This document describes a human liquid ready-to-use stable multi-analyte control containing 27 different analytes including antibody isotypes, complement components, and other specific proteins. It reports that the control material has an open vial stability of 30 days when stored between 2-8 degrees Celsius and a shelf life stability of at least 2 years under the same storage conditions based on measurements on various automated systems. The control is concluded to be a convenient ready-to-use material for clinical applications that standardizes the test menu and reduces errors.

1. W
QUALITY CONTROL
Human ready-to-use stable liquid multi-analyte control for specific
proteins including antibody isotypes and complement components
Spon-Smith C., Shanks A., Rodríguez M.L., Campbell J., FitzGerald S.P | Randox Laboratories Ltd - Diamond Road, Crumlin, County Antrim, N. Ireland, BT29 4QY, United Kingdom.
Introduction
The performance and interpretation of tests for the diagnosis and management of a variety
of immune-mediated diseases requires the maintenance of high-quality output. Quality
control material is required to monitor the accuracy and precision of the tests,this will lead
to improved result quality.
The use of liquid stable multi-analyte control material consolidates the test menu, reduces
the risk of errors associated with reconstitution and decreases the operator training
requirements. A human liquid ready-to-use,stable multi-analyte control containing antibody
isotypes, complement components and other specific proteins is reported.
Methodology
•Three levels of human liquid control material containing 27 analytes were prepared.
• Open vial stability was determined as the percentage recovery of each level of analyte
opened and stored at +2°C to +8°C over a period of 30 days related to day 0 at
+2°C to +8°C.
• Shelf life was assessed as the percentage recovery of each level of analyte stored at
+2°C to +8°C compared to the same material stored at -70°C over a 48 month period.
Measurements were made on various automated systems.
Conclusion
Thehumanliquidmulti-analytecontrolmaterialforspecificproteinscontained27parameters
at three levels covering clinically relevant ranges.This control material presented an open
vial stability of 30 days and data supporting at least a 2 year shelf life.This control is of value
as a convenient, ready-to-use material for clinical applications.
Randox Laboratories Ltd, 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
+44 (0) 28 9442 2413 +44 (0) 28 9445 2912 marketing@randox.com randoxqc.comQUALITY CONTROL
Analyte Unit
Level 1 Level 2 Level 3
Method
Target Range Target Range Target Range
CRP
mg/L 27.5 22.0-33.0 54.6 43.7-65.5 81.8 65.4-98.2 Turbidimetric
mg/L 25.3 20.2-30.4 52.9 42.3-63.5 79.1 63.3-94.9 Nephelometric
mg/L 36.2 29.0-43.4 58.6 47-70.3 64.5 51.6-77.4 Vitros
Complement
C3
g/L 0.72 0.57-0.86 1.45 1.16-1.74 2.17 1.74-2.60
Turbidimetric
mg/dL 72.0 57.6-86.4 145 116-174 217 174-260
g/L 0.727 0.58-0.87 1.49 1.19-1.79 2.27 1.82-2.72
Nephelometric
mg/dL 72.7 58.2-87.2 149 119-179 227 182-272
g/L 0.714 0.57-0.85 1.40 1.12-1.68 2.15 1.72-2.58
Vitros
mg/dL 71.4 57.1-85.7 140 112-168 215 172-258
Complement
C4
g/L 0.175 0.14-0.21 0.35 0.28-0.42 0.53 0.42-0.63
Turbidimetric
mg/dL 17.5 14.0-21.0 35 28-42 53 42.4-63.6
g/L 0.196 0.15-0.23 0.399 0.31-0.47 0.60 0.48-0.72
Nephelometric
mg/dL 19.6 15.7-23.5 39.9 31.9-47.9 60.4 48.3-72.5
g/L 0.181 0.14-0.22 0.356 0.28-0.42 0.53 0.42-0.63
Vitros
mg/dL 18.1 14.5-21.7 35.6 28.5-42.7 53 42.4-63.6
Free Kappa
Light Chains
mg/L 17.9 14.3-21.5 29.9 23.9-35.9 34 25.5-42.5 Turbidimetric
mg/L 21.7 17.4-26.0 34.2 27.4-41.0 40.2 30.2-50.3 Nephelometric
Free Lambda
Light Chains
mg/L 16.9 13.5-20.3 29.4 23.5-35.3 40.3 30.2-50.4 Turbidimetric
mg/L 18.4 14.7-22.1 33.3 26.6-40 46.3 34.7-57.9 Nephelometric
IgA
g/L 1.22 0.91-1.53 2.42 1.82-3.03 3.65 2.74-4.56
Turbidimetric
mg/dL 122 91.5-153 242 182-302 365 274-456
g/L 1.29 0.96-1.61 2.64 1.98-3.30 4.04 3.03-5.05
Nephelometric
mg/dL 129 96.8-161 264 198-330 404 303-505
g/L 1.18 0.88-1.48 2.48 1.86-3.10 3.46 2.60-4.33
Vitros
mg/dL 118 88.5-148 248 186-310 346 260-432
IgE
KIU/L
=
IU/mL
89.3 71.4-107 175 140-210 262 210-314 Turbidimetric
KIU/L
=
IU/mL
100 80-120 198 158-238 310 248-372 Nephelometric
KIU/L
=
IU/mL
103 82.4-124 200 160-240 299 239-359 Chemiluminescence
KIU/L
=
IU/mL
100 80-120 211 169-253 299 239-359
Enzyme
Immunoassay
KIU/L
=
IU/mL
105 84-126 210 168-252 315 252-378 Fluorimetric
IgG
g/L 7.0 5.74-8.26 14 11.5-16.5 21 17.2-24.8
Turbidimetric
mg/dL 700 574-826 1400 1150-1650 2100 1720-2480
g/L 7.34 6.02-8.66 14.5 11.9-17.1 21.6 17.7-25.5
Nephelometric
mg/dL 734 602-866 1450 1190-1710 2160 1770-2550
g/L 7.14 5.85-8.43 14 11.5-16.5 19.6 16.1-23.1
Vitros
mg/dL 714 585-843 1400 1150-1650 1960 1610-2310
IgM
g/L 0.94 0.75-1.13 1.87 1.50-2.24 2.83 2.26-3.40
Turbidimetric
mg/dL 94 75.2-113 187 150-224 283 226-340
g/L 0.99 0.79-1.19 1.96 1.57-2.35 2.95 2.36-3.54
Nephelometric
mg/dL 99 79.2-119 196 157-235 295 236-354
g/L 0.917 0.73-1.10 1.97 1.58-2.36 2.73 2.18-3.28
Vitros
mg/dL 91.7 73.4-110 197 158-236 273 218-328
Kappa Light
Chain
g/L 1.83 1.46-2.20 3.71 2.97-4.45 5.55 4.16-6.94
Turbidimetric
mg/dL 183 146-220 371 297-445 555 416-694
g/L 1.87 1.50-2.24 3.57 2.86-4.28 5.40 4.05-6.75
Nephelometric
mg/dL 187 150-224 357 286-428 540 405-675
Lambda Light
Chain
g/L 0.924 0.73-1.11 1.87 1.50-2.24 2.89 2.17-3.61
Turbidimetric
mg/dL 92.4 73.9-111 187 150-224 289 217-361
g/L 0.962 0.77-1.15 1.88 1.50-2.26 2.87 2.15-3.59
Nephelometric
mg/dL 96.2 77-115 188 150-226 287 215-359
Results - Examples of typical ranges
Open vial stability
Temperature Time period
Recovery (%) for different
concentration levels for all
the analytes
+2ºC to +8ºC 30 days (from day 0) 90-110
Shelf life stability
Temperature Time period
Recovery (%) for different
concentration levels for all
the analytes
+2ºC to +8ºC 48 months 90-110
Stability
AFP Complement C3 Kappa Light Chain (free)
Albumin Complement C4 Lambda Light Chain
α-I-Antitrypsin CRP Lambda Light Chain (free)
α-I-Acid Glycoprotein Haptoglobin Prealbumin (Transthyretin)
α-2-Macroglobulin IgA Serum Ferritin
ASO IgE RF
Anti-thrombin III IgG RBP
β-2-Microglobulin IgM Total Protein
Ceruloplasmin Kappa Light Chain Transferrin
Analytes