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Scope 1:10 Dulution ELFA (Enzyme-Linked Flourescence Assay) VDIAS

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Scope 1:10 Dulution ELFA (Enzyme-Linked Flourescence Assay) VDIAS 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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