Lessons from the Field

Field expansion of DNA polymerase chain reaction for early infant diagnosis of HIV-1: The Ethiopian experience

Peter Fonjungo, Mulu Girma, Zenebe Melaku, Teferi Mekonen, Amilcar Tanuri, Bereket Hailegiorgis, Belete Tegbaru, Yohannes Mengistu, Aytenew Ashenafi, Wubshet Mamo, Tesfay Abreha, Gudetta Tibesso, Artur Ramos, Gonfa Ayana, Richard Freeman, John N. Nkengasong, Solomon Zewdu, Yenew Kebede, Almaz Abebe, Thomas A. Kenyon, Tsehaynesh Messele
African Journal of Laboratory Medicine | Vol 2, No 1 | a31 | DOI: https://doi.org/10.4102/ajlm.v2i1.31 | © 2013 Peter Fonjungo, Mulu Girma, Zenebe Melaku, Teferi Mekonen, Amilcar Tanuri, Bereket Hailegiorgis, Belete Tegbaru, Yohannes Mengistu, Aytenew Ashenafi, Wubshet Mamo, Tesfay Abreha, Gudetta Tibesso, Artur Ramos, Gonfa Ayana, Richard Freeman, John N. Nkengasong, Solomon Zewdu, Yenew Kebede, Almaz Abebe, Thomas A. Kenyon, Tsehaynesh Messele | This work is licensed under CC Attribution 4.0
Submitted: 20 March 2012 | Published: 22 May 2013

About the author(s)

Peter Fonjungo,, Ethiopia
Mulu Girma, Ethiopian Health and Nutrition Research Institute (EHNRI), Addis Ababa, Ethiopia
Zenebe Melaku, ICAP, Columbia University, Addis Ababa, Ethiopia
Teferi Mekonen, Center for Disease Control and Prevention (CDC), Addis Ababa, Ethiopia
Amilcar Tanuri, ICAP, Columbia University, Addis Ababa, Ethiopia
Bereket Hailegiorgis, ICAP, Columbia University, Addis Ababa, Ethiopia
Belete Tegbaru, Ethiopian Health and Nutrition Research Institute (EHNRI), Addis Ababa, Ethiopia
Yohannes Mengistu, Center for Disease Control and Prevention (CDC), Addis Ababa, Ethiopia
Aytenew Ashenafi, John Hopkins University TSEHAI program, AddisAbaba, Ethiopia
Wubshet Mamo, University of Washington, ITECH Program, Addis Ababa, Ethiopia
Tesfay Abreha, ICAP, Columbia University, Addis Ababa, Ethiopia
Gudetta Tibesso, Ethiopian Health and Nutrition Research Institute (EHNRI), Addis Ababa, Ethiopia
Artur Ramos, Center for Global Health, Centers for Disease Control and Prevention (CDC), Atlanta, United States
Gonfa Ayana, Ethiopian Health and Nutrition Research Institute (EHNRI), Addis Ababa, Ethiopia
Richard Freeman, Clinton HIV/AIDS Access Initiative (CHAI), AddisAbaba, Ethiopia
John N. Nkengasong, Center for Global Health, Centers for Disease Control and Prevention (CDC), Atlanta, United States
Solomon Zewdu, John Hopkins University TSEHAI program, AddisAbaba, Ethiopia
Yenew Kebede, Center for Disease Control and Prevention (CDC), Addis Ababa, Ethiopia
Almaz Abebe, Ethiopian Health and Nutrition Research Institute (EHNRI), Addis Ababa, Ethiopia
Thomas A. Kenyon, Center for Disease Control and Prevention (CDC), Addis Ababa, Ethiopia
Tsehaynesh Messele, Ethiopian Health and Nutrition Research Institute (EHNRI), Addis Ababa, Ethiopia


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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 challengesto identification of HIV-1-infected infants is availability and/or access to quality molecular laboratory facilities which perform molecular virologic assays suitable for accurate identificationof the HIV status of infants.

Method: 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 insix 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).

Conclusion: 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.


Keywords

HIV, Early Infant Diagnosis, Dried Blood Spot, Polymerase Chain Reaction, Laboratory rollout, quality assurance

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