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 |