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Analytical and clinical validation of the Immulite 1000 hCG assay for quantitative analysis in urine
Frances L Cate1, Courtney Moffett, Ann M Gronowski
1Department of Pathology, Microbiology, and Immunology, Vanderbilt University Medical Center, Nashville, TN 37232, United States.
Background:
The Siemens Immulite hCG assay detects all major hCG variants in serum. Currently, this assay is only FDA approved for qualitative measurement of hCG in urine.
Methods:
Complete validation of the hCG assay in urine was performed on the Siemens Immulite 1000 immunoassay platform. Reference intervals were established for females <55 y, females ≥55 y, and males 20-70 y.
Results:
The limit of quantitation was 2.0 IU/l. The Immulite hCG assay was precise for measuring hCG in urine from pregnant patients with intra- and inter-assay imprecision of <11% CV. The assay was linear over a dynamic range of 2-2600 IU/l and 2-3500 IU/l for hCG and hCGβ respectively. The assay was non-linear for hCGβcf. No hook effect was observed at concentrations up to 1,200,000 pmol/l, for hCGβ or hCGβcf. The reference intervals were <2.0 IU/l for males, <2.2I U/l for females <55 y, and <12.2I U/l for females ≥55 y.
Conclusion:
The Immulite 1000 hCG assay can accurately quantify hCG in urine.
