Whole Blood Capcellia CD4/CD8 Immunoassay for Enumeration of CD4+ and CD8+ Peripheral T Lymphocytes

Carrière, D.; Vendrell, Jean-François; Claude, Fontaine; Jansen, Aline; Reynes, Jacques; Pages, Isabelle; Holzmann, Catherine; Laprade, Michel; Pau, Bernard

doi:10.1093/clinchem/45.1.92

Cited by 21 publications

(7 citation statements)

References 10 publications

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“…It appears that this assay was affected by soluble CD4 molecules in the serum and by a high background bias. Finally, the Zynaxis Zymmune CD4/CD8 (145,154,158), the Pasteur-Sanofi Capcellia CD4/CD8 (159,160), and the DuPont Medical CD4-CCS kit were labor-intensive assays with a limited throughput, which suffered from design simplification by assuming that CD4 expression by monocytes does not interfere.…”

Section: Noncytometric Methodsmentioning

confidence: 99%

Cytofluorometric methods for assessing absolute numbers of cell subsets in blood

et al. 2000

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The enumeration of absolute levels of cells and their subsets in clinical samples is of primary importance in human immunodeficiency virus (HIV)؉ individuals (CD4؉ T-lymphocyte enumeration), in patients who are candidates for autotransplantation (CD34؉ hematopoietic progenitor cells), and in evaluating leukoreduced blood products (residual white blood cells). These measurements share a number of technical options, namely, single-or multiple-color cell staining and logical gating strategies. These can be accomplished using single-or dual-platform counting technologies employing cytometric methods. Dual-platform counting technologies couple the percentage of positive cell subsets obtained by cytometry and the absolute cell count obtained by automated hematology analyzers to derive the absolute value of such subsets. Despite having many conceptual and technical limitations, this approach is traditionally considered as the reference method for absolute cell count enumeration. As a result, the development of single-platform technologies has recently attracted attention with several different technical approaches now being readily available. These single-platform approaches have less sources of variability. A number of reports clearly demonstrate that they provide better coefficients of variation (CVs) in multicenter studies and a lower chance to generate aberrant results. These methods are therefore candidates for the new gold standard for absolute cell assessments. The currently available technical options are discussed in this review together with the results of some cross-comparative studies. Each analytical system has its own specific requirements as far as the dispensing precision steps are concerned. The importance of precision reverse pipetting is emphasized. Issues still under development include the establishment of the critical error ranges, which are different in each test setting, and the applicability of simplified low-cost techniques to be used in countries with limited resources. Cytometry (Comm. Clin. Cytometry) 42:327-346, 2000.

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Section: Noncytometric Methodsmentioning

confidence: 99%

Cytofluorometric methods for assessing absolute numbers of cell subsets in blood

et al. 2000

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“…14 Smaller instruments like the Guava EasyCD4 offer limited improvements and have not been widely adopted. Non-cytofluoro-graphic methods, including ELISA format 15 and bead format assays 16,17 have been suggested as useful alternatives for CD4+ T lymphocyte quantification, since these methods require less equipment and have lower reagent costs than flow cytometry. However, they have much lower throughput, are more labour-intensive and less accurate, and are not widely used or recommended by World Health Organization guidelines.…”

Section: Introductionmentioning

confidence: 99%

A microfluidic device for practical label-free CD4+ T cell counting of HIV-infected subjects

et al. 2007

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Practical HIV diagnostics are urgently needed in resource-limited settings. While HIV infection can be diagnosed using simple, rapid, lateral flow immunoassays, HIV disease staging and treatment monitoring require accurate counting of a particular white blood cell subset, the CD4(+) T lymphocyte. To address the limitations of current expensive, technically demanding and/or time-consuming approaches, we have developed a simple CD4 counting microfluidic device. This device uses cell affinity chromatography operated under differential shear flow to specifically isolate CD4(+) T lymphocytes with high efficiency directly from 10 microliters of unprocessed, unlabeled whole blood. CD4 counts are obtained under an optical microscope in a rapid, simple and label-free fashion. CD4 counts determined in our device matched measurements by conventional flow cytometry among HIV-positive subjects over a wide range of absolute CD4 counts (R(2) = 0.93). This CD4 counting microdevice can be used for simple, rapid and affordable CD4 counting in point-of-care and resource-limited settings.

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“…Immunoassay detection technology can be divided into direct analysis and indirect analysis. , The traditional immunoassay method is based on the double antibody sandwich principle to directly assay CD4 cells. ,,, Carinelli et al developed an electrochemical immunoassay to directly detect CD4 cells, which first isolated CD4 cells from whole blood by magnetic separation and then performed electrochemical analysis. , The Burnet Institute and the Omega Diagnostics Group jointly reported a colloidal gold immunochromatographic strip used for rough estimation of CD4 cell numbers, which is easy to operate, fast to detect, and the reagent does not require cold storage . The field performance and diagnostic accuracy of the colloidal gold immunochromatographic strip were evaluated, which demonstrated excellent specificity and sensitivity .…”

Section: Resultsmentioning

confidence: 99%

A Rapid, Simple, and Low-Cost CD4 Cell Count Sensor Based on Blocking Immunochromatographic Strip System

Xiao¹,

Xiao²,

Yao³

et al. 2019

ACS Sens.

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The counting of CD4 + T lymphocytes (CD4 cells) is a critical test for evaluating the immune function of HIV-infected peoples and tumor patients. A rapid, simple, accurate, and low-cost CD4 cell counting method as a diagnostic tool is increasingly required in the clinic. We designed and developed a novel fluorescent immunochromatographic strips (ICS) system based on the blocking principle for counting CD4 cells. The strategy of this system is to count CD4 cells indirectly, by measuring the free CD4 antibodies that were not bound by CD4 cells. The fluorescent antibodies bound to CD4 cells were blocked at the filter pads, resulting in a decrease in fluorescence of free CD4 antibodies measured. The number of CD4 cells was inversely related to the fluorescence intensity. The CD4 count-ICSs exhibited a quasilinear response (R 2 = 0.96) to logarithmic CD4 cell concentrations in PBMC samples in the range of 50−1000 cells/μL. In addition, the CD4 count-ICSs reliably quantified CD4 cells in whole blood samples, where the assay exhibited a linear correlation (R 2 = 0.976) readout for CD4 cell concentrations ranging from 100 to 800 cells/μL. To validate the clinical applicability of this method, 54 blood samples were measured: the detection results showed a high correlation (R 2 > 0.97) with the flow cytometry (FCM) analysis. The fluorescent ICSs can be used to count CD4 cells in blood samples, which have a high coincidence rate with FCM analysis; therefore, the CD4 count ICS system is an excellent candidate method for CD4 cell counting in resource-limited settings.

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Whole Blood Capcellia CD4/CD8 Immunoassay for Enumeration of CD4+ and CD8+ Peripheral T Lymphocytes

Cited by 21 publications

References 10 publications

Cytofluorometric methods for assessing absolute numbers of cell subsets in blood

Cytofluorometric methods for assessing absolute numbers of cell subsets in blood

A microfluidic device for practical label-free CD4+ T cell counting of HIV-infected subjects

A Rapid, Simple, and Low-Cost CD4 Cell Count Sensor Based on Blocking Immunochromatographic Strip System

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