Validation of a particle enhanced immunoturbidimetric assay for serum beta 2-microglobulin on the Dade aca.
We describe the development and validation of a fully automated homogeneous immunoassay for serum beta 2-microglobulin on the Dade aca clinical analyzer. The assay employs latex enhanced immunoturbidimetry, with an affinity purified polyclonal antibody covalently coupled to a 40 nm latex particle. The assay working range is < 0.5 to 20 mg/l with no evidence of loss of signal due to antigen excess at concentrations up to 120 mg/l. The assay sensitivity is 0.2 mg/l; within run and between run imprecision showed coefficients of variations of < 7%, across the assay range 1-20 mg/l. A method comparison with an established RIA procedure gave a regression equation of (aca) = 1.14 (RIA)-0.26, r = 0.996, n = 109. Good analytical recovery (98-101%), no evidence of a lack of parallelism and no interference from rheumatoid factor (tested up to 1.2 x 10(6) U/l) were observed. The low method to be considered as an effective means of monitoring seroconversion in HIV infected subjects and treatment of patients with myelomatosis.
Newman
D J
DJ
Department of Clinical Biochemistry, St Bartholomew's School of Medicine and Dentistry, London, UK.
Kassai
M
M
Craig
A R
AR
Gorman
E G
EG
Price
C P
CP
D001172:Arthritis, Rheumatoid / Q000097:blood; D002021:Buffers; D015658:HIV Infections / Q000097:blood; D006801:Humans; D007158:Immunologic Techniques / Q000295:instrumentation; D009101:Multiple Myeloma / Q000097:blood; D009391:Nephelometry and Turbidimetry / Q000295:instrumentation* / Q000379:methods; D011092:Polyethylene Glycols; D011786:Quality Control; D011863:Radioimmunoassay / Q000379:methods; D051437:Renal Insufficiency / Q000097:blood; D012680:Sensitivity and Specificity; D001613:beta 2-Microglobulin / Q000032:analysis*
D002021:Buffers; D001613:beta 2-Microglobulin; D011092:Polyethylene Glycols