Preclinical evaluation of a TEX101 protein ELISA test for the differential diagnosis of male infertility.

ABSTRACT:

Background

TEX101 is a cell membrane protein exclusively expressed by testicular germ cells and shed into seminal plasma. We previously verified human TEX101 as a biomarker for the differential diagnosis of azoospermia, and developed a first-of-its-kind TEX101 ELISA. To demonstrate the clinical utility of TEX101, in this work we aimed at evaluating ELISA performance in a large population of fertile, subfertile, and infertile men.

Methods

Mass spectrometry, size-exclusion chromatography, ultracentrifugation, and immunohistochemistry were used to characterize TEX101 protein as an analyte in seminal plasma. Using the optimized protocol for seminal plasma pretreatment, TEX101 was measured by ELISA in 805 seminal plasma samples.

Results

We demonstrated that TEX101 was pres

SUBMITTER: Korbakis D 

PROVIDER: S-EPMC5363040 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature