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

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

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

Flow chart of the study.

<p>The results of the two index tests, DBS-HTP-LAMP and WB-HTP-LAMP, against the gold standard nPCR results are summarized. Discrepancies between the gold standard and the index tests are highlighted. Abbreviation: EDTA ethylenediaminetetraacetic acid; PCR polymerase chain reaction; HTP-LAMP dried blood spot high throughput loop mediated isothermal amplification; DBS dried blood spot; WB whole blood.</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

Distribution of quantitative PCR determined parasite densities.

<p>pan- <i>Pan plasmodium</i>, Geometric mean values are indicated by horizontal lines. Geometric mean values are for PCR + 1.8 p/μL (range 0.1–770), for PCR+/ pan HTP-LAMP + 2.5 p/μL (range 0.2–770), for PCR+/ pan-HTP-LAMP– 1.4 p/μL (range 0.1–7) and for Chelex pan-LAMP + 3.4 p/μL (range 0.1–770).</p

Characterization of HTP-LAMP versus PCR discordant samples for diagnosis of <i>Plasmodium</i> infection (N = 31).

<p>Characterization of HTP-LAMP versus PCR discordant samples for diagnosis of <i>Plasmodium</i> infection (N = 31).</p

Diagnostic accuracy of Malaria pan HTP-LAMP compared to PCR for 3008 field samples.

<p>Diagnostic accuracy of Malaria pan HTP-LAMP compared to PCR for 3008 field samples.</p