1. What is the ProteoGenix Amniotic Fluid Endpoint PCR Test?
The ProteoGenix Amniotic Fluid Endpoint PCR Test uses broad-spectrum PCR (polymerese chain reaction) to provide a qualitative and sensitive tool for detecting the presence of microbial DNA in amniotic fluid. The ProteoGenix Amniotic Fluid Endpoint PCR Test offers the following clinical benefits:

• Demonstrated sensitivity of 100% and specificity of 96% versus microbial species in amniotic fluid culture.

• The ability to detect the most common causative pathogens of intraamniotic infection ; including Mycoplasma and Ureaplasma species that have been shown to be present in 30% to 50% of IAI cases. Tests to detect these pathogens are not commonly available in most laboratories.

• Test results are typically available within 24 hours, as compared to 40 to 72 hours typically required for amniotic fluid culture test results.

2. How will results from the ProteoGenix Amniotic Fluid Endpoint PCR Test help my doctor?
Because the ProteoGenix PCR test can assist your physician in quickly and accurately determining the presence or absence of IAI, it facilitates your physician’s ability to determine the best treatment for you and your baby.

3. How is the sample for the ProteoGenix Amniotic Fluid Endpoint PCR Test obtained?
The sample is obtained using a procedure called amniocentesis. The procedure involves obtaining a small sample of amniotic fluid from around the fetus. Guided by ultrasound imaging, a thin needle is inserted into the mother’s abdomen. A sample of amniotic fluid is drawn through the needle into a syringe. This sample is sent to ProteoGenix’s CLIA certified clinical laboratory for analysis.

4. Will I feel any pain when the sample is obtained?
There is minimal discomfort associated with the amniocentesis procedure and seldom any need for medication after the procedure.

5. How long does the procedure take?
Including preparation, the amniocentesis procedure usually takes 30 minutes.

6. How accurate are the results of the ProteoGenix Amniotic Fluid Endpoint PCR Test?
The ProteoGenix Amniotic Fluid Endpoint PCR Test provides a qualitative and accurate tool for detecting the presence of microbial DNA in amniotic fluid. It has demonstrated sensitivity of 100% and specificity of 96% versus microbial amniotic fluid culture.

7. What are the clinical benefits of using the ProteoGenix Amniotic Fluid Endpoint PCR Test?
The clinical benefits of using the ProteoGenix Amniotic Fluid Endpoint PCR Test to diagnose intraamniotic infection is that intraamniotic infection is an important and potentially treatable cause of premature births, neonatal sepsis, bleeding within the brain/cerebral palsy and maternal febrile complications.

8. How is the ProteoGenix Amniotic Fluid Endpoint PCR Test better than current methods for detecting IAI?
Numerous investigators have demonstrated that 16S rDNA PCR (polymerase chain reaction) assays have significant advantages and offer superior performance as compared to culture alone for detection of microorganisms in amniotic fluid.

The fundamental advantage of PCR for diagnosis of intraamniotic infection is that PCR identifies infection by detecting and identifying the unique DNA gene sequences of microorganisms. This allows the PCR technique to detect microbial species that may be difficult or impossible to cultivate and therefore not detectable by amniotic fluid culture.