Royal College of Pathologists of Australasia Allowable Limits of Performance

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1 The RCPA (Royal College of Pathologists of Australasia) have developed a thorough set of specifications for allowable error. For those not bound by the CLIA regulations, these can serve as a valuable resource. Many analytes that are non-regulated by CLIA can be found here, too. Updated for 2014 Royal College of Pathologists of Australasia Allowable Limits of Performance The tables below contain information on quality requirements set by the Royal College of Pathologists of Australasia and the Australasian Clincal Biochemist association Quality Assurance Program.These guidelines for acceptable performance can be used as Analytical Quality Requirements in the QC Design and Planning process Update: In August, the AACB Scientific and Regulatory Affairs Committee updated the guidelines, tightening the allowable limits of performance for 21 analytes, as well as loosened the limits for 8 analytes. A bulletin with an explanation of the chances can be found here (RCPA website). You can skip ahead to specific areas of laboratory tests by clicking on the listed items: Alcohol / Ammonia Antibiotics Bile Acids Biogenic Amines Blood Gases BNP Co-oximetry CSF Endocrine General Serum Chemistry General Therapeutic Drugs Glycohaemoglobin IGF-1 / C Peptide Immunosuppressants Near Patient Testing (POC) Neonatal Bilirubin Plasma Metanephrines Porphyrins Special Lipids Special Therapeutic Drugs Sweat Electrolytes Trace Elements Tumour Markers Urine Chemistry Urine Pregnancy Testing Vitamins Alcohol/Ammonia (reviewed January 2012) Alcohol ± 2.0 < 20.0 ± 10% > 20.0

2 Ammonia ± 5 < 50 ± 20% > 50 Note: Analytical Quality Requirements are a plus/minus percentage.some browsers may not display the plus/minus character (it shouldappear right here, ±. If it does not, your browser doesnot support this Antibiotics (reviewed April 2013) Amikacin ± 3.4 < 34.0 ± 10% > 34.0 Gentamicin ± 0.2 mg/l < 2.0 mg/l ± 10% > 5.3 mg/l Tobramycin ± 0.5 mg/l < 5.0 mg/l ± 10% > 5.1 mg/l Vancomycin ± 2.0 mg/l < 20.3 mg/l ± 10% > 20.3 mg/l Bile Acids (reviewed January 2012) Total Bile Acids ± 4 < 40 ± 10% > 40 Biogenic Amines (Reviewed April 2012) Adrenaline ± 30 < 100 ± 30% > 100 Dopamine ± 0.20 < 2.0 ± 20% > 1.0 5HIAA ± 8 < 40 ± 20% > 40 HMMA ± 6 < 40 ± 15% > 40 HVA ± 6 < 40 ± 15% > 40 umol/day Metanephrine ± 0.2 < 1.0 ± 20% > 1.0 Noradrenaline ± 75 < 500 ± 15% > 500 Normetanephrine ± 0.4 < 2.0 ± 20% > Methoxytyramine ± 0.3 < 2.0 ± 15% > 2.0

3 Serotonin ± 0.2 < 1.0 ± 20% > 1.0 Blood Gas Chloride ± 3.0 Glucose ± 1.0 < 10.0 ± 10% > 10.0 Ionised Calcium ± 0.05 Lactate ± 1.0 < 10.0 ± 10% > 10.0 ph ± 0.04 pco 2 ± 2.0 mm Hg < 25.0 mm Hg ± 8% > 25.0 mm Hg po 2 ± 5 mm Hg < 100 mm Hg ± 5% > 100 mm Hg Potassium ± 0.2 Sodium ± 3.0 Urea ± 1.0 < 10.0 ± 10% > 10.0 Creatinine ± 10 < ± 10% > BNP (reviewed January 2012) NT-Pro BNP ± 25 ng/l < 125 ng/l ± 20% > 125 ng/l BNP ± 20 ng/l < 100 ng/l ± 20% > 100 ng/l

4 Co-oximetry Hemoglobin ± 3 g/l < 100 g/l ± 3% > 100 g/l concentration Fractional ± 3 < 75% ± 4% > 75% Oxyhemoglobin Fractional ± 2.0% Carboxyhemoglobin Fractional Methemoglobin ± 1.0 < 10% ± 10% > 100% CSF Albumin ± 0.02 g/l < 0.45 g/l ± 20% > 0.45 g/l Glucose ± 0.2 < 2.0 ± 10% > 2.0 Immunoglobin G ± 0.02 g/l < 0.1 g/l ± 20% > 0.1 g/l Lactate ± 0.3 < 3.0 ± 10% > 3.0 Total Protein ± 0.02 g/l < 0.45 g/l ± 5% > 0.45 g/l Bilirubin Concentration ± 0.12 < 0.60 ± 20% > 0.60 Xanthochromia-Bilirubin ± AU < AU ± 20% > AU screen Xanthochromia-Haemoglob ± 0.02 AU < 0.10 AU ± 20% > 0.10 AU in screen

5 Endocrine (Reviewed January 2012) AFP ± 2 kiu/l < 17 kiu/l ± 12% > 17 kiu/l Aldosterone ± 24 < 160 ± 15% > 160 Androstenedione ± 1.5 < 10 ± 15% > 10 CA 125 ± 6 ku/l < 50 ku/l ± 12% > 50 ku/l CEA ± 0.6 ug/l < 5.0 ug/l ± 12% > 5.0 ug/l Cortisol ± 15 < 100 ± 15% > 100 DHEA Sulphate ± 1.2 < 10 ± 12% > 10 Ferritin ± 4.0 ug/l < 27.0 ug/l ± 15% > 27.0 ug/l Folate ± 1.5 < 6.0 ± 25% > 6.0 FSH ± 1.0 IU/L < 10.0 IU/L ± 10% > 10.0 IU/L Growth Hormone ± 1 mu/l < 7 mu/l ± 15% > 7 mu/l hcg ± 1 IU/L < 10 IU/L ± 10% > 10.0 IU/L Homocysteine ± 1.5 < 15.0 ± 10% > Hydroxyprogesterone ± 2.0 < 10.0 ± 20% > 10.0 Insulin ± 0.6 mu/l < 5.0 mu/l ± 12% > 5.0 mu/l LH ± 1.5 IU/L < 10.0 IU/L ± 15% > 10.0 IU/L Oestradiol ± 25 < 100 ± 25% > 100 Oestriol(unconjugated) ± 0.9 < 6.0 ± 15% > 6.0 PTH ± 1.0 < 8.0 ± 12% > 8.0 Progesterone ± 2 < 10 ± 15% > 10 Prolactin ± 40 miu/l < 400 miu/l ± 10% > 400 miu/l SHBG ± 6 < 50 ± 12% > 50 Testosterone ± 0.4 < 2.7 ± 15% > 2.7 TSH ± 0.1 mu/l < 0.5 mu/l ± 20% > 0.5 mu/l Free T3 ± 0.7 < 3.5 ± 20% > 3.5 Free T4 ± 1.5 < 12 ± 12% > 12 Total T3 ± 0.2 < 1.3 ± 15% > 1.3 Total Tyroxine ± 12 < 120 ± 10% > 120

6 Vitamin B12 ± 18 < 120 ± 15% > 120 Vitamin D3 ± 9 < 60 ± 15% > 60 Total PSA ± 0.4 ug/l < 5.0 ug/l ± 8% > 5.0 ug/l Free PSA ± 0.2 ug/l < 1.4 ug/l ± 15% > 1.4 ug/l ACE ± 1.0 U/L < 10.0 U/L ± 10% > 10.0 U/L Red Cell Folate ± 80 < 400 ± 20% > 400 Faecal Occult Blood (reviewed May 2012) FOB Not detected < 125 Detected > 50 ng/ml Hb ng/ml Hb General Serum Chemistry Albumin ± 2.0 g/l < 33.0 g/l ± 6% > 33.0 g/l Alkaline Phosphatase ± 15 U/L < 125 U/L ± 12% > 125 U/L ALT ± 5 U/L < 40 U/L ± 12% > 40 U/L Amylase ± 10 U/L < 100 U/L ± 10% > 100 U/L AST ± 5 U/L < 40 U/L ± 12% > 60 U/L Bicarbonate ± 2.0 < 20 ± 10% > 20.0 Bilirubin - Total ± 3 < 25 ± 12% > 25 Bilirubin Conjugated ± 3 < 15 ± 20% > 15 Calcium ± 0.10 < 2.5 ± 4% > 2.5

7 Chloride ± 3.0 < 100 ± 3% > 100 Cholesterol ± 0.3 < 5 ± 6% > 5 Cholinesterase ± 500 U/L < 5000 U/L ± 10% > 5000 U/L Creatine Kinase ± 15 U/L < 125 U/L ± 12% > 125 U/L CK-MB ± 3 U/L & ug/l < 15 U/L ± 20% > 15 U/L & ug/l & ug/l Cortisol ± 30 < 150 ± 15% > 150 Creatinine ± 8 < 100 ± 8% > 100 Ferritin ± 4.0 ug/l < 27.0 ug/l ± 15% > 27 ug/l Fructosamine ± 15 < 250 ± 6% > 250 Glucose ± 0.4 < 5.0 ± 8% > 5.0 GGT ± 5 U/L < 40 U/L ± 12% > 40 U/L hcg-quantitative ± 1.0 IU/L < 10 IU/L ± 10% > 10 IU/L hcg-qualtitative Negative < 5 IU/L Equivocal 5-25 IU/L Positive > 25 IU/L HDL cholesterol ± 0.1 < 0.8 ± 12% > 0.8 Iron ± 3 < 25 ± 12% > 25 umoll Lactate Dehydrogenase ± 20 U/L < 250 U/L ± 8% > 250 U/L Lactate ± 0.5 < 4 ± 12% > 4 Lipase ± 12 U/L < 60 U/L ± 20% > 60 U/L Lithium ± 0.2 Magnesium ± 0.1 < 1.25 ± 8% > 1.25 Osmolality ± 8 mmol/kg < 266 ± 3% > 266 mmol/kg mmol/kg Phosphate ± 0.06 < 0.75 ± 8% > 0.75 Potassium ± 0.2 < 4.0 ± 5% > 4.0 Protein (Total) ± 3.0 g/l < 60 g/l ± 5% > 60 g/l Sodium ± 3 < 150 ± 2% > 150 Total T3 ± 0.2 < 1.3 ± 15% > 1.3 Free T3 ± 0.7 < 3.5 ± 20% > 3.5 Free T4 ± 1.5 < 12 ± 12% > 12

8 TSH ± 0.1 mu/l < 0.5 mu/l ± 20% > 0.5 mu/l Thyroxine ± 12 < 120 ± 10% > 120 TIBC ± 4 < 50 ± 8% > 50 Transferrin ± 0.2 g/l < 2.5 g/l ± 8% > 2.5 g/l Triglyceride ± 0.2 < 1.6 ± 12% > 1.6 Troponin I ± ug/ml < ± 20% > ug/ml ug/ml Troponin T ± 0.01 ug/l < ± 20% > ug/l ug/l Urate ± 0.03 < 0.38 ± 8% > 0.38 Urea ± 0.5 < 4.0 ± 12% > 4.0 General Therapeutic Drugs (Reviewed August 2013) Carbamazepine ± 2.0 < 20.0 ± 10% > 20.0 Digoxin ± 0.2 < 2.0 ± 10% > 2.0 Gentamicin ± 0.2 mg/l < 2.0 mg/l ± 10% > 5.3 mg/l Paracetamol ± 20 < 200 ± 10% > 200 Phenobarbitone ± 3.0 < 30.0 ± 10% > 30.0 Phenytoin ± 3.0 < 30.0 ± 10% > 30.0 Salicylate ± 0.1 < 1.0 ± 10% > 1.0 Theophylline ± 3.0 < 30.0 ± 10% > 30.0 Valproate ± 25 < 250 ± 10% > 250 Vancomycin ± 2.0 mg/l < 20.3 mg/l ± 10% > 20.3 mg/l

9 Glycohaemoglobin Hemoglobin A1C (NSP) ± 0.5 < 10% ± 5% > 10% (%) Hemoglobin A1c (IFCC) (mmol/mol) ± 4 < 186 mmol/mol ± 5% > 86 mmol/mol IGF-1 / C Peptide (Reviewed February 2012) IGF-1 ± 3 < 25.0 ± 12% > 25.0 C Peptide ± 0.15 < 1.25 ± 12% > 1.25 IGFBP-3 ± 15.0 < 100 ± 15% > 100 Immunosuppressants (Reviewed April 2012) Cyclosporing ± 10 ug/l < 100 ug/l ± 10% > 100 ug/l Siroliumus ± 0.5 ug/l < 5.0 ug/l ± 10% > 5.0 ug/l Tacrolimus ± 0.5 ug/l < 5.0 ug/l ± 10% > 5.0 ug/l

10 Near Patient Testing (Reviewed April 2012) Albumin ± 2.0 g/l < 33.0 g/l ± 6% > 33.0 g/l Alkaline Phosphatase ± 15 U/L < 125 U/L ± 12% > 125 U/L ALT ± 4 U/L < 40 U/L ± 12% > 40 U/L Amylase ± 10 U/L < 100 U/L ± 10% > 100 U/L AST ± 5 U/L < 40 U/L ± 12% > 40 U/L Bicarbonate ± 2.0 < 20.0 ± 10% > 20.0 Bilirubin ± 3.0 < 25.0 ± 12% > 25.0 Calcium ± 0.1 < 2.5 ± 4% > 2.5 Chloride ± 3.0 < 100 ± 3% > 100 Cholesterol ± 0.50 < 5.0 ± 6% > 5.0 Creatinine Kinase ± 15 U/L < 125 U/L ± 12% > 125 U/L Creatinine ± 8.0 < ± 8% > Glucose ± 0.4 < 5.0 ± 8% > 5.0 GGT ± 5 U/L < 40 U/L ± 12% > 40 U/L HDL Cholesterol ± 0.1 < 0.80 ± 12% > 0.80 Lactate Dehydrogenase ± 20 U/L < 250 U/L ± 8% > 250 U/L Magnesium ± 0.1 < 1.25 ± 8% > 1.25 Potassium ± 0.2 < 4.0 ± 5% > 4.0 Protein (total) ± 3 g/l < 60 g/l ± 5% > 60 g/l Sodium ± 3 < 150 ± 2% > 150 Triglyceride ± 0.2 < 1.6 ± 12% > 1.6 Troponin I ± 0.00 ug/l < 0.01 ug/l ± 20% > 0.01 ug/l

11 Troponin T Negative < 50 ng/l Low ng/l Quantitative ng/l High >2000 ng/l Troponin (Quantitative) ± 0.0 ng/l < 10 ng/l ± 20% > 10 ng/l Urate ± < ± 8% > Urea ± 0.5 < 4.0 ± 12% > 4.0 Neonatal Bilirubin (Reviewed January 2012) Total Bilirubin ± 8 < 80 ± 10% > 80 Conjugated Bilirubin ± 3 < 15 ± 20% > 15 Plasma Metanephrines (Reviewed January 2012) Metanephrine ± 75 < 500 ± 15% > 500 Normetanephrine ± 200 < 1000 ± 20% > 1000 Methyoxytyramine ± 36 < 120 ± 30% > 120

12 Porphyrins (Reviewed December 2012) Urine ALA ± 8 < 32 ± 25% > 32.0 Urine Porphobilinogen ± 5 < 20 ± 25% > 20 (Quantitative) Urine Porphobilinogen (Qualitative) neg < > 100 Urine Total Porphyrin ± 60 < 300 ± 20% > 300 Faecal Percent Dry Weight ± 2 < 20% ± 10% > 20% Faecal Total Porphyrin ± 40 umol/kg < 200 ± 20% > 200 umol/kg umol/kg Plasma Total Porphyrin ± 4 < 20 ± 20% > 20 RBC Total Porphyrin ± 0.4 rc < 2.0 rc ± 20% > 2.0 rc Special lipids (Reviewed April 2012) Cholesterol ± 0.30 < 5.0 ± 6% > 5.0 HDL Cholesterol ± 0.10 < 0.80 ± 12% > 0.80 LDL Cholesterol ± 0.20 < 2.0 ± 10% > 2.0 Triglyceride ± 0.20 < 1.6 ± 12% > 1.6 Apolipoprotein A1 ± 0.2 g/l < 2.0 g/l ± 10% > 2.0 g/l Apolipoprotein B ± 0.2 g/l < 2.0 g/l ± 10% > 2.0 g/l Lipoprotein(a) ± 0.2 g/l < 2.0 g/l ± 10% > 2.0 g/l

13 Special Therapeutic Drugs (Reviewed April 2013) Amiodarone ± 0.2 < 2.0 ± 10% > 2.0 Amitriptyline ± 10 < 100 ± 10% > 100 Clozapine ± 10 ug/l < 100 ug/l ± 10% > 100 ug/l Methotrexate ± 0.1 < 1.0 ± 10% > 1.0 Mycophenylate ± 0.1 mg/l < 1.00 mg/l ± 10% > 1.00 mg/l Nortriptyline ± 10 < 100 ± 10% > 100 Sweat Electrolytes Sodium ± 2 < 20 ± 10% > 20 Chloride ± 2 < 20 ± 10% > 20 Sweat Conductivity ± 2 < 20 ± 10% > 20 Trace Elements (Reviewed April 2012) Serum Aluminum ± 0.08 < 0.40 ± 20% > 0.40

14 Chromium ± 3 < 25 ± 12% > 25 Cobalt ± 1 < 10 ± 10% > 10 Copper ± 1.6 < 20.0 ± 8% > 20.0 Manganese ± 3 < 25 ± 12% > 25 Selenium ± 0.18 < 1.5 ± 12% > 1.50 Zinc ± 2.0 < 20.0 ± 10% > 20.0 Urine Aluminum ± 0.1 < 0.50 ± 20% > 0.50 Arsenic (Total) ± 0.05 < 0.50 ± 10% > 0.50 Cadmium ± 3 < 20 ± 15% > 20 Chromium ± 3 < 25 ± 12% > 25 Cobalt ± 2 < 20 ± 10% > 20 Copper ± 0.05 < 0.50 ± 10% > 0.50 Iodine ± 0.08 < 0.80 ± 10% > 0.80 Lead ± 0.05 < 0.50 ± 10% > 0.50 Manganese ± 3 < 25 ± 12% > 25 Mercury ± 9 < 60 ± 15% > 60 Nickel ± 0.04 < 0.40 ± 10% > 0.40 Selenium ± 0.06 < 0.50 ± 12% > 0.50 Thallium ± 1 < 10 ± 10% > 10 Vanadium ± 1 < 10 ± 10% > 10 Zinc ± 2.0 < 20.0 ± 10% > 20.0 Whole Blood Arsenic (Total) ± 0.01 < 0.10 ± 10% > 0.10 Cadmium ± 3 < 20 ± 15% > 20 Lead ± 0.05 < 0.50 ± 10% > 0.50 Manganese ± 30 < 250 ± 12% > 250 Mercury ± 9 < 60 ± 15% > 60 Selenium ± 0.3 < 2.50 ± 12% > 2.50

15 Zinc ± 6 < 60 ± 10% > 60 Tumour Markers ACTH ± 2.0 < 20 ± 10% > 20 Alpha-fetoprotein ± 2 kiu/l < 17 kiu/l ± 12% > 17 kiu/l Calcitonin ± 2 ng/l < 20 ng/l ± 10% > 20 ng/l CEA ± 0.6 ug/l < 5.0 ug/l ± 12% > 5.0 ug/l CA125 ± 6 ku/l < 50 ku/l ± 12% > 50 ku/l CA15-3 ± 3 ku/l < 30 ku/l ± 10% > 30 ku/l CA19-9 ± 6 ku/l < 40 ku/l ± 15% > 40 ku/l hcg ± 1 IU/L < 10 IU/L ± 10% > 10 IU/L Beta-2 Microglobulin ± 0.2 mg/l < 2.0 mg/l ± 10% > 2.0 mg/l NSE ± 2.0 ug/l < 20 ug/l ± 10% > 20 ug/l Gastrin ± 10 < 100 ± 10% > 100 Prolactin ± 40 mu/l < 400 mu/l ± 10% > 400 mu/l Total PSA ± 0.4 ug/l < 5.0 ug/l ± 8% > 5.0 ug/l Thyroglobulin ± 0.2 ug/l < 1.7 ug/l ± 12% > 1.7 ug/l Urine Chemistry

16 Albumin ± 4.0 mg/l < 20.0 g/l ± 20% > 20.0 g/l Calcium ± 0.20 Chloride ± 2.0 < 20.0 ± 10% > 20.0 Cortisol ± 30 < 200 ± 15% > 200 Creatinine ± 0.5 < 5.0 ± 10% > 5.0 DPD (Free) ± 15 < 80 ± 15% > 80 Glucose ± 1.0 < 10.0 ± 10% > 10.0 hcg-qualitative Negative < 5 IU/L Equivocal 5-25 UI/L Positive > 25 IU/L hcg-quantitative ± 5 IU/L < 50 IU/L ± 10%; > 50 IU/L Magnesium (serum) ± 0.2 N-Telopeptides ± 80 nmolbce/l < 700 ± 10% > 700 nmolbce/l nmolbce/l Osmolality ± 6 mmol/kg < 300 ± 2% > 300 mmol/kg mmol/kg Potassium ± 2.0 < 20.0 ± 10% > 20.0 Phosphate ± 2.5 Sodium ± 2.0 < 20.0 ± 10% > 20.0 Total Protein ± 0.1 g/l < 1.0 g/l ± 10% > 1.0 g/l Urate ± 0.3 Urea ± 20 < 200 ± 10% > 200 ACR ± 0.5 mg/mmol < 3.5 mg/mmol ± 15% > 3.5 mg/mmol Urine Pregnancy Testing hcg Negative < 5 IU/L Equivocal 5-25 IU/L Positive > 25 IU/L

17 Powered by TCPDF ( Vitamins (Reviewed April 2013) Vitamin A ± 0.2 < 1.7 ± 12% > 1.7 Vitamin E ± 3 < 25 ± 12% > 25 Beta Carotene ± 0.4 < 2.0 ± 25% > 2.0 Total Carotenoids ± 0.8 < 4.0 ± 25% > 4.0 Vitamin B6 - Plasma ± 9 < 60 ± 15% > 60 (Pyridoxal Phosphate) Vitamin B6 - Whole ± 9 < 60 ± 15% > 60 Blood (Pyridoxal Phosphate) Vitamin B1 (Thiamine ± 15 < 150 ± 10% > 150 Pyrophosphate) Vitamin B2 ± 25 < 250 ± 10% > 250 Vitamin C ± 9 < 36 ± 25% > 36