title: Sensitivity and specificity of a urinary screening test used in an emergency setting to detect abnormal first trimester pregnancies.
abstract: OBJECTIVE
  To evaluate the performance of a commercial urinary test to screen for abnormal first trimester pregnancies in women presenting to an emergency room.
  
  
  METHODS
  In this prospective observational cohort, women with a confirmed first trimester pregnancy (gestational age <12 weeks) provided a urine sample for diagnosing the viability of their gestation. Pregnancy viability and location testing were confirmed by ultrasound and/or laparoscopy.
  
  
  RESULTS
  From 815 eligible patients for the study, 12 were excluded for not having a confirmed pregnancy (n = 6) or were lost to follow-up (n = 6). A total of 803 patients underwent testing and completed follow-up. The pretest probability of an abnormal pregnancy was 44% (9% for ectopic pregnancy and 35% for miscarriage). The test had the following parameters to identify an abnormal first-trimester pregnancy (sensitivity, 13%; 95% confidence interval [CI], 10-17; specificity, 82%; 95% CI, 78-86; positive predictive value, 36; 95% CI, 28-46; negative predictive value, 54; 95% CI, 50-58; accuracy, 47%; positive likelihood ratio, 0.74; 95% CI, 0.53-1.03; negative likelihood ratio, 1.06; 95% CI, 1-1.12). The reproducibility of the test in our study was high (kappa index between readers, 0.89; 95% CI, 0.77-1).
  
  
  CONCLUSIONS
  In our emergency setting, we were not able to confirm that the commercial test is adequate to detect or exclude an abnormal first-trimester pregnancy.
authors.affiliation: Programa de Pós-Graduação em Ciências Cirúrgicas, Universidade Federal do Rio Grande do Sul Departamento e Serviço de Ginecologia e Obstetrícia, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.
authors.forename: João L G
authors.initials: JL
authors.lastname: Teixeira
authors.affiliation: Departamento de Ginecologia e Obstetrícia, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.
authors.forename: Paola
authors.initials: P
authors.lastname: Rabaioli
authors.affiliation: Programa de Pós-Graduação em Ciências Cirúrgicas, Universidade Federal do Rio Grande do Sul Departamento e Serviço de Ginecologia e Obstetrícia, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil; Departamento de Ginecologia e Obstetrícia, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil. Electronic address: rsavaris@hcpa.ufrgs.br.
authors.forename: Ricardo F
authors.initials: RF
authors.lastname: Savaris
mesh_terms: D000293:Adolescent; D000328:Adult; D004630:Emergencies; D005260:Female; D006801:Humans; D008875:Middle Aged; D011247:Pregnancy; D011248:Pregnancy Complications / Q000175:diagnosis* / Q000652:urine*; D011258:Pregnancy Tests; D011261:Pregnancy Trimester, First / Q000652:urine*; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D055815:Young Adult
keywords: Inexscreen; abnormal pregnancy; first trimester; pregnancy; screening test; sensitivity; specificity