Patient safety organization releases report on usability of COVID-19 home testing

The group’s report also suggests that home clinical laboratory tests for COVID-19 that are difficult to use may lead to inaccurate results.

Home clinical laboratory tests for COVID-19[feminine sont devenus très populaires. Mais quelle est leur précision ? Maintenant, une organisation de sécurité indépendante a enquêté Tests antigéniques rapides COVID-19 pour savoir s’ils sont faciles ou non à utiliser et ce que cela signifie pour la précision des résultats des tests.

ECRI (Emergency Care Research Institute) de Plymouth Meeting, Penn., “a mené une évaluation de la convivialité pour déterminer s’il y avait des différences dans la facilité d’utilisation des tests COVID-19 rapides”, selon le site Web de l’entreprise. L’association à but non lucratif a été fondée dans les années 1960 par un chirurgien et inventeur Joel J.Nobel pour évaluer les dispositifs médicaux qui ont été approuvés par le Administration américaine des aliments et des médicaments (FDA).

“En raison de l’urgence de fournir des informations utiles aux consommateurs le plus rapidement possible, l’ECRI a sélectionné les sept kits de test en fonction de la disponibilité au détail”, a noté l’ECRI.

L’ECRI a classé les sept tests antigéniques rapides à domicile en vente libre en fonction de leurs cotes d’utilisabilité SUS. le Échelle d’utilisabilité du système (SUS), inventé par John Brooke en 1986, « note les produits sur une échelle de 0 à 100, 100 étant le plus facile à utiliser. Plus de 30 points séparaient les tests du haut et du bas analysés », selon Cadre de la santé gérée.

Sur les sept kits de test rapide d’antigènes pour le COVID-19, l’ECRI a trouvé “des problèmes d’utilisation notables” et “des différences significatives dans la facilité d’utilisation”. Aucun des tests n’a obtenu une note SUS “excellent”, a déclaré l’ECRI dans un communiqué de presse.

L’ECRI a publié ses conclusions dans un rapport intitulé «Facilité d’utilisation des kits de test à domicile de l’antigène COVID-19.”

« Notre évaluation montre que certains [COVID-19] the tests are much easier to use than the others. Given the choice, consumers should choose the tests that are easiest to use, because when a [COVID-19] is difficult for a consumer to use, it may lead to an inaccurate result,” said ECRI’s Chief Executive Officer Marcus Schabacker, MD, Ph.D., in a press release. Marcus “is a board-certified anesthesiologist and critical care specialist with over 35 years of healthcare experience in complex global environments, and over 20 years of leadership responsibilities serving medical device and pharmaceutical industries along the healthcare value chain,” says ECRI. . (Photo copyright: Commercial newspapers.)

Seven rapid antigen tests for SARS-CoV-2 evaluated

As clinical laboratory scientists and pathologists know, it is possible to use different testing methodologies for the same biomarker to produce dissimilar results. Another factor affecting the accuracy of medical laboratory tests is batch-to-batch or batch-to-batch variability. And, as the ECRI report suggests, the way a sample is collected and handled can affect the accuracy, reliability and reproducibility of the test results generated by that sample.

Here are the OTC COVID-19 rapid antigen tests assessed by ECRI and their SUS ratings:

Some tests, ECRI analysts found, required “fine motor control” or were filled with written instructions that ECRI determined were too small for older people to read.

How ECRI assessed COVID-19 rapid antigen tests

SUS reviewers took each quick test and completed questionnaires specifying their level of agreement (out of a range of one to five) with these statements. (Edited by Daily Dark for space):

  • Desire to use
  • Perception of unnecessary complexity
  • Easy to use
  • Support from a technical person required
  • Well-integrated functions
  • Too much system inconsistency
  • Easy to learn for most people
  • A very cumbersome system to use
  • Feeling of confidence in use
  • A need to learn before starting

ECRI then used a algorithm to derive an overall score (from 0 to 100) for each test, notes the report.

“Based on the aggregated SUS scores, none of the COVID-19 test kits would be rated as having ‘excellent’ usability. The On/Go, CareStart, Flowflex test kits we rate as ‘very good’ because the score usability of these kits is just short of ‘excellent’,” the report states.

Among the positive responses ECRI has received from SUS participants are:

  • “One of the easiest tests to use with good printed instructions” (On/Go and CareStart).
  • “The cassette facilitates handling without touching the test strip” (CareStart and Flowflex).
  • “The QR code (quick reply)-the linked instructional video is helpful, but probably not necessary” (QuickVue).
  • “Once the swab is inserted into the test card, the test seems less likely to be knocked over or disrupted than other test kits” (BinaxNOW).

Is it time for rapid COVID-19 antigen tests?

contrary to RT-PCR tests which can take hours or days to return results, rapid antigen tests provide a rapid result that is used for screening worldwide. And with COVID-19 Omicron variant rapidly spreading around the world, speed is a must, according to Etienne Kisslerdoctorateresearcher in the department of immunology and infectious diseases at Harvard TH Chan School of Public Health.

“I think rapid tests offer one of the best protections we have against the spread of disease, especially since we now have a variant on hand that is going to be able to cause a tremendous amount of infectious breakthroughs,” Kissler said. . The Constitution of the Atlantic Journal.

One of the ways clinical laboratory managers can help is by reaching out to their local markets and providing information on the importance of proper sampling and collection to get accurate results from rapid drug tests. antigen COVID-19.

Donna Marie Pocius

Related information:

ECRI Report: Ease of use of COVID-19 antigen home test kits

ECRI finds significant gaps in usability of home COVID tests

Concerns about ease of use of home COVID tests

Rapid tests, a key to controlling pandemics, face shortcomings

Aubrey L. Morgan