#AMNIOTIC FLUID TEST STRIPS PLUS#
*ROM CS is only available for the ROM Plus ® Rupture of Membranes Test in the US. CLIA regulations only require a positive or a negative sample and do not require low/high positives. The ROM CS samples are either positive or negative. It test results for these samples fall within the manufacturers stated acceptable limits, accuracy is verified.” This can be done by testing commercially available calibrators/calibration and quality control materials with known values, proficiency testing materials that have established values, and previously tested patient specimens with established values. “The laboratory needs to compare the accuracy of the test results it obtains when using a test system with the manufacturer’s accuracy claims.
This is best done by comparison to truth, but if truth is not available, the ROM-CS can be used.įrom the CLIA Certification of Performance Specifications Brochure #2: When implementing a new system, such as ROM Plus, the facility must verify the accuracy of the new system. The ROM CS is a commercially available quality control material with known values, View All Obstetrics, Gynecology & Neonatal Products.ROM Plus® Rupture of Membrane Test Family of Products.URGENT PC® (US) Treatment for Overactive Bladder.Optilume® Urethral Drug Coated Balloon for the treatment of Anterior Urethral Stricture.At this time, the agency is not aware of adverse events related to the recalled products. It is easy to use and results reading is clear. AL-SENSE can distinguish between amniotic fluid leak (positive result) and urine (negative result). Inaccurate interpretation of these lab test results can lead to serious adverse events, including fetal deaths and health complications for the mother," the recall notice states. The AL-SENSE Amniotic fluid detection kit is an in vitro self-test that allows detection of possible amniotic fluid leakage in the event of pregnant women sensing unidentified vaginal wetness. In addition, it is possible that the display of a test line in the absence of a control line could be misinterpreted as a negative test when it is a positive test.
"Failure of a control line to appear leads to an invalid test and delay in obtaining test results due to the need of repeat testing. Qiagen Sciences LLC has received customer complaints that some tests are not displaying a control line.
The test is designed to display one line (control line) if the result for the presence of amniotic fluid is negative and two lines (control line and test result line) if the result for the presence of amniotic fluid is positive. In a separate communication, the FDA is alerting health providers to a voluntary recall of AmniSure ROM Test Strips, made by Qiagen Sciences LLC, due to a potential manufacturing defect causing the control line to not display, which may lead to misinterpretation of test results. We urge healthcare providers to carefully follow the labeled instructions for use on these tests," said Lias. "We will continue to monitor adverse events regarding these tests and will communicate further if there is additional information that will benefit women and their healthcare providers. "Our review of the risks associated with improper use of these ROM tests is ongoing, but we want to be transparent with providers and patients about the information that we have indicating an issue, and provide recommendations to minimize the risks," Courtney Lias, PhD, director, Division of Chemistry and Toxicology Devices in the FDA's Center for Devices and Radiological Health, said in a statement. "To help protect patients and reduce the chance of adverse events, ROM tests should be part of an overall clinical assessment, which may include physical examination of the patient and testing to detect leaking amniotic fluid," the FDA advises in the letter.
The FDA says it has received information indicating that healthcare providers may be "over-relying" on ROM test results when making patient management decisions, "despite labeling instructions warning against this practice." The FDA is aware of several adverse events related to the use of ROM tests, including 15 fetal deaths and multiple reports of health complications in pregnant women.