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Table 5 Usability Assessment (n = 708)

From: An observed, prospective field study to evaluate the performance and acceptance of a blood-based HIV self-test in Canada

Question Yes No
  % n % n
Instructions for Use (IFU)
 Did the study participant read/use the Instructions for Use (IFU)? 99.4% 700 0.6% 4
 If yes, was the Instructions for Use (IFU) read before the test? 94.6% 668 5.4% 38
 Was it referred to during the test process? 99.4% 695 0.6% 4
Pre-Test
 Did the study participant wash and dry their hands as instructed in the Instructions for Use (IFU)? 47.2% 334 52.8% 374
 Was it difficult for the study participant to remove the test device from the pouch? 12.5% 88 87.5% 616
 Was the study participant able to remove the cap of Bottle 1? 99.0% 696 1.0% 7
 Did the study participant twist the tip of the lancet off? 99.7% 705 0.3% 2
 Did the study participant rub his/her finger correctly (up and down/vertical motion)?a 88.8% 626 11.2% 79
Blood Draw
 Was the study participant able to lance his/her finger correctly?a 92.1% 650 7.9% 56
 Was the study participant able to form a blood droplet? 88.7% 627 11.3% 80
 Was the study participant able to get the blood droplet to fall into Bottle 1?a 81.2% 575 18.8% 133
 Was the study participant able to twist the cap onto Bottle 1? 98.7% 697 1.3% 9
 Did the study participant apply bandage? 91.4% 645 8.6% 61
Self-Test Procedure
 Did the study participant shake Bottle 1, four (4) times?a 88.9% 627 11.1% 78
 Did the study participant pour all the liquid from Bottle 1 into test device?a 97.3% 686 2.7% 19
 Did participant wait until liquid from Bottle 1 disappeared before adding liquid from Bottle 2 into device?a 98.0% 689 2.0% 14
 Did the study participant shake Bottle 2, four (4) times?a 88.8% 627 11.2% 79
 Did the study participant pour the liquid from Bottle 2 into test device?a 99.0% 699 1.0% 7
 Did participant wait until liquid from Bottle 2 disappeared before adding liquid from Bottle 3 into device?a 98.2% 692 1.8% 13
 Did the study participant shake Bottle 3, four (4) times?a 90.2% 638 9.8% 69
 Did the study participant pour the liquid from Bottle 3 into device and wait until liquid disappeared?a 97.3% 687 2.7% 19
Procedure Check
 Did the participant quit the process at any point? 1.0% 7 99.0% 701
 Did the participant perform the steps out of the order?a 10.7% 76 89.3% 632
 Did the participant miss any step and continued the process despite a missed or incorrect step? 9.5% 67 90.5% 640
  1. aCritical step
  2. Average on all desired outcomes = 91.8%
  3. Average on critical steps = 92.4%