title: Field expansion of DNA polymerase chain reaction for early infant diagnosis of HIV-1: The Ethiopian experience.
abstract: BACKGROUND
  Early diagnosis of infants infected with HIV (EID) and early initiation of treatment significantly reduces the rate of disease progression and mortality. One of the challenges to identification of HIV-1-infected infants is availability and/or access to quality molecular laboratory facilities which perform molecular virologic assays suitable for accurate identification of the HIV status of infants.
  
  
  METHODS
  We conducted a joint site assessment and designed laboratories for the expansion of DNA polymerase chain reaction (PCR) testing based on dried blood spot (DBS) for EID in six regions of Ethiopia. Training of appropriate laboratory technologists and development of required documentation including standard operating procedures (SOPs) was carried out. The impact of the expansion of EID laboratories was assessed by the number of tests performed as well as the turn-around time.
  
  
  RESULTS
  DNA PCR for EID was introduced in 2008 in six regions. From April 2006 to April 2008, a total of 2848 infants had been tested centrally at the Ethiopian Health and Nutrition Research Institute (EHNRI) in Addis Ababa, and which was then the only laboratory with the capability to perform EID; 546 (19.2%) of the samples were positive. By November 2010, EHNRI and the six laboratories had tested an additional 16 985 HIV-exposed infants, of which 1915 (11.3%) were positive. The median turn-around time for test results was 14 days (range 14-21 days).
  
  
  CONCLUSIONS
  Expansion of HIV DNA PCR testing facilities that can provide quality and reliable results is feasible in resource-limited settings. Regular supervision and monitoring for quality assurance of these laboratories is essential to maintain accuracy of testing.
authors: Center for Disease Control and Prevention (CDC), Addis Ababa, Ethiopia.
authors: Peter N
authors: PN
authors: Fonjungo
authors: Ethiopian Health and Nutrition Research Institute (EHNRI), Addis Ababa, Ethiopia.
authors: Mulu
authors: M
authors: Girma
authors: ICAP, Columbia University, Addis Ababa, Ethiopia.
authors: Zenebe
authors: Z
authors: Melaku
authors: Center for Disease Control and Prevention (CDC), Addis Ababa, Ethiopia.
authors: Teferi
authors: T
authors: Mekonen
authors: ICAP, Columbia University, Addis Ababa, Ethiopia.
authors: Amilcar
authors: A
authors: Tanuri
authors: ICAP, Columbia University, Addis Ababa, Ethiopia.
authors: Bereket
authors: B
authors: Hailegiorgis
authors: Ethiopian Health and Nutrition Research Institute (EHNRI), Addis Ababa, Ethiopia.
authors: Belete
authors: B
authors: Tegbaru
authors: Center for Disease Control and Prevention (CDC), Addis Ababa, Ethiopia.
authors: Yohannes
authors: Y
authors: Mengistu
authors: John Hopkins University, TSEHAI program, Addis Ababa, Ethiopia.
authors: Aytenew
authors: A
authors: Ashenafi
authors: University of Washington, ITECH Program, Addis Ababa, Ethiopia.
authors: Wubshet
authors: W
authors: Mamo
authors: ICAP, Columbia University, Addis Ababa, Ethiopia.
authors: Tesfay
authors: T
authors: Abreha
authors: Ethiopian Health and Nutrition Research Institute (EHNRI), Addis Ababa, Ethiopia.
authors: Gudetta
authors: G
authors: Tibesso
authors: Center for Global Health, Centers for Disease Control and Prevention (CDC), Atlanta, USA.
authors: Artur
authors: A
authors: Ramos
authors: Ethiopian Health and Nutrition Research Institute (EHNRI), Addis Ababa, Ethiopia.
authors: Gonfa
authors: G
authors: Ayana
authors: Clinton HIV/AIDS Access Initiative (CHAI), Addis Ababa, Ethiopia.
authors: Richard
authors: R
authors: Freeman
authors: Center for Global Health, Centers for Disease Control and Prevention (CDC), Atlanta, USA.
authors: John N
authors: JN
authors: Nkengasong
authors: John Hopkins University, TSEHAI program, Addis Ababa, Ethiopia.
authors: Solomon
authors: S
authors: Zewdu
authors: Center for Disease Control and Prevention (CDC), Addis Ababa, Ethiopia.
authors: Yenew
authors: Y
authors: Kebede
authors: Ethiopian Health and Nutrition Research Institute (EHNRI), Addis Ababa, Ethiopia.
authors: Almaz
authors: A
authors: Abebe
authors: Center for Disease Control and Prevention (CDC), Addis Ababa, Ethiopia.
authors: Thomas A
authors: TA
authors: Kenyon
authors: Ethiopian Health and Nutrition Research Institute (EHNRI), Addis Ababa, Ethiopia.
authors: Tsehaynesh
authors: T
authors: Messele