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Total hCG tests.

Laurence A Cole1, Stephen DuToit, Trefor N Higgins

  • 1The USA hCG Reference Service, Women's Health Research, Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, NM 87131, USA. lac@unm.edu

Clinica Chimica Acta; International Journal of Clinical Chemistry
|August 26, 2011
PubMed
Summary
This summary is machine-generated.

Selecting a total human chorionic gonadotropin (hCG) test requires care, as most assays fail to detect all hCG variants. The Siemens Immulite test demonstrated superior detection of hCG variants, making it suitable for all clinical applications.

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Area of Science:

  • Reproductive endocrinology
  • Clinical chemistry
  • Assay development and validation

Background:

  • Automated total human chorionic gonadotropin (hCG) tests vary in their ability to detect all hCG variants.
  • The definition of 'total hCG' is inconsistent across 12 commercially available assays.
  • Accurate detection of all hCG variants is crucial for diverse clinical applications.

Purpose of the Study:

  • To evaluate the performance of 12 automated total hCG tests in detecting various hCG variants.
  • To determine which hCG tests are suitable for all clinical applications based on variant detection.

Main Methods:

  • Blind testing of coded samples containing nine different hCG variants in serum and urine.
  • Inclusion of pure hCG, nicked hCG, hyperglycosylated hCG, and hCG fragments.
  • Testing conducted at 10 independent laboratories.

Main Results:

  • Siemens Immulite test detected 8 of 9 hCG variants, outperforming other assays.
  • Most assays showed poor detection of critical variants like nicked hCG missing C-terminal peptide and beta-core fragment.
  • Assay performance varied significantly, with some detecting only 1 of 7 variants.

Conclusions:

  • Careful selection of total hCG tests is essential due to performance variability.
  • Siemens Immulite demonstrated the best performance in detecting hCG variants for broad clinical use.
  • Several assays have limited applications, with some suitable only for advanced pregnancy testing.