Development and validation of 14 human serum protein assays on the Roche cobas® c 501.
Many laboratories rely on dedicated nephelometers and turbidimeters for the measurement of serum proteins. There are, however, a number of chemistry analyzers that offer open channel configurations for end-user applications. We developed and validated 14 human serum protein assays (α(1)-antitrypsin, α(2)-macroglobulin, albumin, apolipoproteins AI and B, complement components 3 and 4, haptoglobin, immunoglobulins A, G, and M, orosomucoid, transferrin, and transthyretin) on the Roche cobas(®) c 501. We obtained excellent precision at low, normal, and high physiologic concentrations of each protein (within-run imprecision CVs ≤2.5%, total imprecision CVs ≤3.6%). Linearity for each method was within 5% of the expected value throughout the calibration range, and method comparison studies to commercial assays from Roche or Siemens were in good agreement (r>0.975). We observed no significant interference from bilirubin (up to 414  mg/l), hemoglobin (up to 8.9  g/l), triglyceride (up to 28  g/l), or rheumatoid factor (up to 3,930 IU/ml). Calibration was stable for at least 14 days. The instrument's small reaction cell allowed us to conserve nearly 60% of our specimen and reagent volume compared with our previous system. These newly developed assays provide precise and accurate results with high throughput, but without the associated cost of a dedicated instrument.
Foundation for Blood Research, Scarborough, Maine 04074, USA. tledue@fbr.org
Thomas B
TB
Ledue
Marilyn F
MF
Collins
D057205:Automation, Laboratory; D001798:Blood Proteins / Q000032:analysis*; D002138:Calibration; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation / Q000379:methods*; D057230:Limit of Detection; D008832:Microchemistry / Q000295:instrumentation / Q000379:methods; D009391:Nephelometry and Turbidimetry / Q000295:instrumentation / Q000379:methods*; D015203:Reproducibility of Results; D013997:Time Factors
D001798:Blood Proteins
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