SydPath Reference Intervals for Clinical Trials (Contract Pathology Unit) Unauthorised Copy

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1 HAEMATOLOGY APTT M sec APTT F sec Basophils Cord 2 weeks M ^9/L Basophils Cord 2 weeks F ^9/L Basophils 2 wks 3 mths M ^9/L Basophils 2 wks 3 mths F ^9/L Basophils 3 mths 6 mths M ^9/L Basophils 3 mths 6 mths F ^9/L Basophils 6 mths 2 yrs M ^9/L Basophils 6 mths 2 yrs F ^9/L Basophils 2 yrs 4 yrs M ^9/L Basophils 2 yrs 4 yrs F ^9/L Basophils 4 yrs 8 yrs M ^9/L Basophils 4 yrs 8 yrs F ^9/L Basophils 8 yrs 12 yrs M ^9/L Basophils 8 yrs 12 yrs F ^9/L Basophils M ^9/L Basophils F ^9/L Basophils M % Basophils F % Eosinophils Cord 2 weeks M ^9/L Eosinophils Cord 2 weeks F ^9/L Eosinophils 2 wks 3 mths M ^9/L Eosinophils 2 wks 3 mths F ^9/L Eosinophils 3 mths 6 mths M ^9/L Eosinophils 3 mths 6 mths F ^9/L Eosinophils 6 mths 2 yrs M ^9/L Eosinophils 6 mths 2 yrs F ^9/L Eosinophils 2 yrs 4 yrs M ^9/L Eosinophils 2 yrs 4 yrs F ^9/L Eosinophils 4 yrs 8 yrs M ^9/L Eosinophils 4 yrs 8 yrs F ^9/L Eosinophils 8 yrs 12 yrs M ^9/L Eosinophils 8 yrs 12 yrs F ^9/L Eosinophils M ^9/L Eosinophils F ^9/L Eosinophils M % Eosinophils F % Erythropoietin M 4 19 miu/ml Erythropoietin F 4 19 miu/ml ESR M 0 10 mm/h ESR F 0 10 mm/h Fibrinogen M g/l Fibrinogen F g/l Haematocrit Cord 2 weeks M Haematocrit Cord 2 weeks F Haematocrit 2 wks 3 mths M Haematocrit 2 wks 3 mths F Haematocrit 3 mths 6 mths M Haematocrit 3 mths 6 mths F Haematocrit 6 mths 2 yrs M Haematocrit 6 mths 2 yrs F Haematocrit 2 yrs 4 yrs M Haematocrit 2 yrs 4 yrs F Haematocrit 4 yrs 8 yrs M Haematocrit 4 yrs 8 yrs F Haematocrit 8 yrs 12 yrs M Haematocrit 8 yrs 12 yrs F Haematocrit M Haematocrit F Haemoglobin Cord 2 weeks M g/l Haemoglobin Cord 2 weeks F g/l Haemoglobin 2 wks 3 mths M g/l Haemoglobin 2 wks 3 mths F g/l Haemoglobin 3 mths 6 mths M g/l Haemoglobin 3 mths 6 mths F g/l Haemoglobin 6 mths 2 yrs M g/l LOC:3 Auth: Contract Pathology Manager Effective Date: 5th March 2010 Page 1 of 12

2 HAEMATOLOGY Haemoglobin 6 mths 2 yrs F g/l Haemoglobin 2 yrs 4 yrs M g/l Haemoglobin 2 yrs 4 yrs F g/l Haemoglobin 4 yrs 8 yrs M g/l Haemoglobin 4 yrs 8 yrs F g/l Haemoglobin 8 yrs 12 yrs M g/l Haemoglobin 8 yrs 12 yrs F g/l Haemoglobin M g/l Haemoglobin F g/l INR M INR F Lymphocytes Cord 2 weeks M ^9/L Lymphocytes Cord 2 weeks F ^9/L Lymphocytes 2 wks 3 mths M ^9/L Lymphocytes 2 wks 3 mths F ^9/L Lymphocytes 3 mths 6 mths M ^9/L Lymphocytes 3 mths 6 mths F ^9/L Lymphocytes 6 mths 2 yrs M ^9/L Lymphocytes 6 mths 2 yrs F ^9/L Lymphocytes 2 yrs 4 yrs M ^9/L Lymphocytes 2 yrs 4 yrs F ^9/L Lymphocytes 4 yrs 8 yrs M ^9/L Lymphocytes 4 yrs 8 yrs F ^9/L Lymphocytes 8 yrs 12 yrs M ^9/L Lymphocytes 8 yrs 12 yrs F ^9/L Lymphocytes M ^9/L Lymphocytes F ^9/L Lymphocytes M % Lymphocytes F % MCH Cord 2 weeks M pg MCH Cord 2 weeks F pg MCH 2 wks 3 mths M pg MCH 2 wks 3 mths F pg MCH 3 mths 6 mths M pg MCH 3 mths 6 mths F pg MCH 6 mths 2 yrs M pg MCH 6 mths 2 yrs F pg MCH 2 yrs 4 yrs M pg MCH 2 yrs 4 yrs F pg MCH 4 yrs 8 yrs M pg MCH 4 yrs 8 yrs F pg MCH 8 yrs 12 yrs M pg MCH 8 yrs 12 yrs F pg MCH M pg MCH F pg MCHC M g/l MCHC F g/l MCV Cord 2 weeks M fl MCV Cord 2 weeks F fl MCV 2 wks 3 mths M fl MCV 2 wks 3 mths F fl MCV 3 mths 6 mths M fl MCV 3 mths 6 mths F fl MCV 6 mths 2 yrs M fl MCV 6 mths 2 yrs F fl MCV 2 yrs 4 yrs M fl MCV 2 yrs 4 yrs F fl MCV 4 yrs 8 yrs M fl MCV 4 yrs 8 yrs F fl MCV 8 yrs 12 yrs M fl MCV 8 yrs 12 yrs F fl MCV M fl MCV F fl Monocytes Cord 2 weeks M ^9/L Monocytes Cord 2 weeks F ^9/L Monocytes 2 wks 3 mths M ^9/L Monocytes 2 wks 3 mths F ^9/L LOC:3 Auth: Contract Pathology Manager Effective Date: 5th March 2010 Page 2 of 12

3 HAEMATOLOGY Monocytes 3 mths 6 mths M ^9/L Monocytes 3 mths 6 mths F ^9/L Monocytes 6 mths 2 yrs M ^9/L Monocytes 6 mths 2 yrs F ^9/L Monocytes 2 yrs 4 yrs M ^9/L Monocytes 2 yrs 4 yrs F ^9/L Monocytes 4 yrs 8 yrs M ^9/L Monocytes 4 yrs 8 yrs F ^9/L Monocytes 8 yrs 12 yrs M ^9/L Monocytes 8 yrs 12 yrs F ^9/L Monocytes M ^9/L Monocytes F ^9/L Monocytes M % Monocytes F % Neutrophils Cord 2 weeks M ^9/L Neutrophils Cord 2 weeks F ^9/L Neutrophils 2 wks 3 mths M ^9/L Neutrophils 2 wks 3 mths F ^9/L Neutrophils 3 mths 6 mths M ^9/L Neutrophils 3 mths 6 mths F ^9/L Neutrophils 6 mths 2 yrs M ^9/L Neutrophils 6 mths 2 yrs F ^9/L Neutrophils 2 yrs 4 yrs M ^9/L Neutrophils 2 yrs 4 yrs F ^9/L Neutrophils 4 yrs 8 yrs M ^9/L Neutrophils 4 yrs 8 yrs F ^9/L Neutrophils 8 yrs 12 yrs M ^9/L Neutrophils 8 yrs 12 yrs F ^9/L Neutrophils M ^9/L Neutrophils F ^9/L Neutrophils M % Neutrophils F % Platelets Cord 2 weeks M ^9/L Platelets Cord 2 weeks F ^9/L Platelets 2 wks 3 mths M ^9/L Platelets 2 wks 3 mths F ^9/L Platelets 3 mths 6 mths M ^9/L Platelets 3 mths 6 mths F ^9/L Platelets 6 mths 2 yrs M ^9/L Platelets 6 mths 2 yrs F ^9/L Platelets 2 yrs 4 yrs M ^9/L Platelets 2 yrs 4 yrs F ^9/L Platelets 4 yrs 8 yrs M ^9/L Platelets 4 yrs 8 yrs F ^9/L Platelets 8 yrs 12 yrs M ^9/L Platelets 8 yrs 12 yrs F ^9/L Platelets M ^9/L Platelets F ^9/L PT M sec PT F sec RBC Cord 2 weeks M ^12L RBC Cord 2 weeks F ^12L RBC 2 wks 3 mths M ^12L RBC 2 wks 3 mths F ^12L RBC 3 mths 6 mths M ^12L RBC 3 mths 6 mths F ^12L RBC 6 mths 2 yrs M ^12L RBC 6 mths 2 yrs F ^12L RBC 2 yrs 4 yrs M ^12L RBC 2 yrs 4 yrs F ^12L RBC 4 yrs 8 yrs M ^12L RBC 4 yrs 8 yrs F ^12L RBC 8 yrs 12 yrs M ^12L RBC 8 yrs 12 yrs F ^12L RBC M ^12L RBC F ^12L RDW Cord 2 weeks M % LOC:3 Auth: Contract Pathology Manager Effective Date: 5th March 2010 Page 3 of 12

4 HAEMATOLOGY RDW Cord 2 weeks F % RDW 2 wks 3 mths M % RDW 2 wks 3 mths F % RDW 3 mths 6 mths M % RDW 3 mths 6 mths F % RDW 6 mths 2 yrs M % RDW 6 mths 2 yrs F % RDW 2 yrs 4 yrs M % RDW 2 yrs 4 yrs F % RDW 4 yrs 8 yrs M % RDW 4 yrs 8 yrs F % RDW 8 yrs 12 yrs M % RDW 8 yrs 12 yrs F % RDW M % RDW F % Reticulocytes Cord 2 weeks M % Reticulocytes Cord 2 weeks F % Reticulocytes 2 wks 3 mths M % Reticulocytes 2 wks 3 mths F % Reticulocytes 3 mths 6 mths M % Reticulocytes 3 mths 6 mths F % Reticulocytes 6 mths 2 yrs M % Reticulocytes 6 mths 2 yrs F % Reticulocytes 2 yrs 4 yrs M % Reticulocytes 2 yrs 4 yrs F % Reticulocytes 4 yrs 8 yrs M % Reticulocytes 4 yrs 8 yrs F % Reticulocytes 8 yrs 12 yrs M % Reticulocytes 8 yrs 12 yrs F % Reticulocytes M % Reticulocytes F % Reticulocytes Cord 2 weeks M n/a n/a 10^9/L Reticulocytes Cord 2 weeks F n/a n/a 10^9/L Reticulocytes 2 wks 3 mths M ^9/L Reticulocytes 2 wks 3 mths F ^9/L Reticulocytes 3 mths 6 mths M ^9/L Reticulocytes 3 mths 6 mths F ^9/L Reticulocytes 6 mths 2 yrs M ^9/L Reticulocytes 6 mths 2 yrs F ^9/L Reticulocytes 2 yrs 4 yrs M ^9/L Reticulocytes 2 yrs 4 yrs F ^9/L Reticulocytes 4 yrs 8 yrs M ^9/L Reticulocytes 4 yrs 8 yrs F ^9/L Reticulocytes 8 yrs 12 yrs M ^9/L Reticulocytes 8 yrs 12 yrs F ^9/L Reticulocytes M ^9/L Reticulocytes F ^9/L Thrombin Time M sec Thrombin Time F sec WBC Cord 2 weeks M ^9/L WBC Cord 2 weeks F ^9/L WBC 2 wks 3 mths M ^9/L WBC 2 wks 3 mths F ^9/L WBC 3 mths 6 mths M ^9/L WBC 3 mths 6 mths F ^9/L WBC 6 mths 2 yrs M ^9/L WBC 6 mths 2 yrs F ^9/L WBC 2 yrs 4 yrs M ^9/L WBC 2 yrs 4 yrs F ^9/L WBC 4 yrs 8 yrs M ^9/L WBC 4 yrs 8 yrs F ^9/L WBC 8 yrs 12 yrs M ^9/L WBC 8 yrs 12 yrs F ^9/L WBC M ^9/L WBC F ^9/L LOC:3 Auth: Contract Pathology Manager Effective Date: 5th March 2010 Page 4 of 12

5 CHEMISTRY 25 - OH Vit D M nmol/l 25 - OH Vit D F nmol/l Albumin M g/l Albumin F g/l Albumin excre M mg/d Albumin excre F mg/d Alk. phos. 0 5 M U/L Alk. phos M U/L Alk. phos M U/L Alk. phos M U/L Alk. phos M U/L Alk. phos. 0 9 F U/L Alk. phos F U/L Alk. phos F U/L Alk. phos F U/L ALT M 0 30 U/L ALT F 0 30 U/L Amylase M U/L Amylase F U/L AST M 0 30 U/L AST F 0 30 U/L Bicarbonate M mmol/l Bicarbonate F mmol/l Bilirubin - conj. * M 0 10 umol/l Bilirubin - conj. * F 0 10 umol/l Bilirubin - Total * M 0 18 umol/l Bilirubin - Total * F 0 18 umol/l Bilirubin - Unconj. * M 0 18 umol/l Bilirubin - Unconj. * F 0 18 umol/l Caeruloplasmin M mg/l Caeruloplasmin F mg/l Calcium M mmol/l Calcium F mmol/l Chloride M mmol/l Chloride F mmol/l Cholesterol M mmol/l Cholesterol F mmol/l Cortisol M nmol/l Cortisol F nmol/l C-peptide M ug/l C-peptide F ug/l Creat. excret M 5 16 mmol/d Creat. excret F 5 16 mmol/d Creat.Cl(calc) M ml/s Creat.Cl(calc) F ml/s Creat.Cl(calc) M ml/min Creat.Cl(calc) F ml/min Creatinine kinase M U/L Creatinine kinase F U/L CKMB M ug/l CKMB F ug/l Creatinine M umol/l Creatinine F umol/l CRP M <10.0 mg/l CRP F <10.0 mg/l Digoxin M ug/l Digoxin F ug/l Ferritin 0 16 M ug/l Ferritin M ug/l LOC:3 Auth: Contract Pathology Manager Effective Date: 5th March 2010 Page 5 of 12

6 CHEMISTRY Ferritin 0 16 F ug/l Ferritin F ug/l Ferritin F ug/l Free T M pmol/l 08/10/09 Free T F pmol/l 08/10/09 Free Testost M pmol/l Free Testost F pmol/l Free thyroxine* M pmol/l 08/10/09 Free thyroxine* F pmol/l 08/10/09 GGT M 0 35 U/L GGT F 0 35 U/L Globulins M g/l Globulins F g/l Glucose-fasting M mmol/l Glucose-fasting F mmol/l Glucose-random M mmol/l Glucose-random F mmol/l Growth hormone M mu/l Growth hormone F mu/l HBA1c M <6.0 % HBA1c F <6.0 % HDL Cholesterol M >1.0 mmol/l HDL Cholesterol F >1.0 mmol/l Insulin M mu/l Insulin F mu/l Ionised calcium M mmol/l Ionised calcium F mmol/l Lactate M mmol/l Lactate F mmol/l LDH M U/L LDH F U/L LDL Cholesterol M mmol/l LDL Cholesterol F mmol/l Lipase M 0 60 U/L Lipase F 0 60 U/L Magnesium M mmol/l Magnesium F mmol/l MB Index M MB Index F Neopterin M 0 13 nmol/l Neopterin F 0 13 nmol/l Osmolality M mm/kg Osmolality F mm/kg Osteocalcin M ug/l Osteocalcin F ug/l Phosphate M mmol/l Phosphate F mmol/l Potassium M mmol/l Potassium F mmol/l Prealbumin M mg/l Prealbumin F mg/l Prolactin M miu/l 24/11/09 Prolactin F miu/l 24/11/09 PSA M ug/l 23/02/10 LOC:3 Auth: Contract Pathology Manager Effective Date: 5th March 2010 Page 6 of 12

7 CHEMISTRY PSA M ug/l 23/02/10 PSA M ug/l 23/02/10 PSA M ug/l 23/02/10 PTH (Intact) M pmol/l PTH (Intact) F pmol/l PTHrP M <1.3 pmol/l PTHrP F <1.3 pmol/l Red Cell Folate M > 630 nmol/l Red Cell Folate F > 630 nmol/l Serum B M >180 pmol/l Serum B F >180 pmol/l Serum Folate M > 8.0 nmol/l Serum Folate F > 8.0 nmol/l Serum Iron M umol/l Serum Iron F umol/l SHBG M nmol/l SHBG F nmol/l Sodium M mmol/l Sodium F mmol/l Total protein M g/l Total protein F g/l Transferrin M g/l Transferrin F g/l Transferrin Sat M % Transferrin Sat F % Triglycerides M mmol/l Triglycerides F mmol/l Troponin I M <0.06 ug/l Troponin I F <0.06 ug/l TSH* M miu/l 08/10/09 TSH* F miu/l 08/10/09 Urea M mmol/l Urea F mmol/l Uric acid M mmol/l Uric acid F mmol/l Urine Amylase (spot) M U/L Urine Amylase (spot) F U/L Urine Creatinine (spot) M mmol/l Urine Creatinine (spot) F mmol/l NOTE 1: Reference range is normally charted in SydPath reports as <X. However, where EDI is required for specific clinical trials, then it is primed in the SydPath test database as 0-X. NOTE: * Reference range for some analytes is from 0, however the limits of detection of some of these assays may not reach zero. In such instances, SydPath reports as <Limit of Detection (eg for ALT, reference range is from 0-30 U/L. Sydpath reports down to 5, and then <5). Excludes Paediatric Range LOC:3 Auth: Contract Pathology Manager Effective Date: 5th March 2010 Page 7 of 12

8 ANALYTE / SEX PHASE REFERENCE REFERENCE SI UNITS REVISION TEST LOW HIGH DATE Human Chorionic Gonadotrophin (hcg) - serum/plasma F Pre-menopausal <10 IU/L F Post-menopausal <10 IU/L F Preg - negative <10 IU/L F Preg - borderline IU/L F Preg - positive >25 IU/L M <10 IU/L Luteinising Hormone (LH): F Follicular IU/L 8/10/2009 F Mid cycle IU/L 8/10/2009 F Luteal IU/L 8/10/2009 F Post Menopausal IU/L 8/10/2009 M Adult IU/L 8/10/2009 M/F Child <2.0 IU/L Oestradiol (E2) F Follicular pmol/l F Mid cycle pmol/l F Luteal pmol/l F Post menopausal <100 pmol/l F Preg - 1st Trim <11 nmol/l F Preg - 2nd Trim 8 20 nmol/l F Preg - 3rd Trim nmol/l M Adult pmol/l Testosterone (TESTO) F Adult <3.0 nmol/l M Adult nmol/l M Early Puberty nmol/l M/F Child <3.0 nmol/l Follicle Stimulating Hormone (FSH): F Follicular IU/L 8/10/2009 F Mid cycle IU/L 8/10/2009 F Luteal IU/L 8/10/2009 F Post Menopausal IU/L 8/10/2009 M Adult IU/L 8/10/2009 Progesterone: F Follicular nmol/l F Luteal >15.0 nmol/l F Pregnancy nmol/l M Adult nmol/l LOC:3 Auth: Contract Pathology Manager Effective Date: 5th March 2010 Page 8 of 12

9 ANALYTE / AGE SEX NORMAL RESULT CUT/OFF SI UNITS REVISION TEST DATE Urine Drug Screens Amphetamines All Ages M/F Negative 300 ug/l Barbituates All Ages M/F Negative 200 ug/l Benzodiazepines All Ages M/F Negative 200 ug/l Cannabinoids All Ages M/F Negative 50 ug/l Cocaine All Ages M/F Negative 300 ug/l Methadone All Ages M/F Negative 300 ug/l Methaqualone All Ages M/F Negative 300 ug/l Opiates All Ages M/F Negative 300 ug/l Phencyclidine All Ages M/F Negative 25 ug/l Propoxyphene All Ages M/F Negative 300 ug/l TCA-tricylics All Ages M/F Negative 300 ug/l LOC:3 Auth: Contract Pathology Manager Effective Date: 5th March 2010 Page 9 of 12

10 IMMUNOLOGY A-1 Antitrypsin M g/l A-1 Antitrypsin F g/l Beta2 Microglob M <2.4 mg/l Beta2 Microglob F <2.4 mg/l C M g/l C F g/l CD3+ % M % CD3+ % F % CD3+ Count M ^6/L CD3+ Count F ^6/L CD4:CD8 Ratio M CD4:CD8 Ratio F CD4+ % M % CD4+ % F % CD4+ Count M ^6/L CD4+ Count F ^6/L CD8+ % M % CD8+ % F % CD8+ Count M ^6/L CD8+ Count F ^6/L dsdna M <7 IU/mL dsdna F <7 IU/mL Haptoglobin M g/l Haptoglobin F g/l IgG 0 3 months M/F g/l IgG 3 months 6 months M/F g/l IgG 6 months 2 years M/F g/l IgG 2 3 M/F g/l IgG 3 4 M/F g/l IgG 4 6 M/F g/l IgG 6 9 M/F g/l IgG 9 12 M/F g/l IgG M/F g/l IgG M/F g/l Rheumatoid Factor M <9 IU/mL 01/07/08 Rheumatoid Factor F <9 IU/mL 01/07/08 Total T cells M ^6/L Total T cells F ^6/L LOC:3 Auth: Contract Pathology Manager Effective Date: 5th March 2010 Page 10 of 12

11 ANALYTE / AGE SEX NORMAL REVISION TEST RESPONSE DATE SEROLOGY Hepatitis B Surface Antigen All Ages M/F Non Reactive (NR) Hepatitis C Antibodies All Ages M/F Non Reactive (NR) HIV Antibody/Antigen All Ages M/F Non Reactive (NR) Syphilis CMIA Total Antibody All Ages M/F Non Reactive (NR) Rubella IgG CMIA All Ages M/F IU/mL = Negative IU/mL = Equivocal IU/mL = Positive HTLV I & II All Ages M/F Negative added 19/03/08 ANALYTE / AGE SEX NORMAL ABNORMAL ANALYTICAL RANGE REVISION TEST RESPONSE RESPONSE DATE MOLECULAR DIAGNOSTICS COBAS Amplicor HIV-1 VL All Ages M/F Not Detected Detected 40-10,000,000 copies 01/09/08 LOC:3 Auth: Contract Pathology Manager Effective Date: 5th March 2010 Page 11 of 12

12 ANALYTE / AGE SEX REFERENCE SI UNITS REVISION TEST RANGE DATE URINALYSIS Blood All Ages M/F Negative Glucose All Ages M/F Negative Ketones All Ages M/F Negative Leucocyte Esterase All Ages M/F Negative Nitrite All Ages M/F Negative ph All Ages M/F Specific Gravity All Ages M/F Bilirubin All Ages M/F Negative Protein All Ages M/F Negative Urobilinogen All Ages M/F Negative MICROSCOPY White Cells (WBC) All Ages M/F <10 10^6/L Red Cells (RBC) All Ages M/F <10 10^6/L Squamous Epithelial Cells All Ages M/F Nil 10^6/L Non-squamous Epithelial Cells All Ages M/F Nil 10^6/L Hyaline Casts All Ages M/F Nil N/A Granular Casts All Ages M/F Nil N/A Cellular Casts All Ages M/F Nil N/A Crystals All Ages M/F Nil N/A Bacteria All Ages M/F None Seen N/A Yeast All Ages M/F None Seen N/A LOC:3 Auth: Contract Pathology Manager Effective Date: 5th March 2010 Page 12 of 12