Sensitivity, specificity and accuracy of RDTs.

<p>Errors are 95% confidence intervals.</p>a<p>For CATT an approximate range of reported sensitivity and specificity is quoted after <a href="http://www.plosntds.org/article/info:doi/10.1371/journal.pntd.0003373#pntd.0003373-Mitashi1" target="_blank">[8]</a>.</p><p>Sensitivity, specificity and accuracy of RDTs.</p

(a) 4-point-standard reference card for scoring RDT bands.

<p>Bands were assessed in realtion to the -, +, ++, +++ or ++++ ranges on the reference card, and then converted to scores of 0, 1+, 2+, 3+ and 4+ respectively. Additionally faint bands (+/-) were recorded as 0.5 and unless otherwise stated scored as sub-threshold (0). (b) Examples of positive and negative results with each device. Negative devices are presented in panels (i)–(iii): (i) BBI, (ii) RecSD (iii) NatSD. In all of these devices the bands are scored: 4+, 0, 0 (control, band 2, Band 1). Positive devices are presented in panels (iv)–(vi.) (iv) BBI bands were scored: control  =  4+, 3+, 4+ (v) RecSD bands were scored: 4+, 3+, 1+ (vi) NatSD bands were scored: 4+, 2+ 2+. (vii): Example of a BBI device scored as negative (4+, 0, 0) but where the readers noted faint bands (+/-) in positions 1 and 2.</p

Sensitivity, specificity and accuracy of RDTs after sub-threshold faint bands (+/-) were scored as positive (1+).

<p>Errors are 95% confidence intervals.</p><p>Sensitivity, specificity and accuracy of RDTs after sub-threshold faint bands (+/-) were scored as positive (1+).</p

Sensitivity and specificity of devices by each reader (R1 and R2) and by duplicate device (D1 and D2).

<p>Error bars are 95% confidence intervals of a proportion.</p

Partial receiver operating characteristic (ROC) curves for (a) individual antigens, (b) RDT devices and (c) top six performing hypothetical combinations of two antigens.

<p>Each curve represents a changing antigen band intensity limit from <i>L</i> = 1 (top right) to <i>L</i> = 4 (bottom left). Error bars are 95% confidence intervals.</p

Cohen's kappa and its 95% confidence intervals calculated for each RDT between duplicate devices and between independent readers after sub-threshold faint bands (+/-) were scored as positive (1+).

<p>Cohen's kappa and its 95% confidence intervals calculated for each RDT between duplicate devices and between independent readers after sub-threshold faint bands (+/-) were scored as positive (1+).</p

Cohen's kappa and its 95% confidence intervals calculated for each RDT between duplicate devices and between independent readers.

<p>Cohen's kappa and its 95% confidence intervals calculated for each RDT between duplicate devices and between independent readers.</p

Performance of (a) each RDT, (b) each antigen, and (c) all pairwise combinations of antigens, ordered by sensitivity.

<p>Error bars represent 95% confidence intervals, derived from 4 replicates (2 readers using 2 duplicate RDTs). The asterisks in (a) indicate statistically significant difference between the mean accuracy (from a t-test) of <i>p</i>* = 0.01 and <i>p</i>** = 0.003. The antigen combinations above the dashed horizontal line in (c) have significantly better sensitivity to NatSD device.</p

Flow diagram of participant enrolment.

<p>Note that for illustrative purposes in this flow diagram, if either reader recorded a positive result then it is recorded as positive in this Figure.</p

Screening test specificity.

<p>Screening test specificity.</p