Performance evaluation of the MBio Diagnostics point-of-care CD4 counter

Journal of Immunological Methods

Volumn 387, Issue 1-2, 2013, Pages 107-113

  Logan, Cathy ^b   Givens, Monique ^a   Ives, Jeffrey T ^a   Delaney, Marie ^a   Lochhead, Michael J ^a   Schooley, Robert T ^b   Benson, Constance A ^b  

^a MBIO DIAGNOSTICS INC   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

CD4; Diagnostic; HIV; Point of care

Indexed keywords

ADULT; AGED; ARTICLE; BLOOD ANALYSIS; BLOOD SAMPLING; CAPILLARY BLOOD; CD4 LYMPHOCYTE COUNT; CD4 QUANTIFICATION SYSTEM; CONTROLLED STUDY; DIAGNOSTIC ACCURACY; DIAGNOSTIC EQUIPMENT; DIAGNOSTIC TEST ACCURACY STUDY; FEMALE; FLOW CYTOMETRY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; VEIN PUNCTURE; VENOUS BLOOD;

ADULT; AGED; CD4 LYMPHOCYTE COUNT; FEMALE; FLOW CYTOMETRY; HIV INFECTIONS; HUMANS; MALE; MIDDLE AGED; POINT-OF-CARE SYSTEMS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; YOUNG ADULT;

EID: 84871453529     PISSN: 00221759     EISSN: 18727905     Source Type: Journal    
DOI: 10.1016/j.jim.2012.10.002     Document Type: Article

References (42)

1. Amuron B., Namara G., Birungi J., Nabiryo C., Levin J., Grosskurth H., Coutinho A., Jaffar S. Mortality and loss-to-follow-up during the pre-treatment period in an antiretroviral therapy programme under normal health service conditions in Uganda. BMC Publ. Health 2009, 9:290.
2. Balakrishnan P., Solomon S., Mohanakrishnan J., Cecelia A.J., Kumarasamy N., Murugavel K.G., Venkatakrishnan B., Solomon S.S., Crowe S.M., Ganesh A.K., Thyagarajan S.P., Flanigan T., Mayer K.H. A reliable and inexpensive EasyCD4 assay for monitoring HIV-infected individuals in resource-limited settings. J. Acquir. Immune Defic. Syndr. 1999, 43:23.
3. Bassett I.V., Wang B., Chetty S., Mazibuko M., Bearnot B., Giddy J., Lu Z., Losina E., Walensky R.P., Freedberg K.A. Loss to care and death before antiretroviral therapy in Durban, South Africa. J. Acquir. Immune Defic. Syndr. 1999, 51:135.
4. Boyle D.S., Hawkins K.R., Steele M.S., Singhal M., Cheng X. Emerging technologies for point-of-care CD4 T-lymphocyte counting. Trends Biotechnol. 2012, 30:45.
5. Diaw P.A., et al. Multisite evaluation of a point-of-care instrument for CD4+ T-cell enumeration using venous and finger-prick blood: the PIMA CD4. J. Acquir. Immune Defic. Syndr. 2011, 58(4):e103-e111. (Dec 1).
6. Diaw P.A., Daneau G., Coly A.A., Ndiaye B.P., Wade D., Camara M., Mboup S., Kestens L., Dieye T.N. Multisite evaluation of a point-of-care instrument for CD4(+) T-cell enumeration using venous and finger-prick blood: the PIMA CD4. J. Acquir. Immune Defic. Syndr. 1999, 58:e103.
7. Djomand G., Roels T., Ellerbrock T., Hanson D., Diomande F., Monga B., Maurice C., Nkengasong J., Konan-Koko R., Kadio A., Wiktor S., Lackritz E., Saba J., Chorba T. Virologic and immunologic outcomes and programmatic challenges of an antiretroviral treatment pilot project in Abidjan, Cote d'Ivoire. AIDS 2003, 17(Suppl. 3):S5.
8. Embree J., Bwayo J., Nagelkerke N., Njenga S., Nyange P., Ndinya-Achola J., Pamba H., Plummer F. Lymphocyte subsets in human immunodeficiency virus type 1-infected and uninfected children in Nairobi. Pediatr. Infect. Dis. J. 2001, 20:397.
9. Fredlund V.G., Nash J. How far should they walk? Increasing antiretroviral therapy access in a rural community in northern KwaZulu-Natal, South Africa. J. Infect. Dis. 2007, 196(Suppl. 3):S469.
10. Gernow A., Lisse I.M., Bottiger B., Christensen L., Brattegaard K. Determination of CD4+ and CD8+ lymphocytes with the cytosphere assay: a comparative study with flow cytometry and the immunoalkaline phosphatase method. Clin. Immunol. Immunopathol. 1995, 76:135.
11. Glencross D.K., Aggett H.M., Stevens W.S., Mandy F. African regional external quality assessment for CD4 T-cell enumeration: development, outcomes, and performance of laboratories. Cytometry B Clin. Cytom. 2008, 74(Suppl. 1):S69.
12. Glencross D.K., Janossy G., Coetzee L.M., Lawrie D., Aggett H.M., Scott L.E., Sanne I., McIntyre J.A., Stevens W. Large-scale affordable PanLeucogated CD4+ testing with proactive internal and external quality assessment: in support of the South African national comprehensive care, treatment and management programme for HIV and AIDS. Cytometry B Clin. Cytom. 2008, 74(Suppl. 1):S40.
13. Glencross D.K., Coetzee L.M., Faal M., Masango M., Stevens W.S., Venter W.F., Osih R. Performance evaluation of the point-of-care CD4 analyser Pima using capillary blood sampling in field tests in South Africa. J. Int. AIDS Soc. 2012, 15:3.
14. Herbert S., Edwards S., Carrick G., Copas A., Sandford C., Amphlett M., Benn P. Evaluation of PIMA point-of-care CD4 testing in a large UK HIV service. Sex. Transm. Infect. 2012, 88(6):413-417. (Oct, Epub 2012 Apr 27).
15. Idigbe E.O., Audu R.A., Oparaugo C.T., Onwujekwe D., Onubogu C.C., Adedoyin J., Mafe A.G., Okoye R., Onyewuche J.I., Funso-Adebayo E.O., Meshack E. Comparison of Dynabeads and Capcellia methods with FACScount for the estimation of CD4 T-lymphocyte levels in HIV/AIDS patients in Lagos, Nigeria. East Afr. Med. J. 2006, 83:105.
16. Jani I.V., Sitoe N.E., Alfai E.R., Chongo P.L., Quevedo J.I., Rocha B.M., Lehe J.D., Peter T.F. Effect of point-of-care CD4 cell count tests on retention of patients and rates of antiretroviral therapy initiation in primary health clinics: an observational cohort study. Lancet 2011, 378:1572.
17. Jani I.V., Sitoe N.E., Chongo P.L., Alfai E.R., Quevedo J.I., Tobaiwa O., Lehe J.D., Peter T.F. Accurate CD4 T-cell enumeration and antiretroviral drug toxicity monitoring in primary healthcare clinics using point-of-care testing. AIDS 2011, 25:807.
18. Karcher H., Bohning D., Downing R., Mashate S., Harms G. Comparison of two alternative methods for CD4+ T-cell determination (Coulter manual CD4 count and CyFlow) against standard dual platform flow cytometry in Uganda. Cytometry B Clin. Cytom. 2006, 70:163.
19. Landay A., Ho J.L., Hom D., Russell T., Zwerner R., Minuty J.G., Kataaha P., Mmiro F., Jackson B. A rapid manual method for CD4+ T-cell quantitation for use in developing countries. AIDS 1993, 7:1565.
20. Larsen C.H. The fragile environments of inexpensive CD4+ T-cell enumeration in the least developed countries: strategies for accessible support. Cytometry B Clin. Cytom. 2008, 74(Suppl. 1):S107.
21. Lochhead M.J., Todorof K., Delaney M., Ives J.T., Greef C., Moll K., Rowley K., Vogel K., Myatt C., Zhang X.Q., Logan C., Benson C., Reed S., Schooley R.T. Rapid multiplexed immunoassay for simultaneous serodiagnosis of HIV-1 and coinfections. J. Clin. Microbiol. 2011, 49:3584.
22. Losina E., Bassett I.V., Giddy J., Chetty S., Regan S., Walensky R.P., Ross D., Scott C.A., Uhler L.M., Katz J.N., Holst H., Freedberg K.A. The "ART" of linkage: pre-treatment loss to care after HIV diagnosis at two PEPFAR sites in Durban, South Africa. PLoS One 2010, 5:e9538.
23. Lutwama F., Serwadda R., Mayanja-Kizza H., Shihab H.M., Ronald A., Kamya M.R., Thomas D., Johnson E., Quinn T.C., Moore R.D., Spacek L.A. Evaluation of Dynabeads and Cytospheres compared with flow cytometry to enumerate CD4+ T cells in HIV-infected Ugandans on antiretroviral therapy. J. Acquir. Immune Defic. Syndr. 1999, 48:297.
24. Manabe Y.C., Wang Y., Elbireer A., Auerbach B., Castelnuovo B. Evaluation of portable point-of-care CD4 counter with high sensitivity for detecting patients eligible for antiretroviral therapy. PLoS One 2012, 7:e34319.
25. Micek M.A., Gimbel-Sherr K., Baptista A.J., Matediana E., Montoya P., Pfeiffer J., Melo A., Gimbel-Sherr S., Johnson W., Gloyd S. Loss to follow-up of adults in public HIV care systems in central Mozambique: identifying obstacles to treatment. J. Acquir. Immune Defic. Syndr. 1999, 52:397.
26. Mnyani C.N., McIntyre J.A., Myer L. The reliability of point-of-care CD4 testing in identifying HIV-infected pregnant women eligible for antiretroviral therapy. J. Acquir. Immune Defic. Syndr. 1999, 60:260.
27. Moodley D., Bobat R.A., Coovadia H.M., Doorasamy T., Munsamy S., Gouws E. Lymphocyte subset changes between 3 and 15 months of age in infants born to HIV-seropositive women in South Africa. Tropical Med. Int. Health 1997, 2:415.
28. Mtapuri-Zinyowera S., Chideme M., Mangwanya D., Mugurungi O., Gudukeya S., Hatzold K., Mangwiro A., Bhattacharya G., Lehe J., Peter T. Evaluation of the PIMA point-of-care CD4 analyzer in VCT clinics in Zimbabwe. J. Acquir. Immune Defic. Syndr. 1999, 55:1.
29. Nakanjako D., Colebunders R., Coutinho A.G., Kamya M.R. Strategies to optimize HIV treatment outcomes in resource-limited settings. AIDS Rev. 2009, 11:179.
30. Peter T., Badrichani A., Wu E., Freeman R., Ncube B., Ariki F., Daily J., Shimada Y., Murtagh M. Challenges in implementing CD4 testing in resource-limited settings. Cytometry B Clin. Cytom. 2008, 74(Suppl. 1):S123.
31. Rosen S., Fox M.P. Retention in HIV care between testing and treatment in sub-Saharan Africa: a systematic review. PLoS Med. 2011, 8:e1001056.
32. Scott L.E., Galpin J.S., Glencross D.K. Multiple method comparison: statistical model using percentage similarity. Cytometry B Clin. Cytom. 2003, 54:46.
33. Spacek L.A., Shihab H.M., Lutwama F., Summerton J., Mayanja H., Kamya M., Ronald A., Margolick J.B., Nilles T.L., Quinn T.C. Evaluation of a low-cost method, the Guava EasyCD4 assay, to enumerate CD4-positive lymphocyte counts in HIV-infected patients in the United States and Uganda. J. Acquir. Immune Defic. Syndr. 1999, 41:607.
34. Taiwo B.O., Murphy R.L. Clinical applications and availability of CD4+ T cell count testing in sub-Saharan Africa. Cytometry B Clin. Cytom. 2008, 74(Suppl. 1):S11.
35. Thakar M.R., Kumar B.K., Mahajan B.A., Mehendale S.M., Paranjape R.S. Comparison of capillary based microflurometric assay for CD4+ T cell count estimation with dual platform flow cytometry. AIDS Res. Ther. 2006, 3:26.
36. Vitoria M., Granich R., Gilks C.F., Gunneberg C., Hosseini M., Were W., Raviglione M., De Cock K.M. The global fight against HIV/AIDS, tuberculosis, and malaria: current status and future perspectives. Am. J. Clin. Pathol. 2009, 131:844.
37. WHO World Health Organization, UNAIDS, UNICEF. Towards universal access: scaling up priority HIV/AIDS interventions in the health sector-progress report 2009 2010, (In).
38. WHO World Health Organization. Antiretroviral therapy for HIV infection in adults and adolescents. Recommendations for a public health approach. 2010 Revision 2010, (In).
39. WHO World Health Organization, UNAIDS. The treatment 2.0 framework for action: catalysing the next phase of treatment, care and support 2011, (In).
40. WHO HIV/AIDS Diagnostic Technology Landscape 2012, (In). Second ed.
41. Yang Z.W., Yang S.H., Chen L., Qu J., Zhu J., Tang Z. Comparison of blood counts in venous, fingertip and arterial blood and their measurement variation. Clin. Lab. Haematol. 2001, 23:155.
42. Zachariah R., Reid S.D., Chaillet P., Massaquoi M., Schouten E.J., Harries A.D. Viewpoint: why do we need a point-of-care CD4 test for low-income countries?. Tropical Med. Int. Health 2011, 16:37.