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Clin Chim Acta. 2015 Jun 15;446:165-70. doi: 10.1016/j.cca.2015.04.025. Epub 2015 Apr 25.

Analytical performance evaluation of the i-STAT Total β-human chorionic gonadotropin immunoassay.

Author information

1
Department of Pathology, University of Utah School of Medicine, Salt Lake City, UT, USA.
2
Department of Pathology and Immunology, Washington University School of Medicine, St. Louis, MO, USA.
3
ARUP Laboratories, Salt Lake City, UT, USA.
4
Department of Pathology and Immunology, Washington University School of Medicine, St. Louis, MO, USA; Department of Obstetrics and Gynecology, Washington University School of Medicine, St. Louis, MO, USA.
5
Department of Pathology, University of Utah School of Medicine, Salt Lake City, UT, USA; ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT, USA. Electronic address: david.grenache@path.utah.edu.

Abstract

BACKGROUND:

The ability to perform quantitative hCG testing in whole blood at the point-of-care is desirable. The purpose of this study was to perform an analytical validation of the Abbott i-STAT Total β-hCG test.

METHODS:

Whole blood, plasma, and serum samples were prepared by the addition of hCG and were used to evaluate precision, linearity, analytical sensitivity, accuracy, the high-dose hook effect, and dilution recovery.

RESULTS:

Imprecision was highest with whole blood (CV = 16.0% and 6.7% at 10 and 1184 IU/l, respectively) and lowest in serum (CV = 8.1% and 4.3% at 11 and 1305 IU/l, respectively). The limits-of-quantitation were 8 and <5 IU/l for whole blood and both plasma and serum, respectively. The assay was linear between 5 and 2000 IU/l in all sample types (R(2) ≥ 0.998). i-STAT results agreed most closely with the Architect Total β-hCG assay and with greater differences observed with Beckman DxI Total βhCG and Roche Cobas e601 hCG+β assays (mean differences across all sample types were 9.3% and 12.3%, respectively). A high-dose hook effect was observed at concentrations > 400,000 IU/l. Accuracy was achieved in samples diluted with serum but not saline.

CONCLUSIONS:

The i-STAT Total β-hCG test demonstrates acceptable performance for quantifying hCG in whole blood, plasma and serum.

KEYWORDS:

Human chorionic gonadotropin; Point-of-care; Pregnancy test; Quantitative; Whole blood

PMID:
25916696
DOI:
10.1016/j.cca.2015.04.025
[Indexed for MEDLINE]

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