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

Capsule:
Progesterone measurements by direct immunoassay can be imprecise, affectingmedical decisions during IVF. A validated progesterone standard used in daily immunoassays could attenuate errors in assay imprecision.

Authors:
Phillip Patton, M.D., Jeong Lim, Ph.D., Lee Hickok, M.D., L. Michael Kettel, M.D., Janine M. Larson, B.S., M.Ed., K.Y. Francis Pau, M.D.

Volume 101, Issue 6, Pages 1629–1636

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.

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