Rupture of Fetal Membranes by ROM Plus


Abbrev Code:ROM   
Order Code:LAB8002Order Name:Rupture of Membranes by Rom Plus
Synonyms:Rupture of Membranes by ROM Plus; Amniotic Fluid Detection by Rom Plus
Methodology:Immunochromatographic assay
CPT Codes: 84112 x1
Turnaround Time:Performed and reported 24 hours/day.
Special Instructions:Requires special collection kit.


Collection Instructions

Specimen:Cervicovaginal secretions
Container:ROM Plus Collection Kit
Collection Instructions:Requires ROM Plus Collection Kit that includes sterile polyester swab and plastic vial with buffer solution.
  1. Insert sterile swab 2 to 3 inches into the vagina.
  2. Allow swab to remain in vagina for a minimum of 15 seconds, then withdraw.
  3. The swab is placed in the buffer solution vial. Break off the swab tip at the scored mark and leave the tip in the vial.
  4. Place the shipping cap back on the buffer vial and send the vial to the lab.
  5. The sample must be tested within 6 hours of collection.
Patient Preparation:The specimen should be obtained prior to digital cervical examination.
Causes for Rejection:Swab contaminated with lubricants, soaps, creams or disinfectants. Specimens with meconium or a large amount of blood.


Processing and Shipping

Specimen Processing:Do not process.
Shipping Instructions:Send at room temperature; do not freeze or exceed 24°C.
Test Performed at or Referral Lab Chemistry  (Lakes, Northland, Range, Ridges, Southdale, St. John's, UMMC West Bank, Woodwinds)


Interpretive

Reference Range:Negative indicates no rupture of fetal membranes.
Limitations: 
  1. 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.
  2. You must follow all directions carefully to get an accurate reading of the results.
  3. Each test is a single use disposable unit and cannot be re-used.
  4. The ROM Plus® Test results are qualitative.
  5. No quantitative interpretation should be made based on the test results.
  6. 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.
  7. Test performance in patients without signs or symptoms of ROM is unknown.
  8. Results should be used in conjunction with other clinical information.
  9. Bleeding, placenta previa, and performing digital exams prior to sample collection can lead to inaccurate test results.
  10. Failure to detect membrane rupture does not assure the absence of membrane rupture.
  11. Women may labor spontaneously despite a negative result.
  12. False negative results and delay in the diagnosis of rupture of membranes can increase the risk of chorioamnionitis, oligochydramnios and fetal umbilical cord accident.
  13. Test failure can result from failure to follow test instructions and improper storage of test/collection kit.
  Interferences
  1. 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.
  2. 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.
  3. 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.
  4. The PP12/GFBP-1 assay does not cross-react with IGFBP-2, IGFBP-3 and IGFBP-4 based on Western Blot results.
  5. ROM Plus® was shown to be negative when tested with specimens that were positive for bacterial vaginosis and other sexually transmitted diseases.
Use:Detection of amniotic fluid in vaginal secretions of a pregnant woman.


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