Analytical and clinical validation of the Immulite 1000 hCG assay for quantitative analysis in urine

Clin Chim Acta. 2013 Jun 5;421:104-8. doi: 10.1016/j.cca.2013.02.026. Epub 2013 Mar 5.

Abstract

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.

Publication types

  • Research Support, N.I.H., Extramural
  • Validation Study

MeSH terms

  • Adult
  • Age Factors
  • Aged
  • Chorionic Gonadotropin / urine*
  • Female
  • Humans
  • Immunoassay
  • Limit of Detection
  • Male
  • Middle Aged
  • Pregnancy
  • Protein Subunits / urine*
  • Reference Values
  • Sex Factors

Substances

  • Chorionic Gonadotropin
  • Protein Subunits