Malaria RDT product testing: interactive guide

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Set parameters:			Choose data to display:
Select target malaria species	All species P. falciparum + other species P. falciparum only PAN only P. vivax only		Panel detection score, 200 parasites/µl
Minimum panel detection score "Panel detection score", termed "Detection rate" in the Round 1 Report, is defined as the frequency with which all RDTs tested on a sample in the evaluation panel were positive (2 RDTs from each of 2 lots positive against each 200 parasites/µl sample and 1 RDT from each lot positive against each 2000-5000 parasites/µl sample). If an invalid result occurred, this test was ignored in the result (but is reflected in the “Invalid rate”). Therefore, this index of performance is a measure of positivity rate and inter-test and inter-lot consistency.  for P. falciparum (%)			Panel detection score, 2000-5000 parasites/µl
Minimum panel detection score for P. vivax (%)			Invalid rate
Maximum false positive rate “False positive rate” is the frequency with which RDTs developed visible test lines when tested against samples of the ‘clean negative’ panel (samples with no malaria parasites and no known other infectious agents or blood abnormalities).			False positive rate
Maximum invalid test rate “Invalid rate” is the frequency with which RDTs failed to develop a control line, (invalid result) when tested against the parasite-positive panel.			Heat stability, 200 parasites/µl
Test format	Any Cassette Dipstick Card Hybride		Heat stability, 2000 parasites/µl

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Notes:
^a A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive
^b The total number of times a positive result for malaria was generated when it should not have been
^c Round 1, n=79; Round 2, n=100
^d Round 1, n=20; Round 2, n=40
^e For combination tests, Pan or Pv line, only, positive indicates a false positive P. falciparum infection (Round 1 n=316; Round 2, n=400)
^f Pf line positive indicates a false positive P. falciparum infection (Round 1, n=80; Round 2, n=160)
^g For combination tests, Pan or Pv line, only, positive indicates a false positive P. falciparum infection (Round 1, n=158, Round 2, n=200)
^h Pf line positive indicates a false positive P. falciparum infection (Round 1, n=40; Round 2, n=80) ⁱ Round 1, n=168; Round 2, n=200