title: The Performance of a Rapid Diagnostic Test in Detecting Malaria Infection in Pregnant Women and the Impact of Missed Infections.
abstract: BACKGROUND
  Intermittent screening and treatment in pregnancy (ISTp) is a potential strategy for the control of malaria during pregnancy. However, the frequency and consequences of malaria infections missed by a rapid diagnostic test (RDT) for malaria are a concern.
  
  
  METHODS
  Primigravidae and secundigravidae who participated in the ISTp arm of a noninferiority trial in 4 West African countries were screened with an HRP2/pLDH RDT on enrollment and, in Ghana, at subsequent antenatal clinic (ANC) visits. Blood samples were examined subsequently by microscopy and by a polymerase chain reaction (PCR) assay.
  
  
  RESULTS
  The sensitivity of the RDT to detect peripheral blood infections confirmed by microscopy and/or PCR at enrollment ranged from 91% (95% confidence interval [CI], 88%, 94%) in Burkina Faso to 59% (95% CI, 48%, 70% in The Gambia. In Ghana, RDT sensitivity was 89% (95% CI, 85%, 92%), 83% (95% CI, 76%, 90%) and 77% (95% CI, 67%, 86%) at enrollment, second and third ANC visits respectively but only 49% (95% CI, 31%, 66%) at delivery. Screening at enrollment detected 56% of all infections detected throughout pregnancy. Seventy-five RDT negative PCR or microscopy positive infections were detected in 540 women; these were not associated with maternal anemia, placental malaria, or low birth weight.
  
  
  CONCLUSIONS
  The sensitivity of an RDT to detect malaria in primigravidae and secundigravidae was high at enrollment in 3 of 4 countries and, in Ghana, at subsequent ANC visits. In Ghana, RDT negative malaria infections were not associated with adverse birth outcomes but missed infections were uncommon.
authors.affiliation: Navrongo Health Research Centre, Ghana.
authors.forename: John E
authors.initials: JE
authors.lastname: Williams
authors.affiliation: Faculties of Epidemiology and Population Health and Infectious & Tropical Diseases, London School of Hygiene & Tropical Medicine, United Kingdom.
authors.forename: Matthew
authors.initials: M
authors.lastname: Cairns
authors.affiliation: Medical Research Unit, Fajara, The Gambia.
authors.forename: Fanta
authors.initials: F
authors.lastname: Njie
authors.affiliation: Navrongo Health Research Centre, Ghana.
authors.forename: Stephen
authors.initials: S
authors.lastname: Laryea Quaye
authors.affiliation: Navrongo Health Research Centre, Ghana.
authors.forename: Timothy
authors.initials: T
authors.lastname: Awine
authors.affiliation: Navrongo Health Research Centre, Ghana.
authors.forename: Abraham
authors.initials: A
authors.lastname: Oduro
authors.affiliation: Department of Community Medicine, Kwame Nkrumah University of Sciences and Technology, Kumasi, Ghana.
authors.forename: Harry
authors.initials: H
authors.lastname: Tagbor
authors.affiliation: Medical Research Unit, Fajara, The Gambia.
authors.forename: Kalifa
authors.initials: K
authors.lastname: Bojang
authors.affiliation: Department of Veterinary Disease Biology and Centre for Medical Parasitology, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.
authors.forename: Pascal
authors.initials: P
authors.lastname: Magnussen
authors.affiliation: Department of Clinical Sciences, Liverpool School of Tropical Medicine, United Kingdom.
authors.forename: Feiko O
authors.initials: FO
authors.lastname: Ter Kuile
authors.affiliation: Faculties of Epidemiology and Population Health and Infectious & Tropical Diseases, London School of Hygiene & Tropical Medicine, United Kingdom.
authors.forename: Arouna
authors.initials: A
authors.lastname: Woukeu
authors.affiliation: Faculties of Epidemiology and Population Health and Infectious & Tropical Diseases, London School of Hygiene & Tropical Medicine, United Kingdom.
authors.forename: Paul
authors.initials: P
authors.lastname: Milligan
authors.affiliation: Faculties of Epidemiology and Population Health and Infectious & Tropical Diseases, London School of Hygiene & Tropical Medicine, United Kingdom.
authors.forename: Daniel
authors.initials: D
authors.lastname: Chandramohan
authors.affiliation: Faculties of Epidemiology and Population Health and Infectious & Tropical Diseases, London School of Hygiene & Tropical Medicine, United Kingdom.
authors.forename: Brian
authors.initials: B
authors.lastname: Greenwood
mesh_terms: D000293:Adolescent; D000328:Adult; D000354:Africa, Western; D005260:Female; D006801:Humans; D008288:Malaria / Q000097:blood / Q000175:diagnosis*; D008853:Microscopy / Q000706:statistics & numerical data; D010274:Parasitology / Q000379:methods* / Q000706:statistics & numerical data*; D016133:Polymerase Chain Reaction / Q000706:statistics & numerical data; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000097:blood / Q000175:diagnosis*; D011295:Prenatal Care; D012680:Sensitivity and Specificity; D055815:Young Adult
keywords: Ghana; intermittent screening and treatment; malaria in pregnancy; rapid diagnostic test