Comparison of HIV-1 detection in plasma specimens and dried blood spots using the Roche COBAS Ampliscreen HIV-1 test in Kisumu, Kenya

Journal of Virological Methods

Volumn 179, Issue 1, 2012, Pages 21-25

  Okonji, Jully A ^a   Basavaraju, Sridhar V ^b   Mwangi, Jane ^c   Shiraishi, Ray W ^b   Odera, Matthew ^d   Ouma, Kenneth ^a   Pitman, John P ^b   Marum, Lawrence H ^b   Ou, Chin Yih ^b   Zeh, Clement ^c  

^a KENYA MEDICAL RESEARCH INSTITUTE   (Kenya)

^b CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^c CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^d Kenya National Blood Transfusion Service   (Kenya)

Author keywords

Blood donors; Dried blood spots; HIV 1; Nucleic acid testing

Indexed keywords

VIRUS RNA;

ARTICLE; BLOOD ANALYSIS; BLOOD SAMPLING; BLOOD TRANSFUSION; COBAS AMPLISCREEN HIV 1 TEST; COMPARATIVE STUDY; CONTROLLED STUDY; DRIED BLOOD SPOT TESTING; HIV TEST; HUMAN; HUMAN CELL; HUMAN IMMUNODEFICIENCY VIRUS 1; KENYA; LIMIT OF DETECTION; NUCLEIC ACID ANALYSIS; PRIORITY JOURNAL; PROCESS OPTIMIZATION; RNA ANALYSIS; STANDARD; VIRUS DETECTION; VIRUS LOAD; VIRUS REPLICATION;

AFRICA SOUTH OF THE SAHARA; BLOOD; DESICCATION; HIV INFECTIONS; HIV-1; HUMANS; KENYA; MOLECULAR DIAGNOSTIC TECHNIQUES; PLASMA; REAGENT KITS, DIAGNOSTIC; SENSITIVITY AND SPECIFICITY; SPECIMEN HANDLING;

HUMAN IMMUNODEFICIENCY VIRUS 1;

EID: 84855228389     PISSN: 01660934     EISSN: 18790984     Source Type: Journal    
DOI: 10.1016/j.jviromet.2011.07.001     Document Type: Article

References (28)

1. Alvarez-Munoz M.T., Zaragoza-Rodri{dotless}guez S., Rojas-Montes O., Palacios-Saucedo G., Vazquez-Rosales G., Gomez-Delgado A., Torres J., Muñoz O. High correlation of human immunodeficiency virus type-1 viral load measured in dried blood spot samples and in plasma under different storage conditions. Arch. Med. Res. 2005, 36:382-386.
2. Basavaraju S.V., Mwangi J., Nyamongo J., Zeh C., Kimani D., Shiraishi R.W., Madoda R., Okonji J.A., Sugut W., Ongwae S., Pitman J.P., Marum L.H. 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.
3. Busch M.P., Glynn S.A., Stramer S.L., Strong D.M., Caglioti S., Wright D.J., Pappalardo B., Kleinman S.H. 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. NHLBI-REDS NAT Study Group.
4. Corfec E.L., Pont F.L., Tuckwell H.C., Rouzioux C., Costagliola D. Direct HIV testing in blood donations: variation of the yield with detection threshold and pool size. Transfusion 1999, 39:1141-1144.
5. Crignis E.D., Re M.C., Cimatti L., Zecchi L., Gibellini D. HIV-1 and HCV detection in dried blood spots by SYBR Green multiplex real-time RT-PCR. J. Virol. Methods 2010, 165:51-56.
6. Dandona L., Dandona R., Kumar G.A., Reddy G.B., Ameer M.A., Ahmed G.M., Ramgopal S.P., Akbar M., Sudha T., Lakshmi V. Risk factors associated with HIV in a population-based study in Andhra Pradesh state of India. Int. J. Epidemiol. 2008, 37:1274-1286.
7. Food and Drug Administration, 1999. Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2. Retrieved from: (accessed 07.03.2011). http://www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/blood/ucm077067.htm%23CLINICALVALIDATIONOFASSAYPERFORMANCE.
8. Finney D.J. Probit Analysis: Parallel Line Analysis 1971, Cambridge University Press, Cambridge. 3rd ed.
9. Gupta B.P., Jayasuryan N., Jameel S. Direct detection of hepatitis B virus from dried blood spots by polymerase chain reaction amplification. J. Clin. Microbiol. 1992, 30:1913-1916.
10. Heyns A.d.P., Benjamin R.J., Swanevelder J.P.R., Laycock M.E., Pappalardo B.L., Crookes R.L., Wright D.J., Busch M.P. Prevalence of HIV-1 in blood donations following implementation of a structured blood safety policy in South Africa. JAMA 2006, 295:519-526.
11. Jardi R., Rodriguez-Frias F., Buti M., Schaper M., Valdes A., Martinez M., Esteban R., Guardia J. Usefulness of dried blood samples for quantification and molecular characterization of HBV-DNA. Hepatology 2004, 40:133-139.
12. Lakshmi V., Sudha T., Bhanurekha M., Dandona L. Evaluation of the Murex HIV Ag/Ab combination assay when used with dried blood spots. Clin. Microbiol. Infect. 2007, 13:1134-1136.
13. Laperche S., Morel P., Deschaseaux M., Bouchardeau F., Alimardani G., Guillaume N., Rouger P., Lefrère J.J. HIV antibody screening remains indispensable for ensuring viral safety of blood components despite NAT implementation. Transfusion 2003, 43:1428-1432.
14. Leelawiwat W., Young N.L., Chaowanachan T., Ou C.Y., Culnane M., Vanprapa N., Waranawat N., Wasinrapee P., Mock P.A., Tappero J., McNicholl J.M. 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 2009, 155:109-117.
15. Lelie P.N., Drimmelen H.A.J.v., Cuypers H.T.M., Best S.J., Stramer S.L., Hyland C., Allain J.P., Moncharmont P., Defer C., Nübling M., Glauser A., da Silva Cardoso M., Viret J.F., Lankinen M.H., Grillner L., Wirthmüller U., Coste J., Schottstedt V., Masecar B., Dax E.M. Sensitivity of HCV RNA and HIV RNA blood screening assays. Transfusion 2002, 42:527-536.
16. Ly T.D., Laperche S., Brennan C., Vallari A., Ebel A., Hunt J., Martin L., Daghfal D., Schochetman G., Devare S. Evaluation of the sensitivity and specificity of six HIV combined p24 antigen and antibody assays. J. Virol. Methods 2004, 122:185-194.
17. Margaritis A.R., Brown S.M., Seed C.R., Kiely P., D'Agostino B., Keller A.J. Comparison of two automated nucleic acid testing systems for simultaneous detection of human immunodeficiency virus and hepatitis C virus RNA and hepatitis B virus DNA. Transfusion 2007, 47:1783-1793.
18. Monleau M., Montavon C., Laurent C., Segondy M., Montes B., Delaporte E., Boillot F., Peeters M. Evaluation of different RNA extraction methods and storage conditions of dried plasma or blood spots for human immunodeficiency virus type 1 RNA quantification and PCR amplification for drug resistance testing. J. Clin. Microbiol. 2009, 47:1107-1118.
19. Ouwe-Missi-Oukem-Boyer O.N., Hamidou A.A., Sidikou F., Garba A., Louboutin-Croc J.P. The use of dried blood spots for HIV-antibody testing in Sahel. Bull. Soc. Pathol. Exot. 2005, 98:343-346.
20. Roche. COBAS Ampliscreen HIV-1 Test Version 1.5 Manufacturer's Package Insert. Retrieved from: (accessed 2 February 2011). http://www.roche-diagnostics.cz/download/PCR_MD/Testy_nahradit/Transfuzni_sluzba/Cobas%2520AmpliScreen%2520%2520HIV-1%2520test%2520v1.5_200805.pdf.
21. Schmidt M., Pichl L., Jork C., Hourfar M.K., Schottstedt V., Wagner F.F., Seifried E., Müller T.H., Bux J., Saldanha J. Blood donor screening with cobas s 201/cobas TaqScreen MPX under routine conditions at German Red Cross institutes. Vox. Sang. 2010, 98:37-46.
22. Solmone M., Girardi E., Costa F., Pucillo L., Ippolito G., Capobianchi M.R. Simple and reliable method for detection and genotyping of hepatitis C virus RNA in dried blood spots stored at room temperature. J. Clin. Microbiol. 2002, 40:3512-3514.
23. Solomon S.S., Solomon S., Rodriguez I.I., McGarvey S.T., Ganesh A.K., Thyagarajan S.P., Mahajan A.P., Mayer K.H. Dried blood spots (DBS): a valuable tool for HIV surveillance in developing/tropical countries. Int. J. STD AIDS 2002, 13:25-28.
24. Steinmetzer K., Seidel T., Stallmach A., Ermantraut E. HIV load testing with small samples of whole blood. J. Clin. Microbiol. 2010, 48:2786-2792.
25. Vermeulen M., Lelie N., Sykes W., Crookes R., Swanevelder J., Gaggia L., Le Roux M., Kuun E., Gulube S., Reddy R. 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.
26. World Health Organization, 2002. AIDE-MEMOIRE for National Blood Programmes. Retrieved from: (accessed 01.02.2011). http://www.who.int/bloodsafety/transfusion_services/en/Blood_Safety_Eng.pdf.
27. World Health Organization, 2010. Screening Donated Blood for Transfusion-Transmissible Infections: Recommendations. Retrieved from: (accessed 01.02.2011). http://www.who.int/bloodsafety/ScreeningDonatedBloodforTransfusion.pdf.
28. Yen-Lieberman B., Brambilla D., Jackson B., Bremer J., Coombs R., Cronin M., Herman S., Katzenstein D., Leung S., Lin H.J., Palumbo P., Rasheed S., Todd J., Vahey M., Reichelderfer P. 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. 1996, 34:2695-2701.