title: Premature preterm rupture of the membrane diagnosis in early pregnancy: PAMG-1 and IGFBP-1 detection in amniotic fluid with biochemical tests.
abstract: OBJECTIVE
  Previable premature rupture of the membranes (pPROM), occurring before 24WG, is associated with a 25% neonatal survival rate. This terrible prognosis may lead to elective pregnancy termination on parents' request. Therefore, certain diagnosis is essential but remains difficult in about 10% of patients. Bed-side biochemical tests developed to help in diagnosis had never been evaluated in early pregnancies. This study aimed to evaluate and compare the in vitro sensitivity, detection limit, reaction time and consistency of AmniSure detecting placental alpha microglobulin-1 (PAMG-1) and actim PROM detecting Insulin Growth Factor Binding Protein-1 (IGFBP-1) in amniotic fluid between 15 and 20weeks of gestation (WG).
  
  
  METHODS
  Samples of amniotic fluid were collected by amniocentesis performed between 15 and 20 completed WG in 55 patients. Dilution series were prepared and both tests were performed twice at each dilution. In vitro sensitivity, detection limit, and reaction time were evaluated and compared in serial dilution.
  
  
  RESULTS
  A total of 460 AmniSure and 476 actim PROM tests were performed. Both tests' in vitro sensitivity was 100% at dilution 1:20 and remained up to 90% until dilution 1:80. In vitro sensitivities were not different at any dilution. Detection limit and consistency were similar for both tests at all dilution. Actim PROM reaction time was shorter than AmniSure at all dilutions, except 1:320 (p<0.05).
  
  
  CONCLUSIONS
  PAMG-1 and IGFBP-1 can be detected in amniotic fluid between 15 and 20 completed WG, using respectively AmniSure and actim PROM.
authors.affiliation: Hospices Civils de Lyon, Hôpital Femme-Mère-Enfant, Service d'obstétrique, 59 boulevard Pinel, Bron cedex F-69677, France. Electronic address: muriel.doret@chu-lyon.fr.
authors.forename: Muriel
authors.initials: M
authors.lastname: Doret
authors.forename: Régine
authors.initials: R
authors.lastname: Cartier
authors.forename: Juliette
authors.initials: J
authors.lastname: Miribel
authors.forename: Jérome
authors.initials: J
authors.lastname: Massardier
authors.forename: Mona
authors.initials: M
authors.lastname: Massoud
authors.forename: Agnès
authors.initials: A
authors.lastname: Bordes
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Moret
authors.forename: Pascal
authors.initials: P
authors.lastname: Gaucherand
mesh_terms: D000328:Adult; D000649:Amniocentesis; D000653:Amniotic Fluid / Q000737:chemistry*; D005260:Female; D005322:Premature Rupture of Fetal Membranes / Q000175:diagnosis; D005865:Gestational Age; D006801:Humans; D018970:Insulin-Like Growth Factor Binding Protein 1 / Q000032:analysis*; D057230:Limit of Detection; D011247:Pregnancy; D012680:Sensitivity and Specificity
chemical_list: C032231:IGFBP1 protein, human; D018970:Insulin-Like Growth Factor Binding Protein 1
keywords: Actim PROM; AmniSure; Biochemical test; Early pregnancy; IGFBP-1; Insulin Growth Factor Binding Protein-1; PAMG-1; Placental alpha microglobulin-1; Premature rupture of the membranes; WG; pPROM; placental alpha migroglobulin-1; premature preterm rupture of the membranes; weeks of gestation