Table 1 Number of RDTs (n = 42) with inadequacies in malaria RDT boxes, device packages, devices, buffer vials and package inserts*
Items considered to be inadequate | Number (%) | |
|---|---|---|
Box: construction and design | Â | |
| Â | Materials: plastic bag or simple cardboard (not humidity-resistant) | 9 (21.4) |
| Â | No labels, no printed information or labels not humidity-resistant | 6 (14.3) |
| Â | Differences in name on device packaging, device, buffer and information insert | 27 (64.3) |
Box: information displayed | Â | |
| Â | No EC-REP mentioned on CE labelled RDTs, although required (n = 25) | 3 (12.0) |
| Â | RDT kit's name nor additional information refer to intended use | 3 (7.1) |
| Â | RDT kit's name incorrectly refers to P. vivax instead of non-falciparum species (n = 29) | 4 (13.8) |
| Â | Kit components not displayed | 26 (62%) |
| Â | Essential information lacking: expiry date, numbers of tests included, storage conditions | 12 (28.6) |
Kit contents: | Â | |
| Â | Capillary sampling system (lancet and alcohol swap) not included or not optionally included | 24 (57%) |
| Â | Blood transfer system (capillary, pipette or tube) not included | 3 (7.1%) |
Device package and content: construction and design | Â | |
| Â | Material not humidity-resistant | 4 (9.5) |
| Â | No desiccant or desiccant without saturation indicator | 18 (42.9) |
Device package and content: information displayed | Â | |
| Â | Essential information lacking: expiry date, lot number, test kit name | 9 (21.4) |
| Â | No warning label "do not swallow" on desiccant | 6 (14.3) |
Device: construction and design | Â | |
| Â | Space for sample identification too small or not writable with standard pen (felt pen needed) | 40 (95.2) |
| Â | No or incomplete RDT name on the device | 29 (69.0) |
| Â | No reading label or simultaneous presence two reading labels consisting of symbols only | 6 (14.3) |
Buffer: construction and design | Â | |
| Â | Buffer vial not leak proof | 2 (4.8) |
| Â | Label does not stick well to the vial, prints are not humidity-resistant (n = 40) | 16 (40.0) |
Buffer: information displayed | Â | |
| Â | Essential information lacking: expiry date, lot number, storage conditions, correct RDT kit's name (n = 41) | 24 (58.5) |
| Â | No instructions included on how to pierce the buffer vial dropper (n = 15) | 5 (33.3) |
Package insert: information | Â | |
| Â | Absence of date of release or version number | 20 (47.6) |
Package insert: content | Â | |
| Â | Identity of target antigens not clearly mentioned | 2 (4.8) |
| Â | No referral to biosafety precautions (gloves, safe waste disposal, etc.) | 18 (42.9) |
| Â | Major differences between depicted and real device (n = 40) | 8 (20.0) |
| Â | Use of figures with unrealistic colours (e.g. control and test lines depicted as green) | 4 (9.5) |
| Â | No data on test characteristics (sensitivity, specificity) | 8 (19.0) |