The Use of Rapid Diagnostic Tests for Transfusion Infectious Screening in Africa: A Literature Review

Transfusion Medicine Reviews

Volumn 29, Issue 1, 2015, Pages 35-44

  Pruett, Cristina R ^a   Vermeulen, Marion ^b   Zacharias, Pete ^c   Ingram, Charlotte ^b   Tayou Tagny, Claude ^c   Bloch, Evan M ^a,d  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b SOUTH AFRICAN NATIONAL BLOOD SERVICE   (South Africa)

^c Safe Blood for Africa Foundation   (United States)

^d BLOOD SYSTEMS RESEARCH INSTITUTE   (United States)

Author keywords

Africa; Blood safety; Blood transfusion; Point of care technology; Transfusion transmitted viruses

Indexed keywords

AFRICA; ALGORITHM; BLOOD DONOR; BLOOD SAFETY; BLOOD TRANSFUSION; CHEMOLUMINESCENCE; DIAGNOSTIC TEST; DONOR SELECTION; ENZYME ASSAY; HEPATITIS B; HEPATITIS B VIRUS; HEPATITIS C; HEPATITIS C VIRUS; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; RAPID DIAGNOSTIC TEST; REVIEW; SYPHILIS; VIRUS INACTIVATION; BLOOD; BLOODBORNE BACTERIUM; COMMUNICABLE DISEASES; ISOLATION AND PURIFICATION; MASS SCREENING; PROCEDURES; STANDARDS; STATISTICS AND NUMERICAL DATA; TIME; UTILIZATION;

AFRICA; BLOOD DONORS; BLOOD SAFETY; BLOOD TRANSFUSION; BLOOD-BORNE PATHOGENS; COMMUNICABLE DISEASES; DIAGNOSTIC TESTS, ROUTINE; DONOR SELECTION; HUMANS; MASS SCREENING; TIME FACTORS;

EID: 84921820713     PISSN: 08877963     EISSN: 15329496     Source Type: Journal    
DOI: 10.1016/j.tmrv.2014.09.003     Document Type: Review

References (116)

1. Zou S., Stramer S.L., Dodd R.Y. Donor testing and risk: current prevalence, incidence, and residual risk of transfusion-transmissible agents in US allogeneic donations. Transfus Med Rev 2012, 26:119-128.
2. Tapko J.-B., Mainuka P., Diarra-Nama A.J. Status of blood safety in the WHO African region: report of the 2006 survey. Brazzaville, Republic of Congo: WHO Regional Office for Africa 2006.
3. Dhingra N. Blood safety in the developing world and WHO initiatives. Vox Sang 2002, 83(Suppl 1):173-177.
4. WHO Global database on blood safety, summary report 2011, 1-9.
5. Tapko J.B., Toure B., Sambo L.G. Status of blood safety in the WHO African region: report of the 2010 survey. Brazzaville, Republic of Congo: WHO Regional Office for Africa 2014.
6. WHO Screening donated blood for transfusion-transmissible infections: recommendations 2010, 1-66.
7. Vermeulen M., Reddy R. Current screening strategies for blood donor screening in developing countries. ISBT Sci Ser 2010, 5:308-313.
8. Laperche S. Multinational assessment of blood-borne virus testing and transfusion safety on the African continent. Transfusion 2013, 53:816-826.
9. Scheiblauer H., El-Nageh M., Diaz S., Nick S., Zeichhardt H., Grunert H.P., et al. Performance evaluation of 70 hepatitis B virus (HBV) surface antigen (HBsAg) assays from around the world by a geographically diverse panel with an array of HBV genotypes and HBsAg subtypes. Vox Sang 2010, 98:403-414.
10. Scheiblauer H., El-Nageh M., Nick S., Fields H., Prince A., Diaz S. Evaluation of the performance of 44 assays used in countries with limited resources for the detection of antibodies to hepatitis C virus. Transfusion 2006, 46:708-718.
11. Mbanya D. Use of quality rapid diagnostic testing for safe blood transfusion in resource-limited settings. Clin Microbiol Infect 2013, 19:416-421.
12. Allain J.-P., Lee H. Rapid tests for detection of viral markers in blood transfusion. Expert Rev Mol Diagn 2005, 5:31-41.
13. Baha W., Foullous A., Dersi N., They-they T.P., El alaoui K., Nourichafi N., et al. Prevalence and risk factors of hepatitis B and C virus infections among the general population and blood donors in Morocco. BMC Public Health 2013, 13:1-8.
14. Tagny C.T., Owusu-Ofori S., Mbanya D., Deneys V. The blood donor in sub-Saharan Africa: a review. Transfus Med 2010, 20:1-10.
15. Tagny C.T., Diarra A., Yahaya R., Hakizimana M., Nguessan A., Mbensa G., et al. Characteristics of blood donors and donated blood in sub-Saharan Francophone Africa. Transfusion 2009, 49:1592-1599.
16. Noubouossie D., Tagny C.T., Same-Ekobo A., Mbanya D. Asymptomatic carriage of malaria parasites in blood donors in Yaounde. Transfus Med 2012, 22:63-67.
17. UNAIDS Global report: UNAIDS report on the global AIDS epidemic 2013 2013.
18. Cable R., Lelie N., Bird A. Reduction of the risk of transfusion-transmitted viral infection by nucleic acid amplification testing in the Western Cape of South Africa: a 5-year review. Vox Sang 2013, 104:93-99.
19. Vermeulen M., Lelie N., Sykes W., Crookes R., Swanevelder J., Gaggia L., et al. Impact of individual-donation nucleic acid testing on risk of human immunodeficiency virus, hepatitis B virus, and hepatitis C virus transmission by blood transfusion in South Africa. Transfusion 2009, 49:1115-1125.
20. Cunha L., Plouzeau C. Use of replacement blood donors to study the epidemiology of major blood-borne viruses in the general population of Maputo, Mozambique. J Med Virol 2007, 79:1832-1840.
21. CDC Progress toward strengthening national blood transfusion services-14 countries, 2008-2010. MMWR Morb Mortal Wkly Rep 2011, 60:1578-1582.
22. Bank T.W. New HIV Infections by mode of transmission in West Africa: A Multi Country Analysis 2010.
23. Lefrere J.J., Dahourou H., Dokekais A.E., Kouao M.D., Diarra A., Diop S., et al. Estimate of the residual risk of transfusion-transmitted human immunodeficiency virus infection in sub-Saharan Africa: a multinational collaborative study. Transfusion 2011, 51:486-492.
24. Hou J., Liu Z., Gu F. Epidemiology and prevention of hepatitis B virus infection. Int J Med Sci 2005, 2:50-57.
25. Alter M.J. Epidemiology of viral hepatitis and HIV co-infection. J Hepatol 2006, 44:S6-S9.
26. Lok A.S., McMahon B.J. Chronic hepatitis B. Hepatology 2001, 34:1225-1241.
27. Apata I.W., Averhoff F., Pitman J., Bjork A., Yu J., Amin N.A., et al. Progress toward prevention of transfusion-transmitted hepatitis B and hepatitis C infection-sub-saharan Africa, 2000-2011. MMWR Morb Mortal Wkly Rep 2014, 63:613-619.
28. Kupek E. Residual risk of hepatitis-B-infected blood donations: estimation methods and perspectives. ISRN Infect Dis 2013, 2013:1-15.
29. Jayaraman S., Chalabi Z., Perel P., Guerriero C., Roberts I. The risk of transfusion-transmitted infections in sub-Saharan Africa. Transfusion 2010, 50:433-442.
30. Seed C.R., Kiely P. A method for estimating the residual risk of transfusion-transmitted HBV infection associated with occult hepatitis B virus infection in a donor population without universal anti-HBc screening. Vox Sang 2013, 105:290-298.
31. Gerlich W.H., Bremer C., Saniewski M., Schüttler C.G., Wend U.C., Willems W.R., et al. Occult hepatitis B virus infection: detection and significance. Dig Dis 2010, 28:116-125.
32. Raimondo G., Allain J.-P., Brunetto M.R., Buendia M.-A., Chen D.-S., Colombo M., et al. Statements from the Taormina expert meeting on occult hepatitis B virus infection. J Hepatol 2008, 49:652-657.
33. Hollinger F.B. Hepatitis B virus infection and transfusion medicine: science and the occult. Transfusion 2008, 48:1001-1026.
34. Sy T., Jamal M.M. Epidemiology of hepatitis C virus (HCV) infection. Int J Med Sci 2006, 3:41-46.
35. Karoney M.J., Siika A.M. Hepatitis C virus (HCV) infection in Africa: a review. Pan Afr Med J 2013, 14:14-44.
36. Madhava V., Burgess C., Drucker E. Epidemiology of chronic hepatitis C virus infection in sub-Saharan Africa. Lancet Infect Dis 2002, 2:293-302.
37. Frank C., Mohamed M.K., Strickland G.T., Lavanchy D., Arthur R.R., Magder L.S., et al. The role of parenteral antischistosomal therapy in the spread of hepatitis C virus in Egypt. Lancet 2000, 355:887-891.
38. Zou S., Notari E.P., Fang C.T., Stramer S.L., Dodd R.Y. Current value of serologic test for syphilis as a surrogate marker for blood-borne viral infections among blood donors in the United States. Transfusion 2009, 49:655-661.
39. Chattopadhyay R., Majam V.F., Kumar S. Survival of Plasmodium falciparum in human blood during refrigeration. Transfusion 2011, 51:630-635.
40. Mbanya D.N., Takam D., Ndumbe P.M. Serological findings amongst first-time blood donors in Yaoundé, Cameroon: is safe donation a reality or a myth?. Transfus Med 2003, 13:267-273.
41. Ampofo W., Nii-Trebi N., Ansah J., Abe K., Naito H., Aidoo S., et al. Prevalence of blood-borne infectious diseases in blood donors in Ghana. J Clin Microbiol 2002, 40:1-4.
42. WHO World malaria report: 2013 2013.
43. Kitchen A.D., Chiodini P.L. Malaria and blood transfusion. Vox Sang 2006, 90:77-84.
44. Owusu-Ofori A.K., Betson M. Transfusion-transmitted malaria in Ghana. Clin Infect Dis 2013, 56:1735-1741.
45. Nansseu J.R.N., Noubiap J.J.N., Ndoula S.T., Zeh A.F.M., Monamele C.G. What is the best strategy for the prevention of transfusion-transmitted malaria in sub-Saharan African countries where malaria is endemic?. Malar J 2013, 12:1-9. [465].
46. Rajab J.A., Waithaka P.M., Orinda D.A.O., Scott C.S. Analysis of cost and effectiveness of pre-transfusion screening of donor blood and anti-malarial prophylaxis for recipients. East Afr Med J 2005, 82:565-571.
47. Gessain A., Cassar O. Epidemiological aspects and world distribution of HTLV-1 infection. Front Microbiol 2012, 3:1-23.
48. Diop S., Calattini S. Seroprevalence and molecular epidemiology of human T-cell leukemia virus type 1 (HTLV-1) and HTLV-2 in blood donors from Dakar, Senegal. J Clin Microbiol 2006, 44:1550-1554.
49. Sykes W., Coleman C., Gaggia L., Beck G., Mhlanga J., Hlela C., et al. Prevalence of HTLV-1 in the South African donor population. Paper presented at: 7th AfSBT Congress 2014, Jul 30 - Aug 2; Victoria Falls, Zimbabwe.
50. Hillyer C.D., Josephson C.D., Blajchman Ma, Vostal J.G., Epstein J.S., Goodman J.L. Bacterial contamination of blood components: risks, strategies, and regulation: Joint ASH and AABB educational session in transfusion medicine. Hematology 2003, 575-589.
51. Hassall O., Maitland K., Pole L., Mwarumba S., Denje D., Wambua K., et al. Bacterial contamination of pediatric whole blood transfusions in a Kenyan hospital. Transfusion 2009, 49:2594-2598.
52. Adjei A.A., Kuma G.K., Tettey Y., Ayeh-Kumi P.F., Opintan J., Apeagyei F., et al. Bacterial contamination of blood and blood components in three major blood transfusion centers, Accra, Ghana. Jpn J Infect Dis 2009, 62:265-269.
53. McDonald C.P. Bacterial risk reduction by improved donor arm disinfection, diversion and bacterial screening. Transfus Med 2006, 16:381-396.
54. Meza B.P., Lohrke B., Wilkinson R., Pitman J.P., Shiraishi R.W., Bock N., et al. Estimation of the prevalence and rate of acute transfusion reactions occurring in Windhoek, Namibia. Blood Transfus 2014, 12:352-361.
55. Tagny C.T., Mbanya D., Tapko J.-B., Lefrère J.-J. Blood safety in Sub-Saharan Africa: a multi-factorial problem. Transfusion 2008, 48:1256-1261.
56. Diarra A., Kouriba B., Baby M., Murphy E., Lefrere J.J. HIV, HCV, HBV and syphilis rate of positive donations among blood donations in Mali: lower rates among volunteer blood donors. Transfus Clin Biol 2009, 16:444-447.
57. WHO Towards self-sufficiency in safe blood and blood products based on voluntary non-remunerated donation: global status 2013 2013.
58. Allain J.-P., Sarkodie F., Boateng P., Asenso K., Kyeremateng E., Owusu-Ofori S. A pool of repeat blood donors can be generated with little expense to the blood center in sub-Saharan Africa. Transfusion 2008, 48:735-741.
59. Osaro E., Charles A.T. The challenges of meeting the blood transfusion requirements in Sub-Saharan Africa: the need for the development of alternatives to allogenic blood. J Blood Med 2011, 2:7-21.
60. Bates I., Manyasi G., Medina Lara A. Reducing replacement donors in Sub-Saharan Africa: challenges and affordability. Transfus Med 2007, 17:434-442.
61. Dahourou H., Tapko J.B., Kienou K., Nebie K., Sanou M. Recruitment of blood donors in Burkina Faso: how to avoid donations from family members?. Biologicals 2010, 38:39-42.
62. Mbanya D.N., Tayou C. Blood safety begins with safe donations: update among blood donors in Yaounde, Cameroon. Transfus Med 2005, 15:395-399.
63. Allain J.-P. Moving on from voluntary non-remunerated donors: who is the best blood donor?. Br J Haematol 2011, 763-769.
64. Mapako T., Mvere D.A., Chitiyo M.E., Rusakaniko S., Postma M.J., van Hulst M. Human immunodeficiency virus prevalence, incidence, and residual transmission risk in first-time and repeat blood donations in Zimbabwe: implications on blood safety. Transfusion 2013, 53:2413-2421.
65. Laperche S. Antigen-antibody combination assays for blood donor screening: weighing the advantages and costs. Transfusion 2008, 48:576-579.
66. Tagny C.T., Mbanya D., Leballais L., Murphy E., Lefrère J.-J., Laperche S. Reduction of the risk of transfusion-transmitted human immunodeficiency virus (HIV) infection by using an HIV antigen/antibody combination assay in blood donation screening in Cameroon. Transfusion 2011, 51:184-190.
67. Aghokeng A.F., Ewane L., Awazi B., Nanfack A., Delaporte E., Peeters M., et al. Evaluation of four simple/rapid assays and two fourth-generation ELISAs for the identification of HIV infection on a serum panel representing the HIV-1 group M genetic diversity in Cameroon. Epidemiol Soc Sci 2004, 37:1632-1640.
68. WHO Guidelines for using HIV testing technologies in surveillance: selection, evaluation, and implementation-2009 update 2009, 1-52.
69. Busch M.P., Glynn S.A., Stramer S.L. A new strategy for estimating risks of transfusion-transmitted viral infections based on rates of detection of recently infected donors. Transfusion 2005, 45:254-264.
70. Basavaraju S.V., Mwangi J., Nyamongo J., Zeh C., Kimani D., Shiraishi R.W., et al. Reduced risk of transfusion-transmitted HIV in Kenya through centrally co-ordinated blood centres, stringent donor selection and effective p24 antigen-HIV antibody screening. Vox Sang 2010, 99:212-219.
71. Prowse C.V. Component pathogen inactivation: a critical review. Vox Sang 2013, 104:183-199.
72. Lozano M., Cid J. Pathogen inactivation: coming of age. Curr Opin Hematol 2013, 20:540-545.
73. Schmidt M., Geilenkeuser W.-J., Sireis W., Seifried E., Hourfar K. Emerging pathogens-how safe is blood?. Transfus Med and Hemother 2014, 41:10-17.
74. Custer B. Update on pathogen reduction technology. ISBT Sci Ser 2013, 8:80-84.
75. WHO Diagnostics and Laboratory Technology 2014, [Available from: www.who.int/diagnostics_laboratory/procurement/en/].
76. WHO List of diagnostics eligible to tender for procurement by WHO in 2014 (including WHO prequalified diagnostics) 2014.
77. WHO Hepatitis B surface antigen assays: operational characteristics (phase 1) 2001, 1-41.
78. WHO Hepatitis C assays: operational characteristics (phase i) 2001.
79. WHO, UNAIDS HIV assays: operational characteristics report 14/simple/rapid tests 2004, 1-63.
80. UNICEF HIV diagnosis: a guide for selecting rapid diagnostic test (RDT) kits 2008, 1-10.
81. Zhang G., Guo J., Wang X. Immunochromatographic later flow strip tests 2009, 169-183. Humana Press. A. Rasooly, K.E. Herold (Eds.).
82. Downing R.G., Otten R.A., Marum E., Biryahwaho B., Alwano-Edyegu M.G., Sempala S.D., et al. Optimizing the delivery of HIV counseling and testing services: the Uganda experience using rapid HIV antibody test algorithms. J Acquir Immune Defic Syndr Hum Retrovirol 1998, 18:384-388.
83. WHO The importance of simple/rapid assays for HIV testing. Wkly Epidemiol Rec 1998, 73:321-328.
84. Connell R.J.O., Gates R.G., Bautista C.T., Imbach M., Eggleston J.C., Beardsley S.G., et al. Laboratory evaluation of rapid test kits to detect hepatitis C antibody for use in predonation screening in emergency settings. Transfusion 2013, 53:505-517.
85. Mvere D., Constantine N.T., Katsawde E., Dambire S., Corcoran P. Rapid and simple hepatitis assays: encouraging results from a blood donor population in Zimbabwe. Bull World Health Organ 1996, 74:19-24.
86. Eller L.A., Eller M.A., Ouma B.J., Kataaha P., Bagaya B.S., Olemukan R.L., et al. Large-scale human immunodeficiency virus rapid test evaluation in a low-prevalence Ugandan blood bank population. J Clin Microbiol 2007, 45:3281-3285.
87. Laperche S., Boukatou G., Kouegnigan L., Nébié Y., Boulahi M.O., Tagny C.T., et al. Transfusion safety on the African continent: an international quality control of virus testing in blood banks. Transfusion 2009, 49:1600-1608.
88. Lyamuya E.F., Aboud S., Urassa W.K., Sufi J., Mbwana J., Ndugulile F., et al. Evaluation of simple rapid HIV assays and development of national rapid HIV test algorithims in Dar es Salaam, Tanzania. BMC Infect Dis 2009, 7:1-7.
89. Owusu-ofori S., Temple J., Sarkodie F., Anokwa M., Candotti D. Predonation screening of blood donors with rapid tests: implementation and efficacy of a novel approach to blood safety in resource-poor settings. Transfusion 2005, 45:133-140.
90. Dessie A., Abera B., Walle F., Wolday D., Tamene W. Evaluation of Determine HIV-1/2 rapid diagnostic test by 4th generation ELISA using blood donors' serum at Felege Hiwot Referral Hospital, northwest Ethiopia. Ethiop Med J 2008, 46:1-5.
91. Stokx J., Gillet P., De Weggheleire A., Casas E.C., Maendaenda R., Beulane A.J., et al. Seroprevalence of transfusion-transmissible infections and evaluation of the pre-donation screening performance at the Provincial Hospital of Tete, Mozambique. BMC Infect Dis 2011, 11:1-8. [141].
92. Allain J.-P., Candotti D., Soldan K., Sarkodie F., Phelps B., Giachetti C., et al. The risk of hepatitis B virus infection by transfusion in Kumasi, Ghana. Blood 2003, 101:2419-2425.
93. El-Ghitany E.M., Farghaly A.G. Evaluation of commercialized rapid diagnostic testing for some hepatitis B biomarkers in an area of intermediate endemicity. J Virol Methods 2013, 194:190-193.
94. Lin Y.-H., Wang Y., Loua A., Day G.-J., Qiu Y., Nadala E.C.B., et al. Evaluation of a new hepatitis B virus surface antigen rapid test with improved sensitivity. J Clin Microbiol 2008, 46:3319-3324.
95. Al-Tahish G., El-Barrawy M.A., Hashish M.H., Heddaya Z. Effectiveness of three types of rapid tests for the detection of hepatitis C virus antibodies among blood donors in Alexandria, Egypt. J Virol Methods 2013, 189:370-374.
96. Tagny C.T., Mbanya D., Murphy E.L., Lefrère J.-J., Laperche S. Screening for hepatitis C virus infection in a high prevalence country by an antigen/antibody combination assay versus a rapid test. J Virol Methods 2014, 199:119-123.
97. Tagny C.T. Syphilis and blood safety in developing countries. Tech 2011, 123-130. N. Satomi Sato (Ed.).
98. Tagny C.T. Screening of syphilis in the Subsaharan African blood donor: which strategy?. Transfus Clin Biol 2009, 16:448-453.
99. WHO The use of rapid syphilis tests 2006, 1-28.
100. Herring A.J., Ballard R.C., Pope V., Adegbola R.A., Changalucha D., Fitzegerald D.W., et al. A multi-centre evaluation of nine rapid, point-of-care syphilis tests using archived sera. Sex Transm Infect 2006, 82:v7-v12.
101. Owusu-Ofori A.K., Parry C., Bates I. Transfusion-transmitted malaria in countries where malaria is endemic: a review of the literature from sub-Saharan Africa. Clin Infect Dis 2010, 51:1192-1198.
102. Moody A. Rapid diagnostic tests for malaria parasites rapid diagnostic tests for malaria parasites. Clin Microbiol Rev 2002, 15:66-78.
103. Freimanis G., Sedegah M., Owusu-Ofori S., Kumar S., Allain J.-P. Investigating the prevalence of transfusion transmission of Plasmodium within a hyperendemic blood donation system. Transfusion 2013, 53:1429-1441.
104. Ali M.S.M., Yousif A.G.M., Mustafa M.S., Ibrahim M.H. Evaluation of malaria parasite screening procedures among Sudanese blood donors. Clin Lab Sci 2005, 18:69-73.
105. Salawu L., Murainah H.A. Pre-donation screening of intending blood donors for antibodies to infectious agents in a Nigerian tertiary health institution: a pilot study. Afr J Med Med Sci 2006, 35:453-456.
106. Allain J.-P., Opare-Sem O., Sarkodie F., Rahman R., Owusu-Ofori S. Deferred donor care in a regional hospital blood center in Ghana. Transfusion 2009, 49:669-675.
107. Clark K.A., Kataaha P., Mwangi J., Nyamongo J. Predonation testing of potential blood donors in resource-restricted settings. Transfusion 2005, 45:1542-1543.
108. Shanks L., Klarkowski D., O'Brien D.P. False positive HIV diagnoses in resource limited settings: operational lessons learned for HIV programmes. PLoS One 2013, 8(3):e59906.
109. Consten E.C.J., Meer J.T.M., Wolf F. Risk of iatrogenic human immunodeficiency virus infection through transfusion of blood tested by inappropriately stored or expired rapid antibody assays in a Zambian hospital. Transfusion 1997, 37:930-934.
110. Kubio C., Tierney G., Quaye T., Nabilisi J.W., Ziemah C., Zagbeeb S.M., et al. Blood transfusion practice in a rural hospital in Northern Ghana, Damongo, West Gonja District. Transfusion 2012, 52:2161-2166.
111. Peeters M., Toure-Kane C., Nkengasong J.N. Genetic diversity of HIV in Africa: impact on diagnosis, treatment, vaccine development and trials. AIDS 2003, 17:2547-2560.
112. Engelbrecht S., de Jager G.J., van Rensburg E.J. Evaluation of commercially available assays for antibodies to HIV-1 in serum obtained from South African patients infected with HIV-1 subtypes B, C, and D. J Med Virol 1994, 44:223-228.
113. Phillips S., Granade T.C., Pau C.-P., Hu D.J., Parekh B.S., Candal D. Diagnosis of human immunodeficiency virus type 1 infection with different subtypes using rapid tests. Clin Vaccine Immunol 2000, 7:698-699.
114. Bloch E.M., Shah A., Kaidarova Z., Laperche S., Lefrere J.J., van Hasselt J., et al. A pilot external quality assurance study of transfusion screening for HIV, HCV and HBsAG in 12 African countries. Vox Sang 2014, 10.1111/vox.12182.
115. WHO WHO list of prequalified in vitro diagnostic products 2014, [Available from: http://www.who.int/diagnostics_laboratory/evaluations/PQ_list/en/].
116. Shott J.P., Galiwango R.M., Reynolds S.J. A quality management approach to implementing point-of-care technologies for HIV diagnosis and monitoring in Sub-Saharan Africa. J Trop Med 2012, 2012:1-8.