![]() ![]() *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: Negative Test for amniotic fluid A purple line in the control line area of the test strip. Positive tests for amniotic fluid require A purple line in the control line area of the test strip Any intensity purple line in the test line area of the test strip. When implementing a new system, such as ROM Plus, the facility must verify the accuracy of the new system. The test strips should be read in good light. The ROM CS is a commercially available quality control material with known values, Eclipse™ for treatment of Fecal Incontinence.View All Obstetrics, Gynecology & Neonatal Products.LifeBubble™ Umbilical Catheter Securement System. ![]() ABBy™ Postoperative Panniculus Retractor.ROM Plus® Rupture of Membrane Test Family of Products. ![]()
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