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ROM Plus Rupture of Membrane
Test CodeROMP
Alias/See Also
ROM
Preferred Specimen
Vaginal swab in buffer
Patient Preparation
None
Minimum Volume
N/A
Other Acceptable Specimens
None
Instructions
A. Remove ROM Plus contents from the packaging
B. Holding the buffer vial in an upright position, remove the shipping cap and set it aside.
C. Remove the sterile swab from its package to collect a sample from the vagina. The tip of the swab should not touch anything prior to its insertion.
D. Insert the swab tip into the vagina 2-3 (5-7 cm) deep.
E. Withdraw the swab after a minimum of 15 seconds.
Mix and break the swab in buffer vial
A. Mix the swab in buffer solution for 15 seconds.
B. Lift the swab 1 cm from the bottom of the vial.
C. Bend the swab stick 90° in the forward direction and then 180° in the reverse direction.
D. Leave the tip in the vial and dispose of the remaining swab stick.
E. Place the drop dispenser lid on the buffer vial.
F. Label the buffer vial with the patient identifiers and submit to the laboratory for testing.
B. Holding the buffer vial in an upright position, remove the shipping cap and set it aside.
C. Remove the sterile swab from its package to collect a sample from the vagina. The tip of the swab should not touch anything prior to its insertion.
D. Insert the swab tip into the vagina 2-3 (5-7 cm) deep.
E. Withdraw the swab after a minimum of 15 seconds.
Mix and break the swab in buffer vial
A. Mix the swab in buffer solution for 15 seconds.
B. Lift the swab 1 cm from the bottom of the vial.
C. Bend the swab stick 90° in the forward direction and then 180° in the reverse direction.
D. Leave the tip in the vial and dispose of the remaining swab stick.
E. Place the drop dispenser lid on the buffer vial.
F. Label the buffer vial with the patient identifiers and submit to the laboratory for testing.
Transport Container
ROM Plus collection kit containing one sterile polyester vaginal swab and one vial with buffer solution (phosphate-buffered saline)
Transport Temperature
Sample is transported at room temperature
Specimen Stability
Room Temperature: 6 hours (4-37°C)
Refrigerated: 6 hours (4-37°C)
Frozen: not acceptable
Refrigerated: 6 hours (4-37°C)
Frozen: not acceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Specimens that are unlabeled, improperly labeled, or those that do not meet stated criteria are unacceptable. ROM Plus testing should not be performed on specimens that are extremely bloody. This test should not be run on patients who have grossly ruptured membranes.
Methodology
ROM Plus is a self-contained test kit that provides qualitative results for rupture of fetal membranes which is obtained at the bedside and read in the lab. A speculum is not needed to obtain ROM Plus results. The test is non-invasive, with only a simple vaginal swab required. The sample is collected by placing the swab into the vagina for 15 seconds. The swab is then mixed into a vial containing buffer solution, and the diluted sample is applied to the sample pad of the test strip via the sample well on the cassette. A built-in timer is then activated and visualized as a convenient feature to indicate the time of the test. The liquid moves chromatographically and unidirectionally towards the absorbent pad.
During migration, the sample reacts with mono/polyclonal antibodies bound to the test strip membrane. These antibodies are immunoreactive to a combination of proteins, IGFBP-1 and AFP, which are markers of amniotic fluid. As the membrane absorbs the liquid sample, a control line will appear, indicating a sample was applied. If the sample contains the IGFBP-1 and/or AFP markers of amniotic fluid, it binds to the antibody of the test line, causing the test line to appear and indicating a positive result. If the sample does not contain the IGFBP-1 and/or AFP specific to amniotic fluid, only the control line will be visible, indicating a negative result.
Setup Schedule
Testing must take place within 6 hours of specimen collection.
Limitations
ROM Plus test kits will function properly with trace amount of blood in the sample. Significant amounts of blood discharge may cause the test to malfunction and is not recommended.
False negatives are more likely to occur if a sample is not properly collected or processed, f a contaminating protein is present that interferes with the test, if the protein breaks down rapidly when exposed to the vaginal environment, and when extreme amounts of protein are present.
Elevated fetal serum, urine, cord blood, and amniotic fluid as well as maternal serum levels of AFP have been reported in the literature in various developmental disorders such as neural-tube defects, hypothyroidism, autoimmune states, congenital heart defects, cystic fibrosis, etc. ROM Plus has not been evaluated for potential interference in these conditions
False negatives are more likely to occur if a sample is not properly collected or processed, f a contaminating protein is present that interferes with the test, if the protein breaks down rapidly when exposed to the vaginal environment, and when extreme amounts of protein are present.
Elevated fetal serum, urine, cord blood, and amniotic fluid as well as maternal serum levels of AFP have been reported in the literature in various developmental disorders such as neural-tube defects, hypothyroidism, autoimmune states, congenital heart defects, cystic fibrosis, etc. ROM Plus has not been evaluated for potential interference in these conditions
Reference Range
Negative in a normal healthy female
Clinical Significance
The ROM Plus fetal membrane rupture test is a rapid, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal secretions of pregnant women with signs and symptoms of fetal membrane rupture. This test is used by healthcare professionals to aid in the detection of rupture of membranes (ROM) in pregnant women in conjunction with other signs and symptoms.
Performing Laboratory
White Oak Medical Center
