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Table 3 Primary health care clinic field testing using capillary blood

From: Performance evaluation of the Pima™ point-of-care CD4 analyser using capillary blood sampling in field tests in South Africa

PHASE III

Rural clinic Pima™ (3 sites)

versus Predicate (Phase IIIA)

Inner-city clinic Pima™ (1 site)

versus Predicate (Phase IIIB)

 

PREDICATE

Pima™

PREDICATE

Pima™

Lancet 1

(Sarsedt)

PREDICATE

Pima™

Lancet 2

(Caralet Blue)

N

96

96

87

87

52

52

Range of CD4 counts*

2 - 1871

31 - 2747

2 - 1604

1 - 1358

3 - 966

2 - 968

Mean CD4 count*(median)

617.5

(492.0)

719.4

(677.5)

350

(302.0)

359.0

(305.0)

268.4

(255.5)

257.2

(238.0)

% Similarity to Predicate

( %SIM Mean ± SD)

114.8% ± 32.6

101.4% ± 10.1

98.6% ± 11.2

%SIM CV #

28.4%CV

10.0%

11.3%

BA bias* ± 1 STDev

(PIMA - PLG)

(95% CI of bias mean)

+105.7 ± 225.4

(60.1 to 151.4)

+8.9 ± 112.3

(-14.9 to 32.8)

-11.2 ± 69.3

(-30.5 to 8.1)

BA 95% LOA*

-336.0 to 547.0

-211.1 to 229.0

-147.0 to 124.6

  1. Statistical analysis of for Pima™ analysers field-tested in Phases IIIA and IIIB across two rural (N = 96) and one inner-city HCT clinic (N = 139), respectively, versus predicate reporting. All values, with the exception of N, refer to CD4 cell counts in cells/mm3. BA = Bland Altman statistical analysis. LOA = limits of agreement. #Precision of Pima™ to Predicate method expressed as %SIM CV.
  2. *cells/mm3