Table 1.

Summary of analytical validationand clinical equivalencyresults for the in-lab FIT. Acceptance criteria required ≥85 % concordance or <15 % coefficient of variation (%CV) across all samples within a given experiment. Clinical equivalency results were compared to previously reported sensitivity metrics.

Study	Sample Size	Result
Freeze thawstability
0 freeze thaw cycles	n = 30	100 % concordance
1 freeze thaw cycle	n = 30	100 % concordance
2 freeze thaw cycles	n = 30	100 % concordance
3 freeze thaw cycles	n = 30	100 % concordance
Interferingsubstances
Red radish	n = 30	90 % concordance
Broccoli	n = 30	93 % concordance
Cauliflower	n = 30	97 % concordance
Horseradish	n = 30	100 % concordance
Turnip	n = 30	100 % concordance
Cantaloupe	n = 30	100 % concordance
Beef	n = 30	100 % concordance
Pork	n = 30	100 % concordance
Parsnip	n = 30	100 % concordance
Stoolinputvolume
50 grams stool / 250 ml buffer	n = 48	100 % concordance
100 grams stool / 250 ml buffer	n = 30	100 % concordance
150 grams stool / 250 ml buffer	n = 30	97 % concordance
200 grams stool / 250 ml buffer	n = 30	97 % concordance
250 grams stool / 250 ml buffer	n = 48	96 % concordance
Precision
Low Negative (concordance)	n = 108	100 % concordance
High Negative (%CV)	n = 108	14 %CV
Low Positive (%CV)	n = 108	9.5 %CV
High Positive (%CV)	n = 108	6.8 %CV
In-transit stability
0 hours	n = 60	100 % concordance
24 hours	n = 60	97 % concordance
48 hours	n = 60	100 % concordance
72 hours	n = 60	100 % concordance
96 hours	n = 60	100 % concordance
120 hours	n = 60	98 % concordance
Clinical equivalency
Negative findings	n = 70	94 % concordance
Colorectal cancer	n = 35	77 % sensitivity
Advanced adenomas	n = 6	33 % sensitivity