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AmniSure PAMG 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 Aim: This study was designed to compare the accuracy of placental alpha microglobulin-1 (PAMG-1) versus insulin-like growth factor binding protein-1 (IGFBP-1) to diagnose premature rupture of fetal membranes (PROM). Material and methods: This comparative prospective study was carried out over 3 years in Al-Rashid Maternity and Ahmadi Hospitals, Kuwait

AmniSure ROM Test (Rupture of [fetal] Membranes test

AmniSure test kit is for the in vitro detection of human amniotic fluid PAMG-1 protein in vaginal secretion of pregnant women. The test should be used to evaluate patients with clinical signs/symptoms suggestive of feta • PAMG-1 test is classified as CLIA moderately complex (i.e., non-waived) • Regardless of accreditation all non-waived testing requirements must be met (follow your accreditation agency) • QC options will change Jan. 1, 2016 . Should an IQCP for the PAMG-1 Test be considered? AmniSure ® is a non-invasive, one-step immunochromatographic assay which detects the placental alpha microglobulin-1 protein (PAMG-1) using specific monoclonal antibodies. AmniSure ® has been evaluated in more than 20 peer reviewed clinical studies. It has been found to have a sensitivity of 98.9% and specificity of 100% 1

Placental alpha microglobulin-1 (AmniSure test) versus

AmniSure detects PAMG-1 protein marker of the amniotic fluid in vaginal secretions. The test is for use by health care professionals to aid in the detection of rupture of membranes (ROM) in pregnant women at > 34 weeks gestation when patients report signs, symptoms or complaints suggestive of ROM (FDA, 2004) The IGFBP-1 test specificity decreased by 12.8 percentage points to a value of 75% whereas the PAMG-1 (AmniSure) test only decreased by 7 percentage points to a value of 91.5%. Showing that while the presence of vaginal bleeding impacts both tests the IGFBP-1 is much more affected than the PAMG-1 test Control Kit AmniSure® PAMG-1 Positive Level / Negative Level CONTOLS, POSTIVE/NEGATIVE F/PAMG-1 QC PACK AMNISURE. No Image. Features. For the positive and negative controls of PAMG-1

Amnisure is a test for premature rupture of membranes or PPRO

AMA's CPT code® 84112 can be used to describe Amnisure ROM test.. .0 EXPECTED VALUES AND CLINICAL SIGNIFICANCE: fluid. tis or 0 c fluid increases PAMG-1 concentration in ervico-vaginal secretions by a factor of thousands. y a factor of 20 above the background level of AMG-1 (AmniSure detects ~5 ng/ml of PAMG-1) IGFPB-1/PAMG-1 levels in the range of 9 to 23688 ng/ml and an AFP range of >10 to 39276 ng/ml. The threshold for the lower limit of detection for the test kits are, respectively, ActimTM Prom = IGFBP-1 25 ng/ml, AmniSure ® = PAMG-1 5 ng/ml and ROM+plus® = IGFBP-1 5 ng/ml, AFP 150 ng/ml. Thus, all amniotic fluid samples tested were above the.

Use of AmniSure: Equivocal findings with history of PROM The AmniSure test is a rapid, non-invasive strip test for the detection of the placental alpha microglobulin-1 protein (PAMG-1). It is used to help diagnose whether patients have ruptured membranes in patients presenting with signs and symptoms of PROM/PPROM. I The AmniSure immunoassay involves detecting the presence of high concentration of glycoprotein PAMG-1 in the cervicovaginal secretion. PAMG-1 is a 34-kd glycoprotein [ 27 ]. Due to its unique features (i.e., high concentration in the amniotic fluid, low concentration in blood, and very low concentration in cervicovaginal discharge), it was. In cervicovaginal secretion, PAMG-1 concentration at term is lower (0.05 to 0.22 ng/mL) than the AmniSure detection limit (5 ng/mL) whereas IGFBP-1 concentrations vary from 0.5 to 90 ng/mL and the detection limit of actim PROM test is 25 ng/mL. This could affect test result in clinical situation The AmniSure® ROM rest is a rapid immune assay supplied as a single. Cost-effective test for in vitro diagnostics. The 4-step test procedure detects placental alpha microglobulin-1 (PAMG-1) protein that is found in high concentrations in amniotic fluid and low concentrations in cervicovaginal fluid. 5. Saves time and the costs of additional. AmniSure detects PAMG-1 protein marker of the amniotic fluid in vaginal secretions. The test is for use by health care professionals to aid in the detection of ROM in pregnant women at > 34 weeks gestation when patients report signs, symptoms or complaints suggestive of ROM. The Human freeze-dried PAMG-1 (amniotic fluid protein control) is a

AmniSure ROM-test | 10 stuks - Vroedvrouwenloket

The PartoSure test is used to detect the presence of placental alpha microglobulin-1 (PAMG-1), a protein present in the amniotic fluid throughout pregnancy Call the laboratory to notify them that a sample is being collected for an amnisure test. Order a ROM Test (Rupture of Fetal Membranes). Label the solvent vial appropriately with two identifiers, patient name and another identifier, (patient ID number, DOB, etc.) include date and time of collection and initial of person collecting the specimen Mechanism. Placental Alpha Microglobulin-1 Rapid Immunoassay (PAMG-1 Protein Marker Assay) PAMG-1 is 1000 to 10,000 times more concetrated in amniotic fluid than in cervical or vaginal secretions. Technique. No vaginal exam should be done prior to testing. Sterile Dacron swab is placed at the posterior vaginal fornix for 1 minute PAMG-1 was accurate (98%) for detection of PROM than Ferning (81.33%) or Nitrazine (84.0%) tests. Conclusion. Detection of the PAMG-1 in the vaginal fluid using AmniSure ® test is an accurate method to diagnose rupture of the fetal membranes, with high sensitivity, specificity, negative and positive predictive values Abstract Aim This study was designed to compare the accuracy of placental alpha microglobulin-1 (PAMG-1) Although AmniSure test seems to be the most accurate test to diagnose rupture of the fetal membranes with high sensitivity and specificity, in this study the sensitivity, specificity and accuracy of AmniSure test to diagnose PROM were.

PAMG-1 may be found in high levels in amniotic fluid and low levels in cervicovaginal discharge when fetal membranes are intact. AmniSure ROM is an example of a PAMG-1 test. A sample of secretions are obtained via a vaginal swab and placed in a vial with a solvent designed to extract the amniotic fluid from the swab. If the PAMG-1 protei 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 detects PAMG-1 protein marker of the amniotic fluid in vaginal discharge Technology Description: The AmniSure ROM Test (Rupture of [fetal] Membranes test) (Qiagen N.V., the Netherlands) has been developed to detect fetal membrane rupture based on the presence of placental alpha-microglobulin-1 protein (PAMG-1) in vaginal fluid. Controversy: Although the AmniSure test is relatively easy to perform and could enable. The PAMG-1 immunoassay is ~99% accurate to aid in the diagnosis ROM, does not require a speculum examination, and can be used at any gestational age. Amnisure ROM Test. Fetal membran rüptürlerinin (ROM) tanısı, doktor için kritik öneme sahiptir

for other detection methods. One such method is AmniSure, which is an immunoassay for placental alpha microglobulin-1 (PAMG-1). PAMG-1 is abundant in amniotic fluid, but is found in negligible amounts in vaginal secretions without membrane rupture.3,4 It is also not present i The AmniSure test measures the presence of placental alpha macroglobulin-1 (PAMG-1) protein in the amniotic fluid using an immunochromotographic assay from a vaginal swab. This test has been reported to have a high sensitivity for detecting the PAMG-1 protein. 2 . However, th

AmniSure® PROM Test - Accurate PROM / PPROM Diagnosis

La Prueba RPM de AmniSure ® no requiere un examen con espéculo y detecta específicamente la proteína Placental Alpha Microglobulin-1 (PAMG-1) en el líquido amniótico. La muestra se toma con un hisopo estéril, que se inserta a una profundidad de 2-3 pulgadas (5-7 cm) en la vagina Amnisure (PAMG-1 assay) is a bedside strip test with a sensitivity of 98.9%, specificity of 100%, a PPV of 100%, and an NPV of 99.1% , but its positive results should be interpreted cautiously, because the clinical significance of a positive test due to micro-leakage of amniotic fluid is not yet clear (15, 16)

The AmniSure ROM Test uses the principles of immunochroma- tography 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 TEST KIT, PREGNACY AMNISURE F/DETECTION OF PAMG-1 D/S. No Image. Features. 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 swa Keywords: Amnisure ROM testTM, placental a microglobulin-1, rupture of membranes, labor, term birth Introduction The Amnisure ROM testTM is a new method to diagnose rupture of the fetal membranes (ROM). The test detects placental a-microglobulin-1 (PAMG-1) in cervicovaginal fluid. The concentra-tion of this protein in amniotic fluid is 1000. PAMG-1 is 1000 to 10,000 times more concetrated in amniotic fluid than in cervical or vaginal secretions. IV. Technique. No vaginal exam should be done prior to testing. Sterile Dacron swab is placed at the posterior vaginal fornix for 1 minute. Swab is placed in solvent vial for 1 minute. Test strip is placed in solvent and result is available. Specimen Requirements. Contact Billings Clinic Laboratory at 657-4060 or 866-232-2522 for kit and collection procedure. Collect specimen using an AmniSure® ROM Collection Kit. Forward promptly at ambient temperature

AmniSure® is a one-step immunochromatographic device. The test is based on the use of several, specifically selected, monoclonal antibodies that detect trace amounts of the amniotic fluid protein PAMG-1, which is present in cervico-vaginal discharge after the rupture of the fetal membranes The presence of PAMG-1 was determined using a commercially available kit (AmniSure, AmniSure International LLC, Boston, MA). RESULTS: A total of 100 women were enrolled, of which 86 had outcome data available. PAMG-1 was detected in 19/86 (22.1%) subjects

AmniSure ROM Test Positive Control - QIAGE

(2005) AmniSure® placental alpha microglobulin-1 rapid immunoassay versus standard diagnostic methods for detection of rupture of membranes. Am. J. Perinatol. 22, 317-20. - Read here Lee, S.E. et al. (2007) Measurement of placental alpha-microglobulin-1 in cervicovaginal discharge to diagnose rupture of membranes. Obstet. Gynecol. 109, 634. AmniSure tm Use in Pregnancy. AmniSure tm is a rapid test for diagnosis of ruptured membranes (ROM). It detects the presence of placental alpha microglobulin-1 (PAMG-1) in cervical and vaginal secretions. The test has shown sensitivity of 93-99% and specificity of 88-100% in published data, with PPV of 95-100% and NPV of 91-99% For the detection of PAMG-1 in the 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 limit. Not affected by urine, semen, vaginal infections and trace amounts of blood on the swab (1). More

ALPHA 1-MICROGLOBULIN (AMNISURE ROM) - NorDx Test Catalo

Over 40 publications have been produced analysing IGFBP-1 and PAMG-1 (AmniSure). In 2012 the most recognised (P)PROM publication was produced. A meta-analysis which reviewed all 40 publications - Ramsauer et al. 2012 To investigate the utility of vaginal placental alpha microglobulin-1 (PAMG-1) protein as a predictor of preterm delivery within 7 days in pregnancies at risk of premature birth. This prospective study was performed in women at risk of premature birth. The levels of vaginal PAMG-1 and foetal fibronectin (fFN) and the transvaginal cervical length measurement (CLM) were investigated and compared Ehsanipoor et al. showed that the presence of PAMG-1, detected by the AmniSure® test, is associated with a high risk of delivery within 7 days when cervical length is less than 20 mm, with a sensitivity of 84% and a specificity of 82% [].The AmniSure® test works within a wide range of PAMG-1 concentrations potentially found in vaginal discharge (from 5 ng/ml to 200 µg/ml) Amnisure is an immunochromatographic assay measuring the placental alpha macroglobulin-1 (PAMG-1), while Actim PROM detects insulin-like growth factor-binding protein-1. Both of these bedside assays have been shown to have high sensitivity and specificity for the diagnosis of PROM and to be more accurate than clinica

The Amnisure ROM test is for the detection of human amniotic fluid PAMG -1 protein in vaginal discharge of pregnant women. The test should be used to evaluate patients with clinical signs/symptoms suggestive of fetal membrane rupture A total of 460 AmniSure and 476 actim PROM tests were performed on eight different amniotic fluid dilutions ranging from 1:20 to. Discussion. This is the first study evaluating PAMG-1 and IGFBP-1 detection in amniotic fluid in early pregnancy, with respectively AmniSure and actim PROM tests

PPT - LES MENACES D’ACCOUCHEMENT PREMATURE PowerPointROM Plus Rupture of Membranes Test - Clinical Innovations

The AmniSure ROM Test does not require a speculum examination and specifically detects the Placental Alpha Microglobulin-1 (PAMG-1) protein in amniotic fluid. The sample is taken by sterile swab, which is inserted 2-3 inches deep (5-7 cm) into the vagina. A clear Yes/No result can be read in minutes Amnisure ® is a bedside immunoassay for placental alpha macroglobulin-1 (PAMG-1), which has been shown to have high sensitivity and specificity in the diagnosis of PROM. However, whether the use of Amnisure ® alters clinical management remains untested. The objective of this study was to assess the clinical utility of Amnisure ®

Detection of PPROM With AmniSure PAMG-1 Rapid Immunoassay

  1. The detection of PAMG-1 using Amnisure in the diagnosis of PROM in this study yielded 1.43% false negative results when compared with the final diagnosis. This finding was slightly higher than 0.49% false negative results documented by Cousins et al., however,.
  2. Amnisure ROM test results (presented with spontaneous preterm labor and intact membranes), delivered spontaneously within 72h and the other within 7 days of the test result. Accordingly, it was hypothesized that the presence of PAMG-1 in cervicovaginal fluid may be independently associated with test-to-delivery dura

LAB.00029 Rupture of Membranes Testing in Pregnanc

PAMG-1 was accurate (98%) for detection of PROM than Ferning (81.33%) or Nitrazine (84.0%) tests.ConclusionDetection of the PAMG-1 in the vaginal fluid using AmniSure® test is an accurate method to diagnose rupture of the fetal membranes, with high sensitivity, specificity, negative and positive predictive values were for Actim PROM IGFBP-1 (n=1,066), four were for AmniSure PAMG-1 testing (n=1,081), and three additional studies included both biomarker tests. Pooled analysis included only those women with suspected ROM who had later confirmation of the diagnosis. This analysis foun

AmniSure ® AmniSure International developed PartoSure™ as a complementary test to theAmniSure. ROM Test ® ROM (rupture of foetal membranes) test, which was launched ®in the UK in 2012. AmniSure. and PartoSure™ share the same characteristics and method for detecting the PAMG-1 protein marker of amniotic fluid in vaginal discharge. AmniSure a monoclonal immunoassay that detects the PAMG-1 (AmniSure®, QIAGEN N.V., Netherlands), and 2) a monoclonal/polyclonal immunoassay that detects the presence of IGFBP-1 and AFP (ROM Plus®, Clinical Innovations, Salt Lake City, UT USA). One hundred eleven (111) pregnant women, ≥ 15 weeks gestation presenting with a complaint of ROM were en PAMG-1 was accurate (98%) for detection of PROM than Ferning (81.33%) or Nitrazine (84.0%) tests. CONCLUSION Detection of the PAMG-1 in the vaginal fluid using AmniSure(®) test is an accurate method to diagnose rupture of the fetal membranes, with high sensitivity, specificity, negative and positive predictive values PAMG-1 (AmniSure® test) done following manufacturer's instructions (QIAGEN, Maryland, USA) using third swab which inserted into the vagina for 1 minute, then rinsed in the solvent for 1 minute, then removed from the solvent and disposed. Test strip dipped into the solvent for 5-10 minutes and the results interpreted

In Vitro Technologies :: AmniSure: The effect of blood on

  1. AmniSure detects the PAMG-1 protein marker of the amniotic fluid. The test is marketed for use by health care professionals to aid in the detection of ROM in pregnant women when patients report signs, symptoms, or complaints suggestive of ROM. [2] ROM Plus® Fetal Membranes Rupture Test
  2. imum amount of the PAMG-1 (5.0 ng/ml) and not affected by semen, urine, blood or vaginal infection . Although Stafford et al. [ 30 ] concluded that there is excellent agreement between fetal fibronectin results obtained by speculum and non-speculum collection methods, fFN swabs were collected in this study.
  3. e the efficacy of the test in predicting im
  4. PAMG-1 (AmniSure®): placental alpha microglobulin-1 protein . Rapid, noninstrumental, point of care immunochromatographic assay ; PAMG-1 is present in the blood, amniotic fluid and cervico-vaginal discharge of pregnant women; Gestational age range: 11-42 weeks ; Sensitivity 98.9% | Specificity 98.1
  5. Qiagen's immunoassay AmniSure ROM is supposed to offer a better alternative. The test detects placental alpha-microglobulin-1 (PAMG-1), a protein that is found in high concentrations in amniotic fluid and low concentrations in cervicovaginal fluid. The difference in concentrations means the presence of high concentrations of PAMG-1 in the.
  6. g an antigen-antibody complex. This complex then flows to the test region of the strip where it is immobilised by a second anti-PAMG-1 antibody and causes the appearance of a test line if the concentration of PAMG-1 in the sample exceeds the.
  7. pregnancy to ensure timely and proper hospitalization and treatment. AmniSure® detects trace amounts of placental alpha microglobulin-1 protein (PAMG-1) in vaginal fluid after rupture of fetal membranes. With intact fetal membranes, the test does not normally detect PAMG-1, due to its low background concentration

Qiagen LLC ASQC-010 - McKesson Medical-Surgica

  1. AmniSure ROM Test (AmniSure International, Cambridge, MA) is a rapid, qualitative immunochromatographic assay for the in vitro detection of PAMG-1 (placental α microglobulin-1) protein in vaginal swabs. This test was compared with the current diagnostic methods of nitrazine/pH test, microscopic fern test, and assessment of amniotic fluid pooling
  2. AIM: This study was designed to compare the accuracy of placental alpha microglobulin-1 (PAMG-1) versus insulin-like growth factor binding protein-1 (IGFBP-1) to diagnose premature rupture of fetal membranes (PROM). MATERIAL AND METHODS: This comparative prospective study was carried out over 3 years in Al-Rashid Maternity and Ahmadi Hospitals, Kuwait
  3. Also, the accuracy (98%) of PAMG-1 was statistically insignificant compared with the accuracy (86%) of IGFBP-1 (P > 0.05). CONCLUSION: Although AmniSure test seems to be the most accurate test to diagnose rupture of the fetal membranes with high sensitivity and specificity,.
  4. Container/Tube: AmniSure Kit. Specimen Volume: Swab. Collection Instructions: 1. Collect vaginal specimen with Dacron swab included in the AmniSure Kit. a. Label the vial containing the liquid AmniSure solvent with the patient's name, MRN, collection date and time. b
  5. Objective: We aimed to do a study in the use of the identification of Placental Alpha Micro Globulin-1 or PAMG-1, in the form of Amnisure ® test, as a method to diagnose rupture of membrane (ROM), compared with other conventional method (direct visualization and nitrazine test)
  6. The AmniSure test measures the presence of placental alpha macroglobulin-1 (PAMG-1) protein in the amniotic fluid using an immunochromotographic assay from a vaginal swab. This test has been reported to have a high sensitivity for detecting the PAMG-1 protein. 2. However, th
  7. swab is disposed. The AmniSure test strip, a lateral flow device, is then placed into the vial. The solvent containing antibodies to the PAMG-1 flows from the pad region of the strip to the Test Region. If PAMG-1 is present in the patient sample it will bind with antibodies in the test region producing a second line

Evaluation of a Novel Diagnostic Kit for the Detection of

Non-Invasive Fetal Membranes Rupture Tests - Medical

  1. The PAMG-1 test is marketed as AmniSure at a reimbursement cost of $85.42 per test, whereas the cost of the traditional test is $14.16. 9 Furthermore, the cost of a single patient transfer ranges from $800 to $8,800. 10-12 Therefore, the question of whether to use PAMG-1 or the traditional test in resource-limited settings should be guided by.
  2. AmniSure® ROM Test Clinical evidence consistently validates the high accuracy of the AmniSure ROM Test Science that Makes Sense The AmniSure ROM Test is a FDA-cleared rapid immunoassay intended to aid in the diagnosis of PROM. The Test detects placental alpha microglobulin-1 (PAMG-1) in the vaginal discharge o
  3. AmniSure ROM Test (Rupture of [fetal] Membranes test). For the detection of PAMG-1 in amniotic fluid found in vaginal discharge of pregnant women. Kit contents: For the detection of PAMG-1 in the amniotic fluid found in vaginal discharge of pregnan
  4. utes after sampling False results after 15
  5. Amnisure • Detects PAMG-1(placental microglobulin) • 99% sensitivity,100%specificity • PAMG-1 is a protein produced by cells of decidual part of placenta and can be detected in amniotic fluid after rupture of membranes. • Recently approved by FDA in US 14

Video: Placental alpha microglobulin-1 (PAMG-1) - Wikipedi

Trust Guideline for the use of Fetal Fibronectin and AmniSur

  1. Prah citlivosti testu AmniSure je nastavený podľa 20-násobku základnej koncentrácie PAMG-1 (AmniSure deteguje 5 - 7 ng/ml PAMG-1). VLASTNOSTI ÚČINNOSTI . Klinická účinnosť testu AmniSure sa overovala v klinickom skúšaní, ktoré sa uskutočnilo v dvoch zdravotníckych zariadeniach v Kalifornii v USA. Pacientky v 34. - 41
  2. The AmniSure test strip, a lateral flow device, is then placed into the vial. The solvent containing antibodies to the PAMG-1 flows from the pad region of the strip to the Test Region. If PAMG-1 is present in the patient sample it will bind with antibodies in the test region producing a second line
  3. utes of collection. This test is not affected by semen or trace.
  4. AmniSure is an immunoassay performed using a vaginal swab sample. This rapid test detects placental alpha microglobulin-1 (PAMG-1) protein, found in high concentrations in amniotic fluid. AmniSure does not have the high frequency of false-positive and false-negative results found with the pH and fern tests
  5. contains colloidal gold labeled mouse monoclonal antibodies to PAMG-1, immobilized mouse monoclonal antibodies (test region), and rabbit anti-mouse anti-immunoglobulin antibodies (control region). J. Substantial Equivalence Information: 1. Predicate device name(s): AmniSure™ ROM (Rupture Of fetal Membranes) Test 2. Predicate 510(k) number(s)

Comparison between Amnisure Placental Alpha Microglobulin

AmniSure: The effect of blood on ROM diagnosis accuracy of PAMG-1 and IGFBP-1 detecting rapid tests. Research shows that conventional diagnostic tests, such as nitrazine (pH), ferning, pooling and ultrasound can be inaccurate and invasive. In fact Neil 2010 shows that 47% of the time clinicians are not confident in their diagnosis of PROM based. AmniSure detects PAMG-1 (placental alpha-1 microglobulin) protein marker of the amniotic fluid in vaginal secretions and is intended to aid in the detection of rupture of membrane in pregnant women . xiv greater than 34 weeks gestation with signs, symptoms or complaints suggestiv AmniSure ROM Test ® Diagnosticar con precisión la ruptura prematura de membranas fetales (ROM) es de vital importancia para un médico. Un diagnóstico preciso de ROM en cualquier momento durante el embarazo es crucial para un tratamiento oportuno, adecuado y para determinar la necesidad de una hospitalización inmediata. Si no s Abstract Objective: The PartoSure™ time-to-delivery (TTD) test (AmniSure International, Boston, MA, USA) is a newly available bedside test for the prediction of time to spontaneous preterm delivery via the detection of placental alpha microglobulin-1. The objective of this study was to determine the efficacy of the test in predicting imminent delivery in 7 or 14 days from the time of testing.

Premature preterm rupture of the membrane diagnosis in

The transition from AmniSure to ROM Plus was incredibly easy. I was anticipating push back from the staff but I had absolutely none. The staff felt that ROM Plus was a reliable test and even easier to run than their previous POC test. The ROM Plus representatives were organized, friendly and made the transition that much easier PRINCIPLE: Amnisure is a one-step immunochromatographic assay. Three monoclonal antibodies are used in the test to detect PAMG-1, one of the amniotic fluid proteins that appear in the vaginal secretion after the membranes rupture. With intact fetal membranes, the test does not normally detect PAMG-1 due to its low background concentration PAMG-1 was tested using AmniSure in all patients. Immunochromatography kit is one-step test based on specific monoclonal antibodies which have the ability to reveal amounts of protein in amniotic fluid (PAMG-1). The placenta. The AmniSure ROM test (placental -microglobulin 1 immunoassay, AmniSure. Page 2 of 2 References 1. Amnisure- Tests for the presence of placental alpha microglobulin-1 protein in vaginal fluid. Per the package insert: Presence of significant blood on the swab can lead to a false positive result. The test functions properl PAMG-1 TTD TEST KURZANLEITUNG info@partosure.com | www.partosure.com Wichtiger Hinweis: Bitte folgen sie der Gebrauchsanweisung, um korrekte Ergebnisse zu erhalten. Die Interpretation der Testergebnisse entnehmen Sie bitte dem Abschnitt Auswertung der Ergebnisse weiter unten. Durchführung des Tests Der Test in Kürze Auswertung der.

The presence of PAMG-1 was determined using a commercially available kit (AmniSure, AmniSure International LLC, Boston, MA). Results A total of 100 women were enrolled, of which 86 had outcome data available. PAMG-1 was detected in 19/86 (22.1%) subjects The Amnisure ROM (rupture of fetal membrane) Test is a rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal secretions of pregnant women. Amnisure detects PAMG-1 protein marker of the amniotic fluid in vaginal secretions. The test is for use by health care professionals to aid. The search for accuracy and increased specificity in diagnosis of premature rupture of membrane is an ongoing process. Objective: To determine the accuracy of placental alpha micro globulin 1(PAMG 1) Amnisure ROM in diagnosing presence of amniotic fluid in cervicovaginal secretions and hence diagnose rupture of fetal membranes the AmniSure ROM test. J. Perinat. Med. 37, 956. 8. Tagore, S. and Kwek, K. (2010) Comparative analysis of insulin-like growth factor binding protein-1 (IGFBP-1), placental alpha-microglobulin-1 (PAMG-1) and nitrazine test to diagnose premature rupture of membranes in pregnancy. J. Perinat. Med. 38, 609-12. 9 In the final analysis, the AmniSure diagnostic test demonstrated a sensitivity of 98.9%, specificity of 100%, positive predictive value of 100%, and a negative predictive value of 99.1%. AmniSure is the first FDA approved ROM immunoassay. AmniSure detects Placental Alpha Microglobulin-1 (PAMG-1), a protein that is abundant in amniotic fluid AmniSure's reported sensitivity and specificity ranges between 93-99% and 69-99% respectively. 2,4,5,8 Actim PROM's reported sensitivity and specificity ranges between 74-97%.4 Chen and Dudenhausen (2008) concluded in a comparative study of AmniSure and Actim PROM that the PAMG-1 test (AmniSure) seemed to be a more sensitive immunoassay.