Target product profiles for malaria diagnostics.

D, desirable; E, essential; O, optional.aAnalytic sensitivity: detection threshold against the marker of the infective agent (target) in controlled conditions. Diagnostic sensitivity: proportion (percent) of target cases detected by the test in the setting of intended use. The sensitivity required for P. vivax is generally at least that required for P. falciparum, and the parameters here should be applied to both. To achieve the required diagnostic sensitivity in low-prevalence settings, a greater analytic sensitivity (lower threshold of detection) may be required in some cases.bNot required for febrile case management, but in an elimination setting, it would be desirable to detect incidental parasitemia at this level.cEssential where stored in the field in ambient temperatures that frequently reach this level. Ambient temperature of prolonged storage in place of use should be considered the essential temperature stability requirement for a particular product.dAreas in which infections are almost exclusively monospecies or mixed species P. falciparum infections. It is likely that many such infections have subpatent coinfections with other species. Where this represents a minority of infections, treatment on the basis of P. falciparum alone is likely to be acceptable from a programmatic and public health point of view. Non-P. falciparum infections are likely to become relatively more prominent as P. falciparum infections decline in prevalence, making the detection of non-P. falciparum species more desirable.eMay be of importance in areas undergoing certification for elimination.fAll inner (individual test) packaging should display, at a minimum: manufacturer name, product name, expiry date, lot number, target use (malaria).gOutcome of temperature stability and integrity of packaging (ability to exclude moisture).hRapidity of results: For case management, results must be available before a patient is likely to leave the clinic. For surveillance, result availability in time for finding and managing cases is highly desirable.