SIM 70042 CPT Synonyms Amnisure Specimen Type Use only Amnisure Specimen Collection swabs and vials included in the kit. Amnisure vials (which include a solvent) and swabs are available from the Core Lab. Container Use only Amnisure swabs and vials included in the kit, available from the Core Lab. Collection Instructions Collection performed by physician or nurse: 1. filexlib. AmniSure™ Fetal Membranes Rupture Test/AmniSure™ ROM (Rupture Of fetal Membranes) Test F. Regulatory Information: 1. Regulation section: 21 CFR 862.1550; 21 CFR 862.1660 2. Classification: I 3. Product Code: kit consists of a sterile Dacron swab (applicator) for sampling, plastic vial with solvent for extracting the sample from the swab The AmniSure® ROM test is a simple 4 step immunoassay which detects the PAMG-1 biomarker in cervico-vaginal fluid. Around 20-25% of pregnancies present with
References: 1. AmniSure ROM (Rupture of [fetal] Membranes) Test Instructions for Use.QIAGEN, 2019. 2. ROM plus Rupture of Membranes Test Instructions for Use. P/N 050-0642 REV E, 2016. 3. Actim PROM Instructions for Use OACE30831-9.
parison with the ROM-check Membrane immunoassay in the diagnosis of ruptured fetal membranes. Clinica Chimica Acta. 214: 73-81. 7. Abdelazim, I. A. (2013). Insulin-like growth factor binding protein-1 (Actim® PROM test) for detection of premature rupture of fetal membranes. Journal of Obstetrics and Gynaecology Research, 40(4), 961-967. 8. The ROM CS kit comes with: 20 blinded samples Sealed known results ROM CS correlation log Instructions for use The ROM CS samples are either positive or negative. CLIA regulations only require a positive or a negative sample and do not require low/high positives. *ROM CS is only available for the ROM Plus ® Rupture of Membranes Test in the US.
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Amnisure International LLC F. Proprietary and Established Names: AmniSure™ ROM (Rupture of Fetal Membranes) Test G. Regulatory Information: 1. Regulation section: 21 CFR 862.1550, Urinary pH 2. Classification: Class I, meets limitations of exemptions under 21 CFR 862.9 for changes to the indication for use and near patient testing. 3.
Rapid Test Starter Kit AmniSure® Fertility Test ROM Test Amniotic Fluid Sample 50 Tests TEST KIT, PREGNACY AMNISURE F/DETECTION OF PAMG-1 D/S. No Image. Compare . Features. 99% sensitive and 98% specific to support accuracy of negative and positive ROM clinical results No gestational age limit
The AmniSure assay does not require speculum examination. The sample is taken by sterile swab only, inserted 2-3 inches deep. The clear yes/no result can be read in 5-10 minutes. Materials: AmniSure ROM Kit in foil pouch with desiccant (FMRT-1-25 for 25 test kit; FMRT-1-10 for 10 test kit) Sterile polyester swab (supplied in kit)
• ROM Plus is for healthcare professional use only. • Allow pouch containing ROM Plus to reach room temperature prior to utilizing the test. • All instructions should be followed carefully for accurate results. • Each ROM Plus test kit is single use and disposable and should not be reused. • ROM Plus results are qualitative.
1. Open the AmniSure test kit and remove the contents 2. Shake the solvent vial to make sure that all of the liquid in the vial settles to the bottom 3. Open the solvent vial and place it in a vertical position 4. Insert the sterile polyester swab from the AmniSure test kit into the vagina 2-3 inches. 5. Withdraw the swab after one minute has
1. Open the AmniSure test kit and remove the contents 2. Shake the solvent vial to make sure that all of the liquid in the vial settles to th