Evaluation of PIMA™® Point of Care Technology for CD4 T Cell Enumeration in Kenya

Mwau, Matilu; Adungo, Ferdinard; Kadima, Silvia; Njagi, Ephantus; Kirwaye, Carolyne; Abubakr, Najma Salim; Okubi, Lucy; Waihenya, Mary; Lusike, Judi; Hungu, Jackson

doi:10.1371/journal.pone.0067612

Cited by 32 publications

(38 citation statements)

References 23 publications

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“…This is in line with the results of previous studies that showed excellent instrumental precision with mean %CV of <5% reflecting the significant contribution of operators to the %CV 20,22. The Pima CD4 results using venous blood showed acceptable correlation and agreement with the FACSCalibur results, similar to those reported by previous studies20–23,26,46 and partially in agreement with the study by Mwau et al47 in Kenya, comparing Pima CD4 with FACSCount. Mwau et al47 obtained discordant results comparing Pima CD4 with FACSCalibur but concordant results comparing Pima CD4 with FACSCount.…”

Section: Discussionsupporting

confidence: 92%

“…The Pima CD4 results using venous blood showed acceptable correlation and agreement with the FACSCalibur results, similar to those reported by previous studies20–23,26,46 and partially in agreement with the study by Mwau et al47 in Kenya, comparing Pima CD4 with FACSCount. Mwau et al47 obtained discordant results comparing Pima CD4 with FACSCalibur but concordant results comparing Pima CD4 with FACSCount. This discrepancy could be because of less reliable results generated by the FACSCalibur used, which showed a substantial absolute bias (LOA) against the FACSCount of −76.5 cells per microliter (−316 to 163).…”

Section: Discussionsupporting

confidence: 91%

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WHO Multicenter Evaluation of FACSCount CD4 and Pima CD4 T-Cell Count Systems

Wade

Daneau

Aboud

et al. 2014

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 91%

WHO Multicenter Evaluation of FACSCount CD4 and Pima CD4 T-Cell Count Systems

Wade

Daneau

Aboud

et al. 2014

JAIDS Journal of Acquired Immune Deficiency Syndromes

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“…For a count of 200 cells/mm 3 , 29 cells represents 14.5%. The precision of Pima CD4 was in line with the CV of 10.3% found in the study conducted in Kenya by Mwau and colleagues [34].…”

Section: Discussionsupporting

confidence: 88%

“…Moreover, a recent study in Kenya showed lower performance than our [34]. The influence of different operators (2 to 9 sites) [31] and the use of capillary blood to determine the sensibility and specificity may explain the lower performance of Pima CD4 when compared to FACSCount or when compared to CyFlow SL3 [34].…”

Section: Discussionmentioning

confidence: 58%

CD4 T-Cell Enumeration in a Field Setting: Evaluation of CyFlow Counter Using the CD4 Easy Count Kit-Dry and Pima CD4 Systems

et al. 2013

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BackgroundFlow Cytometry (FCM) is still considered to be the method of choice for accurate CD4 enumeration. However, the use of FCM in developing countries is problematic due to their cost and complexity. Lower-cost technologies have been introduced. We evaluated CyFlow Counter together with its lyophilized reagents, and Pima CD4 in high-temperature area, using FACSCount as reference.Materials and MethodsWhole blood samples were consecutively collected by venipuncture from 111 HIV+ patients and 17 HIV-negative donors. CD4 T-cell enumeration was performed on CyFlow Counter, Pima CD4 and FACSCount.ResultsCyFlow Counter and Pima CD4 systems showed good correlation with FACSCount (slope of 0.82 and 0.90, and concordance ρc of 0.94 and 0.98, respectively). CyFlow Counter showed absolute or relative biases (LOA) of −63 cells/mm3 (−245 to 120) or −9.8% (−38.1 to 18.4) respectively, and Pima CD4 showed biases (LOA) of −30 cells/mm3 (−160 to 101) or −3.5% (−41.0 to 33.9%). CyFlow Counter and Pima CD4 showed respectively 106.7% and 105.9% of similarity with FACSCount. According to WHO-2010 ART initiation threshold of 350 cells/mm3, CyFlow Counter and Pima CD4 showed respectively sensibility of 100% and 97%, and specificity of 91% and 93%. CyFlow Counter and Pima CD4 were strongly correlated (slope of 1.09 and ρc of 0.95). These alternative systems showed good agreement with bias of 33 cells/mm3 (−132 to 203) or 6.3% (−31.2 to 43.8), and similarity of 104.3%.ConclusionCyFlow Counter using CD4 easy count kit-dry and Pima CD4 systems can accurately provide CD4 T-cell counts with acceptable agreement to those of FACSCount.

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“…These POC have been dedicated to the clinical team, especially when the number of patients is not too high [10][11][12].…”

Section: Introductionmentioning

confidence: 99%

Evaluation of Three Medium Throughput Flow Cytometers for Monitoring People Living with HIV in Resources Limited Laboratories: How to Choose?

Inwoley¹,

Adiko²,

Kabran³

et al. 2017

J immuno Biol

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Objective: Absolute and percentage CD4+ T-lymphocytes counts are useful in monitoring people living with HIV. In spite of point-of-care development, CD4 testing in some laboratories of resources-limited countries still use flow cytometers from many manufacturers. We evaluated three flow cytometers (FACSCOUNT CD4/CD4%, GUAVA Auto CD4/CD4%, CYFLOW Counter® CD4/CD4%) and brought out choice criteria according to laboratory resources.Methods: CD4 percent and absolute count obtained with 180 HIV-infected patients (adults and children) with evaluated platforms (FACSCOUNT CD4/CD4%, GUAVA Auto CD4/CD4%, CYFLOW Counter CD4/CD4%) were compared with those provided by FACSCalibur TruCount®. Agreement was analyzed using Bland-Altman analysis. We also carried out a Comparative analysis of technical and operational characteristics to identify strengths and weaknesses of each tested cytometer. Results:The median CD4 percentage and absolute count obtained with FACSCOUNT and CYFLOW were similar to those of FACSCALIBUR. By contrast, GUAVA showed higher values. Bland-Altman analysis did not show measurement error. However, GUAVA and CYFLOW gave a relative high bias with mean difference respectively -69 and +27CD4 cells/μl. The overall bias of CD4 percentage were >5% for the evaluated cytometers. There was a good interclass agreement (Kappa ≥ 0.78) and good measurement precision (coefficient of variation <10%) with the 3 cytometers. Only FACSCOUNT showed good stability (CV<5%) even for stained and unstained samples within 24 and 48 hours after blood collection. FACSCOUNT, GUAVA and CYFLOW have good technical performances. Conclusion:Though we found differences in their operational characteristics, it appears very important to know how to use these kinds of cytometers before making a choice for peripheral laboratory in limited-resources countries.

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Evaluation of PIMA™® Point of Care Technology for CD4 T Cell Enumeration in Kenya

Cited by 32 publications

References 23 publications

WHO Multicenter Evaluation of FACSCount CD4 and Pima CD4 T-Cell Count Systems

WHO Multicenter Evaluation of FACSCount CD4 and Pima CD4 T-Cell Count Systems

CD4 T-Cell Enumeration in a Field Setting: Evaluation of CyFlow Counter Using the CD4 Easy Count Kit-Dry and Pima CD4 Systems

Evaluation of Three Medium Throughput Flow Cytometers for Monitoring People Living with HIV in Resources Limited Laboratories: How to Choose?

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