Sexual & Reproductive HealthCervical Cancer Screening3Maternal/Fetal Testing2STI Testing4AmniSure ROM Test (Rupture of [fetal] Membranes test)Print For the detection of PAMG-1 in amniotic fluid found in vaginal discharge of pregnant women 99% sensitive and 98% specific to support accuracy of negative and positive ROM clinical results No gestational age limit Not affected by urine, semen, vaginal infections and trace amounts of blood on the swab (1)The AmniSure ROM (Rupture Of [fetal] Membranes) Test is a rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women. The AmniSure ROM Test uses amniotic fluid test strips to detect the PAMG-1 protein marker of the amniotic fluid in vaginal discharge. The amniotic fluidtest isused by health care professionalsto aid in the detection of ROM in pregnant women reporting signs, symptoms, or complaints suggestive of ROM. 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Watch the AmniSure training video here.Buy ProductsProduct DetailsProduct ResourcesBuy ProductsCat No./ID:ASSK100AmniSure Test Starter KitInquireFor the detection of PAMG-1 in the amniotic fluid found in vaginal discharge of pregnant women.Cat No./ID:ASSKCP100AmniSure ROM Test CAP Starter KitInquireFor the detection of PAMG-1 in the amniotic fluid found in vaginal discharge of pregnant women.Cat No./ID:ASSKNE100AmniSure ROM Test ExtStarter KitInquireFor the detection of PAMG-1 in the amniotic fluid found in vaginal discharge of pregnant women.Cat No./ID:ASVC020AmniSure Solution with Cap and Vial (20)InquireFor the detection of PAMG-1 in the amniotic fluid found in vaginal discharge of pregnant women.Cat No./ID:FMRT-1-10-USAmniSure ROM Test (10)InquireFor the detection of PAMG-1 in the amniotic fluid found in vaginal discharge of pregnant womenCat No./ID:FMRT-1-25-USAmniSure ROM Test (25)$1,499.00Order ProductFor the detection of PAMG-1 in the amniotic fluid found in vaginal discharge of pregnant womenThe AmniSure ROM Test (Rupture of [fetal] Membranes test) are intended for in vitro diagnostic use. AmniSure ROM (Rupture of [fetal] Membranes) Test Instructions for Use. QIAGEN, 2015. Cousins LM et al. AmniSure placental alpha microglobulin-1 rapiimmunoassay versus standard diagnostic methods for detection of rupture of membranes. Am J Perinatol. 2005 Aug; 22(6): 317-20. Lockwood CJ et al. Fetal membrane rupture is associated with the presence of insulin-like growth factor-binding protein-1 in vaginal secretions. Am. J. Obstet. Gynecol. 1994 Jul;171(1):146-50. Caughey AB et al. Contemporary diagnosis and management of preterm premature rupture of membranes. Rev Obstet Gynecol. 2008 Winter; 1(1): 11-22. Product DetailsPerformancePremature rupture of fetal membranes (PROM) occurs in about 10% of pregnancies and poses one of the most important therapeutic dilemmas in current obstetric practice (2). Management of patients with PROM and pPROM (pre-term PROM, occurring before 37 weeks gestation) is expensive and remains an important perinatal dilemma as the clinician attempts to balance the risk of prolonging gestation against the risks of infection (2).Risks of PROM at term are related to serious neonatal consequences such as pre-term delivery, fetal distress, prolapsed cord, abruptio placentae and infection (2). pPROM accounts for 20% to 40% of PROM cases, and is associated with 20% to 50% of premature births. Complications of pPROM include infectious morbidity in the mother and fetus, pulmonary hypoplasia of the fetus, prolapse of the umbilical cord, development of fetal deformities, and postnatal endometritis (2). All of these consequences significantly increase risk of fetal and maternal morbidity and mortality.The AmniSure ROM Test kit is a self-contained system that can serve as part of your overall clinical evaluation of PROM, which is crucial to ensure appropriate obstetric measures are taken in the event of a rupture. Failure to identify patients with ROM can result in the failure to intervene appropriately.Conversely, the false diagnosis of ROM can lead to inappropriate interventions (e.g., hospitalization or induction of labor). Therefore the correct and timely diagnosis of ROM is of crucial importance for the clinician (2). Accurate diagnosis of [fetal] membranes rupture, however, remains a frequent clinical problem in obstetrics (2-4).Other available tests have limitations or are in some degree invasive (2). The AmniSure ROM Test is a rapid, non-invasive, amniotic fluidtest that can aid in the detection of ROM, providing rapid, easy-to-interpret and timely results. As an alternative to conventional methods of ROM detection, the AmniSure test has a 99% sensitivity and 98% specificity to support accuracy of negative and positive ROM clinical results.PrincipleThe AmniSure ROM Test uses the principles of immunochromatography to detect human PAMG-1 protein present in amniotic fluid. The test employs highly sensitive monoclonal antibodies that detect even a minimal amount of PAMG-1, which is present in cervicovaginal discharge after rupture of fetal membranes. PAMG-1 was selected as a marker of fetal membranes rupture due to its high level in amniotic fluid, low level in blood, and extremely low background level in cervicovaginal discharge when fetal membranes are intact. To minimize the frequency of false results, two monoclonal antibodies were selected to set the sensitivity threshold of the AmniSure ROM Test at the optimal low level of 5 ng/ ml.The maximum background concentration of PAMG-1 in cervicovaginal discharge is slightly lower than the sensitivity cut-off of the AmniSure ROM Test, reducing false results and allowing for ~99% accuracy (2). A sample of cervicovaginal discharge (collected by vaginal swab) is placed into a vial with solvent for extraction. PAMG-1 is then detected in the sample through an amniotic fluidtest strip (lateral flow device). The result is read visually by the presence of one or two lines in the test region of the strip.ProcedureThe simple 4-step test procedure* detects placental alpha microglobulin-1 (PAMG-1) a protein found in high concentrations in amniotic fluid and low concentration in cervicovaginal fluid (4). Collect sample of vaginal discharge with sterile collection swab (no speculum required). Rinse specimen swab in solvent vial. Discard swab. Insert amniotic fluidtest strip into vial and remove if 2 lines are visible, or at 10 minutes sharp. Results are observed and recorded. *Please refer to package insert for complete instructions for use.ApplicationsThe AmniSure test is for use by healthcare professionals to aid in the detection of fetal membranes rupture in pregnant women when they report signs, symptoms, or complaints suggestive of such a rupture.Product ResourcesYou are not authorized to download the resourceBrochures & Guides (3) Sort optionsSort alphabetically Your Answer Can Impact a Life. Evaluate PROM Confidently with AmniSureShow detailsAmniSure Quick Reference GuideShow detailsAmniSure Quick Reference PosterShow detailsShow allShow lessKit Handbooks (1) Sort optionsSort alphabetically AmniSure ROM Test Instructions For UseShow detailsShow allShow lessSafety Data Sheets (6) Sort optionsSort alphabetically MSDS AmniSure ROM Test (10)MSDS AmniSure ROM Test (25)MSDS AmniSure ROM Test CAP Starter KitMSDS AmniSure ROM Test ExtStarter KitMSDS AmniSure Test Starter KitMSDS AmniSure Solution with Cap and Vial (20)Show allShow lessfragment fix placeholderCustomers who bought these products also boughtCat No./ID:AST1000AmniSure Timer and Vial HolderFor the detection of PAMG-1 in the amniotic fluid found in vaginal discharge of pregnant women.$79.00Add To CartCat No./ID:ASQC-010Positive and Negative Controls For the positive and negative controls ofPAMG-1$99.00Add To CartCat No./ID:635051AS Bulk USAS Bulk US$5,996.00Add To CartCat No./ID:1055628TopElute Fluid (60 ml)60 mlTopElute Fluid for use withautomated nucleic acid purification protocols$26.60Add To CartCat No./ID:931436QIAsymphony DNA Investigator Kit (192)For 192 preps of 200 µl each from casework and reference samples: includes 2 reagent cartridges and enzyme racks and accessories$1,133.00Add To CartCat No./ID:75144RNeasy Midi Kit (50)50 RNeasy Midi Spin Columns, Collection Tubes (15 ml), RNase-free Reagents and Buffers$708.00Add To CartCat No./ID:622832QuantiFERON-TB Gold PlusReference LabPack ELISA Kit20 sets of 12 x 8 Microplate Strips; IFN-gamma Standard, lyophilized; Green Diluent; Conjugate 100x Concentrate, lyophilized; Wash Buffer 20x Concentrate; Enzyme Substrate Solution; Enzyme Stopping Solution$7,752.00Add To CartCat No./ID:80004AllPrep DNA/RNA/Protein Mini Kit (50)For 50 preps: AllPrep DNA Spin Columns, RNeasy Spin Columns, Collection Tubes, RNase-Free Reagents and Buffers$686.00Add To CartCat No./ID:80224AllPrep DNA/RNA/miRNA Universal Kit (50)For 50 preps: 50 AllPrep DNA Mini Spin Columns, 50 RNeasy Mini Spin Columns, Collection Tubes, and Buffers$676.00Add To CartCat No./ID:56504QIAamp DNA Investigator Kit (50)For 50 DNA preps: 50 QIAamp MinElute Columns, Proteinase K, Carrier RNA, Buffers, Collection Tubes (2 ml)$271.00Add To CartCat No./ID:622433QuantiFERON-TB Gold Plus Dispenser PackDispenser pack of QFT-Plus Blood Collection Tubes in25 packs per carton, each pack including: 1 Nil tube, 1 TB1Antigentube, 1 TB2Antigentube and 1 Mitogentube. 1 Package Insert is included per carton.$766.00Add To CartCat No./ID:51306QIAamp DNA Mini Kit (250)For 250 DNA preps: 250 QIAamp Mini Spin Columns, QIAGEN Proteinase K, Reagents, Buffers, Collection Tubes (2 ml)$757.00Add To CartCat No./ID:208052QuantiNova SYBR Green PCR Kit (100)For 100 x 20 µl reactions: 1 ml 2x QuantiNova SYBR Green PCR Master Mix, 500 µl QuantiNova Yellow Template Dilution Buffer, 250 µl QN ROX Reference Dye, 1.9 ml Water$116.00Add To CartCat No./ID:619204 digene HC2 DNA Collection DeviceFor cervical specimen collection, includes: 50 cervical brushes and Specimen Transport Medium$119.00Add To CartCat No./ID:19588Elution Microtubes CL (24 x 96)Nonsterile polypropylene tubes (0.85 ml maximum capacity, less than 0.7 ml storage capacity, 0.4 ml elution capacity); 2304 in racks of 96; includes cap strips$624.00Add To CartCat No./ID:19089Buffer AVL (w/o carrier RNA, 155 ml)For 250 preps: 155 ml Viral Lysis Buffer$146.00Add To CartCat No./ID:52904QIAamp Viral RNA Mini Kit (50)For 50 RNA preps: 50 QIAamp Mini Spin Columns, carrier RNA, Collection Tubes (2 ml), RNase-free buffers$271.00Add To CartCat No./ID:1020953Buffer AVE (108 x 2 ml)Buffer AVE for elution of RNA$477.00Add To CartCat No./ID:56404QIAamp DNA FFPE Tissue Kit (50)For 50 DNA preps: 50 QIAamp MinElute Columns, Proteinase K, Buffers, Collection Tubes (2 ml)$256.00Add To CartCat No./ID:623536QuantiFERON-TB Gold Plus HA Blood CollectionTubes200 QFT-PlusHA Blood Collection Tubes (50 each: Nil, TB1, TB2 and Mitogen tubes)$1,499.00Add To Cart