Detection of Intraamniotic Infection

A method for the diagnosis of intra-amniotic infection in a pregnant female mammalian subject comprising:

• (a) measuring in a sample of cervical-vaginal fluid obtained from said subject the levels of interleukin-6 (IL-6) and fetal fibronectin (fFN) relative to the corresponding levels of said proteins in normal cervical-vaginal fluid or cervical-vaginal fluid known to be indicative of intra-amniotic infection;
• and
• (b) diagnosing said subject with intra-amniotic infection if each of said levels of each of said proteins in said sample is determined to show a statistically significant difference relative to the corresponding levels of each of said proteins in said normal cervical-vaginal fluid, or is determined not to show a statistically significant difference relative to the corresponding levels of each of said proteins in said cervical-vaginal fluid known to be indicative of intra-amniotic infection.

The method of claim 34 or 52 wherein said protein level is determined by methods comprising the use of an immunoassay, a protein array, an immunochromatographic test, mass spectrometry, or combinations thereof.

A method for determining signs and symptoms indicating intra-amniotic infection comprising

• (a) measuring in a sample of cervical-vaginal fluid obtained from said subject the levels of interleukin-6 (IL-6) and fetal fibronectin (fFN), relative to the levels of IL-6 and fFN in normal cervical-vaginal fluid or cervical-vaginal fluid known to be indicative of intra-amniotic infection;
• and
• (b) diagnosing said subject with intra-amniotic infection if each of said levels of IL-6 and fFN in said sample are determined to show a statistically significant difference relative to the corresponding levels of IL-6 and fFN in said normal cervical-vaginal fluid, or are determined not to show a statistically significant difference relative to the corresponding levels of IL-6 and fFN in said cervical-vaginal fluid known to be indicative of intra-amniotic infection.

An immunochromatographic test device comprising one or more chromatography strips for the detection of interleukin-6 (IL-6) and fetal fibronectin (fFN).