Literature DB >> 17638858

Diagnostic accuracy and clinical utility of a simplified low cost method of counting CD4 cells with flow cytometry in Malawi: diagnostic accuracy study.

Calman A MacLennan1, Michael K P Liu, Sarah A White, Joep J G van Oosterhout, Felanji Simukonda, Joseph Bwanali, Michael J Moore, Eduard E Zijlstra, Mark T Drayson, Malcolm E Molyneux.   

Abstract

OBJECTIVES: To assess the diagnostic accuracy and clinical utility of a simplified low cost method for measuring absolute and percentage CD4 counts with flow cytometry.
DESIGN: A CD4 counting method (Blantyre count) using a CD4 and CD45 antibody combination with reduced blood and reagent volumes. Diagnostic accuracy was assessed by measuring agreement of the index test with two other assays (TruCount and FACSCount). Clinical utility was investigated by comparing CD4 counts with the new assay with WHO clinical staging in patients with HIV.
SETTING: Research laboratories and antiretroviral therapy clinic at a medical school and large government hospital in southern Malawi. PARTICIPANTS: Assay comparisons were performed on consecutive blood samples sent for CD4 counting from 129 patients with HIV. Comparison of CD4 count with staging was conducted on 253 consecutive new patients attending the antiretroviral therapy clinic. MAIN OUTCOME MEASURES: Limits of agreement with 95% confidence intervals between index test and reference standards.
RESULTS: The limits of agreement for Blantyre count and TruCount were excellent (cell count -48.9 to 27.0 x10(9)/l for absolute counts in the CD4 range <400x10(9)/l and -2.42% to 2.37% for CD4 percentage). The assay was affordable with reagent costs per test of $0.44 ( pound0.22, euro0.33) for both absolute count and CD4 percentage, and $0.11 for CD4 percentage alone. Of 193 patients with clinical stage I or II disease, who were ineligible for antiretroviral therapy by clinical staging criteria, 73 (38%) had CD4 counts <200x10(9)/l. By contrast, 12 (20%) of 60 patients with stage III or IV disease had CD4 counts >350x10(9)/l.
CONCLUSIONS: This simplified method of counting CD4 cells with flow cytometry has good agreement with established commercial assays, is affordable for routine clinical use in Africa, and could improve clinical decision making in patients with HIV.

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Year:  2007        PMID: 17638858      PMCID: PMC1934500          DOI: 10.1136/bmj.39268.719780.BE

Source DB:  PubMed          Journal:  BMJ        ISSN: 0959-8138


  21 in total

1.  Evaluation of TruCount absolute-count tubes for determining CD4 and CD8 cell numbers in human immunodeficiency virus-positive adults. Site Investigators and The NIAID DAIDS New Technologies Evaluation Group.

Authors:  C T Schnizlein-Bick; J Spritzler; C L Wilkening; J K Nicholson; M R O'Gorman
Journal:  Clin Diagn Lab Immunol       Date:  2000-05

2.  Affordable CD4+ T cell counts by flow cytometry. II. The use of fixed whole blood in resource-poor settings.

Authors:  V Jani; G Janossy; A Iqbal; F S Mhalu; E F Lyamuya; G Biberfeld; D K Glencross; L Scott; J T Reilly; V Granger; D Barnett
Journal:  J Immunol Methods       Date:  2001-11-01       Impact factor: 2.303

3.  Affordable CD4(+) T-cell counts on 'single-platform' flow cytometers I. Primary CD4 gating.

Authors:  G Janossy; I Jani; W Göhde
Journal:  Br J Haematol       Date:  2000-12       Impact factor: 6.998

4.  Use of CD45 gating in three and four-color flow cytometric immunophenotyping: guideline from the National Institute of Allergy and Infectious Diseases, Division of AIDS.

Authors:  Carol T Schnizlein-Bick; Francis F Mandy; Maurice R G O'Gorman; Helene Paxton; Janet K A Nicholson; Lance E Hultin; Rebecca S Gelman; Cynthia L Wilkening; Daniella Livnat
Journal:  Cytometry       Date:  2002-04-15

5.  Targeting CD4 testing to a clinical subgroup of patients could limit unnecessary CD4 measurements, premature antiretroviral treatment and costs in Thyolo District, Malawi.

Authors:  R Zachariah; R Teck; O Ascurra; P Humblet; A D Harries
Journal:  Trans R Soc Trop Med Hyg       Date:  2005-09-30       Impact factor: 2.184

Review 6.  Cytofluorometric methods for assessing absolute numbers of cell subsets in blood. European Working Group on Clinical Cell Analysis.

Authors:  B Brando; D Barnett; G Janossy; F Mandy; B Autran; G Rothe; B Scarpati; G D'Avanzo; J L D'Hautcourt; R Lenkei; G Schmitz; A Kunkl; R Chianese; S Papa; J W Gratama
Journal:  Cytometry       Date:  2000-12-15

7.  Impact of the international program for Quality Assessment and Standardization for Immunological Measures Relevant to HIV/AIDS: QASI.

Authors:  Francis Mandy; Michèle Bergeron; Guy Houle; John Bradley; John Fahey
Journal:  Cytometry       Date:  2002-04-15

8.  Quality control of CD4+ T-lymphocyte enumeration: results from the last 9 years of the United Kingdom National External Quality Assessment Scheme for Immune Monitoring (1993-2001).

Authors:  Liam Whitby; Viv Granger; Ian Storie; Karen Goodfellow; Alex Sawle; John T Reilly; David Barnett
Journal:  Cytometry       Date:  2002-04-15

9.  CD45-assisted PanLeucogating for accurate, cost-effective dual-platform CD4+ T-cell enumeration.

Authors:  Deborah Glencross; Lesley E Scott; Ilesh V Jani; David Barnett; George Janossy
Journal:  Cytometry       Date:  2002-04-15

10.  Successful implementation of a low-cost method for enumerating CD4+ T lymphocytes in resource-limited settings: the ANRS 12-26 study.

Authors:  Serge Diagbouga; Corine Chazallon; Michel D Kazatchkine; Philippe Van de Perre; André Inwoley; Souleymane M'Boup; Mireille Prince David; Aoua Thiéro Ténin; Robert Soudré; Jean-Pierre Aboulker; Laurence Weiss
Journal:  AIDS       Date:  2003-10-17       Impact factor: 4.177

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  9 in total

1.  Technological challenges in diagnosis and management of HIV infection in resource limited settings.

Authors:  Purnima Madhivanan; Karl Krupp
Journal:  BMJ       Date:  2007-07-28

2.  CD4 Count Pattern and Demographic Distribution of Treatment-Naïve HIV Patients in Lagos, Nigeria.

Authors:  Akinsegun Akinbami; Adedoyin Dosunmu; Adewumi Adediran; Sarah Ajibola; Olajumoke Oshinaike; Kikelomo Wright; Olanrewaju Arogundade
Journal:  AIDS Res Treat       Date:  2012-09-26

3.  Normal Range of CD4 Cell Counts and Temporal Changes in Two HIVNegative Malawian Populations.

Authors:  A C Crampin; F D Mwaungulu; L R Ambrose; H Longwe; N French
Journal:  Open AIDS J       Date:  2011-08-10

4.  The effects of setarud on the immunological status of HIV-positive patients: Efficacy of a novel multi-herbal drug.

Authors:  Mehdi Gholamzadeh Baeis; Ghasem Amiri; Mojtaba Miladinia
Journal:  Avicenna J Phytomed       Date:  2017 May-Jun

5.  Leukocyte counts and lymphocyte subsets in relation to pregnancy and HIV infection in Malawian women.

Authors:  Wilson L Mandala; Esther N Gondwe; Malcolm E Molyneux; Jenny M MacLennan; Calman A MacLennan
Journal:  Am J Reprod Immunol       Date:  2017-04-06       Impact factor: 3.886

6.  Lymphocyte subsets in healthy Malawians: implications for immunologic assessment of HIV infection in Africa.

Authors:  Wilson L Mandala; Jenny M MacLennan; Esther N Gondwe; Steven A Ward; Malcolm E Molyneux; Calman A MacLennan
Journal:  J Allergy Clin Immunol       Date:  2009-11-26       Impact factor: 10.793

7.  Comparison of two methodologies for CD4⁺ T lymphocytes relative counting on immune monitoring of patients with human immunodeficiency virus.

Authors:  Danielle Cristyane Kalva Borato; Emerson Carraro; Sônia Regina Weber Ribas; Carlos Augusto Kalva-Filho; José Carlos Rebuglio Vellosa
Journal:  ScientificWorldJournal       Date:  2012-11-28

8.  Interlaboratory comparison of the TransFix®/EDTA Vacuum Blood Collection tube with the 5 mL Cyto-Chex® BCT.

Authors:  Daniel Harrison; Rosalie Ward; Sarah Bastow; Andrew Parr; Susan Macro; Paul K Wallace
Journal:  Cytometry B Clin Cytom       Date:  2018-10-24       Impact factor: 3.248

9.  Affordable pediatric CD4 counting by flow cytometry in Malawi.

Authors:  Calman A Maclennan; Felix Dzumani; Alinane Namarika; Peter Moons; Edward Senga; Malcolm E Molyneux; Mark T Drayson; James E G Bunn
Journal:  Cytometry B Clin Cytom       Date:  2008       Impact factor: 3.058

  9 in total

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