title: Performance of HIV Rapid Tests Among Breastfeeding, Malawian Infants.
abstract: Timely, accurate and affordable testing algorithms at point-of-care are critical for early infant HIV diagnosis and initiation of antiretroviral therapy in the postpartum period. We aimed to assess the utility of HIV rapid tests for young, breast-fed HIV-exposed infants in resource limited, high HIV burden settings.
  
  
  
  We collected data on the performance of 2 commonly used rapid tests (Determine and Unigold) in Malawi between 2008 and 2012 or at the University of North Carolina between 2014 and 2015. For each 3-month interval between ages 3 and 18 months, we calculated the sensitivity, specificity, positive and negative predictive values of each test compared with the HIV DNA/RNA PCR gold standard. We also assessed the utility of each rapid test to diagnose incident HIV infection during the breastfeeding period.
  
  
  
  Among 121 HIV-exposed infants who were negative at age 6 weeks, 21 (17.2%) became infected by 18 months. At 3 months of age, both rapid tests had minimal clinical value with specificity values of 7.0% [95% confidence interval (CI): 2.3-15.7] for Determine and 19.4% (95% CI: 11.1-30.5) for Unigold. Starting at age 6 and 9 months, the Unigold test could be used as a screening tool in the follow-up of HIV-exposed infants with specificity values of 83.7% (95% CI: 74.4-89.9) and 97.7% (95% CI: 94.6-99.7), respectively. Starting at age 12 months, the type of test became less important as both tests performed well in identifying HIV-free children, although both tests failed to detect some incident HIV infections.
  
  
  
  Updated guidelines for the use of rapid tests in young HIV-exposed children that explicitly take type of test and infant age into account are urgently needed to ensure optimal care for the 1.5 million HIV-exposed infants born annually.
authors: From the *Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina; †MLW Clinical Research Programme, University of Malawi College of Medicine, Blantyre, Malawi; ‡Division of Infectious Diseases, Department of Medicine, §Department of Health Policy and Management, Gillings Schools of Global Public Health, ¶Department of Biostatistics, Gillings School of Global Public Health, and ‖Department of Microbiology and Immunology, School of Medicine, University of North Carolina, Chapel Hill, North Carolina; **Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Queen Elizabeth Central Hospital, Blantyre, Malawi; and ††Epidemiology and Social Medicine, University of Antwerp, Antwerp, Belgium.
authors: Emily R
authors: ER
authors: Smith
authors: Anna D
authors: AD
authors: Sheahan
authors: Robert S
authors: RS
authors: Heyderman
authors: William C
authors: WC
authors: Miller
authors: Stephanie
authors: S
authors: Wheeler
authors: Michael
authors: M
authors: Hudgens
authors: Julie A E
authors: JA
authors: Nelson
authors: Queen
authors: Q
authors: Dube
authors: Annelies
authors: A
authors: Van Rie
mesh_terms: D001942:Breast Feeding; D004279:DNA, Viral / Q000032:analysis; D042241:Early Diagnosis; D005260:Female; D015658:HIV Infections / Q000175:diagnosis*; D015497:HIV-1; D006801:Humans; D007223:Infant; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D016133:Polymerase Chain Reaction; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D014773:Virology / Q000379:methods*
chemical_list: D004279:DNA, Viral