{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,7,25]],"date-time":"2024-07-25T16:02:39Z","timestamp":1721923359044},"reference-count":48,"publisher":"Bentham Science Publishers Ltd.","issue":"1","license":[{"start":{"date-parts":[[2017,10,24]],"date-time":"2017-10-24T00:00:00Z","timestamp":1508803200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/legalcode"}],"content-domain":{"domain":["openaidsjournal.com","benthamopen.com"],"crossmark-restriction":true},"short-container-title":["TOAIDJ"],"published-print":{"date-parts":[[2017,10,24]]},"abstract":"<jats:sec><jats:title>Background:<\/jats:title><jats:p>The BD FACSPresto<jats:sup>\u2122<\/jats:sup>system uses capillary and venous blood to measure CD4 absolute counts (CD4), %CD4 in lymphocytes, and hemoglobin (Hb) in approximately 25 minutes. CD4 cell count is used with portable CD4 counters in resource-limited settings to manage HIV\/AIDS patients. A method comparison was performed using capillary and venous samples from seven clinical laboratories in five countries. The BD FACSPresto system was assessed for variability between laboratory, instrument\/operators, cartridge lots and within-run at four sites.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods:<\/jats:title><jats:p>Samples were collected under approved voluntary consent. EDTA-anticoagulated venous samples were tested for CD4 and %CD4 T cells using the gold-standard BD FACSCalibur<jats:sup>\u2122<\/jats:sup>system, and for Hb, using the Sysmex<jats:sup>\u00ae<\/jats:sup>KX-21N<jats:sup>\u2122<\/jats:sup>analyzer. Venous and capillary samples were tested on the BD FACSPresto system. Matched data was analyzed for bias (Deming linear regression and Bland-Altman methods), and for concordance around the clinical decision point. The coefficient of variation was estimated per site, instrument\/operator, cartridge-lot and between-runs.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results:<\/jats:title><jats:p>For method comparison, 93% of the 720 samples were from HIV-positive and 7% from HIV-negative or normal subjects. CD4 and %CD4 T cells venous and capillary results gave slopes within 0.96\u20131.05 and R<jats:sup>2<\/jats:sup>\u22650.96; Hb slopes were \u22651.00 and R<jats:sup>2<\/jats:sup>\u22650.89. Variability across sites\/operators gave %CV &lt;5.8% for CD4 counts, &lt;1.9% for %CD4 and &lt;3.2% for Hb. The total %CV was &lt;7.7% across instrument\/cartridge lot.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion:<\/jats:title><jats:p>The BD FACSPresto system provides accurate, reliable, precise CD4\/%CD4\/Hb results compared to gold-standard methods, irrespective of venous or capillary blood sampling. The data showed good agreement between the BD FACSPresto, BD FACSCalibur and Sysmex systems.<\/jats:p><\/jats:sec>","DOI":"10.2174\/1874613601711010076","type":"journal-article","created":{"date-parts":[[2017,10,27]],"date-time":"2017-10-27T07:39:17Z","timestamp":1509089957000},"page":"76-90","update-policy":"http:\/\/dx.doi.org\/10.2174\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["CD4 Lymphocyte Enumeration and Hemoglobin Assessment Aid for Priority Decisions: A Multisite Evaluation of the BD FACSPresto\u2122 System"],"prefix":"10.2174","volume":"11","author":[{"given":"Madhuri","family":"Thakar","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francis","family":"Angira","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kovit","family":"Pattanapanyasat","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alan H.B.","family":"Wu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maurice","family":"O\u2019Gorman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hui","family":"Zeng","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chenxue","family":"Qu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bharati","family":"Mahajan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kasama","family":"Sukapirom","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Danying","family":"Chen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yu","family":"Hao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yan","family":"Gong","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Monika De Arruda","family":"Indig","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sharon","family":"Graminske","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Diana","family":"Orta","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicole","family":"d\u2019Empaire","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Beverly","family":"Lu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Imelda","family":"Omana-Zapata","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Clement","family":"Zeh","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"965","reference":[{"key":"ref1","unstructured":"WHO, UNAIDS, UNICEF, Global HIV\/AIDS response. Epidemic update and health sector progress towards Universal Access. Progress Report 2011. Progress Report [Internet]. Available from: http:\/\/apps.who.int\/iris\/bitstream\/ 10665\/44787\/1\/9789241502986_eng.pdf 2011. 2017 Jan 10"},{"key":"ref2","doi-asserted-by":"publisher","unstructured":"Eholi\u00e9 SP, Aoussi FE, Ouattara IS, Bissagn\u00e9n\u00e9 E, Anglaret X. HIV treatment and care in resource-constrained environments: Challenges for the next decade. J Int AIDS Soc 2012; 15 (2) : 17334.","DOI":"10.7448\/IAS.15.2.17334"},{"key":"ref3","unstructured":"Center for Disease Control and Prevention. Revised Guidelines for Performning CD4+ T-Cell Determinations in Persons Infected with Human Immunodeficiency Virus (HIV) MMWR 1997; 46 (No. RR2) 10 January"},{"key":"ref4","doi-asserted-by":"publisher","unstructured":"Lawn SD, Myer L, Harling G, Orrell C, Bekker LG, Wood R. Determinants of mortality and nondeath losses from an antiretroviral treatment service in South Africa: Implications for program evaluation. Clin Infect Dis 2006; 43 (6) : 770-6.","DOI":"10.1086\/507095"},{"key":"ref5","doi-asserted-by":"publisher","unstructured":"Shearer WT, Rosenblatt HM, Gelman RS, et al. Lymphocyte subsets in healthy children from birth through 18 years of age: the Pediatric AIDS Clinical Trials Group P1009 study. J Allergy Clin Immunol 2003; 112 (5) : 973-80.","DOI":"10.1016\/j.jaci.2003.07.003"},{"key":"ref6","doi-asserted-by":"publisher","unstructured":"Denny T, Yogev R, Gelman R, et al. Lymphocyte subsets in healthy children during the first 5 years of life. JAMA 1992; 267 (11) : 1484-8.","DOI":"10.1001\/jama.1992.03480110060034"},{"key":"ref7","unstructured":"WHO. Guidelines on ART initiation for infants and children 2010."},{"key":"ref8","doi-asserted-by":"publisher","unstructured":"Faal M, Naidoo N, Glencross DK, Venter WD, Osih R. Providing immediate CD4 count results at HIV testing improves ART initiation. J Acquir Immune Defic Syndr 2011; 58 (3) : e54-9.","DOI":"10.1097\/QAI.0b013e3182303921"},{"key":"ref9","unstructured":"Antiretroviral therapy HIV infection in adults and adolescents Recommendations for a public health approach 2010 revision 2010."},{"key":"ref10","doi-asserted-by":"publisher","unstructured":"Mocroft A, Kirk O, Barton SE, et al. Anaemia is an independent predictive marker for clinical prognosis in HIV-infected patients from across Europe. EuroSIDA study group. AIDS 1999; 13 (8) : 943-50.","DOI":"10.1097\/00002030-199905280-00010"},{"key":"ref11","doi-asserted-by":"publisher","unstructured":"Jaggernath M, Naicker R, Madurai S, Brockman MA, Ndung\u2019u T, Gelderblom HC. Diagnostic Accuracy of the HemoCue Hb 301, STAT-Site MHgb and URIT-12 Point-of-Care Hemoglobin Meters in a Central Laboratory and a Community Based Clinic in Durban, South Africa. PLoS One 2016; 11 (4) : e0152184.","DOI":"10.1371\/journal.pone.0152184"},{"key":"ref12","doi-asserted-by":"publisher","unstructured":"Gunda DW, Kilonzo SB, Mpondo BC. Magnitude and correlates of moderate to severe anemia among adult HIV patients receiving first line HAART in Northwestern Tanzania: a cross sectional clinic based study. Pan Afr Med J 2016; 23 : 26.","DOI":"10.11604\/pamj.2016.23.26.8268"},{"key":"ref13","doi-asserted-by":"publisher","unstructured":"Sartorius BK, Chersich MF, Mwaura M, et al. Maternal anaemia and duration of zidovudine in antiretroviral regimens for preventing mother-to-child transmission: A randomized trial in three African countries. BMC Infect Dis 2013; 13 : 522.","DOI":"10.1186\/1471-2334-13-522"},{"key":"ref14","doi-asserted-by":"publisher","unstructured":"Pau AK, George JM. Antiretroviral therapy: current drugs. Infect Dis Clin North Am 2014; 28 (3) : 371-402.","DOI":"10.1016\/j.idc.2014.06.001"},{"key":"ref15","doi-asserted-by":"publisher","unstructured":"Paton NI, Sangeetha S, Earnest A, Bellamy R. The impact of malnutrition on survival and the CD4 count response in HIV-infected patients starting antiretroviral therapy. HIV Med 2006; 7 (5) : 323-30.","DOI":"10.1111\/j.1468-1293.2006.00383.x"},{"key":"ref16","unstructured":"CLSI. Measurement procedure comparison and bias estimation using patient samples; Approved guideline- Third edition. CLSI document EP09-A3 2013."},{"key":"ref17","unstructured":"CLSI. Assessment of the Diagnostic Accuracy of Laboratory Tests Using Received Operating Characteristic Curves; Approved Guideline- Second Edition. CLSI document EP24-A2 2011."},{"key":"ref18","unstructured":"CLSI. Evaluation of Precision Performance of Quantitative Measurement Procedures; Approved Guideline- Third Edition. CLSI document EP5-A3 2014."},{"key":"ref19","unstructured":"ICH. E6, International Conference on Harmonization: Good Clinical Practice: Consolidated 1996 (Published in the Federal Register 1997. May 9; 1997."},{"key":"ref20","unstructured":"CLSI. Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard \u2013 Sixth Edition. CLSI Document GP42-A6 2014."},{"key":"ref21","doi-asserted-by":"publisher","unstructured":"Thakar MR, Abraham PR, Arora S, et al. Establishment of reference CD4+ T cell values for adult Indian population. AIDS Res Ther 2011; 8 : 35.","DOI":"10.1186\/1742-6405-8-35"},{"key":"ref22","doi-asserted-by":"publisher","unstructured":"Angira F, Akoth B, Omolo P, et al. Clinical Evaluation of the BD FACSPresto\u2122 Near-Patient CD4 Counter in Kenya. PLoS One 2016; 11 (8) : e0157939.","DOI":"10.1371\/journal.pone.0157939"},{"key":"ref23","unstructured":"Deming W. Statistical adjustment of data 1985."},{"key":"ref24","doi-asserted-by":"publisher","unstructured":"Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986; 1 (8476) : 307-10.","DOI":"10.1016\/S0140-6736(86)90837-8"},{"key":"ref25","doi-asserted-by":"publisher","unstructured":"Linnet K. Estimation of the linear relationship between the measurements of two methods with proportional errors. Stat Med 1990; 9 (12) : 1463-73.","DOI":"10.1002\/sim.4780091210"},{"key":"ref26","doi-asserted-by":"crossref","unstructured":"Linnet K. Necessary sample size for method comparison studies based on regression analysis. Clin Chem 1999; 45 (6 Pt 1) : 882-94.","DOI":"10.1093\/clinchem\/45.6.882"},{"key":"ref27","doi-asserted-by":"publisher","unstructured":"Newcombe RG. Two-sided confidence intervals for the single proportion: comparison of seven methods. Stat Med 1998; 17 (8) : 857-72.","DOI":"10.1002\/(SICI)1097-0258(19980430)17:8<857::AID-SIM777>3.0.CO;2-E"},{"key":"ref28","unstructured":"FDA. Premarket assessment of pediatric medical devices. Premarket assessment of pediatric medical devices Guidance for Industry and Food and Drug Administration staff 2014."},{"key":"ref29","doi-asserted-by":"publisher","unstructured":"Palella FJ Jr, Deloria-Knoll M, Chmiel JS, et al. Survival benefit of initiating antiretroviral therapy in HIV-infected persons in different CD4+ cell strata. Ann Intern Med 2003; 138 (8) : 620-6.","DOI":"10.7326\/0003-4819-138-8-200304150-00007"},{"key":"ref30","doi-asserted-by":"publisher","unstructured":"Lundgren JD, Babiker AG, Gordin F, et al. Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection. N Engl J Med 2015; 373 (9) : 795-807.","DOI":"10.1056\/NEJMoa1506816"},{"key":"ref31","unstructured":"WHO. March 2014 Supplement to the 2013 Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection Recommendations for a public health approach 2014."},{"key":"ref32","unstructured":"Panel on Antiretroviral for Adult and Adolescents. Guideline for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents In 2014. Department of Health and Human Services. Section accessed 10 \/12\/2016"},{"key":"ref33","doi-asserted-by":"publisher","unstructured":"Thakar M, Mahajan B, Shaikh N, et al. Utility of the point of care CD4 analyzer, PIMA, to enumerate CD4 counts in the field settings in India. AIDS Res Ther 2012; 9 (1) : 26.","DOI":"10.1186\/1742-6405-9-26"},{"key":"ref34","doi-asserted-by":"publisher","unstructured":"Sukapirom K, Onlamoon N, Thepthai C, Polsrila K, Tassaneetrithep B, Pattanapanyasat K. Performance evaluation of the Alere PIMA CD4 test for monitoring HIV-infected individuals in resource-constrained settings. J Acquir Immune Defic Syndr 2011; 58 (2) : 141-7.","DOI":"10.1097\/QAI.0b013e31822866a2"},{"key":"ref35","doi-asserted-by":"publisher","unstructured":"Glencross DK, Coetzee LM, Faal M, et al. Performance evaluation of the Pima\u2122 point-of-care CD4 analyser using capillary blood sampling in field tests in South Africa. J Int AIDS Soc 2012; 15 (1) : 3.","DOI":"10.1186\/1758-2652-15-3"},{"key":"ref36","doi-asserted-by":"publisher","unstructured":"Gange SJ, Lau B, Phair J, Riddler SA, Detels R, Margolick JB. Rapid declines in total lymphocyte count and hemoglobin in HIV infection begin at CD4 lymphocyte counts that justify antiretroviral therapy. AIDS 2003; 17 (1) : 119-21.","DOI":"10.1097\/00002030-200301030-00016"},{"key":"ref37","doi-asserted-by":"publisher","unstructured":"Anastos K, Shi Q, French AL, et al. Total lymphocyte count, hemoglobin, and delayed-type hypersensitivity as predictors of death and AIDS illness in HIV-1-infected women receiving highly active antiretroviral therapy. J Acquir Immune Defic Syndr 2004; 35 (4) : 383-92.","DOI":"10.1097\/00126334-200404010-00008"},{"key":"ref38","doi-asserted-by":"publisher","unstructured":"Sitoe N, Luecke E, Tembe N, et al. Absolute and percent CD4+ T-cell enumeration by flow cytometry using capillary blood. J Immunol Methods 2011; 372 (1-2) : 1-6.","DOI":"10.1016\/j.jim.2011.07.008"},{"key":"ref39","doi-asserted-by":"publisher","unstructured":"Tembe N, Joaquim O, Alfai E, et al. Reference values for clinical laboratory parameters in young adults in Maputo, Mozambique. PLoS One 2014; 9 (5) : e97391.","DOI":"10.1371\/journal.pone.0097391"},{"key":"ref40","doi-asserted-by":"crossref","unstructured":"Schalk E, Heim MU, Koenigsmann M, Jentsch-Ullrich K. Use of capillary blood count parameters in adults. Vox Sang 2007; 93 (4) : 348-53.","DOI":"10.1111\/j.1423-0410.2007.00978.x"},{"key":"ref41","doi-asserted-by":"publisher","unstructured":"Jani IV, Sitoe NE, Alfai ER, et al. 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 (9802) : 1572-9.","DOI":"10.1016\/S0140-6736(11)61052-0"},{"key":"ref42","doi-asserted-by":"publisher","unstructured":"Fajardo E, Metcalf C, Piriou E, et al. Errors generated by a point-of-care CD4+ T-lymphocyte analyser: A retrospective observational study in nine countries. Bull World Health Organ 2015; 93 (9) : 623-30.","DOI":"10.2471\/BLT.14.146480"},{"key":"ref43","doi-asserted-by":"crossref","unstructured":"Tosato F, Bernardi D, Sanzari MC, Pantano G, Plebani M. Biological variability of lymphocyte subsets of human adults' blood. Clinica chimica acta; international journal of clinical chemistry 2013; 424 : 159-63.","DOI":"10.1016\/j.cca.2013.06.001"},{"key":"ref44","doi-asserted-by":"publisher","unstructured":"Gale HB, Gitterman SR, Hoffman HJ, et al. Is frequent CD4+ T-lymphocyte count monitoring necessary for persons with counts >=300 cells\/\u03bcL and HIV-1 suppression? Clin Infect Dis 2013; 56 (9) : 1340-3.","DOI":"10.1093\/cid\/cit004"},{"key":"ref45","doi-asserted-by":"publisher","unstructured":"Bekolo CE, Webster J, Batenganya M, Sume GE, Kollo B. Trends in mortality and loss to follow-up in HIV care at the Nkongsamba Regional hospital, Cameroon. BMC Res Notes 2013; 6 : 512.","DOI":"10.1186\/1756-0500-6-512"},{"key":"ref46","doi-asserted-by":"publisher","unstructured":"Girard PM, Nelson M, Mohammed P, Hill A, van Delft Y, Moecklinghoff C. Can we stop CD4+ testing in patients with HIV-1 RNA suppression on antiretroviral treatment? AIDS 2013; 27 (17) : 2759-63.","DOI":"10.1097\/01.aids.0000432458.98851.c1"},{"key":"ref47","doi-asserted-by":"publisher","unstructured":"Shubber Z, Calmy A, Andrieux-Meyer I, et al. Adverse events associated with nevirapine and efavirenz-based first-line antiretroviral therapy: A systematic review and meta-analysis. AIDS 2013; 27 (9) : 1403-12.","DOI":"10.1097\/QAD.0b013e32835f1db0"},{"key":"ref48","doi-asserted-by":"publisher","unstructured":"Vojnov L, Markby J, Boeke C, Harris L, Ford N, Peter T. POC CD4 Testing Improves Linkage to HIV Care and Timeliness of ART Initiation in a Public Health Approach: A Systematic Review and Meta-Analysis. PLoS One 2016; 11 (5) : e0155256.","DOI":"10.1371\/journal.pone.0155256"}],"container-title":["The Open AIDS Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/openaidsjournal.com\/contents\/volumes\/V11\/TOAIDJ-11-76\/TOAIDJ-11-76.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/openaidsjournal.com\/contents\/volumes\/V11\/TOAIDJ-11-76\/TOAIDJ-11-76.xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/openaidsjournal.com\/contents\/volumes\/V11\/TOAIDJ-11-76\/TOAIDJ-11-76.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,10,20]],"date-time":"2020-10-20T16:28:13Z","timestamp":1603211293000},"score":1,"resource":{"primary":{"URL":"https:\/\/openaidsjournal.com\/VOLUME\/11\/PAGE\/76\/"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,10,24]]},"references-count":48,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2017,10,24]]}},"alternative-id":["TOAIDJ-11-76"],"URL":"https:\/\/doi.org\/10.2174\/1874613601711010076","relation":{},"ISSN":["1874-6136"],"issn-type":[{"value":"1874-6136","type":"print"}],"subject":[],"published":{"date-parts":[[2017,10,24]]},"assertion":[{"value":"Peer Reviewed","order":0,"name":"review_status","label":"Review Status","group":{"name":"peer_review_details","label":"Peer Review Details"}},{"value":"Single blind","order":1,"name":"review_process","label":"Review Process","group":{"name":"peer_review_details","label":"Peer Review Details"}},{"value":"Checked with iThenticate","order":0,"name":"screening_status","label":"Screening Status","group":{"name":"plagiarism_screening","label":"Plagiarism Screening"}},{"value":"2017-05-05","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2017-09-19","order":1,"name":"revised","label":"Revised","group":{"name":"publication_history","label":"Publication History"}},{"value":"2017-09-21","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2017-10-24","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}