Overview of RDT products and their lot numbers.

<p>PfHRP2 =  <i>P. falciparum</i> Histidine-rich protein-2; pan-pLDH = pan <i>Plasmodium</i> lactate dehydrogenase; Pf-pLDH = <i>P. falciparum</i>-pLDH.</p>*<p>Websites last accessed on 07-08-2012.</p>†<p>Target antigens not specified.</p>‡<p>On the website a CE label was displayed but not on the delivered products.</p

Lancets and transfer devices delivered with the different RDT products.

<p>CareStart and OptiMAL included a simple lancet, SDFK63 a safety seal lancet and the other products safety lancets with a retractable needle. The systems of TODA and Immunoquick (SMI) do not require a transfer device (direct contact of the test strip with the drop of blood). Sanitoets contained a calibrated pipette and OptiMAL a straw pipette. The other products included a balloon pipette. The transfer devices of OneStep and Labstix did not display a volume mark.</p

Presence of important items that need to be addressed in the instructions for use.

<p>N.A. = not applicable.</p>*<p>The user is advised to take the treatment included in the kit.</p>†<p>Repeating the test after 12 hours is advised, independent of persistence of symptoms.</p>‡<p>The user is advised to use the ‘pan’ line for treatment follow-up.</p

Received product of Unitest (Ciriano global S.L., Zaragoza, Spain).

<p>The delivered Unitest malaria cassette P.f-P.v kit mentions detection of antibodies while the almost identical kit on the website mentions detection of the Pf and Pv antigen. (<a href="http://www.clinica.co.za/index.php?page=shop.product_details&flypage=flypage.tpl&product_id=11&category_id=3&option=com_virtuemart&Itemid=90" target="_blank">http://www.clinica.co.za/index.php?page=shop.product_details&flypage=flypage.tpl&product_id=11&category_id=3&option=com_virtuemart&Itemid=90</a>).</p

Test characteristics of the different RDT products.

<p>PD = parasite density, Pf = <i>P. falciparum</i>, Pv = <i>P. vivax</i>, Po = <i>P. ovale</i>, Pm = <i>P. malariae.</i></p>*<p>including one P. vivax sample that generated a strong positive result upon testing PfHRP2 ELISA.</p>†<p>one sample missed with parasite density 2,458/µl.</p>‡<p>including one invalid result. § including one missed sample with parasite density 3,251/µl.</p

Panel of clinical samples used to assess the test characteristics of the RDT products.

<p>Panel of clinical samples used to assess the test characteristics of the RDT products.</p

Evolution of <i>T</i>. <i>cruzi</i> serology and PCR testing in the blood donor.

<p>^a) Chemoluminescent microparticle immunoassay, Architect Chagas Assay, Abbott Laboratories, Germany (Positive result when unit > 1). This test is used for blood donors screening at the blood transfusion center.</p><p>^b) to g) cf. <a href="http://www.plosntds.org/article/info:doi/10.1371/journal.pntd.0003986#pntd.0003986.t001" target="_blank">Table 1</a></p><p>Evolution of <i>T</i>. <i>cruzi</i> serology and PCR testing in the blood donor.</p

Evolution of <i>T</i>. <i>cruzi</i> serology and PCR testing in the child contaminated by RBC transfusion.

<p>^a) These tests were performed at the Belgian reference center. According to WHO recommendations [<a href="http://www.plosntds.org/article/info:doi/10.1371/journal.pntd.0003986#pntd.0003986.ref019" target="_blank">19</a>], chronic infection with <i>T</i>. <i>cruzi</i> needs two positive serological assays, using different techniques, to be diagnosed.</p><p>^b) PCR performed as described in <a href="http://www.plosntds.org/article/info:doi/10.1371/journal.pntd.0003986#pntd.0003986.g001" target="_blank">Fig 1</a></p><p>^c) Benznidazole has been given for a duration of two months</p><p>^d) Biokit S.A., Barcelona, Spain—Positive result when ratio > 1 (cf. manufacturer instructions)</p><p>^e) ELISA based on soluble extract of <i>T</i>. <i>cruzi</i> trypomastigotes—Positive result if index > 20 (positive control index = 100, negative control index = 0)</p><p>^f) Chagas IFA IgG+IgM, Vircell, Granada, Spain—Positive result when titer ≥ 40 (cf. manufacturer)</p><p>^g) nd: not determined</p><p>Evolution of <i>T</i>. <i>cruzi</i> serology and PCR testing in the child contaminated by RBC transfusion.</p

Sequence of research instruments

<p>Sequence of research instruments</p

<i>T</i>. <i>cruzi</i> PCR results in the contaminated recipient (A) and the infected donor (B).

<p>In the recipient, PCR has been performed at 12, 15, 16, 19, and 26 months after <i>T</i>. <i>cruzi</i> contamination occurred (A), which corresponds to one month before and two, three, six, and 13 months after initiation of treatment with benznidazole, respectively (B). PCR was performed in duplicates on DNA extracted from guanidine-preserved blood samples with TcZ1-TcZ2 primers, giving an amplicon of 188 basepairs (bp), indicated by the arrow [<a href="http://www.plosntds.org/article/info:doi/10.1371/journal.pntd.0003986#pntd.0003986.ref020" target="_blank">20</a>]. Additional bands around 400 and 600 bp are sometimes visible. They originate from tandem repetitions of the target sequence in <i>T</i>. <i>cruzi</i> DNA. Parasite purified DNA from 10, 1, and 0.1 parasites/mL was used as positive control. Blood sample from an uninfected individual was used as negative control.</p