Background
Methods
Study design
Panel of RDT products
Different types of desiccants
Assessment of desiccants and instructions for use
Items checked | Criteria, background and reference |
---|---|
1. Presence of desiccant in device packaging | Desiccant protects the RDT from humidity before the device packaging is opened[20] |
2. Humidity indicator | |
2.1. Presence of humidity indicator (self-indicating, partial-indicating, non-indicating (Figure 1) | Desiccant with a colour indicator of humidity is preferred[1] |
2.2. Composition of humidity indicator (based on colour appearance) | |
3. Material of desiccant sachet: | |
3.1. Permeable | Sachet should be vapor permeable to allow humidity uptake |
3.2. Transparent | |
Colour of beads easily visible with no additional light source needed, additional light source needed, sachet not transparent precluding inspection of colour change | Sachet should be transparent to allow easy colour check of the humidity indicator |
4. Warning message on sachet: | |
4.1. Not to eat the content of the sachet | The desiccant may be harmful if swallowed, so it should be kept away from children[20] |
5. Information available in instructions for use: | |
5.1. To check the colour of the silica gel after opening the device packaging | |
5.2. How to interpret the colour change of the silica gel | Interpretation of colour indication should be mentioned in IFU or on sachet |
5.3. What to do when the silica gel is saturated | |
5.4. To discard the sachet after colour has been checked | Once the packet is opened, the sachet should be discarded[20] |
5.5. Information on properties, safety hazards, remedies and safe disposal of the desiccants should be provided by the manufacturer | It is the responsibility of the manufacturer to provide accurate information on this[1] |
Inspection of the individual self-indicating and partial-indicating silica gels sachets
Data management and statistical analysis
Additional analysis of HIV RDTs
Results
Panel of RDTs assessed
Presence, type and content of the desiccant, labelling of sachet
Desiccant present | Type of desiccant | Ease of observation of colour change of humidity indicator | Warning on desiccant |
---|---|---|---|
Yes (49) | Silica gel, self-indicating (22) | Easily visible (22) | Do not eat (46) |
Silica gel, partial-indicating (8) | Requires additional light (8) | ||
Silica gel, non-indicating (17) | NA | ||
Tablet unknown identity, non-indicating (2) | NA | No warning | |
No (1) | NA | NA | NA |
Information supplied by the instructions for use
Inspection of the individual self-indicating and partial-indicating silica gels sachets
N° | Number of sachets assessed | % saturated* (95% CI) | % without indicator† (95% CI) |
---|---|---|---|
Self-indicating silica gel | |||
1 | 625 | 0.0 | |
2 | 1,933 | 0.05 (0.01 - 2.88) | |
3 | 190 | 0.0 | |
4 | 223 | 0.0 | |
5 | 550 | 0.0 | |
6 | 484 | 1.2 (0.46 - 2.68) | |
7 | 566 | 4.6 (3.02 - 6.66) | |
Partial-indicating silica gel‡ | |||
1 | 1,507 | 0.3 (0.08 - 0.75) | 9.5 (8.06 - 11.08) |
2 | 2,160 | 0.1 (0.13 - 0.39) | 13.5 (12.06 - 14.99) |
3 | 384 | 2.5 (1.09 - 4.87) | 16.7 (13.08 - 20.78) |
4 | 672 | 0.2 (0.00 - 0.94) | 12.5 (10.09 - 15.24) |
5 | 2,066 | 0.0 | 14.6 (13.08 - 16.17) |
6 | 483 | 0.0 | 17.8 (14.50 - 21.52) |
7 | 1,721 | 3.6 (2.75 - 4.68) | 10.2 (8.84 - 11.76) |
8 | 483 | 0.0 | 0.6 (0.13 - 1.80) |
9 | 146 | 0.0 | 6.8 (3.33 - 12.24) |
Differences between CE marked and global fund listed RDTs and those which were not
Additional analysis of HIV RDTs
Desiccant present | Type of desiccant | Ease of observation of colour change of humidity indicator | Warning on desiccant |
---|---|---|---|
Yes (10) | Silica gel, self-indicating (1) | Easily visible (1) | Do not eat (10) |
Silica gel, partial-indicating (4) | Requires additional light (3) | ||
Requires opening of sachet (1) | |||
Silica gel, non-indicating (3) | NA | ||
Other type of desiccant, non-indicating (2) | NA | ||
No (1) | NA | NA | NA |