Sensitivities, specificities, positive and negative predictive values and kappa analysis.

<p><i>P.f.</i>* = <i>P. falciparum</i> mono infections (n = 33), P.m.** = <i>P.malariae</i> mono infections (n = 13), P.f.*** <i>P. falciparum</i> mono and mixed.</p><p>infections (n = 41), CI = confidence interval, PPV = positive predictive value, NPV = negative predictive value.</p><p>Sensitivities, specificities, positive and negative predictive values and kappa analysis for detection of malaria DNA from fever patients and asymptomatic individuals with Pan and Pf-LAMP versus gold standard (real- time PCR corrected Cytochrome b nested PCR).</p

Stratified analysis of parasitaemia comparing DBS and WB HTP-LAMP against nPCR with a cut-off at 2 p/μL.

<p>Stratified analysis of parasitaemia comparing DBS and WB HTP-LAMP against nPCR with a cut-off at 2 p/μL.</p

Limit of detection of LAMP reactions using the high throughput sample processing system.

<p>Representative amplifications experiments using serial dilutions of samples of known parasitaemia (quantified using the WHO International Standard as calibrator). Mean time to turbidity in minutes as follows: 10,000 p/μL = 17.5; 1,000 p/μL = 18.5; 100 p/μL = 19.4; 10 p/μL = 21.3; 1 p/μL = 22.9.</p

Fever patient samples with discordant results.

<p>*Determined by blood smear microscopy, RDT = rapid diagnostic test + positive, − negative.</p><p>Outcome summery of fever patient samples with discordant results between Pan and/or Pf-LAMP and nested PCR using ABI extracted DNA and after DNA re-extraction with Chelex.</p

Flow chart of study. Reference standard

<p> = Cytochrome B nested PCR. <b>Gold standard</b> = Cytochrome B real-time PCR corrected nested PCR.</p

Baseline characteristics of fever patients and asymptomatic individuals.

<p>*determined by microscopy,</p><p>**determined by quantitative PCR,</p><p>ND = not done, p/µL = parasites/microliter, values in ( ) = range.</p

Layout of the high throughput set-up on the bench.

<p>The layout of the high throughput set-up which includes a shaker, hot block, vacuum manifold and pressure gauge.</p

Comparison of Malaria HTP-LAMP results from 699 DBS and WB samples against the equivalent gold standard nPCR results from 2011.

<p>Comparison of Malaria HTP-LAMP results from 699 DBS and WB samples against the equivalent gold standard nPCR results from 2011.</p

The transportable hard-cover case containing the high throughput LAMP set-up.

<p>The transportable hard-cover case containing the high throughput LAMP set-up.</p

Layout of the contents of the high throughput sample processing kit on the bench.

<p>The contents of the sample processing kit which includes a LYSIS plate, PURE plate, EXTRACT plate, sample record sheet, lysis fluid, individual foam plugs and instruction manual.</p