TY - JOUR
T1 - Analytical and clinical validation of the Immulite 1000 hCG assay for quantitative analysis in urine
AU - Cate, Frances L.
AU - Moffett, Courtney
AU - Gronowski, Ann M.
AU - Grenache, David G.
AU - Hartmann, Katherine E.
AU - Woodworth, Alison
PY - 2013/6/5
Y1 - 2013/6/5
N2 - 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.
AB - 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.
KW - HCG
KW - Human chorionic gonadotropin
KW - Quantitative measurement
KW - Urine
UR - https://www.scopus.com/pages/publications/84875780864
UR - https://www.scopus.com/pages/publications/84875780864#tab=citedBy
U2 - 10.1016/j.cca.2013.02.026
DO - 10.1016/j.cca.2013.02.026
M3 - Article
C2 - 23470427
AN - SCOPUS:84875780864
SN - 0009-8981
VL - 421
SP - 104
EP - 108
JO - Clinica Chimica Acta
JF - Clinica Chimica Acta
ER -