NEW YORK (360Dx) – The US Food and Drug Administration said on Wednesday that Qiagen Sciences is recalling the AmniSure ROM Test due to a manufacturing defect that causes the control line to not display.
The agency also said it has alerted women and their doctors about serious adverse events related to the improper use of these types of tests, which are called rupture of membranes tests.
The AmniSure ROM Test is a rapid noninvasive immunoassay used to aid in diagnosing ruptured fetal membranes. According to the AmniSure website, premature ROM occurs in 1 out of 10 pregnancies. In the US, about 30 percent of pregnant women are checked for premature ROM during pregnancy.
According to a notice by the FDA, the control line on the AmniSure ROM Test may not display, leading to a misinterpretation of test results. The test is supposed to show one line — the control line — if the result for the presence of amniotic fluid is negative, and two lines — the control line and the test result line — if the result for the presence of amniotic fluid is positive.
However, some customers complained to Qiagen Sciences, a Maryland-based subsidiary of Qiagen, about the control line not displaying, which can cause test results to be misinterpreted as negative when they may, in fact, be positive.
"Inaccurate interpretation of these lab test results can lead to serious adverse events, including fetal deaths and health complications for the mother," the FDA said.
Nearly 1,600 test kits, or 39,625 tests, are being recalled, the agency said. The AmniSure ROM Tests that are being recalled were distributed between October 2017 and March 2018.
Separately, the FDA sent out a letter to healthcare providers as a reminder that the labeling for ROM tests "specifies that they should not be used on their own to independently diagnose a ROM in pregnant women." Such tests have been cleared for use only in conjunction with other clinical assessments "to make critical patient management decisions regarding whether a ROM has occurred."
The FDA said that it has received information that some healthcare providers may be solely using ROM tests to make patient management decisions despite manufacturers' labeling instructions.