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Table 4 Sensitivity and specificity of CD4 T cell counting by the Muse™ Auto CD4/CD4% system to identify patients having less than (or more than) 200, 350, 750 CD4 T cells/µl and 25 %CD4+, calculated on the 150 available CD4 T cell count measurements, including the reference results obtained by BD FACSCount

From: Performance evaluation of the touchscreen-based Muse™ Auto CD4/CD4% single-platform system for CD4 T cell numeration in absolute number and in percentage using blood samples from children and adult patients living in the Central African Republic

  Sensitivitya (%) Specificitya (%) Cohen’s κ coefficient$
Thresholds
200 CD4 T cells/μl* 96.7 100 0.98
350 CD4 T cells/μl** 100 100 1.00
750 CD4 T cells/μl*** 100 83.9 0.89
25 %CD4+*** 95.5 100 0.95
  1. * 200 CD4 T cells/µl: threshold of immune-restauration under antiretroviral treatment and the threshold for therapeutic initiation according to the 2006-revised WHO recommendations [28]
  2. ** 350 CD4 T cells/µl: WHO threshold for antiretroviral treatment initiation in adults and children aged more than 5 years according to the 2010-revised WHO guidelines [29] and threshold for antiretroviral treatment initiation as a priority for adults, adolescents (10–19 years old) and children aged more than 5 years according to the 2015-revised WHO guidelines [6] and to the 2016-consolidated WHO guidelines [7]
  3. *** 750 CD4 T cells/µl and 25 %CD4+: absolute and percent CD4 T cell count 2010-revised WHO thresholds for antiretroviral treatment initiation in children aged between 24 and 59 months [29] and thresholds for antiretroviral treatment initiation as a priority for children aged more than 2 years and less than 5 years according to the 2015-revised WHO guidelines [6] and to the 2016-consolidated WHO guidelines [7]
  4. $A 10% bilateral range (i.e., counts between 190 and 210 CD4 T cells/μl for the threshold at 200 CD4 T cells/μl; counts between 332 and 367 CD4 T cells/μl for the threshold at 350 CD4 T cells/μl; counts between 712 and 787 CD4 T cells/μl for the threshold at 750 CD4 T cells/μl; and counts 23.7 and 26.2 %CD4+ for the threshold at 25 %CD4+) was considered similar
  5. aThe sensitivity and specificity of CD4 T cell counting by the Muse™ Auto CD4/CD4% system to identify patients having less than (or more than) 200 CD4 T cells/µl and 350 CD4 T cells/µl, were calculated on the 150 available CD4 T cell count measurements from infants, children, adolescents and adults