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- Sunde, Kathrin, et al.
(författare)
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Performance characteristics of a cystatin C immunoassay with avian antibodies
- 2007
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Ingår i: Upsala Journal of Medical Sciences. - 0300-9734 .- 2000-1967. ; 112:1, s. 21-37
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Tidskriftsartikel (refereegranskat)abstract
- Background: A new particle-enhanced turbidimetric immunoassay (PETIA) with avian antibodies for measuring serum/plasma cystatin C has been developed. The performance characteristics of the assay are described. Methods: Measurements were performed on a Roche Modular P and on an Abbott Architect ci8200 using Gentian cystatin C immunoassay. Results: Measuring range was 0.3 - 8.0 mg/ L. Reference range was 0.57 - 1.09 mg/ L. Total analysis time was 10 minutes. Linearity was absolute over the whole assay range. Recovery of samples and controls was within 98.6 - 109.4%. Total imprecision CV, measured over 20days with two lots, was <= 4.2%. Comparision with a particle enhanced nephelometric cystatin C immunoassay (PENIA) by linear regression resulted in a slope within 0.97 - 1.02 and intercept within +/- 0.05 mg/ L. Interference studies with drugs, anticoagulants, intralipid (<= 11g/L), triglycerides (<= 14 g/L) and bilirubin (<= 420 mg/L) showed no significant interference. Due to the use of avain antibodies, no interference with rheumatoid factor was observed. No carry-over was detected. Lower detection limit and lower quantification limit (CV <= 6%) were both below 0.33 mg/L, which is less than the lowest standard. Sample stability was up to one month at 2 - 8 degrees C. Stability of the reagents at 2 - 8 degrees C was estimated to be 24 months. Stability of the reagents in use was minimum 9 weeks. Conclusions: Gentian cystatin C PETIA is shown to have excellent performance between methods. Interference results are improved due to avian antibodies and a broader span of the calibration curve. Avian antibodies are also known to have better immune response than mammalian antibodies towards mammalian antigens.
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