Detection of intraamniotic infection
View Patent ↗The present invention concerns the identification of biomarkers and groups or combinations of biomarkers that can be used for non-invasive diagnosis of intra-amniotic infection, and diagnostic assays using such biomarkers.
1. An immunoassay kit for detecting in a biological sample alpha-fetoprotein (AFP), interleukin-6(IL-6), and IGF binding protein-1(IGFBP-1), the kit comprising (a) a container containing antibodies and reagents for the detection of AFP, IL-6 and IGFBP-1 and (b) instructions for using said antibodies and reagents for the diagnosis of intra-amniotic infection in a pregnant female mammalian subject.
2. The kit of claim 1 , wherein the antibodies and reagents comprise a capture antibody and a detector antibody.
3. The kit of claim 2 , wherein the capture antibody and detector antibody are monoclonal antibodies.
4. The kit of claim 2 , wherein the capture antibody and detector antibody are polyclonal antibodies.
5. The kit of claim 2 , wherein the capture antibody and detector antibody are either monoclonal or polyclonal antibodies.
6. The kit of claim 1 , further comprising a lateral flow device, such as an immunochromatographic strip (ICS) tests.
7. The kit of claim 1 , wherein the antibodies comprise monoclonal antibodies having binding specificity for AFP, IL-6 and IGFBP-1, and wherein the kit further comprises an anti-antibody immunoglobulin.
8. The kit of claim 7 , wherein the monoclonal antibodies and the anti-antibody immunoglobulin are contained in separate containers.
9. The kit of claim 8 , wherein the monoclonal antibodies and the anti-antibody immunoglobulin are provided in an amount of about 0.001 mg to about 100 grams.
10. The kit of claim 8 , wherein the monoclonal antibodies and the anti-antibody immunoglobulin are provided in an amount of about 0.01 mg to about 1 gram.
11. The kit of claim 1 , wherein the anti-antibody immunoglobulin is selected from the group consisting of a polyclonal immunoglobulin, protein A and protein G, or functional fragments thereof.
12. The kit of claim 11 , wherein the anti-antibody immunoglobulin is labeled.
13. The kit of claim 1 , further comprising agents for reducing background interference in a test or agents for increasing signal.
14. The kit of claim 1 , further comprising software and algorithms for combining and interpolating marker values to produce a prediction of clinical outcome of interest.
15. The kit of claim 1 , further comprising an apparatus for conducting a test.
16. The kit of claim 1 , wherein all antibodies and reagents are provided in a single container along with a sheet of printed instructions for carrying out the test.