Immunology Analytical Performance Specifications


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Measurand Lower limit Upper limit
hsCRP ±0.60 ≤ 3.00 mg/L ±20% > 3.00 mg/L
Measurand Lower limit Upper limit
IgD ±0.2 ≤ 1.0 g/L ±20% > 1.0 g/L
Measurand Lower limit Upper limit
IgE ±20 ≤ 100 kU/L ±20% > 100 kU/L
Measurand Lower limit Upper limit
IgG ±0.6 ≤ 6.0 g/L ±10% > 6 g/L
IgA ±0.06 ≤ 0.60 g/L ±10% if > 0.6 g/L
IgM ±0.08 ≤ 0.50 g/L ±15% > 0.5 g/L
C3 ±0.10 ≤ 1.0 g/L ±10% if > 1.0 g/L
C4 ±0.02 ≤ 0.20 g/L ±10% if > 0.20 g/L
α1AT ±0.10 ≤ 0.50 g/L ±20% if > 0.50 g/L
C1inh ±0.03 ≤ 0.20 g/L ±15% if > 0.20 g/L
Haptoglobin ±0.10 ≤ 0.80 g/L ±10% if > 0.80 g/L
Caeruloplasmin ±0.03 ≤ 0.20 g/L ±15% if > 0.20 g/L
Prealbumin ±0.04 ≤ 0.20 g/L ±20% if > 0.20 g/L
Measurand Lower limit Upper limit
CD3+% ±1.5 ≤ 30% ±5% if > 30%
CD3+CD4+% ±3 ≤ 40% ±7.5% if > 40%
CD3+CD8+% ±1.5 ≤ 15% ±10% if > 15%
CD3-CD16+% ±2 to ≤ 10% ±20% if > 10%
CD3-CD56+% ±2 ≤ 10% ±20% if > 10%
CD3-CD16+56+% ±2 ≤ 10% ±20% if > 10%
CD3+ Alpha-beta % ±4.5 ≤ 30% ±15% if > 30.0%
CD19+% ±2 ≤ 10% ±20% if > 10%
CD3x109/L ±0.02 ≤ 0.10 x109/L ±20% if > 0.10 x109/L
CD4x109/L ±0.02 ≤ 0.10 x109/L ±20% if > 0.10 x109/L
CD8x109/L ±0.02 ≤ 0.10 x109/L ±20% if > 0.10 x109/L
CD19x109/L ±0.02 ≤ 0.10 x109/L ±20% if > 0.10 x109/L
Measurand Lower limit Upper limit
Procalcitonin ±0.05 ≤ 0.15 ng/mL ±30% if > 0.15 ng/mL
Measurand Lower limit Upper limit
Rheumatoid Factor ±12 ≤ 60 IU/mL ±20% if > 60 IU/mL
Measurand Lower limit Upper limit
Tryptase ±0.6 ug/L ≤ 4.0 ug/L ±15% if > 4.0 ug/L