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PartoSure Test

To aid in the diagnosis of preterm labor (PTL)
  • Presence of semen does not interfere with test performance
  • Speculum examination and external reader not required 
  • Results in 5 minutes (1)
     
The PartoSure Test is a rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of placental alpha microglobulin-1 (PAMG-1) in vaginal secretions of pregnant women. The device is designed as an aid to rapidly assess the risk of preterm delivery in ≤7 or ≤14 days from the time of cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labor, intact amniotic membranes and minimal cervical dilatation (≤ 3 cm), sampled between 20 weeks, 0 days and 36 weeks, 6 days gestation. Want to try this solution for the first time? Request a quote for a trial kit.
Cat No./ID: TTDT-1-20-ML
PartoSure TTD Test (20) Multilang 1

To aid in the diagnosis of preterm labor

The PartoSure Test are intended for in vitro diagnostic use.


  1. PartoSure Test Instructions for Use. QIAGEN, 2018.
  2. Alfirevic et al. Ultrasound Obstet Gynecol 2007; 29: 47–50.
  3. Eds. Howson CP, Kinney MV, Lawn JE. March of Dimes, PMNCH, Save the Children, World Health Organization. Born Too Soon: The Global Action Report on Preterm Birth. 2012.
  4. Antenatal Corticosteroids Revisited: Repeat Courses. NIH Consensus Statement: NIH, 2000.
  5. Petrunin DD, Griaznova IM, Petrunina IA, Tatarinov IS. Immunochemical identification of organ specific human placental alpha globulin and its concentration in amniotic fluid. Akush Gynecol (Mosk) 1977;(1):62–4.
  6. Petrunin DD, Graznova IM, Petrunina IA, & Tatarinov IS. Comparative immunochemical and physiochemical characteristics of chorionitic alpha-1 and alpha-2 microglobulins in human placenta. Bulletin of Experimental Biology and Medicine. 1978;(5):600-602.
  7. Lee MS, Romero R, Park JW, Kim SM, Park CW, Korzeniewski S, Chaiworapongsa T, Yoon BH. The clinical significance of a positive Amnisure test™ in women with preterm labor. J Matern Fetal Neonatal Med. 2012 Sep;25(9):1690-8

Performance
Worldwide 15 million babies are born prematurely each year (2). Accurately assessing the risk of preterm labor (PTL) is difficult and has significant implications in the health of patients. PTL can result in health problems at birth and later in life for the baby, including cerebral palsy, intellectual disabilities, chronic lung disease, blindness and hearing loss (3). 

Clinical evaluation alone is limited in its ability to predict imminent delivery. Studies show 85% of patients admitted for threated PTL do not deliver within 7 days. Thus, the accurate risk assessment of imminent preterm delivery in patients with suspected PTL remains an important clinical concern for institutions of all types. This is particularly true with respect to both the administration of corticosteroids, which have an optimal benefit within 7 days of administration, as well as the transfer of patients to a tertiary care center capable of caring for the birth of a premature infant (4).

Placental alpha-microglobulin-1 (PAMG-1), a protein released from decidual cells into the amniotic cavity throughout pregnancy, was first described by Petrunin et al. in 1975 (5,6). Its presence in cervicovaginal discharge when labor and delivery are imminent is likely due to the transudation of the protein through pre-existing pores in the chorioamniotic membranes during uterine contractions and, potentially, degradation of the extracellular matrix of fetal membranes due to an inflammatory process of labor or infection (7). 
Principle
PartoSure is a lateral flow, immunochromatographic assay designed to identify the presence of human placental-alpha-microglobulin-1 (PAMG-1). The test employs monoclonal antibodies sufficiently sensitive to detect 1 ng/ml of PAMG-1. For the analysis, a sample of cervicovaginal discharge collected by vaginal swab is extracted into a solvent. The presence of PAMG-1 antigen is then detected by inserting a lateral flow test strip into the vial. The sample flows from an absorbent pad to a nitrocellulose membrane, passing through a reactive area containing monoclonal anti-PAMG-1 antibodies conjugated to a gold particle. The antigen-antibody complex flows to the test region where it is immobilized by a second anti-PAMG-1 antibody. This event leads to the appearance of the test line. Unbound antigen-antibody complexes continue to flow along the test strip and are immobilized by a second antibody. This leads to the appearance of the internal control line.
Procedure
The simple 4-step test procedure* detects placental alpha microglobulin-1 (PAMG-1) a protein found in amniotic fluid (1).
  1. Collect sample of vaginal discharge with sterile collection swab (no speculum required).
  2. Rinse specimen swab in solvent vial. Discard swab.
  3. Insert amniotic fluid test strip into vial and remove if 2 lines are visible, or at 5 minutes sharp.
  4. Results are observed and recorded.
*Please refer to package insert for complete instructions for use.
Applications
The PartoSure test is for use by healthcare professionals to aid in assessing the risk of preterm delivery in pregnant women when they report signs and symptoms of early preterm labor.

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