Table 3.
User friendliness assessment of four COVID-19 antigen rapid diagnostic tests, adapted from SKUP/2018/114 protocol.
| Mean of N = 3 questioned operators | ||||
|---|---|---|---|---|
| Operation facilities | BD Veritor™ SARS-CoV-2 | Coris COVID-19 Ag Respi-strip | Panbio™ COVID-19 Ag rapid test device | SD Biosensor™ SARS-CoV-2 Rapid Antigen Test |
| To prepare the test | Intermediate (1S 2I)a | Intermediateb | Intermediate (1S 2I)b | Satisfactory (2S 1I)a |
| To prepare the sample | Satisfactory | Satisfactory | Satisfactory | Satisfactory |
| Application of specimen | Satisfactory | Satisfactory | Satisfactory | Satisfactory |
| Number of procedure step | Satisfactory | Satisfactory | Satisfactory | Satisfactory |
| Test design | Satisfactory | Unsatisfactory (2U, 1I)c | Satisfactory | Satisfactory |
| Reading of the result | Satisfactory | Difficultd | Satisfactory | Satisfactory |
| Sources of errors | Satisfactory | Intermediated | Satisfactory | Satisfactory |
| Hygiene when using the test | Satisfactory | Unsatisfactorye | Satisfactory | Satisfactory |
| Size and weight of the package | Satisfactory (2S 1I)f | Satisfactory | Satisfactory | Satisfactory |
| Storage conditions for tests, unopened package* | 15–30°C | 15–30°C | 15–30°C | 15–30°C |
| Storage conditions for tests, opened package* | 15–30°C | 15–30°C | 15–30°C | 15–30°C |
| Environmental aspects: waste handling* | Special precautions | Special precautions | Special precautions | Special precautions |
| Intended users* | Health care personnel | Health care personnel | Health care personnel | Health care personnel |
| Information in instruction in the insert | ||||
| Preparations/Pre-analytic procedure | Satisfactory | Satisfactory | Satisfactory | Satisfactory |
| Specimen collection | Satisfactory | Intermediateg | Satisfactory | Satisfactory |
| Measurement procedure | Satisfactory | Satisfactory | Satisfactory | Satisfactory |
| Reading of result | Satisfactory | Satisfactory | Satisfactory | Satisfactory |
| Description of the sources of error | Satisfactory | Satisfactory | Satisfactory | Satisfactory |
| Help for troubleshooting | Satisfactory | Satisfactory | Satisfactory | Satisfactory |
| Readability/clarity of presentation | Satisfactory | Intermediateh | Satisfactory | Satisfactory (1I 2S)j |
| General impression | Satisfactory | Intermediatei | Satisfactory | Satisfactory (1I 2S)j |
| Measurement principle* | Satisfactory | Satisfactory | Satisfactory | Satisfactory |
| Available insert in ENG + FR + NL* | Partlyk | Partlyk | Partlyl | Partlyk |
| Time factors* | ||||
| Required training time | <2 h | <2 h | <2 h | <2 h |
| Duration of preparations/Pre-analytical time | <6 min | <6 min | <6 min | <6 min |
| Duration of analysis | 10–20 min | >20 min | 10–20 min | 10–20 min |
| Stability of test, unopened package | >5 months | >5 months | >5 months | >5 months |
| Stability of test, opened package | >30 days or disposable | >30 days or disposable | >30 days or disposable | >30 days or disposable |
| Stability of quality control material unopened | >5 months | No QC provided | >5 months | No QC provided |
| Analytical quality control* | ||||
| Reading of the internal quality control | Satisfactory | Unsatisfactorym | Satisfactory | Unsatisfactorym |
| Usefulness of the internal quality control | Satisfactory | Unsatisfactorym | Satisfactory | Unsatisfactorym |
Objective informational items were filled by the principal investigator.
Caps of the buffer tubes difficult to manipulate.
Requires a tube rack.
The use of a strip in a closed tube with a very difficult capping was not considered practical for the operators.
Difficult reading through a closed tube although transparent.
Operators were forced to open the tubes to extract the strip in case of a doubt with the reading causing biosafety concern.
Oversized packaging compared to the number of test.
Lack of precise instruction.
Lack of clarity.
A quick reference guide would have been appreciated.
Small typo and dense content.
Only available in English.
Not available in Dutch.
Not provided.