Novel Gene Expression Blood Test Predicts Premature Birth

High vaginal swabs and urine were collected from each participant for standard hospital bacteria vaginosis screening, microscopy, culture and sensitivities as part of their routine clinical care. The fetal fibronectin (fFN) test (QuikCheck fFN, Hologic, Inc.; Marlborough, MA, USA) was performed where feasible on cervicovaginal secretions, as part of the hospital's protocol and for comparison with microarray data.

Total ribonucleic acid (RNA) was isolated using PAXgene Blood RNA system kit (QIAGEN; Doncaster, Australia). RNA quality check was done using an Agilent 2100 BioAnalyser with the RNA 6000 Nano Kit (Agilent Technologies; Santa Clara, CA, USA). Quantitative real-time PCR (qRT-PCR) was performed to validate a subset of significant genes on the CFX384 Touch Real-Time PCR Detection System (BIO-RAD; Hercules, CA, USA).

The investigators discovered that a set of nine genes, coupled with clinical blood data, could classify whether 70% of participants would or would not have a spontaneous preterm birth within 48 hours of hospital admission. In addition, the nine genes coupled with clinical blood data outperformed the fFN lateral flow test. This newer test highlights the advantages of utilizing a blood-based diagnostic test to predict spontaneous preterm birth, where it can be performed on all women and as part of routine blood work.

Stephen Lye, MD, a professor of Obstetrics and Gynecology and senior author of the study, said, “We want to develop a test that can differentiate between true and false labor so that women in true labor can receive the appropriate medical care while women in false labor will receive supportive care and be discharged. A lot of TPTL women are unnecessarily hospitalized.” The study was published on May 14, 2014, in the journal Public Library of Science ONE.

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Mount Sinai Hospital
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