title: Accurate early infant HIV diagnosis in primary health clinics using a point-of-care nucleic acid test.
abstract: OBJECTIVE
  To evaluate the accuracy of a point-of-care (POC) nucleic acid-based test (NAT) for early infant HIV diagnosis (EID) in primary health clinics in Mozambique.
  
  
  METHODS
  POC and laboratory NAT EID tests were conducted on matched blood samples collected from 827 HIV-exposed infants younger than 18 months who were enrolled consecutively at 4 periurban primary health clinics and the central hospital in Maputo. Lancet heel draw blood collected by nurses was tested on site for HIV-1/-2 RNA on the Alere HIV NAT POC device and also used to create dried blood spots for later laboratory EID testing on the Roche Cobas Taqman/Ampliprep instrument. Results were used to determine the sensitivity, specificity, and agreement between the POC and laboratory NAT EID tests.
  
  
  RESULTS
  The sensitivity and specificity of POC NAT EID testing were 98·5% (95% confidence interval (CI): 91.7 to 99.9, n = 65) and 99·9% (95% CI: 99.3 to 100, n = 762), respectively, compared with laboratory EID tests. Overall agreement was high (Cohen kappa = 0·981; 95% CI: 0.96 to 1.00). Positive (98·5%; 95% CI: 96·3 to 100) and negative 99.9% (95% CI: 99.7 to 100) test agreement was also high.
  
  
  CONCLUSIONS
  Primary health care nurses accurately performed POC NAT EID testing within primary health care clinics. On-site nucleic acid-based EID testing is technically feasible in clinic settings and could be used in efforts to improve access to pediatric HIV antiretroviral treatment.
authors.affiliation: *Instituto Nacional da Saúde, Maputo, Mozambique; †Clinton Health Access Initiative, Maputo, Mozambique; and ‡Department of Mathematics and Informatics, Universidade Eduardo Mondlane, Maputo, Mozambique.
authors.forename: Ilesh V
authors.initials: IV
authors.lastname: Jani
authors.forename: Bindiya
authors.initials: B
authors.lastname: Meggi
authors.forename: Nédio
authors.initials: N
authors.lastname: Mabunda
authors.forename: Adolfo
authors.initials: A
authors.lastname: Vubil
authors.forename: Nadia E
authors.initials: NE
authors.lastname: Sitoe
authors.forename: Ocean
authors.initials: O
authors.lastname: Tobaiwa
authors.forename: Jorge I
authors.initials: JI
authors.lastname: Quevedo
authors.forename: Jonathan D
authors.initials: JD
authors.lastname: Lehe
authors.forename: Osvaldo
authors.initials: O
authors.lastname: Loquiha
authors.forename: Lara
authors.initials: L
authors.lastname: Vojnov
authors.forename: Trevor F
authors.initials: TF
authors.lastname: Peter
mesh_terms: D000554:Ambulatory Care Facilities; D003430:Cross-Sectional Studies; D004311:Double-Blind Method; D042241:Early Diagnosis; D015658:HIV Infections / Q000097:blood / Q000175:diagnosis* / Q000821:virology*; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D007223:Infant; D009073:Mozambique; D016133:Polymerase Chain Reaction; D011446:Prospective Studies; D012367:RNA, Viral / Q000737:chemistry / Q000235:genetics; D012680:Sensitivity and Specificity
chemical_list: D012367:RNA, Viral