Chemical Pathology Analytical Performance Specifications
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| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Alcohol | + or - 2.0 ≤ 20.0mmol/L | + or - 10% > 20.0 mmol/L | Prof. Opinion | |
| Ammonia | + or - 5 ≤ 50 umol/L/L | + or - 10% > 50 umol/L/L | Prof. Opinion |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Itraconazole | + or - 0.1 ≤ 1.0 mg/L | + or - 10% > 1.0 mg/L | Prof. Opinion | |
| Fluconazole | + or - 2.0 ≤ 20.0 mg/L | + or - 10% > 20.0 mg/L | Prof. Opinion | |
| Hydroxyitraconazole | + or - 0.2 ≤ 2.0 mg/L | + or - 10% > 2.0 mg/L | Prof. Opinion | |
| Posaconazole | + or - 0.1 ≤ 1.0 mg/L | + or - 10% > 1.0 mg/L | Prof. Opinion | |
| Voriconazole | + or - 0.2 ≤ 2.0 mg/L | + or - 10% > 2.0 mg/L | Prof. Opinion | |
| Flucytosine | + or - 10 ≤ 100 mg/L | + or - 10% > 100 mg/L | Prof. Opinion |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Amikacin | + or - 2.0 ≤ 19.9 mg/L | + or - 10% > 19.9 mg/L | Prof. Opinion | |
| Gentamicin | + or - 0.2 ≤ 2.0 mg/L | + or - 10% > 2.0 mg/L | Prof. Opinion | |
| Tobramycin | + or - 0.2 ≤ 2.0 mg/L | + or - 10% > 2.0 mg/L | Prof. Opinion | |
| Vancomycin | + or - 2.0 ≤ 20.3 mg/L | + or - 10% > 20.3 mg/L | Prof. Opinion |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Total Bile Acids | + or - 4 ≤ 40 umol/L | + or - 10% > 40 umol/L | Prof. Opinion |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Adrenaline | + or - 30 ≤ 100 nmol/L | + or - 30% > 100 nmol/L | Total Error | Optimal |
| Dopamine | + or - 0.20 ≤ 2.0 µmol/L | + or - 10% > 2.0 µmol/L | Imprecision | Optimal |
| 5HIAA | + or - 8 ≤ 40 µmol/L | + or - 20% > 40 µmol/L | Imprecision | Desirable |
| HMMA | + or - 6 ≤ 40 µmol/L | + or - 15% > 40 µmol/L | Total Error | Optimal |
| HVA | + or - 6 ≤ 40 µmol/L | + or - 15% > 40 µmol/L | Imprecision | Desirable |
| Metanephrine | + or - 0.2 ≤ 1.0 µmol/L | + or - 20% > 1.0 µmol/L | Total Error | Optimal |
| Noradrenaline | + or - 75 ≤ 500 nmol/L | + or - 15% > 500 nmol/L | Total Error | Optimal |
| Normetanephrine | + or - 0.4 ≤ 2.0 µmol/L | + or - 20% > 2.0 µmol/L | Total Error | Optimal |
| 3-Methoxytyramine | + or - 0.3 ≤ 2.0 µmol/L | + or - 15% > 2.0 µmol/L | Total Error | Optimal |
| Serotonin | + or - 0.2 ≤ 1.0 µmol/L | + or - 20% > 1.0 µmol/L | Prof. Opinion |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Chloride | + or - 3 ≤ 100 mmol/L | + or - 3% > 100 mmol/L | Total Error | Minimal |
| Glucose | + or - 0.4 ≤ 5.0 mmol/L | + or - 8% > 5.0 mmol/L | Imprecision | Desirable |
| Ionised Calcium | + or - 0.04 ≤ 1.00 mmol/L | + or - 4% >1.00 mmol/L | Total Error | Minimal |
| Lactate | + or - 0.5 ≤ 4.0 mmol/L | + or - 12% > 4.0 mmol/L | Imprecision | Optimal |
| pH | + or - 0.04 | + or - 0.04 | Prof. Opinion | |
| pCO2 | + or - 2.0 ≤ 34.0 mm Hg | + or - 6% > 34.0 mm Hg | Total Error | Desirable |
| pO2 | +/- 5 to 83 mm Hg | + or - 6% > 83 mm Hg | Prof. Opinion | Desirable |
| Potassium | + or - 0.2 ≤ 4.0 mmol/L | + or - 5% > 4.0 mmol/L | Imprecision | Desirable |
| Sodium | + or - 3 ≤ 150 mmol/L | + or - 2% > 150 mmol/L | Total Error | Minimal |
| Urea | + or - 0.5 ≤ 4.0 mmol/L | + or - 12% > 4.0 mmol/L | Imprecision | Desirable |
| Creatinine | + or - 8.0 ≤ 100.0 µmol/L | + or - 8% > 100.0 µmol/L | Imprecision | Minimal |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| NT-Pro-BNP | + or - 25 ≤ 125 ng/L | + or - 20% > 125 ng/L | Total Error | Optimal |
| BNP | + or - 20 ≤ 100 ng/L | + or - 20% > 100 ng/L | Prof. Opinion |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Albumin | + or - 2.0 ≤ 33.0 g/L | + or - 6% > 33.0 g/L | ||
| Amylase | + or - 20 ≤ 100 U/L | + or - 20% > 100 U/L | ||
| Cholesterol | + or - 0.3 ≤ 2.5 mmol/L | + or - 12% > 2.5 mmol/L | ||
| Creatinine | + or - 16 ≤ 100 umol/L | + or - 16% > 100 umol/L | ||
| Glucose | + or - 0.4 ≤ 5.0 mmol/L | + or - 8% > 5.0 mmol/L | ||
| Lactate | + or - 1.0 ≤ 4.0 mmol/L | + or - 25% > 4.0 mmol/L | ||
| Lactate Dehydrogenase (L->P) | + or - 20 ≤ 250 U/L | + or - 8% > 250 U/L | ||
| Lipase | + or - 24 ≤ 60 U/L | + or - 40% > 60 U/L | ||
| Osmolality | + or - 8 ≤ 266 mmol/kg | + or - 3% > 266 mmol/kg | ||
| pH | + or - 0.2 | + or - 0.2 | ||
| Potassium | + or - 0.4 ≤ 4.0 mmol/L | + or - 10% > 4.0 mmol/L | ||
| Protein | + or - 3.0 ≤ 60.0 g/L | + or - 5% > 60.0 g/L | ||
| Sodium | + or - 6 ≤ 150 mmol/L | + or - 4% > 150 mmol/L | ||
| Triglycerides | + or - 0.3 ≤ 1.2 mmol/L | + or - 25% > 1.2 mmol/L | ||
| Urate | + or - 0.060 ≤ 0.380 mmol/L | + or - 16% > 0.380 mmol/L | ||
| Urea | + or - 1.0 ≤ 4.0 mmol/L | + or - 24% > 4.0 mmol/L | ||
| CA 19-9 | + or - 12 ≤ 40 kU/L | + or - 30% > 40 kU/L | ||
| CEA | + or - 1.2 ≤ 5.0 ug/L | + or - 24% > 5.0 ug/L |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Calprotectin - Quant | + or -10 ≤50 µg/g | + or - 20% >50 µg/g | Prof. Opinion | |
| Elastase - Quant | + or -15 ≤100 µg/ | + or - 20% >100 µg/g | Prof. Opinion |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Chromogranin A | + or - 20 up to 100 | + or - 20.0% > 100 µg/L | ||
| Copeptin | + or - 1.0 up to 5.0 | + or - 20.0% > 5.0 pmol/L | ||
| Cystatin C | + or - 0.10 up to 1.00 | + or - 10.0% > 1.00 mg/L |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Haemoglobin Concentration | + or - 5 ≤ 100 g/L | + or - 5% > 100 g/L | Total Error | Desirable |
| Fractional Oxyhaemoglobin | + or - 3 ≤ 75.0% | + or - 4% > 75.0% | Prof. Opinion | |
| Fractional Carboxyhaemoglobin | + or - 1.0 ≤ 5.0% | + or - 20% > 5.0% | Prof. Opinion | |
| Fractional Methaemoglobin | + or - 2.0 ≤ 20% | + or - 10% > 20% | Prof. Opinion |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| CRP | + or - 0.8 ≤ 4.0 mg/L | + or - 20% > 4.0 mg/L |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Albumin | + or - 0.02 ≤ 0.1 g/L | + or - 20% > 0.1 g/L | Prof. Opinion | |
| Glucose | + or - 0.2 ≤ 2.0 mmol/L | + or - 10% > 2.0 mmol/L | Prof. Opinion | |
| Immunoglobulin G | + or - 0.02 ≤ 0.10 g/L | + or - 20% > 0.10 g/L | Prof. Opinion | |
| Lactate | + or - 0.3 ≤ 3.0 mmol/L | + or - 10% > 3.0 mmol/L | Prof. Opinion | |
| Total Protein | + or - 0.05 ≤ 0.50 g/L | + or - 10% > 0.50 g/L | Prof. Opinion | |
| Bilirubin Concentration | + or - 0.12 ≤ 0.60 µmol/L | + or - 20% > 0.60 µmol/L | Prof. Opinion | |
| Xanthochromia – Bilirubin screen | + or - 0.002 ≤ 0.007 AU | + or - 20% > 0.007 AU | Prof. Opinion | |
| Xanthochromia – Haemoglobin screen | + or - 0.02 ≤ 0.100 AU | + or - 20% > 0.100 AU | Prof. Opinion |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| AFP | + or - 2 ≤ 17 kIU/L | + or -12% > 17 kIU/L | Imprecision | Desirable |
| Aldosterone | + or - 24 ≤ 160 pmol/L | + or - 15% > 160 pmol/L | Imprecision | Optimal |
| Androstenedione | + or - 1.5 ≤ 10 nmol/L | + or - 15% > 10 nmol/L | Total Error | Optimal |
| CA125 | + or - 6 ≤ 50 kU/L | + or - 12% > 50 kU/L | Imprecision | Optimal |
| CEA | + or - 0.6 ≤ 5.0 µg/L | + or - 12% > 5.0 µg/L | Imprecision | Desirable |
| Cortisol | + or - 15 ≤ 100 nmol/L | + or - 15% > 100 nmol/L | Imprecision | Optimal |
| DHEA Sulphate | + or - 1.2 ≤ 10.0 µmol/L | + or - 12% > 10.0 µmol/L | Total Error | Desirable |
| Ferritin | + or - 4.0 ≤ 27.0 µg/L | + or - 15% > 27.0 µg/L | Imprecision | Desirable |
| Folate | + or - 1.5 ≤ 6.0 nmol/L | + or - 25% > 6.0 nmol/L | Imprecision | Desirable |
| FSH | + or - 1.0 ≤ 10.0 IU/L | + or - 10% > 10.0 IU/L | Imprecision | Desirable |
| Growth Hormone | + or - 1 ≤ 7 mU/L | + or - 15% > 7 mU/L | Imprecision | Optimal |
| hCG | + or - 1 ≤ 10 IU/L | + or - 10% > 10 IU/L | Prof. Opinion | |
| Homocysteine | + or - 1.5 ≤ 15.0 µmol/L | + or - 10% > 15.0 µmol/L | Total Error | Optimal |
| 17-Hydroxyprogesterone | + or - 2.0 ≤ 10.0 nmol/L | + or - 20% > 10.0 nmol/L | Total Error | Optimal |
| Insulin | + or - 0.6 ≤ 5.0 mU/L | + or - 12% > 5.0 mU/L | Imprecision | Optimal |
| LH | + or - 1.5 ≤ 10.0 IU/L | + or - 15% > 10.0 IU/L | Imprecision | Desirable |
| Oestradiol | + or - 25 ≤ 100 pmol/Ll | + or - 25% > 100 pmol/L | Total Error | Desirable |
| Oestriol(Unconjugated) | + or - 0.9 ≤ 6.0 nmol/L | + or - 15% > 6.0 nmol/L | Prof. Opinion | |
| PTH | + or - 1.0 ≤ 8.0 pmol/L | + or - 12% > 8.0 pmol/L | Imprecision | Optimal |
| Progesterone | + or - 2 ≤ 10 nmol/L | + or - 15% > 10 nmol/L | Imprecision | Optimal |
| Prolactin | + or - 40 ≤ 400 mIU/L | + or - 10% > 400 mIU/L | Imprecision | Minimal |
| SHBG | + or - 6 ≤ 50 nmol/L | + or - 12% > 50 nmol/L | Imprecision | Desirable |
| Testosterone | + or - 0.4 ≤ 2.7 nmol/L | + or - 15% > 2.7 nmol/L | Imprecision | Minimal |
| TSH | + or - 0.10 ≤ 0.50 mU/L | + or - 20% > 0.50 mU/L | Imprecision | Desirable |
| Free T3 | + or - 0.7 ≤ 3.5 pmol/L | + or - 20% > 3.5 pmol/L | Total Error | Desirable |
| Free T4 | + or - 1.5 ≤ 12 pmol/L | + or - 12% > 12 pmol/L | Total Error | Desirable |
| Total T3 | + or - 0.2 ≤ 1.3 nmol/L | + or - 15% > 1.3 nmol/L | Total Error | Desirable |
| Total Thyroxine | + or - 12 ≤ 120 nmol/L | + or - 10% > 120 nmol/L | Total Error | Desirable |
| Vitamin B12 | + or - 18 ≤ 120 pmol/L | + or - 15% > 120 pmol/L | Imprecision | Desirable |
| Vitamin D3 | + or - 9 ≤ 60 nmol/L | + or - 15 % 60 nmol/L | Imprecision | Minimal |
| Total PSA | + or - 0.4 ≤ 5.0 µg/L | + or - 8% > 5.0 µg/L | Imprecision | Optimal |
| Free PSA | + or - 0.2 ≤ 1.4 µg/L | + or - 15% > 1.4 µg/L | Imprecision | Optimal |
| ACE | + or - 1.0 ≤ 10.0 U/L | + or - 10% > 10.0 U/L | Prof. Opinion | |
| Red Cell Folate | + or - 80 ≤ 400 nmol/L | + or - 20% > 400 nmol/L | Imprecision | Minimal |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Quantitative | + or - 15 ≤ 100 ng/mL | + or - 15% >100 ng/mL |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Albumin | + or - 2.0 ≤ 33.0 g/L | + or - 6% > 33.0 g/L | Total Error | Desirable |
| Alkaline Phosphatase | + or - 15 ≤ 125 U/L | + or - 12% > 125 U/L | Total Error | Desirable |
| ALT | + or - 5 ≤ 40 U/L | + or - 12% > 40 U/L | Imprecision | Optimal |
| Amylase | + or - 10 ≤ 100 U/L | + or - 10% > 100 U/L | Imprecision | Desirable |
| AST | + or - 5 ≤ 40 U/L | + or - 12% > 40 U/L | Imprecision | Desirable |
| Bicarbonate | + or - 2.0 ≤ 20.0 mmol/L | + or - 10% > 20.0 mmol/L | Total Error | Minimal |
| Bilirubin-Total | + or - 3 ≤ 25 µmol/L | + or - 12% > 25 µmol/L | Imprecision | Optimal |
| Bilirubin Conjugated | + or - 3 ≤ 15 µmol/L | + or - 20% > 15 µmol/L | Imprecision | Optimal |
| Calcium | + or - 0.10 ≤ 2.50 mmol/L | + or - 4% > 2.50 mmol/L | Imprecision | Minimal |
| Chloride | + or - 3 ≤ 100 mmol/L | + or - 3% > 100 mmol/L | Total Error | Minimal |
| Cholesterol | + or - 0.30 ≤ 5.00 mmol/L | + or - 6% > 5.00 mmol/L | Imprecision | Desirable |
| Cholinesterase | + or - 500 ≤ 5000 U/L | + or - 10% > 5000 U/L | Prof. Opinion | |
| Creatine Kinase | + or - 15 ≤ 125 U/L | + or - 12% > 125 U/L | Imprecision | Optimal |
| CK-MB | + or - 3 ≤ 15 U/L or µg/L | + or - 20% > 15 U/L or µg/L | Imprecision | Desirable |
| Cortisol | + or - 15 ≤ 100 nmol/L | + or - 15% > 100 nmol/L | Prof. Opinion | |
| Creatinine | + or - 8.0 ≤ 100.0 µmol/L | + or - 8% > 100.0 µmol/L | Imprecision | Minimal |
| Ferritin | + or - 4.0 ≤ 27 µg/L | + or - 15% > 27 µg/L | Imprecision | Desirable |
| Fructosamine | + or - 15 ≤ 250 µmol/L | + or - 6% > 250 µmol/L | Imprecision | Minimal |
| Glucose | + or - 0.4 ≤ 5.0 mmol/L | + or - 8% > 5.0 mmol/L | Imprecision | Desirable |
| GGT | + or - 5 ≤ 40 U/L | + or - 12% > 40 U/L | Imprecision | Desirable |
| hCG-quantitative | + or - 1.0 ≤ 10.0 IU/L | + or - 10% > 10.0 IU/L | Prof. Opinion | |
| HDL Cholesterol | + or - 0.10 ≤ 0.80 mmol/L | + or - 12% > 0.80 mmol/L | Imprecision | Minimal |
| Icterus (Quantitative) | + or 6.0 ≤ 25.0 µmol/L | + or - 25% > 25.0 µmol/L | ||
| Icterus (Numeric Index) | + or - 1 ≤ 10 | + or - 10% > 10 | ||
| Iron | + or - 3.0 ≤ 25.0 µmol/L | + or - 12% > 25.0 µmol/L | Imprecision | Optimal |
| Lactate Dehydrogenase | + or - 20 ≤ 250 U/L | + or - 8% > 250 U/L | Prof. Opinion | |
| Lactate | + or - 0.5 ≤ 4.0 mmol/L | + or - 12% > 4.0 mmol/L | Imprecision | Optimal |
| Lipase | + or - 12 ≤ 60 U/L | + or - 20% > 60 U/L | Imprecision | Desirable |
| Lithium | + or - 0.20 ≤ 2.0 mmol/L | + or - 10% > 2.0 mmol/L | Prof. Opinion | |
| Magnesium | + or - 0.10 ≤ 1.25 mmol/L | + or - 8% > 1.25 mmol/L | Total Error | Minimal |
| Osmolality | + or - 8 ≤ 266 mmol/kg | + or - 3% > 266 mmol/kg | Total Error | Minimal |
| Phosphate | + or - 0.06 ≤ 0.75 mmol/L | + or - 8% > 0.75 mmol/L | Imprecision | Desirable |
| Potassium | + or - 0.2 ≤ 4.0 mmol/L | + or - 5% > 4.0 mmol/L | Imprecision | Desirable |
| Protein (Total) | + or - 3 ≤ 60 g/L | + or - 5% >60 g/L | Total Error | Desirable |
| Sodium | + or - 3 ≤ 150 mmol/L | + or - 2% > 150 mmol/L | Total Error | Minimal |
| Total T3 | + or - 0.2 ≤ 1.3 nmol/L | + or - 15% > 1.3 nmol/L | Total Error | Desirable |
| Free T3 | + or - 0.7 ≤ 3.5 pmol/L | + or - 20% > 3.5 pmol/L | Total Error | Desirable |
| Free T4 | + or - 1.5 ≤ 12.0 pmol/L | + or - 12% > 12.0 pmol/L | Total Error | Desirable |
| TSH | + or - 0.1 ≤ 0.5 mU/L | + or - 20% > 0.5 mU/L | Imprecision | Desirable |
| Total T4 | + or - 12 ≤ 120 nmol/L | + or - 10% > 120 nmol/L | Total Error | Desirable |
| TIBC | + or - 4.0 ≤ 50.0 µmol/L | + or - 8% > 50.0 µmol/L | Prof. Opinion | |
| Transferrin | + or - 0.20 ≤ 2.50 g/L | + or - 8% > 2.50 g/L | Total Error | Minimal |
| Triglyceride | + or - 0.20 ≤ 1.60 mmol/L | + or - 12% > 1.60 mmol/L | Imprecision | Optimal |
| Troponin I | + or - 0.002 ≤ 0.010 µg/L | + or - 20% > 0.010 µg/L | Prof. Opinion | |
| Troponin T | + or - 0.01 ≤ 0.050 µg/L | + or - 20% > 0.050 µg/L | Prof. Opinion | |
| Urate | + or - 0.030 ≤ 0.380 mmol/L | + or - 8% > 0.380 mmol/L | Imprecision | Desirable |
| Urea | + or - 0.5 ≤ 4.0 mmol/L | + or - 12% > 4.0 mmol/L | Imprecision | Desirable |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Carbamazepine | + or - 0.5 ≤ 4.7 mg/L | + or - 10% > 4.7 mg/L | Prof. Opinion | |
| Digoxin | + or - 0.2 ≤ 1.6 µg/L | + or - 10% > 1.6 µg/L | Prof. Opinion | |
| Gentamicin | + or - 0.2 ≤ 2.0 mg/L | + or - 10% > 2.0 mg/L | Prof. Opinion | |
| Paracetamol | + or - 3.0 ≤ 30.0 mg/L | + or - 10% > 30.0 mg/L | Prof. Opinion | |
| Phenobarbitone | + or - 0.7 ≤ 7.0 mg/L | + or - 10% > 7.0 mg/L | Prof. Opinion | |
| Phenytoin | + or - 0.8 ≤ 7.6 mg/L | + or - 10% > 7.6 mg/L | Prof. Opinion | |
| Salicylate | + or - 14.0 ≤ 143.0 mg/L | + or - 10% > 143.0 mg/L | Prof. Opinion | |
| Theophylline | + or - 0.5 ≤ 5.4 mg/L | + or - 10% > 5.4 mg/L | Prof. Opinion | |
| Valproate | + or - 4.0 ≤ 36.0 mg/L | + or - 10% > 36.0 mg/L | Prof. Opinion | |
| Vancomycin | + or - 2.0 ≤ 20.3 mg/L | + or - 10% > 20.3 mg/L | Prof. Opinion |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| MediPro Glucose | + or - 1.0 ≤ 10 mmol/L | + or -10% >10.0 mmol/L | Prof. Opinion | |
| Statstrip Glucose | + or -0.5 ≤ 5 mmol/L | + or -10% >5.0 mmol/L | Prof. Opinion | |
| Statstrip Ketones | + or -0.5 ≤ 5 mmol/L | + or -10% >5.0 mmol/L | Prof. Opinion | |
| iSENS Glucose | + or - 1.0 ≤ 10 mmol/L | + or -10% >10.0 mmol/L | Prof. Opinion | |
| iSENS Ketones | + or - 1.0 ≤ 10 mmol/L | + or -10% >10.0 mmol/L | Prof. Opinion | |
| Lactate | + or -0.5 ≤ 4 mmol/L | + or -12% >4.0 mmol/L | Prof. Opinion |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| HbA1c (NGSP) (%) | + or - 0.4 ≤ 6.7% | + or - 6% > 6.7% | Prof. Opinion | |
| HbA1c (IFCC) (mmol/mol) | + or - 4 ≤ 45 mmol/mol | + or - 8% > 45 mmol/mol | Prof. Opinion |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| IGF-1 | + or - 3 ≤ 25 nmol/L | + or - 12% > 25 nmol/L | Imprecision | Minimal |
| C Peptide | + or - 0.15 ≤ 1.25 nmol/L | + or - 12% > 1.25 nmol/L | Total Error | Optimal |
| IGFBP-3 | + or - 15.0 ≤ 100 nmol/L | + or - 15% > 100 nmol/L | Prof. Opinion |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Cyclosporin | + or - 10 ≤ 100 µg/L | + or - 10% > 100 µg/L | Prof. Opinion | |
| Sirolimus | + or - 0.5 ≤ 5.0 µg/L | + or - 10% > 5.0 µg/L | Prof. Opinion | |
| Tacrolimus | + or - 0.5 ≤ 5.0 µg/L | + or - 10% > 5.0 µg/L | Prof. Opinion | |
| Everolimus | + or - 0.5 ≤ 5.0 µg/L | + or - 10% > 5.0 µg/L | Prof. Opinion |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Total Bilirubin | + or - 8 ≤ 80 µmol/L | + or - 10% > 80 µmol/L | Imprecision | Optimal |
| Conjugated Bilirubin | + or - 3 ≤ 15 µmol/L | + or - 20% >15 µmol/L | Imprecision | Optimal |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Metanephrine | + or - 75 ≤ 500 pmol/L | + or - 15% > 500 pmol/L | Total Error | Optimal |
| Normetanephrine | + or - 200 ≤ 1000 pmol/L | + or - 20% > 1000 pmol/L | Total Error | Optimal |
| Methyoxytyramine | + or - 36 ≤ 120 pmol/L | + or - 30% > 120 pmol/L | Total Error | Desirable |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Troponin I | + or - 0.01 ≤ 0.05 µg/L | + or - 20% > 0.05 µg/L | Prof. Opinion | |
| Troponin T (Quantitative) | + or - 10 ≤ 50 ng/L | + or - 20% > 50 ng/L | Prof. Opinion | |
| hCG | + or - 1 ≤ 10 IU/L | + or - 10% > 10 IU/L | Prof. Opinion |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| pH | + or - 0.04 | + or - 0.04 | Prof. Opinion | |
| pCO2 | + or - 2.0 ≤ 34.0 mm Hg | + or - 6% > 34.0 mm Hg | Total Error | Desirable |
| pO2 | +/- 5 to 83 mm Hg | + or - 6% > 83 mm Hg | Prof. Opinion | Desirable |
| TCO2 | + or - 2.0 ≤ 20.0 mmol/L | + or - 10% > 20.0 mmol/L | Prof. Opinion | |
| Lactate | + or - 0.5 ≤ 4.0 mmol/L | + or - 12% > 4.0 mmol/L | Imprecision | Optimal |
| Sodium | + or - 3 ≤ 150 mmol/L | + or - 2% > 150 mmol/L | Total Error | Minimal |
| Potassium | + or - 0.2 ≤ 4.0 mmol/L | + or - 5% > 4.0 mmol/L | Imprecision | Desirable |
| Chloride | + or - 3 ≤ 100 mmol/L | + or - 3% > 100 µmol/L | Total Error | Minimal |
| Ionised Calcium | + or - 0.04 ≤ 1.00 mmol/L | + or - 4% >1.00 mmol/L | Total Error | Minimal |
| Glucose | + or - 0.4 ≤ 5.0 mmol/L | + or - 8% > 5.0 mmol/L | Imprecision | Desirable |
| Urea | + or - 0.5 ≤ 4.0 mmol/L | + or - 12% > 4.0 mmol/L | Imprecision | Desirable |
| Creatinine | + or - 8.0 ≤ 100.0 µmol/L | + or - 8% > 100.0 µmol/L | Imprecision | Minimal |
| Haematocrit | + or - 4 ≤ 20% | + or - 20% >20% | Prof. Opinion | |
| Haemoglobin | + or - 5 ≤ 100 g/L | + or - 5% > 100 g/L | Prof. Opinion |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Urine ALA | + or - 8 ≤ 32 µmol/L | + or - 25% > 32 µmol/L | Prof. Opinion | |
| Urine Porphobilinogen (Quantitative) | + or - 5 ≤ 20 µmol/L | + or - 25% > 20 µmol/L | Prof. Opinion | |
| Urine Total Porphyrin | + or - 60 ≤ 300 nmol/L | + or - 20% > 300 nmol/L | Prof. Opinion | |
| Faecal Percent Dry Weight | + or - 2 ≤ 20% | + or - 10% > 20% | Prof. Opinion | |
| Faecal Total Porphyrin | + or - 40 ≤ 200 µmol/kg | + or - 20% > 200 µmol/kg | Prof. Opinion | |
| Plasma Total Porphyrin | + or - 4 ≤ 20 nmol/L | + or - 20% > 20 nmol/L | Prof. Opinion | |
| RBC Total Porphyrin | + or - 0.4 ≤ 2.0 µmol/Lrc | + or - 20% > 2.0 µmol/Lrc | Prof. Opinion |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Haemolysis (Quantitative) | + or - 8 ≤ 80 mg/dL | + or - 10% > 80 mg/dL | ||
| Haemolysis (Numeric Index) | + or - 1 ≤ 10 | + or - 10% > 10 | ||
| Icterus (Quantitative) | + or - 6.0 ≤ 25.0 µmol/L | + or - 25% > 25.0 µmol/L | ||
| Icterus (Numeric Index) | + or - 1 ≤ 10 | + or - 10% > 10 | ||
| Lipaemia (Quantitative) | + or - 0.30 ≤ 3.00 g/L | + or - 10% > 3.00 g/L | ||
| Lipaemia (Numeric Index) | + or - 1 ≤ 10 | + or - 10% > 10 |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Cholesterol | + or - 0.30 ≤ 5.00 mmol/L | + or - 6% > 5.00 mmol/L | Prof. Opinion | |
| HDL Cholesterol | + or - 0.1 ≤ 0.80 mmol/L | + or - 12% > 0.80 mmol/L | Prof. Opinion | |
| LDL Cholesterol | + or - 0.20 ≤ 2.00 mmol/L | + or - 10% > 2.00 mmol/L | Prof. Opinion | |
| Triglyceride | + or - 0.20 ≤ 1.60 mmol/L | + or - 12% > 1.60 mmol/L | Prof. Opinion | |
| Apolipoprotein A1 | + or - 0.2 ≤ 2.0 g/L | + or - 10% > 2.0 g/L | Prof. Opinion | |
| Apolipoprotein B | + or - 0.2 ≤ 2.0 g/L | + or - 10% > 2.0 g/L | Prof. Opinion | |
| Lipoprotein(a) | + or - 0.06 ≤ 0.3 g/L | + or - 20% > 0.3 g/L | Imprecision | Desirable |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Amiodarone | + or - 0.1 ≤ 1.3 mg/L | + or - 10% > 1.3 mg/L | Prof. Opinion | |
| Amitriptyline | + or - 3.0 ≤ 28.0 µg/L | + or - 10% > 28.0 µg/L | Prof. Opinion | |
| Clozapine | + or - 12 ≤ 100 µg/L | + or - 12% > 100 µg/L | Prof. Opinion | |
| Methotrexate | + or - 0.10 ≤ 1.00 µmol/L | + or - 10% > 1.00 µmol/L | Prof. Opinion | |
| Mycophenolate | + or - 0.10 ≤ 1.00 mg/L | + or - 10% > 1.00 mg/L | Prof. Opinion | |
| Nortriptyline | + or - 3.0 ≤ 26.0 µg/L | + or - 10% > 26.0 µg/L | Prof. Opinion |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Chloride | + or - 2 ≤ 40 mmol/L | + or - 5% > 40 mmol/L | Imprecision | |
| Sweat Conductivity | + or - 2 ≤ 50 mmol/L | + or - 5% > 50 mmol/L | UK Guidelines | UK Guidelines |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Aluminium | + or - 0.08 ≤ 0.40 µmol/L | + or - 20% > 0.40 µmol/L | Prof. Opinion | |
| Chromium | + or - 3 ≤ 25 nmol/L | + or - 12% > 25 nmol/L | Prof. Opinion | |
| Cobalt | + or - 1 ≤ 10 nmol/L | + or - 10% > 10 nmol/L | Prof. Opinion | |
| Copper | + or - 1.6 ≤ 20.0 µmol/L | + or - 8% > 20.0 µmol/L | Imprecision | Minimal |
| Lithium | + or - 0.2 ≤ 2.0 mmol/L | + or - 10% > 2.0 mmol/L | Prof. Opinion | |
| Magnesium | + or - 0.1 ≤ 1.25 nmol/L | + or - 8% > 1.25 nmol/L | Prof. Opinion | |
| Selenium | + or - 0.18 ≤ 1.50 µmol/L | + or - 12% > 1.50 µmol/L | Imprecision | Desirable |
| Thallium | + or - 1 ≤ 10 nmol/L | + or - 10% > 10 nmol/L | Prof. Opinion | |
| Vanadium | + or - 1 ≤ 10 nmol/L | + or - 10% > 10nmol/L | Prof. Opinion | |
| Zinc | + or - 2.0 ≤ 20.0 µmol/L | + or - 10% > 20.0 µmol/L | Imprecision | Desirable |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Arsenic (Total) | + or - 50 ≤ 500 nmol/L | + or - 10% > 500 nmol/L | Prof. Opinion | |
| Cadmium | + or - 3 ≤ 20 nmol/L | + or - 15% > 20 nmol/L | Prof. Opinion | |
| Chromium | + or - 3 ≤ 25 nmol/L | + or - 12% > 25 nmol/L | Prof. Opinion | |
| Cobalt | + or - 2 ≤ 20 nmol/L | + or - 10% > 20nmol/L | Prof. Opinion | |
| Copper | + or - 0.05 ≤ 0.50 µmol/L | + or - 10% > 0.50 µmol/L | Prof. Opinion | |
| Iodine | + or - 80 ≤ 800 nmol/L | + or - 10% > 800 nmol/L | Prof. Opinion | |
| Iron | + or - 3 ≤ 25 μmol/L | + or - 12% > 25 µmol/L | Prof. Opinion | |
| Lead | + or - 50 ≤ 500 nmol/L | + or - 10% > 500 nmol/L | Prof. Opinion | |
| Magnesium | + or - 0.10 ≤ 1.25 mmol/L | + or - 8% > 1.25 mmol/L | Prof. Opinion | |
| Manganese | + or - 3 ≤ 25 nmol/L | + or - 12% > 25 nmol/L | Prof. Opinion | |
| Mercury | + or - 9 ≤ 60 nmol/L | + or - 15% > 60 nmol/L | Prof. Opinion | |
| Nickel | + or - 40 ≤ 400 nmol/L | + or - 10% > 400 nmol/L | Prof. Opinion | |
| Selenium | + or - 0.06 ≤ 0.50 µmol/L | + or - 12% > 0.50 µmol/L | Prof. Opinion | |
| Thallium | + or - 1 ≤ 10 nmol/L | + or - 10% > 10 nmol/L | Prof. Opinion | |
| Vanadium | + or - 2 ≤ 10 nmol/L | + or - 10% > 10 nmol/L | Prof. Opinion | |
| Zinc | + or - 2.0 ≤ 20.0 µmol/L | + or - 10% > 20.0 µmol/L | Prof. Opinion |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Arsenic (Total) | + or - 10 ≤ 100 nmol/L | + or - 10% > 100 nmol/L | Prof. Opinion | |
| Cadmium | + or - 3 ≤ 20 nmol/L | + or - 15% > 20nmol/L | Prof. Opinion | |
| Cobalt | + or - 2 ≤ 10 nmol/L | + or - 10% > 10 nmol/L | Prof. Opinion | |
| Chromium | + or - 3 ≤ 25 nmol/L | + or - 12% > 25 nmol/L | Prof. Opinion | |
| Lead | + or - 0.05 ≤ 0.50 µmol/L | + or - 10% > 0.50 µmol/L | Optimal | Imprecision |
| Magnesium | + or - 0.10 ≤ 1.25 mmol/L | + or - 8% > 1.25 mmol/L | Prof. Opinion | |
| Manganese | + or - 30 ≤ 250 nmol/L | + or - 12% > 250 nmol/L | Prof. Opinion | |
| Mercury | + or - 9 ≤ 60 nmol/L | + or - 15% > 60 nmol/L | Prof. Opinion | |
| Selenium | + or - 0.30 ≤ 2.50 µmol/L | + or - 12% > 2.50 µmol/L | Desirable | Imprecision |
| Thallium | + or - 2 ≤ 10 nmol/L | + or - 10% > 10 nmol/L | Prof. Opinion | |
| Zinc | + or - 6 ≤ 60 µmol/L | + or - 10% > 60 µmol/L | Desirable | Imprecision |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| ACTH | + or - 2.0 ≤ 20 pmol/L | + or - 10% > 20 pmol/L | Prof. Opinion | |
| Alpha-fetoprotein | + or - 2 ≤ 17 kIU/L | + or - 12% > 17 kIU/L | Imprecision | Desirable |
| Calcitonin | + or - 2 ≤ 20 ng/L | + or - 10% > 20 ng/L | Prof. Opinion | |
| CEA | + or - 0.6 ≤ 5.0 µg/L | + or - 12% > 5.0 µg/L | Imprecision | Desirable |
| CA125 | + or - 6 ≤ 50 kU/L | + or - 12% > 50 kU/L | Imprecision | Optimal |
| CA15-3 | + or - 3 ≤ 30 kU/L | + or - 10% > 30 kU/L | Imprecision | Minimal |
| CA19-9 | + or - 6 ≤ 40 kU/L | + or - 15% > 40 kU/L | Imprecision | Desirable |
| hCG | + or - 1 ≤ 10 IU/L | + or - 10% > 10 IU/L | Prof. Opinion | |
| Beta-2-Microglobulin | + or - 0.2 ≤ 2.0 mg/L | + or - 10% > 2.0 mg/L | Imprecision | Minimal |
| NSE | + or - 2.0 ≤ 20 µg/L | + or - 10% > 20 µg/L | Prof. Opinion | |
| Gastrin | + or - 10 ≤ 100 pmol/L | + or - 10% > 100 pmol/L | Prof. Opinion | |
| Prolactin | + or - 40 ≤ 400 mIU/L | + or - 10% > 400 mIU/L | Imprecision | Minimal |
| Total PSA | + or - 0.4 ≤ 5.0 µg/L | + or - 8% > 5.0 µg/L | Imprecision | Optimal |
| Thyroglobulin | + or - 0.2 ≤ 1.7 µg/L | + or - 12% > 1.7 µg/L | Imprecision | Desirable |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Albumin | + or - 4.0 ≤ 20.0 mg/L | + or - 20% > 20.0 mg/L | Prof. Opinion | |
| Calcium | + or - 0.20 ≤ 2.0 mmol/L | + or - 10% > 2.0 mmol/L | Prof. Opinion | |
| Chloride | + or - 4 ≤ 40 mmol/L | + or - 10% > 40 mmol/L | Prof. Opinion | |
| Cortisol | + or - 30 ≤ 200nmol/L | + or - 15% > 200 nmol/L | Prof. Opinion | |
| Creatinine | + or - 0.5 ≤ 5.0 mmol/L | + or - 10% > 5.0 mmol/L | Prof. Opinion | |
| DPD (Free) | + or - 15 ≤ 80 nmol/L | + or - 15% > 80 nmol/L | Prof. Opinion | |
| Free 3-Methoxytyramine | + or - 15 ≤ 100 nmol/L | + or - 15% > 100 nmol/L | ||
| Free Metanephrine | + or - 30 ≤ 100 nmol/L | + or - 30% > 100 nmol/L | ||
| Free Normetanephrine | + or - 40 ≤ 200 nmol/L | + or - 20% > 200 nmol/L | ||
| Glucose | + or - 1.0 ≤ 10.0 mmol/L | + or - 10% > 10.0 mmol/L | Prof. Opinion | |
| hCG-quantitative | + or - 5 ≤ 50 IU/L | + or - 10% > 50 IU/L | Prof. Opinion | |
| Magnesium | + or - 0.3 ≤ 2.0 mmol/L | + or - 15% > 2.0 mmol/L | Prof. Opinion | |
| N-Telopeptides | + or - 80 ≤ 700 nmolBCE/L | + or - 10% > 700 nmolBCE/L | Prof. Opinion | |
| Osmolality | + or - 6 ≤ 300 mmol/kg | + or - 2% > 300 mmol/kg | Prof. Opinion | |
| Potassium | + or - 2 ≤ 20 mmol/L | + or - 10% > 20 mmol/L | Prof. Opinion | |
| Phosphate | + or - 3 ≤ 20 mmol/L | + or - 15% > 20 mmol/L | Prof. Opinion | |
| Sodium | + or - 4 ≤ 40 mmol/L | + or - 10% > 40 mmol/L | Prof. Opinion | |
| Total Protein | + or - 0.10 ≤ 1.00 g/L | + or - 10% > 1.00 g/L | Prof. Opinion | |
| Urate | + or - 0.3 ≤ 2 mmol/L | + or - 15% > 2 mmol/L | Prof. Opinion | |
| Urea | + or - 20 ≤ 200 mmol/L | + or - 10% > 200 mmol/L | Prof. Opinion | |
| ACR | + or - 0.5 ≤ 3.5 mg/mmol | + or - 15% > 3.5 mg/mmol | Prof. Opinion |
| Analyte | Lower limit | Upper limit | Basis | Level |
|---|---|---|---|---|
| Vitamin A | + or - 0.2 ≤ 1.7 μmol/L | + or - 12% > 1.7 µmol/L | Imprecision | Desirable |
| Vitamin E | + or - 3 ≤ 25 μmol/L | + or - 12% > 25 µmol/L | Imprecision | Desirable |
| β Carotene | + or - 0.4 ≤ 2.0 μmol/L | + or - 25% > 2.0 µmol/L | Total Error | Optimal |
| Total Carotenoids | + or - 0.8 ≤ 4.0 µmol/L | + or - 25% > 4.0 µmol/L | Total Error | Optimal |
| Vitamin B6 - Plasma (Pyridoxal Phosphate) | + or - 9 ≤ 60 nmol/L | + or - 15% > 60 nmol/L | Total Error | Optimal |
| Vitamin B6 – Whole Blood (Pyridoxal Phosphate) | + or - 9 ≤ 60 nmol/L | + or - 15% > 60 nmol/L | Total Error | Optimal |
| Vitamin B1 (Thiamine Pyrophosphate) | + or - 15 ≤ 150 nmol/L | + or - 10% > 150 nmol/L | Imprecision | Desirable |
| Vitamin B2 | + or - 25 ≤ 250 nmol/L | + or - 10% > 250 nmol/L | ||
| Vitamin C | + or - 7 ≤ 35 µmol/L | + or - 20% > 35 µmol/L | Imprecision | Desirable |