| Limitations: |
- The ROM Plus® fetal membranes rupture test is for the in vitro detection of human amniotic fluid PP12 and AFP proteins in the vaginal secretions of a pregnant woman. The test should be used to evaluate patients with clinical signs/symptoms suggestive of fetal membranes rupture.
- You must follow all directions carefully to get an accurate reading of the results.
- Each test is a single use disposable unit and cannot be re-used.
- The ROM Plus® Test results are qualitative.
- No quantitative interpretation should be made based on the test results.
- Presence of significant blood, collected with the swab can lead to false positive results. In cases of only trace amounts of blood on the swab, the test functions properly.
- Test performance in patients without signs or symptoms of ROM is unknown.
- Results should be used in conjunction with other clinical information.
- Bleeding, placenta previa, and performing digital exams prior to sample collection can lead to inaccurate test results.
- Failure to detect membrane rupture does not assure the absence of membrane rupture.
- Women may labor spontaneously despite a negative result.
- False negative results and delay in the diagnosis of rupture of membranes can increase the risk of chorioamnionitis, oligochydramnios and fetal umbilical cord accident.
- Test failure can result from failure to follow test instructions and improper storage of test/collection kit.
Interferences
- The presence of blood, meconium, anti-fungal creams or suppositories, baby powder, baby oil, or the use of lubricant with a vaginal exam may interfere with the device.
- To determine interference and cross-reactivity of the assay, Tylenol, aspirin, KY Gel and three different bath products (Lever soap, Noxema Cream, Pert Shampoo) were spiked into the low positive control at a final concentration of 0.1% without visual loss of activity. The same bath products were spiked into the negative-matrix control and shown to be negative.
- In addition, human semen, urine and blood were spiked into the low positive at a 10% final concentration without loss of activity. Human semen, urine, blood were also spiked into the negative control matrix and shown to be negative.
- The PP12/GFBP-1 assay does not cross-react with IGFBP-2, IGFBP-3 and IGFBP-4 based on Western Blot results.
- ROM Plus® was shown to be negative when tested with specimens that were positive for bacterial vaginosis and other sexually transmitted diseases.
|
