Table 1.
Characteristics of 11 rapid diagnostic tests used in the NIDIAG persistent fever study.
Fig 1.
Cassettes and buffer bottles from different products but indistinguishable from each other.
Table 2.
Assessment of labelling and instructions for use of 11 rapid diagnostic tests used in the NIDIAG persistent fever study.
Fig 2.
Above: Rapid diagnostic test with correct lateral flow and timely migration of sample/buffer mixture. Below: Rapid diagnostic test with blocked lateral flow and no or delayed migration. The sample/buffer mixture is not flowing through the test strip but is staying behind in the sample well. This is considered as an invalid result.
Fig 3.
Two successive versions of the instructions for use of a rapid diagnostic test (most recent version on the right).
The change in reading time (indicated with a red arrow on the picture) was not communicated to the user in writing, by an alert on the box, or through a new version number, “track changes,” or a revision history of the instructions for use. Only the date of issue of the instructions for use had changed.