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Fertil Steril. 2014 Jun;101(6):1629-36. doi: 10.1016/j.fertnstert.2014.02.037. Epub 2014 Mar 21.

Precision of progesterone measurements with the use of automated immunoassay analyzers and the impact on clinical decisions for in vitro fertilization.

Author information

1
Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, Oregon. Electronic address: pattonp@ohsu.edu.
2
Department of Public Health and Preventive Medicine, Oregon Health and Science University, Portland, Oregon.
3
Pacific Northwest Fertility, Seattle, Washington.
4
San Diego Fertility Center, San Diego, California.
5
Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, Oregon.
6
Endocrine Technology and Support Core, Oregon National Primate Research Center, Oregon Health and Science University, Beaverton, Oregon.

Abstract

OBJECTIVE:

To compare the precision of progesterone measurements obtained with the use of immunoassays and of liquid chromatography-tandem mass spectrometry (LC-MS/MS).

DESIGN:

Comparative study.

SETTING:

Academic, private practice, and in vitro fertilization (IVF) research centers.

PATIENT(S):

A total of 189 human serum samples were collected during controlled ovarian hyperstimulation and early pregnancy in women undergoing IVF.

INTERVENTION(S):

Serum progesterone pools (n = 10; 0.2-4 ng/mL) were sent to four laboratory centers that used four different automated immunoassay analyzers. Progesterone was measured by immunoassay in triplicate at three separate time points (n = 9 per pool) and by LC-MS/MS in triplicate once (n = 3 per pool).

MAIN OUTCOME MEASURE(S):

Inter- and intraassay coefficients of variation (CVs) of progesterone measurements were compared for each analyzer and LC-MS/MS.

RESULT(S):

Progesterone measurements by immunoassay were highly correlated with those by LC-MS/MS. Only two analyzers had intraassay CVs <10% at all three experimental time points, and only two analyzers had an interassay CV <10%. Mean progesterone levels by the analyzers were different across multiple progesterone pools.

CONCLUSION(S):

Our results indicate that progesterone threshold measurements used for IVF clinical decisions should be interpreted cautiously and based on laboratory- and method-specific data. A validated progesterone standard incorporated into daily immunoassays could improve medical decision accuracy.

KEYWORDS:

Progesterone levels in IVF; automated analyzers; mass spectrometry

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