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Validation of the usability of a Covid test

Rosengarten Apotheke

The Rosengarten Pharmacy in Bassersdorf commissioned us to carry out a summative usability test of the Lepu Sars-Cov-2 Antigen Rapid Test Kit. We are proud that we were able to help shorten the path back to normality with this project.

Challenge and goal

Before a medical product is approved for sale, it must undergo numerous tests. Only when it has been shown that the product delivers what it promises and is safe to use can it be sold. One of these tests is the usability test. The aim is to show that a product can be used safely by the general public. The test kit included a test card bag, a test cassette, a swab and a sample treatment solution. The accompanying instructions for independent use were enclosed.

Sars-Cov Anitgen Rapid Test Kit with instructions for use.

Fig. 1: Sars-Cov Anitgen Rapid Test Kit with instructions for use. 

Procedure and method

After just one week of preparation and great support from the Rosengarten pharmacy, our small test center was ready in a sports hall near Bassersdorf. Shortly before Easter, we had 91 people - adults, teenagers and children - carry out the self-test and meticulously documented their every action.

Staged test center in a sports hall near Bassersdorf.

Fig. 2: Staged test center in a sports hall near Bassersdorf.

Summative test according to IEC 62366

The self-test was to be carried out exactly as described in the instructions for use. The challenge for our usability experts was to observe closely, record precisely and provide no assistance or instructions for operation. Was the swab turned five times? Were samples taken from both nasal cavities? Were the results interpreted correctly? Precision and accurate analysis were required during the evaluation. What are the reasons why the result was not recognized? It was necessary to get to the bottom of this and explain why errors or uncertainties occurred. A specific focus was placed on the instructions for use: Is it clear and understandable? This was tested with comprehension questions.

Root cause analysis

During the test, the test subjects were asked whether they had experienced difficulties (close calls) or believed that they had made errors (use errors). This user perspective, obtained through interviews, provided information on whether use errors or close calls were caused by a perceptual or cognitive error. This was important in order to determine whether there were previously unknown use-related risks in the design of the user interface that needed to be remedied.

Result

Apart from the very efficient planning and preparation of the tests in Bassersdorf, the Ergonomen test team gained completely new experiences: Testing, interviewing and logging almost 100 participants on a piecework basis, carrying out tests in full protective gear with a cape, mask, visor and gloves and, in between, responding to the test subjects and their individual experiences in times of the pandemic in a friendly manner - it was very exciting and did not escape the media's attention: 20 Minuten was present at the tests and reported on them in an article from March 31, 2021. Watch the 2-minute video here.

Article from 20min: A pharmacist fights for more self-tests.

Fig. 3: Article from 20min: A pharmacist fights for more self-tests.

Customer benefits

Rosengarten pharmacy benefited from a Covid self-test validated for its usability. We also test other medical products and applications such as hearing aids, insulin pumps, diabetes care apps, auto-injectors and even complex instructions for analysis and radiation devices. For validation, we use both summative evaluation (as in this example) and formative evaluation. Do you also have a product that you would like to have tested? Please contact us!

Interested? Please contact us!

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