Haematology Analytical Performance Specifications


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Analyte Lower limit Upper limit Assessment category
WCC + or - 0.5 ≤ 5.0 x 109/L + or - 10% > 5.0 x 109/L Measurement system
RCC + or - 0.2 ≤ 2.0 x 1012/L + or - 10% > 2.0 x 1012/L Measurement system
Hb + or - 5 ≤ 100 g/L + or - 5% > 100 g/L Measurement system
Hct + or - 0.04 ≤ 0.20 + or - 20% > 0.20 Measurement system
MCV + or - 5 ≤ 50 fL + or - 10% > 50 fL Measurement system
MCH + or - 2 ≤ 20 pg + or - 10% > 20 pg Measurement system
MCHC + or -30 ≤ 300 g/L + or - 10% > 300 g/L Measurement system
RDW-CV + or - 2 ≤ 10% + or - 20% > 10% Measurement system
PLT + or - 25 ≤ 100 x 109/L + or - 25% > 100 x 109/L Measurement system
MPV + or - 2 ≤ 10 fL + or - 20% > 10 fL Measurement system
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WCC + or - 0.5 ≤ 5.0 x 109/L + or - 10% > 5.0 x 109/L Measurement system
Neutrophils / Granulocytes + or - 1.0 ≤ 10.0% + or - 10% > 10.0% Measurement system
Lymphocytes + or - 2.0 ≤ 10.0% + or - 20% > 10.0% Measurement system
Monos / Eosinos / Basos / LUC / IG + or - 3.0 ≤ 10.0% + or - 30% > 10.0% Measurement system
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Percentage + or - 1.0 ≤ 10.0 % + or - 10% > 10.0 % Measurement system
Absolute count + or - 10 ≤ 100 + or - 10% > 100 x109/L Measurement system
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Percentage + or 0.6 ≤ 2.0 % + or - 30% > 2.0 % Analytical principle
Absolute count + or 21.0 ≤ 70.0 + or - 30% > 70.0 x109/L Analytical principle
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ESR + or - 3.0 ≤ 10.0 mm/hr + or - 30% > 10.0 mm/hr Measurement system
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G6PD assay + or - 3.0 ≤ 10.0 U/g Hb + or - 30% > 10.0 U/g Hb Reagent
G6PD Screen and assay Interpretation Assessed on qualitative result Assessed on qualitative result N/A
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Hb A2 + or - ≤ 0.3 2.0% + or - 10% > 2.0% Measurement system
Hb F + or - ≤ 0.5 1.50% + or - 30% > 1.50% Measurement system
Hb Variant + or - ≤ 4 20% + or - 20% > 20% Measurement system
Final interpretation Assessed on qualitative result Assessed on qualitative result Consensus and expert advisory
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Red cell sickling Assessed on qualitative result Assessed on qualitative result N/A
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Malaria Rapid Test result Assessed on qualitative result Assessed on qualitative result N/A
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PT + or -2.0 ≤ 10.0 sec + or - 20% > 10.0 sec Reagent
INR / POC INR + or - 0.3 ≤ 2.0 ratio + or - 15% > 2.0 ratio Reagent
APTT + or - 10 ≤ 40 sec + or - 25% > 40 sec Reagent
Fibrinogen + or - 0.20 ≤ 1.0 g/L + or - 25% > 1.0 g/L Reagent
Thrombin Time + or - 3 ≤ 12 sec + or - 25% > 12 sec Reagent
Factor II, V, VII, VIII, IX, X, XI, XII + or - 3 ≤ 10 IU/dL + or - 30% > 10 IU/dL Calibrator
D-Dimer (Automated) + or - 0.25 ≤ 0.50 DD mg/L + or - 50% > 0.50 DD mg/L Reagent
D-Dimer (Automated) + or - 0.5 ≤ 1.0 FEU mg/L + or - 50% > 1.00 FEU mg/L Reagent
D-Dimer (Semi quantitative) Assessment on interpretation Assessment on interpretation N/A
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APTT + or - 9.0 ≤ 30 sec + or - 30% >30 sec Reagent
APTT Screen Ratio + or - 0.3 ≤ 0.9 ratio + or - 30% > 0.9 ratio Reagent
DRVVT screen + or - 9.0 ≤ 30 sec + or - 30% > 30 sec Reagent
DRVVT screen ratio + or - 0.3 ≤ 0.9 ratio + or - 30% > 0.9 ratio Reagent
Final interpretation Assessment on interpretation Assessment on interpretation Reagent
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Protein C functional + or - 12 ≤ 60% + or - 20% > 60% Reagent
Protein S Total Antigen + or - 10 ≤ 40% + or - 25% > 40% Reagent
Protein S Free Antigen + or - 10 ≤ 40% + or - 25% > 40% Reagent
Protein S Free Functional + or - 10 ≤ 40% + or - 25% > 40% Reagent
AT Functional + or - 10 ≤ 40% + or - 25% > 40% Reagent
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APCR APTT, APTT V, APCR RVVT, RVVT V, APCR Staclot Assessed on interpretation Assessed on interpretation N/A
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FVIII:C + or - 3 ≤ 10% + or - 30% > 10% Reagent
VWF:Ag + or - 3 ≤ 10% + or - 30% > 10% Reagent
VWF:RCo + or - 4 ≤ 10% + or - 40% > 10% Reagent
VWF:CB + or - 4 ≤ 10% + or - 40% > 10% Reagent
VWF:Activity + or - 4 ≤ 10% + or - 40% > 10% Reagent
Ratios and final interpretation Assessment on interpretation Assessment on interpretation Reagent
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Inhibitor level BU Assessed on interpretation Assessed on interpretation Reagent deficient plasma
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Closure time Assessed on interpretation Assessed on interpretation N/A
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Inhibition level Assessed on inhibition level interpretation Assessed on inhibition level interpretation N/A
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APTT + or - 10 ≤ 40 sec + or - 25% > 40 sec Reagent
Anti Xa + or - 0.1 ≤ 0.4 U/mL + or - 25% > 0.4 U/mL Reagent
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DTI + or - 25 ≤ 100 ng/mL + or - 25% > 100 ng/mL Reagent
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Anti Xa + or - 25 ≤ 100 ng/mL + or - 25% > 100 ng/mL Reagent
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Anti Xa + or - 25 ≤ 100 ng/mL + or - 25% > 100 ng/mL Reagent
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Factor XIII Assessment on diagnostic interpretation Assessment on diagnostic interpretation N/A
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Clotting Times Assessment on final interpretation Assessment on final interpretation N/A
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Clotting Times Assessment on final interpretation Assessment on final interpretation N/A
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Clotting Times Clotting time interpretation Clotting time interpretation N/A
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%CD34 + or - 0.05 ≤ 0.20% + or - 25% > 0.20% Measurement system
Total CD34 + or -5 ≤ 20.0 + or - 25% > 20.0 μL Measurement system
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CD markers Assessment by Z-Score Assessment by Z-Score N/A
CD marker interpretation and Final interpretation Assessment on interpretation Assessment on interpretation Consensus and expert advisory
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Markers Assessment by Z-Score Assessment by Z-Score N/A
Final interpretation Assessment on interpretation Assessment on interpretation Consensus and expert advisory
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Neutrophils, Total lymphocytes + or 12 ≤ 40 % + or 30% > 40 N/A
Monocytes, Eosinophils, Basophils, Lymphocytes Abnormal, other cells + or 6 ≤ 20 % + or 30% > 20 N/A
Blasts, Promyelocytes, Myelocytes, metamyelocytes, lymphocytes reactive, Nucleated red cells + or 4 ≤ 15 % + or 30% > 15 N/A
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White cell, Red and platelet morphology description Assessed using scoring Assessed using scoring Consensus and expert advisory
Diagnostic interpretation Assessment on interpretation using terminology Assessment on interpretation using terminology Consensus and expert advisory
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White cell, Red and platelet morphology description Assessed using scoring Assessed using scoring Consensus and expert advisory
Diagnostic interpretation Assessment on interpretation using terminology Assessment on interpretation using terminology Consensus and expert advisory
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Blasts, Promyelocytes, Plasma cells + or 4 ≤ 15 % + or 30% > 15 N/A
Myelocytes, metamyelocytes, Neutrophils / band forms, Erythroblasts, Lymphocytes + or 12 ≤ 40 % + or 30% > 40 N/A
Monocytes, Eosinophils, Basophils, other cells + or 6 ≤ 20 % + or 30% > 20 N/A
Myeloid / Erythroid ratio + or 1 ≤ 3.0 + or 30% > 3 N/A
Diagnostic Interpretation Assessment on interpretation using terminology Assessment on interpretation using terminology Consensus and expert advisory
Analyte Lower limit Upper limit Assessment category
Size of parasitised red cells Assessed using scoring Assessed using scoring Consensus and expert advisory
Blood film / parasite description Assessed using scoring Assessed using scoring Consensus and expert advisory
Diagnostic interpretation Assessment on interpretation using terminology Assessment on interpretation using terminology Consensus and expert advisory