Increasing Efficiency and Quality by Consolidation of Clinical Chemistry and Immunochemistry Systems with MODULAR ANALYTICS SWA

Table 1

List of analytes used during the performance evaluation and within-run imprecision for selected analytes (cells with a CV number: analytes were used for within-run imprecision, x: analytes were added for the workflow experiments; CS1 control serum PNU from Roche, HS human serum pool, HU human urine pool, analyte concentrations within or slightly above reference range; CS pool, control serum of a low- and high-level control).

Assays	Method	Units	Material	Lab 1 CV%	Lab 2 CV%	Lab 3 CV%	Lab 4 CV%	Lab 5 CV%	Lab 6 CV%	Qual-Spec CV% ^*
Electrolyte assays
NA	Sodium (ISE-indirect)	mmol/l	CS 1	0.3	0.4	0.3	0.3	0.7	0.4	0.3 (0.7)
K	Potassium (ISE-indirect)	mmol/l	CS 1	0.5	0.5	0.3	0.5	0.8	0.4	2.4
CL	Chloride (ISE-indirect)	mmol/l	CS 1	0.4	0.5	0.4	0.4	0.6	0.5	0.7 (1.0)
Enzyme assays
ACP	acid phosphatase	U/l			x				x	4.5
ALP_A	Alkaline phosphatase AMP	U/l	CS 1					0.9		3.4
ALP_I	Alkaline phosphatase IFCC	U/l	CS 1			0.7	x			3.4
ALP_O	Alkaline phosphatase optimized	U/l	CS 1	x	1				x	3.4
ALT_I	Alanine aminotransferase IFCC, wo Pyp	U/l	CS 1	2.5	x			2.4	2.4	13.6
ALT_IP	Alanine aminotransferase IFCC, w Pyp	U/l	CS 1			2.5	x			13.6
AST_I	Aspartate aminotransferase IFCC wo Pyp	U/l	CS 1	x	3.3			2.2	2.1	7.2
AST_IP	Aspartate aminotransferase IFCC w Pyp	U/l	CS 1			x	2.1			7.2
AMY	Amylase total EPS (ethylidene protected substrate)	U/l	CS 1		0.7	x	x	0.6	0.6	3.7
P-AMY	Amylase pancreatic EPS	U/l	CS 1	0.8						5.9
CHE	Cholinesterase (Butyrylthiocholine substrate)	U/l		x	x		x		x	3.5
CK	Creatine kinase, NAC activated (N-acetylcysteine)	U/l	CS 1	0.6	0.8	x	x	0.7	x	20.7
CKMB	CK-MB—MB isoenzyme of creatine kinase	U/l	CS 1	2.3	x		x		x
GGT	γ-Glutamyl transferase (procedure by Szasz-Persijn)	U/l	CS 1	x	x	1.8	1.6	x	1.7	7.4
GLDH	Glutamate dehydrogenase	U/l		x					x
HBDH	Lactate dehydrogenase-1-isoenzyme	U/l							x
LDH_O	Lactate dehydrogenase DGKC	U/l	CS 1	x	0.4	x	0.7		x	3.9
LD	Lactate dehydrogenase	U/l	CS 1					1		3.9
LIP	Lipase colorimetric	U/l	CS 1	1				1	0.8	11.6
Substrate assays
ALB	Albumin (BCG, bromcresol green, plus)	g/l	CS 1	x	0.8		x	1.2		1.1 (2.8)
D-BIL	Bilirubin direct (Jendrassik)	𝜇mol/l	CS 1	x	x	x	x	1.8	x
T-BIL	Bilirubin total (DPD, dichlorphenyldiazonium method)	𝜇mol/l	CS 1	x	x	x	x	1.9	x	11.3
CHOL	Cholesterol (CHOD-PAP)	mmol/l	CS 1	0.8	1.0	0.9	0.9	1.1	1.4	2.7
HDL	High-density lipoproteins	mmol/l	CS 1		0.8	0.9	x	0.9	x	3.6
LDL	Low-density lipoproteins	mmol/l	CS 1			0.6		x	x	3.3
CREAJ	Creatinine (Jaffé, rate blanked)	𝜇mol/l	CS 1		2.4	1.4	1.9	1.1	1.8	2.2
CREA	Creatinine (enzymatic, plus)-urine	𝜇mol/l		x
GLU_P	Glucose (GOD-PAP)	mmol/l	CS 1			0.8	0.9			2.2
GLU_H	Glucose (hexokinase)	mmol/l	CS 1	0.9	0.7	1.0		1.0	0.6	2.2
FE	iron (FerroZine method)	𝜇mol/l	CS 1	0.5	x	0.7	1.2	x	x	15.9
LACT	Lactate (colorimetric)	mmol/l	CS 1	0.7	0.9					13.6
TP	Total protein (biuret reaction)	g/l	CS 1	x	0.4	x	x	0.8	x	1.4
TG	Triacylglycerol (GPO-PAP)	mmol/l	CS 1	1.1	1.3	0.9	1.2	1.2	0.7	11.5
UREA	UREA/BUN (UV, kinetic)	mmol/l	CS 1	1.8	1.4	1.5	1.6	1.3	1.7	6.3
UA	Uric acid (PAP, plus)	𝜇mol/l	CS 1	x	0.5	1.6	0.6	1.0	1.0	4.2
CO2	Bicarbonate (UV, kinetic)	mmol/l	CS 1					1.6		2.3 (4.9)
CA	Calcium (OCPC, ortho-cresolphthalein complexone)	mmol/l	CS 1	0.8	1.1	0.7	0.9	1.1	x	0.9 (1.5)
MG	Magnesium (xylidyl blue method)	mmol/l	CS 1	0.7	0.7			1.0	x	1.1 (2.6)
PHOS	Phosphorus (molybdate, UV)	mmol/l	CS 1	x	1.1	x	x	1.4	x	4
Protein assays
GPROT	1-acid-glycoprotein (TIA, Tina-quant a)	g/l	HS Pool		0.7	x				5.7
ATRYP	1-antitrypsin (TIA, Tina-quant a)	g/l			x					3.0
MICGL	2-microglobulin (TIA, Tina-quant a)	𝛼g/ml			x					3.0
ASLO	Antistreptolysin O (LPIA, Tina-quant a)	IU/ml	HS Pool		0.6				1.0
C3c	Complement protein C3c (TIA, Tina-quant a)	g/l	HS Pool		x			1.3
C4	Complement protein C4 (TIA, Tina-quant a)	g/l			x			x
CPLAS	Ceruloplasmin (TIA, Tina-quant a)	g/l			x
CRP	C-reactive protein (TIA, Tina-quant a)	mg/l	HS Pool	x	0.8	x	x	1.2	1.3	26.3
FERR	Ferritin (LPIA, Tina-quant a)	𝛼g/l	HS Pool		2.3					7.5
HBA1C%	Glycated haemoglobin A1c (TIA, Tina-quant a)	%	HS Pool				1.1
HGLOB	Haptoglobin (TIA, Tina-quant a)	g/l	HS Pool	0.9	1.1			x		10.2
IGG	Immunoglobulin G (TIA, Tina-quant a)	g/l	CS 1		x	2.5	2.0	2.6	1.9	1.9 (3.7)
IGA	Immunoglobulin A (TIA, Tina-quant a)	g/l	CS 1		x	1.5	0.8	x	1.1	2.2 (3.8)
IGM	Immunoglobulin M (TIA, Tina-quant a)	g/l	CS 1		x	1.7	1.7	x	1.3	2.3 (5.4)
IGE	Immunoglobulin E (TIA, Tina-quant a)	𝛽g/l			x				x
KAPPA	Kappa (TIA, Tina-quant a)	g/l			x
LAMBD	Lambda (TIA, Tina-quant a)	g/l			x
MYO	Myoglobin (TIA, Tina-quant a)	𝜇g/l		x
PALB	Prealbumin (TIA, Tina-quant a)	IU/ml	HS Pool		2.2					5.5
RF	Rheumatoid factor (LPIA, Tina-quant a)	IU/ml	HS Pool		0.5	0.8		0.6	0.9	4.3
TRANS	Transferrin (TIA, Tina-quant a)	g/l	CS 1	x	1.5	1.4	x	1.9	x	1.5
TDM assays
CARB	Carbamazepine (CEDIA)	𝜇mol/l						x
DIG	Digoxin (LPIA)	nmol/l	HS Pool					2.0		3.8 (4.7)
GENT	Gentamicin II (CEDIA)	𝜇mol/l						x
NAPA	NAPA (CEDIA)	𝜇mol/l						x
PHENO	Phenobarbital II (CEDIA)	𝜇mol/l						x
PHNY	Phenytoin II (CEDIA)	𝜇mol/l						x
PROC	Procainamide (CEDIA)	𝜇mol/l						x
SAL	Salicylate (iron complex)	mmol/l						x
THEO	Theophylline II (CEDIA)	𝜇mol/l						x
VALP	Valproic Acid II (CEDIA)	𝜇mol/l	HS Pool					2.0		6.4
Urine assays
NA	Sodium (ISE-indirect)-urine	mmol/l	HU Pool	0.4	0.6		0.4	0.6		14.4
K	Potassium (ISE-indirect)-urine	mmol/l	HU Pool	0.4	0.8		0.4	1.2		9.0
CL	Chloride (ISE-indirect)-urine	mmol/l	HU Pool	0.8	1.3		0.6	0.6
AMY	Amylase liquid-urine	U/l	HU Pool				0.7	x
CREAJ	Creatinine Jaffé (rate blanked)-urine	𝜇mol/l	HU Pool		0.8		1.0	1.2		5.5
CREA	Creatinine (enzymatic, plus)-urine	𝜇mol/l	HU Pool	0.9						5.5
GLU_H	Glucose (hexokinase)-urine	mmol/l	HU Pool	x				x
UREA	UREA/BUN (UV, kinetic)-urine	mmol/l	HU Pool	1.9	1.2		1.4	1.5
UA	Uric Acid (PAP, plus)-urine	𝜇mol/l	HU Pool	0.9	0.9		0.7	x
CA	Calcium (OCPC, ortho-cresolphthalein complex.)-urine	mmol/l	HU Pool	3.0	1.6			x		13.1
MG	Magnesium (xylidyl blue method)-urine	mmol/l	HU Pool		1.0			x		19.2
PHOS	Phosphorus (molybdate, UV)-urine	mmol/l	HU Pool	1.2	1.6			x		9.0
U/CSF	Protein in urine/CSF(turbidim., rate)	g/l	HU Pool		0.8		x	0.7		17.8
MAU	Albumin in urine (TIA, Tina-quant a)	mg/l	HU Pool		1.3		x			18
Immunochemistry assays
T3	Triiodothyronine	nmol/l	CS Pool	x	1.4			x	0.8	4.0 (4.7)
T4	Thyroxine	nmol/l	CS Pool	2.7				x	1.5	3.4 (4.1)
FT3	Free triiodothyronine	pmol/l	CS Pool	1.5		2.0				4.0
FT4	Free thyroxine	pmol/l	CS Pool	x	1.7	x	x	0.9		3.8
TSH	Thyroid-stimulating hormone, thyreotropin	mIU/l	CS Pool	x	2.1	0.8	1.1	1.1	0.6	8.1
DIGIT	Digitoxin	nmol/l	CS Pool	2.5
DIGO	Digoxin	nmol/l	CS Pool	2.8						3.8 (4.7)
PROBNP	N-terminal B-type natriuretic peptide	pmol/l	HS Pool	0.5
TNT	Troponin T	𝜇g/l	CS Pool	1.0			1.1
FERR_E	Ferritin	𝜇g/l	CS Pool	x	x	2.1	0.9	1.6		7.5
FOLAT	Folate	nmol/l	CS Pool	x	x	x	3.9	1.7
B12	Vitamin B12	pmol/l	CS Pool	1.8	x		x	2.6
AFP	1-fetoprotein	𝜇g/l	CS Pool	x	x	0.9	x	1.8
CA_125	Cancer antigen 125	kU/l	CS Pool	x	x	x	0.9	1.0		6.8
CA_153	Cancer antigen 15-3	kU/l	CS Pool	1.1	x	x		x		2.6
CA_199	Cancer antigen 19-9	kU/l	CS Pool	0.9	x	x				12.3
CEA	Carcinoembryonic antigen	𝜇g/l	CS Pool	x	x		1.2	1.3		4.6
TPSA	Total prostate-specific antigen	𝜇g/l	CS Pool	x	x	0.5	x	2.3		9.1
FPSA	Free prostate-specific antigen	𝛼g/l	CS Pool	0.8	1.0	x
CORT	Cortisol	nmol/l	CS Pool		1.6		1.0	x		7.6
DHEA-S	Dehydroepiandrosterone sulfate	𝜇mol/l	CS Pool		2.5			x		1.7
E2	Estradiol	pmol/l	CS Pool		1.6	1.7	x	1.7		10.9
FSH	Follicle stimulating hormone	IU/l	CS Pool		x	0.9	1.3	x		5.1
HCG +	Human chorionic gonadotropin + -subunit	IU/l	CS Pool	1.8	1.2			1.2
LH	Luteinizing hormone	IU/l	CS Pool		x	1.1	x	x		6.2
PROG	Progesterone	nmol/l	CS Pool		x	1.2				9.8
PRL	Prolactin	mIU/l	CS Pool		x	1.2	x	x		3.5
PTH	Parathyroid hormone	pmol/l			x	x		x
INS	Insulin	pmol/l	CS Pool		2.3		1.6			7.6
TESTO	Testosterone	pmol/l			1.4		1.6	x		4.4

^* References [10, 11], values in italics: from Ricós et al. [12]; values in parentheses: interim quality specifications.