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CD4-T cell enumeration in human immunodeficiency virus (HIV)-infected patients: A laboratory performance evaluation of Muse Auto CD4/CD4% system by World Health Organization prequalification of in vitro diagnostics.
Ceulemans, Ann; Bouzahzah, Chaymae; Prat, Irena; Urassa, Willy; Kestens, Luc.
Afiliação
  • Ceulemans A; Laboratory of Immunology, Department of Biomedical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
  • Bouzahzah C; Laboratory of Immunology, Department of Biomedical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
  • Prat I; World Health Organization (WHO), Geneva, Switzerland.
  • Urassa W; World Health Organization (WHO), Geneva, Switzerland.
  • Kestens L; Laboratory of Immunology, Department of Biomedical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
PLoS One ; 14(1): e0209677, 2019.
Article em En | MEDLINE | ID: mdl-30673713
BACKGROUND: CD4 T-cell counts are still widely used to assess treatment eligibility and follow-up of HIV-infected patients. The World Health Organization (WHO) prequalification of in vitro diagnostics requested a manufacturer independent laboratory evaluation of the analytical performance at the Institute of Tropical Medicine (ITM) Antwerp, Belgium, of the Muse Auto CD4/CD4% system (Millipore), a new small capillary-flow cytometer dedicated to count absolute CD4-T cells and percentages in venous blood samples from HIV-infected patients. METHODS: Two hundred and fifty (250) patients were recruited from the HIV outpatient clinic at ITM. Accuracy and precision of CD4 T cell counting on fresh EDTA anticoagulated venous blood samples were assessed in the laboratory on a Muse Auto CD4/CD4% system. Extensive precision analyses were performed both on fresh blood and on normal and low stabilized whole blood controls. Accuracy ((bias) was assessed by comparing results from Muse CD4/CD4% to the reference (single-platform FACSCalibur). Clinical misclassification was measured at 500, 350, 200 and 100 cells/µL thresholds. RESULTS: Intra-assay precision was < 5%, and inter-assay was < 9%. CD4 T cell counts measured on Muse Auto CD4/CD4% System and on the reference instrument resulted in regression slopes of 0.97 for absolute counts and 1.03 for CD4 T cell percentages and a correlation coefficient of 0.99 for both. The average absolute bias as compared to the reference was negligible (4 cells/µL or 0.5%). The absolute average bias on CD4 T cell percentages was < 1%. Clinical misclassification at different CD4 T cell thresholds was small resulting in sensitivities and specificities equal or >90% at all thresholds except at 100 cells/µL (sensitivity = 87%). All samples could be analyzed as there was no repetitive rejection errors recorded. CONCLUSIONS: The Muse Auto CD4/CD4% System performed very well on fresh venous blood samples and met all WHO acceptance criteria for analytical performance of CD4 technologies.
Assuntos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Linfócitos T CD4-Positivos / Infecções por HIV Idioma: En Ano de publicação: 2019 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Linfócitos T CD4-Positivos / Infecções por HIV Idioma: En Ano de publicação: 2019 Tipo de documento: Article