Serum Chemistry

Serum Chemistry

Purpose:
The Serum Chemistry programme is available as part of a comprehensive suite of programmes to assess and monitor the performance of the routine Clinical Biochemistry laboratory’s repertoire of core tests used for the diagnosis and monitoring of disease.

A Serum Indices interference study is included twice a year as part of the Serum Chemistry programme to assess the effects of interference from Haemolysis, Icterus and Lipaemia on the Serum Chemistry analytes.

Serum Indices is also available as a standalone programme to assess the performance of the HIL indices assays.

Scope:
Four liquid human serum samples are distributed monthly, with a minimum of 48 samples distributed over the year covering a wide clinically relevant range. The samples consist of a panel of 8 linearly related samples distributed on a number of occasions over that period which are used to assess both laboratory and method performance, including linearity, bias, within and between batch imprecision. Trueness is also assessed for a number of analytes using high metrological order Reference measurement systems.

Additional challenging samples are distributed to assess diagnostic accuracy near the cut points, method interferences and for educational purposes.

Calculated parameters are also assessed such as:
Adjusted Calcium, e-GFR, Calculated Globulins, TIBC and Transferrin Saturation.

Reference target values are provided for Na, K, Li, Mg, Ca, AST, LDH, GGT, ALT, Creatinine, Glucose and UA.


Key Features:

  • Liquid human serum samples require no pre-analytical preparation.
  • Linearly related panel covering the pathological range with full traceability assists with your compliance to ISO 15189.
  • Traceable Reference Values used to assess analyser bias with uncertainty of measurement provided for Sodium, Potassium, Creatinine, e-GFR, Glucose, Calcium, Magnesium, Urate, Lithium, AST, ALT, GGT and LDH.
  • Interference studies distributed twice a year to assess the effect of positive HIL indices on the Serum Chemistry analytes.
  • Sigma metric scoring based on clinically relevant Milan Model 2 performance specification.

Frequency:
Monthly
Samples:
4 x 3.0mL or
4 x 1.0mL
Material:
Off the clot serum
Serum Chemistry Programme
AnalyteApprox. Range Covered
Sodium100 - 165mmol/L
Potassium1.6 - 8.0mmol/L
Chloride73 -123mmol/L
Bicarbonate7 - 28mmol/L
Urea1.5 - 25mmol/L
Creatinine25 - 600 µmol/L
e-GFR<15 to >90mls/min/1.73m2
Glucose1.4 - 25mmol/L
Calcium1.2 - 3.3mmol/L
Adjusted Calcium1.4 - 3.0mmol/L
Phosphate0.2 - 2.2mmol/L
Total Protein34 - 86g/L
Albumin20 - 53g/L
Calculated Globulin20 - 40g/L
Magnesium0.2 - 2.0mmol/L
Urate100 - 700µmol/L
Lithium0.05 - 2.0mmol/L
Lipase10 - 400IU/L
Osmolality190 - 390mmol/kg
AST5 - 300IU/L IFCC
ALT5 - 500IU/L IFCC
ALP25 - 400IU/L SCE
CK20 - 1200IU/L SCE
Gamma GT10 - 400IU/L SCE
Amylase15 - 800IU/L
Pancreatic Amylase20 - 160IU/L
LDH50 - 700IU/L SCE
Iron7 - 30µmol/L
TIBC28 - 82µmol/L
Transferrin1.5 - 3.5g/L
Transferrin Saturation22 - 30%
Gentamicin1 - 8µg/mL

Related Documents

 

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Accreditation

UKAS Proficiency Testing 4301UKAS Calibration 4301


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