBsAg (Rapid) manual - Anti HCV (Rapid) manual - VDRL/RPR Agglutination Rotating shaker 1-128 dilution Dengue virus Ag-NS1 ELISA ELISA reader - ASO Latex agglutination Rotating shaker 200-1026 IU/ml By Fluorometry on BACTEC , Differential and selective culture, Biochemical/ Aerobic culture and Morphological/ Microscopical BACTEC FX200 - sensitivity blood Identification by conventional method , Antibiotic sensitivity by CLSI Aerobic culture and Differential and selective - sensitivity urine culture, Biochemical/ Aerobic culture and Morphological/ Microscopical identification, Antibiotic - sensitivity Pus sensitivity by CLSI Aerobic culture and - sensitivity Throat swab manual Aerobic culture and - sensitivity CSF Aerobic culture and - sensitivity Eye swab Aerobic culture and sensitivity sterile body - fluids Aerobic culture and sensitivity Stools Aerobic culture and - sensitivity Nasal swab manual Aerobic culture and - sensitivity Ear swab Page 6 of 15 Differential and selective culture, Biochemical/ Morphological/ Microscopical identification, Antibiotic sensitivity by CLSI Chemiluminescent Anti-CCP Architect i1000 SR Microparticle Immunoassay 0.5-200U/ml (CMIA) Anti-dsDNA IFA(immunofluorescence Florescence Assay microscope 1:10 dulution ELFA (enzyme-Linked Flourescence Assay) VDIAS CMV IgM ELFA (enzyme-Linked - Architect i1000 SR Flourescence Assay) ELFA (enzyme-Linked
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