TABLE II

HVLD Replicate Testing of Negative Controls

Method	Sensitivity set point limit	WAL-made units			Novo Nordisk–made units
Method	Sensitivity set point limit	No. bags	No. replicate test days	No. replicate tests	No. bags	No. replicate test days	No. replicate tests
1	Lower	20	3	60	10	3	30
1	Upper	20	3	60	10	3	30
2	Lower	20	5^*	100	10	5^*	50
2	Upper	20	4	80	10	4	40
3	Lower	15	3	45	13	3	39
3	Upper	15	3	45	13	3	39
4	Lower	15	3	45	13	3	39
4	Upper	15	3	45	13	3	39
5	Lower	15	3	45	13	3	39
5	Upper	15	3	45	13	3	39
6	Lower	15	3	45	13	3	39
6	Upper	15	4	60	13	3	39

↵* Four days of testing, but one day included two replicate test series, making the total number of replicate test series = 5.