TABLE VII

Validation Study—False-Positive and False Negative Results

Test MethodClip (none, up, down)Test direction (septum or bag first)Total testedFalse-positive resultsFalse-negative results
CountIncidence rate (%)CountIncidence rate (%)
1NoneSeptum10821.900
2NoneBag1080010.9
3UpSeptum360000
4UpBag360012.8
5DownSeptum360012.8
6DownBag3512.900