Background
The use of malaria RDTs is rapidly expanding
Written instructions add to the correct performance and interpretation of RDTs
Objectives of the present study
Methods
Selection of RDT kits
Criteria used for RDT kit assessment and procedure
Items considered to be inadequate | Number (%) | |
---|---|---|
Box: construction and design
| ||
Materials: plastic bag or simple cardboard (not humidity-resistant) | 9 (21.4) | |
No labels, no printed information or labels not humidity-resistant | 6 (14.3) | |
Differences in name on device packaging, device, buffer and information insert | 27 (64.3) | |
Box: information displayed
| ||
No EC-REP mentioned on CE labelled RDTs, although required (n = 25) | 3 (12.0) | |
RDT kit's name nor additional information refer to intended use | 3 (7.1) | |
RDT kit's name incorrectly refers to P. vivax instead of non-falciparum species (n = 29) | 4 (13.8) | |
Kit components not displayed | 26 (62%) | |
Essential information lacking: expiry date, numbers of tests included, storage conditions | 12 (28.6) | |
Kit contents:
| ||
Capillary sampling system (lancet and alcohol swap) not included or not optionally included | 24 (57%) | |
Blood transfer system (capillary, pipette or tube) not included | 3 (7.1%) | |
Device package and content: construction and design
| ||
Material not humidity-resistant | 4 (9.5) | |
No desiccant or desiccant without saturation indicator | 18 (42.9) | |
Device package and content: information displayed
| ||
Essential information lacking: expiry date, lot number, test kit name | 9 (21.4) | |
No warning label "do not swallow" on desiccant | 6 (14.3) | |
Device: construction and design
| ||
Space for sample identification too small or not writable with standard pen (felt pen needed) | 40 (95.2) | |
No or incomplete RDT name on the device | 29 (69.0) | |
No reading label or simultaneous presence two reading labels consisting of symbols only | 6 (14.3) | |
Buffer: construction and design
| ||
Buffer vial not leak proof | 2 (4.8) | |
Label does not stick well to the vial, prints are not humidity-resistant (n = 40) | 16 (40.0) | |
Buffer: information displayed
| ||
Essential information lacking: expiry date, lot number, storage conditions, correct RDT kit's name (n = 41) | 24 (58.5) | |
No instructions included on how to pierce the buffer vial dropper (n = 15) | 5 (33.3) | |
Package insert: information
| ||
Absence of date of release or version number | 20 (47.6) | |
Package insert: content
| ||
Identity of target antigens not clearly mentioned | 2 (4.8) | |
No referral to biosafety precautions (gloves, safe waste disposal, etc.) | 18 (42.9) | |
Major differences between depicted and real device (n = 40) | 8 (20.0) | |
Use of figures with unrealistic colours (e.g. control and test lines depicted as green) | 4 (9.5) | |
No data on test characteristics (sensitivity, specificity) | 8 (19.0) |
RDT kit package, device package, device and buffer vial
RDT information insert
Layout and figures
Typography
Readability level
Accuracy and relevance of information
Items addressed in procedure section | Number (%) |
---|---|
Bring the RDT device and buffer to room temperature | 32 (80.0) |
Check the integrity of the device package | 9 (22.5) |
Check expiry date | 27 (67.5) |
Use the device immediately after opening | 28 (70.0) |
Place the device on a level surface | 0 (0.0) |
Check the desiccant for signs of exposure to humidity | 11 (27.5) |
Write down sample identification | 3 (7.5) |
Wipe finger with alcohol | 26 (65.0) |
Allow the finger to dry before pricking | 12 (30.0) |
Hold the transfer device (loop, straw) vertical | 8 (20.0) |
Hold the buffer vial vertical | 12 (30.0) |
Do not to use another buffer than the one provided with the kit | 9 (22.5) |
Use an adequate light source for reading | 3 (7.5) |
Items addressed in interpretation section
|
Number (%)
|
All possible line combinations for invalid test results are mentioned | 12 (30.0) |
All possible test line combinations for positive test results are mentioned | 31 (77.5) |
Interpretation of a faint test line as positive is mentioned | 8 (20.0) |
Causes of false negative results are mentioned, in particular low parasite densities | 11 (27.5) |
Causes of false positive results are mentioned, e.g. presence of the rheumatoid factor | 3 (7.5) |
Persistence of HRP-2 is mentioned | 19 (47.5) |
To repeat the test in case of a negative RDT result and persistent suspicion of malaria is mentioned | 1 (2.5) |
Assessment, data registration and statistical analysis
Results
Panel of RDT kits
Evidence of GMP | |||||
---|---|---|---|---|---|
RDT format | Plasmodium antigens targeted | Number | CE mark | WHO list† | Total |
Two band
| HRP-2 | 7 | 4 | 5 | 7 |
pan-pLDH | 1 | 1 | 0 | 1 | |
Pv-pLDH | 1 | 1 | 0 | 1 | |
Three band
| HRP-2, pan-pLDH | 11 | 5 | 7 | 9 |
HRP-2, aldolase‡ | 5 | 5* | 5 | 5 | |
HRP-2, Pv-pLDH | 4 | 1 | 1 | 2 | |
Pf-pLDH, pan-pLDH | 6 | 5 | 6 | 6 | |
Four band
| HRP-2, Pv-pLDH, pan-pLDH | 7 | 3 | 5 | 6 |