title: Evaluation of four commercial virological assays for early infant HIV-1 diagnosis using dried blood specimens.
abstract: Early infant diagnosis (EID) of HIV-1 is necessary to reduce HIV-related mortality. As maternal antibodies transferred across the placenta may persist up to 18 mo, commercial virological assays (CVAs) are needed. This study compares four CVAs for EID using dried blood specimens (DBS) from HIV-1-exposed infants.
  
  
  
  DBS from 68 infants born to HIV-1-infected women were collected from November 2012 to December 2013 in Equatorial Guinea. Four CVAs were performed: Siemens VERSANT HIV-1 RNA 1.0 kPCR assay, Roche CAP/CTM Quantitative Test v2.0, CAP/CTM Qualitative Tests v1.0 and v2.0. Definitive diagnosis was established following World Health Organization (WHO) recommendations.
  
  
  
  Two HIV-1-infected infants (2.9%) were detected by the four CVAs while 49 (72%) resulted negative. Discordant results were observed in 17 (25%) infants and HIV-1 infection was excluded in 14 patients when virological and serological testing was performed in additional DBS. Different false-positive rates HIV-1 were observed with Roche assays.
  
  
  
  CVAs using DBS were useful for EID, although discrepant results were common. Further research is required to reduce false-positive results that could result in wrong diagnosis and unneeded treatment. We propose caution with low viral load (VL) values when using VL assays. Clear guidelines are required for EID of HIV-exposed infants with discrepant virological results.
authors.affiliation: HIV-1 Molecular Epidemiology Laboratory, Microbiology and Parasitology Department, Hospital Universitario Ramón y Cajal, IRYCIS and CIBERESP, Madrid, Spain.
authors.forename: Patricia
authors.initials: P
authors.lastname: Alvarez
authors.affiliation: Hospital Universitario de Getafe, Madrid, Spain.
authors.forename: Luis
authors.initials: L
authors.lastname: Prieto
authors.affiliation: HIV-1 Molecular Epidemiology Laboratory, Microbiology and Parasitology Department, Hospital Universitario Ramón y Cajal, IRYCIS and CIBERESP, Madrid, Spain.
authors.forename: Leticia
authors.initials: L
authors.lastname: Martín
authors.affiliation: Pediatrics Department, Hospital Regional de Bata, Ministerio de Sanidad y Bienestar Social, Bata, Equatorial Guinea.
authors.forename: Jacinta
authors.initials: J
authors.lastname: Obiang
authors.affiliation: Centro Nacional de Medicina Tropical, Instituto de Salud Carlos III-Madrid, RICET, Madrid, Spain.
authors.forename: Pedro
authors.initials: P
authors.lastname: Avedillo
authors.affiliation: Centro Nacional de Medicina Tropical, Instituto de Salud Carlos III-Madrid, RICET, Madrid, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Vargas
authors.affiliation: Pediatrics Department, Hospital Universitario 12 de Octubre, Madrid, Spain.
authors.forename: Pablo
authors.initials: P
authors.lastname: Rojo
authors.affiliation: Pediatrics Department, Hospital Universitario Gregorio Marañón, Madrid, Spain.
authors.forename: Carolina
authors.initials: C
authors.lastname: Fernández McPhee
authors.affiliation: HIV-1 Molecular Epidemiology Laboratory, Microbiology and Parasitology Department, Hospital Universitario Ramón y Cajal, IRYCIS and CIBERESP, Madrid, Spain.
authors.forename: Leticia
authors.initials: L
authors.lastname: Sanz Canalejas
authors.affiliation: Centro Nacional de Medicina Tropical, Instituto de Salud Carlos III-Madrid, RICET, Madrid, Spain.
authors.forename: Agustín
authors.initials: A
authors.lastname: Benito
authors.affiliation: Pediatrics Department, Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors.forename: José Tomás
authors.initials: JT
authors.lastname: Ramos
authors.affiliation: HIV-1 Molecular Epidemiology Laboratory, Microbiology and Parasitology Department, Hospital Universitario Ramón y Cajal, IRYCIS and CIBERESP, Madrid, Spain.
authors.forename: África
authors.initials: Á
authors.lastname: Holguín
mesh_terms: D000328:Adult; D001681:Biological Assay / Q000379:methods; D059788:Dried Blood Spot Testing / Q000379:methods; D042241:Early Diagnosis; D016703:Equatorial Guinea; D005189:False Positive Reactions; D005260:Female; D015658:HIV Infections / Q000175:diagnosis* / Q000635:transmission / Q000821:virology*; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical; D008297:Male; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy / Q000821:virology; D012367:RNA, Viral / Q000097:blood / Q000235:genetics; D014773:Virology / Q000379:methods; D055815:Young Adult
chemical_list: D012367:RNA, Viral