focus 2016 poster: specific proteins
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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.
IntroductionThe 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 The human liquid multi-analyte control material for specific proteins contained 27 parameters 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 [email protected] randoxqc.comQUALITY CONTROL
Analyte UnitLevel 1 Level 2 Level 3
MethodTarget Range Target Range Target Range
CRPmg/L 27.5 22.0-33.0 54.6 43.7-65.5 81.8 65.4-98.2 Turbidimetricmg/L 25.3 20.2-30.4 52.9 42.3-63.5 79.1 63.3-94.9 Nephelometricmg/L 36.2 29.0-43.4 58.6 47-70.3 64.5 51.6-77.4 Vitros
ComplementC3
g/L 0.72 0.57-0.86 1.45 1.16-1.74 2.17 1.74-2.60Turbidimetric
mg/dL 72.0 57.6-86.4 145 116-174 217 174-260g/L 0.727 0.58-0.87 1.49 1.19-1.79 2.27 1.82-2.72
Nephelometricmg/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 1.72-2.58Vitros
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 0.42-0.63Turbidimetric
mg/dL 17.5 14.0-21.0 35 28-42 53 42.4-63.6g/L 0.196 0.15-0.23 0.399 0.31-0.47 0.60 0.48-0.72
Nephelometricmg/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 0.42-0.63Vitros
mg/dL 18.1 14.5-21.7 35.6 28.5-42.7 53 42.4-63.6Free Kappa Light Chains
mg/L 17.9 14.3-21.5 29.9 23.9-35.9 34 25.5-42.5 Turbidimetricmg/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 Turbidimetricmg/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 2.74-4.56Turbidimetric
mg/dL 122 91.5-153 242 182-302 365 274-456g/L 1.29 0.96-1.61 2.64 1.98-3.30 4.04 3.03-5.05
Nephelometricmg/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 2.60-4.33Vitros
mg/dL 118 88.5-148 248 186-310 346 260-432
IgE
KIU/L=
IU/mL89.3 71.4-107 175 140-210 262 210-314 Turbidimetric
KIU/L=
IU/mL100 80-120 198 158-238 310 248-372 Nephelometric
KIU/L=
IU/mL103 82.4-124 200 160-240 299 239-359 Chemiluminescence
KIU/L=
IU/mL100 80-120 211 169-253 299 239-359 Enzyme
ImmunoassayKIU/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 17.2-24.8Turbidimetric
mg/dL 700 574-826 1400 1150-1650 2100 1720-2480g/L 7.34 6.02-8.66 14.5 11.9-17.1 21.6 17.7-25.5
Nephelometricmg/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 16.1-23.1Vitros
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 2.26-3.40Turbidimetric
mg/dL 94 75.2-113 187 150-224 283 226-340g/L 0.99 0.79-1.19 1.96 1.57-2.35 2.95 2.36-3.54
Nephelometricmg/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 2.18-3.28Vitros
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 4.16-6.94Turbidimetric
mg/dL 183 146-220 371 297-445 555 416-694g/L 1.87 1.50-2.24 3.57 2.86-4.28 5.40 4.05-6.75
Nephelometricmg/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 2.17-3.61Turbidimetric
mg/dL 92.4 73.9-111 187 150-224 289 217-361g/L 0.962 0.77-1.15 1.88 1.50-2.26 2.87 2.15-3.59
Nephelometricmg/dL 96.2 77-115 188 150-226 287 215-359
Results - Examples of typical ranges
Open vial stability
Temperature Time periodRecovery (%) for different concentration levels for all
the analytes+2ºC to +8ºC 30 days (from day 0) 90-110
Shelf life stability
Temperature Time periodRecovery (%) 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