Keep the quality high: the benefits of lot testing for the quality control of malaria rapid diagnostic tests

Malaria Journal

Table 1 Summary of Lot Testing failures (2007–2017)

Reasons for lot failure	Nb lots failed at reception (nb RDTs)	Nb lots failed after long-term storage (nb RDTs)
Non-detection of Pv at 200 p/μl	20 (5.7 M)	18 (5.1 M)
Non-detection of Pf and Pv at 200 p/μl	0	1 (0.3 M)
Insufficient buffer^a	6 (1.7 M)	24 (6.8 M)
Total	26 (7.4 M)	43 (12.2 M)

The numbers of lot failures and –in brackets-the corresponding estimate of numbers of RDTs (based on a mean lot size of 283,053 RDTs per lot, as communicated by LT requesters from 2013 to 2017) are shown for different reasons of failed testing (i.e. confirmed negative test results with P. falciparum (Pf) and P. vivax (Pv) samples standardized at a density of 200 parasites per microlitre of blood (p/µl), which were either observed upon reception of the RDT lot or after long-term storage
Nb number, M million
^aCounted as a failure only from June 2016 onwards

ISSN: 1475-2875