Clinical validation and value proposition of Next Generation Malaria Rapid Diagnostic Test in Lao People's Democratic Republic

Intervention: a new "Next Generation" rapid diagnostic test (RDT) with a combined HRP2 and LDH line (SD Biosensor P. f/P. v Combo RDT). Brief Name: NextGen RDT. WHY: To assess diagnostic accuracy of NextGen RDTs in malaria case detection. WHAT Materials: - NextGen RDT usage instructions and information materials, in Lao language - informed consent form for people requiring malaria testing - malaria testing and treatment form (N1 form) - filter paper for dried blood spots - SD Biosensor P. f/P. v Combo RDT kit, including the test device, buffer, sterile lancet, and alcohol swab. - zip lock bag and desiccant for shipment of dried blood spots - unique identifier stickers WHAT Procedures: The Community Health Workers (CHWs) who are providing malaria services in the study area will be invited to use the NextGen RDTs in their malaria testing or screening activities, including active, passive and reactive case detections in the community setting. Community members who are identified for malaria testing in routine practice will be invited into the study to be tested by the NextGen RDT, in addition to the current standard (conventional) RDT, and to also have dried blood spots (DBS) collected for polymerase chain reaction (PCR) testing, the reference (gold standard) for detecting malaria parasites. CHWs will provide information on the study and seek informed consent prior to any testing. If the person agrees to participate, they will be enrolled in the study. After receiving consent from the person to be tested, CHWs will perform malaria testing using the NextGen RDTs and current standard RDT; the RDT results will be read within 15 minutes and recorded at the point of care. the whole process of RDTs testing will take approximately 30 minutes. CHWs will also take two or three drops of whole blood on the filter paper to get the DBS. The blood for both RDTs and the DBS will be taken from the same finger prick, using a single lancet (supplied in the RDT kits). Participant information will be recorded on an ‘N1’ form, including the results of the RDTs and any treatments given. The standard case report form (F1 form) will also be filled in for positive cases as per routine practice. A photo of the RDTs will be taken for quality control purposes. The DBSs will be put in a zip lock bag for shipment to Laos Centre of Malariology, Parasitology and Entomology’s (CMPE) laboratory in Vientiane. The RDTs, DBS, N1 form, and zip lock bag will be deidentified by putting code stickers with unique identifiers. Individuals with a positive result by routine standard RDT will be treated for malaria as per the National Malaria Treatment Guidelines. If the NextGen RDT is positive when the standard RDT is negative (for either species), the CHW will refer the case to the microscopy centre for confirmation; if this is not feasible, the individual will be treated for the NextGen RDT positive result as per the National Malaria Treatment Guidelines. The DBS will be stored and shipped at the end of each month to the CMPE’s laboratory in Vientiane where the PCR is available per standard operating procedures. The DBS will be tested with PCR for malaria parasites species, their density in blood and hrp2/3 deletions in P. falciparum confirmed infections suspected of hrp2/3 deletion (NextGen RDT positive and standard RDT negative for P.f) and as a result of false negative currently used RDT test results in samples with strong PCR signal (low Ct values). WHO Provided: The intervention is being provided by CHWs. CHWs in Lao PDR are trained to perform malaria diagnosis using RDTs and to provide malaria treatment as per the National Malaria Treatment Guidelines if RDT result is positive. Within this study, CHWs will get training of eight hours on the operation of NextGen RDTs, collecting dried blood spot (DBS), data and sample storage, and shipment at least two weeks prior to the start of the intervention. Usage instruction and information materials of NextGen RDT will be translated into Laos and the training will be delivered in local language by national trainers (Health Poverty Action (HPA) [Laos] staff). HOW & WHERE: NextGen RDTs will be delivered via normal malaria testing and screening activities, within the CHW program. This will include: • Passive case detection: occurring at the CHWs place of work (usually their home) • Active case detection: occurring in the field, e.g. screening at check points. • Reactive case detection: occurring after detecting an index malaria case in the area WHEN AND HOW MUCH: The NextGen RDT will be used only once, for each suspected malaria episode. Participants can be enrolled more than once across different episodes. TAILORING: None. HOW WELL: If the CHW has access to a smart phone, they will be instructed to take a picture of the RDTs labelled with unique identifier stickers for quality assurance purposes (i.e. to check that a valid result has been produced, and that it has been interpreted correctly).