title: Performance Evaluation of the MyT4 Technology for Determining ART Eligibility.
abstract: BACKGROUND
  In resource-limited countries, CD4 T-cell (CD4) testing continues to be used for determining antiretroviral therapy (ART) initiation eligibility and opportunistic infection monitoring. To support expanded access to CD4 testing, simple and robust technologies are necessary. We conducted this study to evaluate the performance of a new Point-of-Care (POC) CD4 technology, the MyT4, compared to conventional laboratory CD4 testing.
  
  
  METHODS
  EDTA venous blood from 200 HIV-positive patients was tested in the laboratory using the MyT4 and BD FACSCalibur™.
  
  
  RESULTS
  The MyT4 had an r2 of 0.82 and a mean bias of 12.3 cells/μl. The MyT4 had total misclassifications of 14.7% and 8.8% when analyzed using ART eligibility thresholds of 350 and 500 cells/μl, respectively.
  
  
  CONCLUSIONS
  We conclude that the MyT4 performed well in classifying patients using the current ART initiation eligibility thresholds in Mozambique when compared to the conventional CD4 technology.
authors: Instituto Nacional de Saúde, Maputo, Mozambique.
authors: Nádia
authors: http://orcid.org/0000-0001-7310-8221
authors: N
authors: Sitoe
authors: Instituto Nacional de Saúde, Maputo, Mozambique.
authors: Rosa
authors: R
authors: Macamo
authors: Instituto Nacional de Saúde, Maputo, Mozambique.
authors: Bindiya
authors: B
authors: Meggi
authors: Clinton Health Access Initiative, Maputo, Mozambique.
authors: Ocean
authors: O
authors: Tobaiwa
authors: Clinton Health Access Initiative, Maputo, Mozambique.
authors: Osvaldo
authors: O
authors: Loquiha
authors: Clinton Health Access Initiative, Maputo, Mozambique.
authors: Timothy
authors: T
authors: Bollinger
authors: Clinton Health Access Initiative, Maputo, Mozambique.
authors: Lara
authors: L
authors: Vojnov
authors: Instituto Nacional de Saúde, Maputo, Mozambique.
authors: Ilesh
authors: I
authors: Jani
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018791:CD4 Lymphocyte Count / Q000295:instrumentation*; D002648:Child; D002675:Child, Preschool; D003430:Cross-Sectional Studies; D004608:Eligibility Determination; D005260:Female; D015658:HIV Infections / Q000276:immunology*; D006679:HIV Seropositivity; D006801:Humans; D008297:Male; D008875:Middle Aged; D009073:Mozambique; D019095:Point-of-Care Systems; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D055815:Young Adult