Prospective evaluation of diagnostic accuracy of dried blood spots from finger prick samples for determination of HIV-1 load with the NucliSENS Easy-Q HIV-1 version 2.0 assay in Malawi

Journal of Clinical Microbiology

Volumn 52, Issue 5, 2014, Pages 1343-1351

  Fajardo, Emmanuel ^a   Metcalf, Carol A ^a   Chaillet, Pascale ^b   Aleixo, Lucia ^a   Pannus, Pieter ^a   Panunzi, Isabella ^a   Triviño, Laura ^a   Ellman, Tom ^a   Likaka, Andrew ^c   Mwenda, Reuben ^c  

^a MÉDECINS SANS FRONTIÈRES   (Switzerland)

^b MÉDECINS SANS FRONTIÈRES   (Belgium)

^c MINISTRY OF HEALTH   (Malawi)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIRETROVIRUS AGENT; VIRUS RNA;

ADOLESCENT; ADULT; AGED; ARTICLE; BIOCHEMICAL EQUIPMENT; BLOOD ANALYSIS; BLOOD SAMPLING; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST ACCURACY STUDY; DRIED BLOOD SPOT TESTING; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MALAWI; MALE; NONHUMAN; NUCLEIC ACID AMPLIFICATION; PRICK TEST; PRIORITY JOURNAL; PROSPECTIVE STUDY; SENSITIVITY AND SPECIFICITY; VALIDATION PROCESS; VIREMIA; VIRUS IDENTIFICATION; VIRUS LOAD; BLOOD; GENETICS; HIV INFECTIONS; MIDDLE AGED; PLASMA; PROCEDURES; VIROLOGY; YOUNG ADULT;

ADOLESCENT; ADULT; BLOOD SPECIMEN COLLECTION; DRIED BLOOD SPOT TESTING; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; MALAWI; MALE; MIDDLE AGED; PLASMA; PROSPECTIVE STUDIES; RNA, VIRAL; VIRAL LOAD; YOUNG ADULT;

EID: 84899556677     PISSN: 00951137     EISSN: 1098660X     Source Type: Journal    
DOI: 10.1128/JCM.03519-13     Document Type: Article

References (35)

1. World Health Organization. 2013. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. Recommendations for a public health approach. World Health Organization, Geneva, Switzerland.
2. Wilson D, Keiluhu AK, Kogrum S, Reid T, Seriratana N, Ford N, Kyawkyaw M, Talangsri P, Taochalee N. 2008. HIV-1 viral load monitoring: an opportunity to reinforce treatment adherence in a resource limited setting in Thailand. Trans. R Soc. Trop. Med. Hyg. 103:601-606. http://dx.doi.org/10.1016/j.trstmh.2008.11. 007.
3. Sigaloff KCE, Hamers RL, Wallis CL, Kityo C, Siwale M, Ive P, Botes ME, Mandaliya K, Wellington M, Osibogun A, Stevens WS, van Vugt M, Rinke de Wit TF, PharmAccess African Studies to Evaluate Resistance (PASER). 2011. Unnecessary antiretroviral treatment switches and accumulation of HIV resistance mutations; two arguments for viral load monitoring in Africa. J. Acquir. Immune. Defic. Syndr. 58:23-31. http://dx.doi.org/10.1097/QAI.0b013e318227fc34.
4. Margot NA, Lu B, Miller MD, Study 903 Team. 2006. Resistance development over 144 weeks in treatment-naive patients receiving tenofovir disoproxil fumarate or stavudine with lamivudine and efavirenz in Study 903. HIV Med. 7:442-450. http://dx.doi.org/10.1111/j.1468-1293.2006.00404.x.
5. Arnedo M, Alonso E, Eisenberg N, Ibáñez L, Ferreyra C, Jaén A, Flevaud L, Khamadi S, Roddy P, Gatell JM, Dalmau D, Busia Study Group O R. 2012. Monitoring HIV viral load in resource-limited settings: still a matter of debate? PLoS One 7:e47391. http://dx.doi.org/10.1371/journal.pone. 0047391.
6. Barth RE, Van der Loeff MFS, Schuurman R, Hoepelman AIM, Wensing AMJ. 2010. Virological follow-up of adult patients in antiretroviral treatment programmes in sub-Saharan Africa: a systematic review. Lancet Infect. Dis. 10:155-166. http://dx.doi.org/10.1016/S1473-3099 (09) 70328-7.
7. Stevens WS, Marshall TM. 2010. Challenges in implementing HIV load testing in South Africa. J. Infect. Dis. 201(Suppl 1):S78-S84. http://dx.doi.org/10.1086/650383.
8. Fiscus SA, Cheng B, Crowe SM, Demeter L, Jennings C, Miller V, Respess R, Stevens W, Forum for Collaborative HIV Research Alternative Viral Load Assay Working Group. 2006. HIV-1 viral load assays for resource-limited settings. PLoS Med. 3:e417. http://dx.doi.org/10.1371/journal.pmed.0030417.
9. Roberts T, Bygrave H, Fajardo E, Ford N. 2012. Challenges and opportunities for the implementation of virological testing in resource-limited settings. J. Int. AIDS Soc. 15:17324. http://dx.doi.org/10.7448/IAS.15.2.17324.
10. Johannessen A. 2010. Dried blood spots in HIV monitoring: applications in resource-limited settings. Bioanalysis. 2:1893-1908. http://dx.doi.org/10.4155/ bio.10.120.
11. Hamers RL, Smit PW, Stevens W, Schuurman R, Rinke de Wit TF. 2009. Dried fluid spots for HIV type-1 viral load and resistance genotyping: a systematic review. Antivir. Ther. 14:619-629. http://www.in tmedpress.com/serveFile.cfm? sUID=8d7390e5-08b3-45ad-b56d-b71 84f85d203.
12. Monleau M, Butel C, Delaporte E, Boillot F, Peeters M. 2010. Effect of storage conditions of dried plasma and blood spots on HIV-1 RNA quantification and PCR amplification for drug resistance genotyping. J. Antimicrob. Chemother. 65:1562-1566. http://dx.doi.org/10.1093/jac/dkq205.
13. Neogi U, Gupta S, Rodridges R, Sahoo PN, Rao SD, Rewari BB, Shastri S, Costa AD, Shet A. 2012. Dried blood spot HIV-1 RNA quantification: a useful tool for viral load monitoring among HIV-infected individuals in India. Indian J. Med. Res. 136:956-962.
14. van Deursen P, Oosterlaken T, Andre P, Verhoeven A, Bertens L, Trabaud MA, Ligeon V, de Jong J. 2010. Measuring human immunodeficiency virus type 1 RNA loads in dried blood spot specimens using NucliSENS Easy-Q HIV-1 v2.0. J. Clin. Virol. 47:120-125. http://dx.doi.org/10.1016/j.jcv. 2009.11.021.
15. Johannessen A, Garrido C, Zahonero N, Sandvik L, Naman E, Kivuyo SL, Kasubi MJ, Gundersen SG, Bruun JN, de Mendoza C. 2009. Dried blood spots perform well in viral load monitoring of patients who receive antiretroviral treatment in rural Tanzania. Clin. Infect. Dis. 49:976-981. http://dx.doi.org/10.1086/ 605502.
16. Ministry of Health, Malawi. 2011. Clinical management of HIV in children and adults, 1st ed. Ministry of Health, Lilongwe, Malawi.
17. Brambilla D, Granger S, Bremer J. 2000. Variation in HIV RNA assays at low RNA concentration, abstr 774. 7th Conf. Retrovir. Oppor. Infect. (CROI), San Francisco, CA, 30 January to 2 February 2000.
18. Scott LE, Carmona S, Gous N, Horsfield P, MacKay M, Stevens W. 2012. Use of a prequalification panel for rapid scale-up of highthroughput HIV viral load testing. J. Clin. Microbiol. 50:4083-4086. http://dx.doi.org/10.1128/JCM.01355- 12.
19. African Society of Laboratory Medicine. 2013. Expert consultation on viral load monitoring in African HIV treatment programmes. Cape Town, South Africa, 18 to 20 April 2013. http://www.aslm.org/resource-centre/hiv-viral-load- testing/.
20. Mwaba P, Cassol S, Nunn A, Pilon R, Chintu C, Janes M, Zumla A. 2003. Whole blood versus plasma spots for measurement of HIV-1 viral load in HIV infected African patients. Lancet 362:2067-2068. http://dx.doi.org/10.1016/ S0140-6736 (03) 15103-3.
21. Leelawiwat W, Young NL, Chaowanachana T, Oub CY, Culnaneb M, Vanprapad N, Waranawat N, Wasinrapeea P, Mocka PA, Tapperoa J, McNicholl JM. 2009. Dried blood spots for the diagnosis and quantitation of HIV-1: stability studies and evaluation of sensitivity and specificity for the diagnosis of infant HIV-1 infection in Thailand. J. Virol. Methods 155:109-117. http://dx.doi.org/10.1016/ j.jviromet.2008.09.022.
22. Garrido C, Zahonero N, Corral A, Arredondo M, Soriano V, de Mendoza C. 2009. Correlation between human immunodeficiency virus type 1 (HIV-1) RNA measurements obtained with dried blood spots and those obtained with plasma by use of NucliSENS Easy-Q HIV-1 and Abbott RealTime HIV load tests. J. Clin. Microbiol. 47:1031-1036. http://dx.doi.org/10.1128/JCM.02099-08.
23. Monleau M, Ehlan A, Dagnra A, Eymard-Duvernay S, Salou M, Ali-Edje K, Aghokeng A, Ayouba A, Prince-David M, Peeters M. 2012. Impact of proviral DNA on HIV viral load and resistance genotyping on dried blood spots versus plasma: a field study in Lomé, Togo, West Africa-ANRS 12186/12235 projects, abstr V-142. 19th Conf. Retrovir. Oppor. Infect. (CROI), Seattle, WA, March 2012.
24. Uttayamakul S, Likanonsakul S, Sunthornkachit R, Kuntiranont K, Louisirirotchanakul S, Chaovavanich A, Thiamchai V, Tanprasertsuk S, Sutthent R. 2005. Usage of dried blood spots for molecular diagnosis and monitoring HIV-1 infection. J. Virol. Methods 128:128-134. http://dx.doi.org/10.1016/j.jviromet. 2005.04.010.
25. Barth RE, Aitken SC, Tempelman H, Geelen SP, van Bussel EM, Hoepelman AI, Schuurman R, Wensing AM. 2012. Accumulation of drug resistance and loss of therapeutic options precede commonly used criteria for treatment failure in HIV-1 subtype-C-infected patients. Antivir. Ther. 17:377-386. http://dx.doi.org/10.3851/IMP2010.
26. Rottinghaus EK, Ugbena R, Diallo K, Bassey O, Azeez A, DeVos J, Zhang G, Aberle-Grasse J, Nkengasong J, Yang C. 2012. Dried blood spot specimens are a suitable alternative sample type for HIV-1 viral load measurement and drug resistance genotyping in patients receiving firstline antiretroviral therapy. Clin. Infect. Dis. 54:1187-1195. http://dx.doi.org/10.1093/cid/cis015.
27. Driver AG, Patton JC, Moloi J, Stevens WS, Sherman GG. 2007. Low riskof contamination with automated and manual excision ofdried blood spots for HIV DNA PCR testing in the routine laboratory. J. Virol. Methods 146:397-400. http://dx.doi.org/10.1016/j.jviromet.2007.07.024.
28. Mitchell C, Kraft K, Peterson D, Frenkel L. 2010. Cross-contamination during processing of dried blood spots used for rapid diagnosis of HIV-1 infection of infants is rare and avoidable. J. Virol. Methods 163:489-491. http://dx.doi.org/10.1016/j.jviromet.2009.10.016.
29. Yen-Lieberman B, Brambilla D, Jackson B, Bremer J, Coombs R, Cronin M, Herman S, Katzenstein D, Leung S, Lin HJ, Palumbo P, Rasheed S, Todd J, Vahey M, Reichelderfer P. 1996. Evaluation of a quality assurance program for quantitation of human immunodeficiency virus type 1 RNA in plasma by the AIDS Clinical Trials Group Virology Laboratories. J. Clin. Microbiol. 34:2695-2701.
30. Kane CT, Ndiaye HD, Diallo S, Ndiaye I, Wade AS, Diaw PA, Gaye-Diallo A, Mboup S. 2008. Quantitation of HIV-1 RNA in dried blood spots by the real-time NucliSENS Easy-Q HIV-1 assay in Senegal. J. Virol. Methods 148:291-295. http://dx.doi.org/10.1016/j.jviromet.2007.11.011.
31. Ouma KN, Basavaraju SV, Okonji JA, Williamson J, Thomas TK, Mills LA, Nkengasong JN, Zeh C. 2013. Assay and the fully evaluation of quantification of HIV-1 RNA viral load inplasma and dried blood spots by use of the semiautomated Cobas Amplicor automated Cobas Ampliprep/TaqMan assay, version 2.0, in Kisumu, Kenya. J. Clin. Microbiol. 51:1208-1218. http://dx.doi.org/10.1128/JCM.03048-12.
32. Mtapuri-Zinyowera S, Taziwa F, Metcalf C, Mbofana E, De Weerdt S, Flevaud L, Simons S, Saint-Sauveur JF, Fajardo E. 2013. Field evaluation of performance of dried blood spots (DBS) from finger prick for the determination of viral load in a resource-constrained setting in urban and rural Zimbabwe. Poster number WEPE610. 7th IAS Conference on HIV Pathogenesis, Treatment and Prevention, Kuala-Lumpur, Malaysia.
33. Bhowan K, Scott L, Carmona S, Sherman G. 2011. Precision of HIV viral load (VL) testing on dried blood spots (DBS) in adult and paediatric specimens, abstr CDB083. 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention, Rome, Italy, 17 to 20 July, 2011.
34. Médecins Sans Frontières Access Campaign. 2013. Putting HIV treatment to the test: a product guide for viral load and point-of-care CD4 diagnostic tools. http://www.msfaccess.org/content/putting-hiv-treatment-test.
35. Pannus P, Fajardo E, Metcalf C, Coulborn RM, Durán LT, Bygrave H, Ellman T, Garone D, Murowa M, Mwenda R, Reid T, Preiser W. 2013. Pooled HIV-1 viral load testing using dried blood spots to reduce the cost of monitoring antiretroviral treatment in a resource-limited setting. J. Acquir. Immune Defic. Syndr. 64:134-137. http://dx.doi.org/10.1097/QAI.0b013e3182a61e63.