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

Frances L. Cate, Courtney Moffett, Ann M. Gronowski, David G. Grenache, Katherine E. Hartmann, Alison Woodworth

Research output: Contribution to journalArticlepeer-review

8 Scopus citations


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, <. 2.2. IU/l for females <. 55. y, and <. 12.2. IU/l for females ≥ 55. y. Conclusion: The Immulite 1000 hCG assay can accurately quantify hCG in urine.

Original languageEnglish
Pages (from-to)104-108
Number of pages5
JournalClinica Chimica Acta
StatePublished - Jun 5 2013


  • HCG
  • Human chorionic gonadotropin
  • Quantitative measurement
  • Urine

ASJC Scopus subject areas

  • Biochemistry
  • Clinical Biochemistry
  • Biochemistry, medical


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