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.

The interference of bilirubin in a number of spectrophotometric methods such as kinetic alkaline picrate creatinine assays (Jaffe) for creatinine assays is well known and for this reason, a separate programme is provided for bilirubin to ensure that a true assessment of method performance and bias can be provided in the Serum Chemistry Programme for those analytes affected by icteric interference.

Separate samples, distributed twice a year are provided to assess the effects of interferences i.e Haemolysis, Icterus and Lipaemia on the Serum Chemistry analytes and methods.

Serum Indices is also available as a separate 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 human serum

Serum Chemistry Programme
Analyte	Approx. Range Covered
Sodium	100 - 165	mmol/L
Potassium	1.6 - 8.0	mmol/L
Chloride	73 - 123	mmol/L
Bicarbonate	7 - 28	mmol/L
Urea	1.5 - 25	mmol/L
Creatinine	25 - 600	µmol/L
e-GFR	<15 - >90	mLs/min/1.73m2
Glucose	1.4 - 25	mmol/L
Calcium	1.2 - 3.3	mmol/L
Adjusted Calcium	1.4 - 3.0	mmol/L
Phosphate	0.2 - 2.2	mmol/L
Total Protein	34 - 86	g/L
Albumin	20 - 53	g/L
Calculated Globulin	20 - 40	g/L
Magnesium	0.2 - 2.0	mmol/L
Urate	100 - 700	µmol/L
Lithium	0.05 - 2.0	mmol/L
Lipase	10 - 400	IU/L
Osmolality	190 - 390	mOsmo/kg
AST	5 - 300	IU/L IFCC
ALT	5 - 500	IU/L IFCC
ALP	25 - 400	IU/L SCE
CK	20 - 1200	IU/L SCE
Gamma GT	10 - 400	IU/L SCE
Total Amylase	15 - 800	IU/L
Pancreatic Amylase	20 - 160	IU/L
LDH	50 - 700	IU/L SCE
Iron	7 - 30	µmol/L
TIBC	28 - 82	µmol/L
Transferrin	1.5 - 3.5	g/L
Transferrin Saturation	22 - 30	%
Gentamicin	1 - 8	µg/mL