title: Brief Report: High Sensitivity and Specificity of the Cepheid Xpert HIV-1 Qualitative Point-of-Care Test Among Newborns in Botswana.
abstract: HIV point-of-care (POC) testing allows for early infant HIV diagnosis and treatment, but POC accuracy at birth and in the setting of antiretroviral prophylaxis for the prevention of mother-to-child HIV transmission is unknown.
  
  
  
  We evaluated the Cepheid Xpert HIV-1 Qual POC test against the Roche Taqman HIV-1 DNA polymerase chain reaction (PCR) platform using dried blood spots from 15 HIV-infected and 75 HIV-exposed uninfected newborns. These infants were screened for HIV at <96 hours of life at 5 hospital maternity wards in Botswana; all infants received postexposure antiretroviral prophylaxis with single-dose nevirapine and zidovudine, and most mothers received 3-drug antiretroviral therapy in pregnancy and at delivery.
  
  
  
  Fourteen of the 15 PCR positive samples tested positive by Cepheid POC, yielding a sensitivity of 93.3% (95% confidence interval: 68.1 to 99.8). Baseline viral load among positive infants ranged from <40 to >10,000,000 copies/mL, with a median of 2403 copies/mL. The HIV RNA for the infant with false-negative POC testing was 1661 copies/mL. Of note, 2 infants with low HIV RNA (<40 and 272 copies/mL) were correctly identified as HIV positive by Cepheid POC. All the 75 PCR-negative samples tested negative by Cepheid POC, yielding a specificity of 100% (95% confidence interval: 96.1 to 100).
  
  
  
  Our study demonstrates high sensitivity and specificity for the Cepheid POC assay in the first week of life despite early infection and antiretroviral prophylaxis. This platform may be a useful approach for adding early infant HIV diagnosis to current testing programs.
authors.affiliation: *Harvard Medical School, Doris Duke International Clinical Research Fellowship, Boston, MA; †David Geffen School of Medicine, University of California, Los Angeles, CA; ‡Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana; §Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA; ‖Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, MA; and ¶Division of Infectious Disease, Brigham and Women's Hospital, Boston, MA.
authors.forename: Maryanne
authors.initials: M
authors.lastname: Ibrahim
authors.forename: Sikhulile
authors.initials: S
authors.lastname: Moyo
authors.forename: Terence
authors.initials: T
authors.lastname: Mohammed
authors.forename: Lucy
authors.initials: L
authors.lastname: Mupfumi
authors.forename: Simani
authors.initials: S
authors.lastname: Gaseitsiwe
authors.forename: Kenneth
authors.initials: K
authors.lastname: Maswabi
authors.forename: Gbolahan
authors.initials: G
authors.lastname: Ajibola
authors.forename: Rebecca
authors.initials: R
authors.lastname: Gelman
authors.forename: Oganne
authors.initials: O
authors.lastname: Batlang
authors.forename: Maureen
authors.initials: M
authors.lastname: Sakoi
authors.forename: Chloe
authors.initials: C
authors.lastname: Auletta-Young
authors.forename: Joseph
authors.initials: J
authors.lastname: Makhema
authors.forename: Shahin
authors.initials: S
authors.lastname: Lockman
authors.forename: Roger L
authors.initials: RL
authors.lastname: Shapiro
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use; D001902:Botswana; D042241:Early Diagnosis; D057075:Enzyme Assays / Q000379:methods*; D005260:Female; D015658:HIV Infections / Q000175:diagnosis* / Q000517:prevention & control* / Q000635:transmission; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D008297:Male; D019095:Point-of-Care Systems; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D012367:RNA, Viral; D012680:Sensitivity and Specificity; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D012367:RNA, Viral