Table 1.
Panel of clinical samples used to assess the test characteristics of the RDT products.
Table 2.
Overview of RDT products and their lot numbers.
Figure 1.
Received product of Unitest (Ciriano global S.L., Zaragoza, Spain).
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. (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).
Table 3.
Test characteristics of the different RDT products.
Table 4.
Presence of important items that need to be addressed in the instructions for use.
Figure 2.
Lancets and transfer devices delivered with the different RDT products.
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.