Article Figures & Data
Figures
- Appendix 1.
Images and Materials Associated with Each FIT Kit Tested (N = 6 FITs)
Tables
- Table 1.
Characteristics of FITs Identified for User Testing (Selection Date: Summer/Fall 2015)
FIT Kit Name (Manufacturer) Test Instructions Materials Included in Kit Samples, No. Cards, No. Other Kit Characteristics Collection/ Storage Method Instructions Provided Other Materials Positivity Rate* Sensitivity for CRC† OC-Light® (Polymedco) Place paper in toilet, deposit stool onto paper, use grooved probe to collect sample before stool touches water, store sample inside liquid vial. Fill out the label on the tube, wrap tube in absorbent pad, insert into specimen bag. Grooved probe/vial English—Y Specimen bag, biodegradable paper, absorbent pad, CRC fact sheet 1 N/A 8.4 to 14.2%52,53 88% to 96%52,53 Spanish—Online only Color pictures—N Hemosure® iFOB Test (Hemosure, Inc.) Affix adhesive paper on toilet, deposit stool on paper, poke grooved probe in stool at 6 different sites, screw applicator back into vial, place into specimen bag. Grooved probe/vial English—Y Specimen bag, adhesive flushable tissue 1 N/A No studies available Spanish—Y 88%54 (per company website) Color Pictures—Y QuickVue® (Quidel) Fill out label on collection vial. Affix paper on toilet and deposit stool on paper. Poke grooved probe in stool at 5 different sites, screw probe into vial, shake. Insert vial into absorbent pad and specimen bag, seal. Grooved probe/vial English—Y Specimen bag, absorbent pad, adhesive flushable tissue 1 N/A No studies available No studies available Spanish—Y Color Pictures—Y InSure® FIT™ (Enterix Inc.) Brush stool in toilet water, brush sample on card A. Complete label and affix onto flap to reseal. Repeat process with a different bowel for card B. Brush (2)/ card English—Y N/A 2 1 4.6 to 5.6%55 87%55 Spanish—Online only Color pictures—English only OneStep+ (Henry Schein) Affix paper on toilet, deposit stool on paper, collect sample from 4 different sites of stool using wooden stick. Open flap on sample card, apply sample to window 1, spread evenly to cover, close flap. Repeat to complete window 2 with next bowel movement. Wooden Stick (2)/ Card English—Y Adhesive flushable tissue 1 to 2 1 No studies available No studies available Spanish—Y Color Pictures—N Hemoccult® ICT (Beckman Coulter) Place plastic wrap or newspaper over toilet, place provided tissue on top of wrap/newspaper to catch stool over water. Deposit stool, collect two samples with wooden stick, open flap on card, spread samples on flap, close, and dry overnight. Repeat with additional card(s) on a new day. Wooden stick (2 to 3)/cards English—Y Flushable tissue 2 or 3 days 2 to 3 3.2% to 9%56,57 98%53 Spanish—Online only Color Pictures—N ↵* Positivity rate is the proportion of test that have a positive result.
↵† Sensitivity is the proportion of actual positives which are correctly identified as such (eg, the percentage of patients with CRC who are correctly identified as having the condition).
Note: All 6 FIT kits are Clinical Laboratory Improvement Amendments (CLIA) waived and can be used at the point of care. We could not locate clinical effectiveness data for 2 of the tests. Many of the 132 tests listed by the Federal Drug Administration for detection of fecal occult blood lack publicly available data on clinical effectiveness.
- Table 2.
Demographic Characteristics of Participants Engaged in FIT Testing and Focus Groups
Characteristics Completed FIT Kits and Questionnaires (N = 18) Participated in Focus Group (N = 13) Female 9 (50) 8 (62) Age, mean (SD) 55.6 (4.3) 55.5 (7.4) Hispanic 10 (55.6) 7 (53.8) Primary language English 9 (50.0) 7 (53.8) Spanish 9 (50.0) 6 (46.2) Insurance Medicaid 9 (50.0) 6 (46.2) Medicare 2 (11.1) 0 (0) Uninsured 3 (16.7) 5 (38.4) Private 3 (16.7) 2 (15.4) Unknown 1 (5.5) 0 (0) County of residence Wasco 10 (55.6) 9 (69.2) Hood river 5 (27.8) 2 (15.4) Multnomah 2 (11.0) 1 (7.7) Klickitat 1 (5.6) 1 (7.7) FIT or gFOBT in prior 3 years 5 (29)* 1 (7.7)† - Table 3.
Participant Agreement with Statements about the FIT Kits on the Study Questionnaires
OC-Light®, % (N = 12) Hemosure® iFOB Test, % (N = 13) InSure® FIT™, % (N = 14) QuickVue®, % (N = 12) OneStep+, % (N = 11) Hemoccult® ICT, % (N = 11) % Responses Agree/Strongly Agree After reading the directions, I felt sure I knew how to use the kit correctly. 83 62 79 75 73 45 The kit package was easy to open. 100 92 100 100 100 100 The collection tool (tube, brush or stick) was easy for me to use. 100 100 93 75 91 64 Collecting the sample was quick. 92 85 86 83 91 60 I feel confident I did everything correctly. 83 77 86 75 82 64 Most people I know would be willing to complete a kit like this. 83 50 67 55 50 27 Using this kit was no big deal. 83 75 77 58 82 36 % Responses Disagree/Strongly Disagree I had problems collecting the stool sample. 82 85 79 83 73 60 Collecting the sample was disgusting. 55 46 46 50 18 36 [It was] embarrassing to store the sample. N/A N/A 55 N/A 50 25 OC-Light® (N = 12) Hemosure® iFOB Test (N = 13) InSure® FIT™ (N = 7) QuickVue® (N = 11) OneStep+ (N = 12) Hemoccult® ICT (N = 11) Packaged correctly 7 (58) 8 (62) 7 (100) 8 (73) 12 (100) 10 (91) In mailer (Y) 11 (92) 11 (85) 7 (100) 10 (91) 12 (100) 10 (91) In bio bag (Y) 8 (67) 11 (85) N/A 11 (100) N/A N/A With pad (C) 7 (58) 8 (62) N/A 9 (82) N/A N/A Labeled correctly 8 (67) 5 (38) 6 (86) 5 (45) 8 (67) 7 (64) Label (Y) 7 (58) 5 (38) 5 (71) 5 (45) 7 (58) 7 (64) Different days (Y) N/A N/A 4 (57) N/A 4 (33) 5 (45) Collection date (Y) 8 (67) 5 (38) 6 (86) 4 (36) 7 (58) 7 (64) Sampled correctly 10 (83) 12 (92) 6 (86) 11 (100) 11 (92) 7 (64) Color of liquid (T/B) 10 (83) 12 (92) N/A 11 (100) N/A N/A Returned all cards N/A N/A 7 (100)* N/A 12 (100)* 9 (82)† Sample on all cards N/A N/A 7 (100) N/A 11 (92) 8 (73)† Specimen appearance N/A N/A 7 (100) N/A 12 (100) 10 (91) Coverage (>50%) N/A N/A 6 (86) N/A 11 (92) 7 (64) Closed N/A N/A 7 (100) N/A 12 (100) 10 (91) - Table 5.
FIT Kit Rankings from Most to Least Preferred by Questionnaire and Focus Group Data
A. Combined Rankings for FIT Kit User Testing Data Sets
FIT Name Data Source Overall Questionnaire (N = 79) English Focus Group (N = 6) Spanish Focus Group (N = 8) OC-Light® 1 1 2/3* 1 Hemosure® iFOB Test 2/3* 3 1 2 InSure® FIT™ 2/3* 2 2/3* 3 QuickVue® 4 4 4 4 OneStep+ 5 5 5 5 Hemoccult® ICT 6 6 6 6 ↵* 2/3 signifies a tie for second place.
B. Test Characteristics for Overall FIT Kit Ranking
Kit Ranking Collection Tool Instructions No. Sampling Days No. Cards Probe Stick Brush Colored Pictures Large Font 1 2 3 1 2 3 1. OC-Light® X X X 2. Hemosure® iFOB Test X X X X 3. InSure® FIT™ X X X X 4. QuickVue® X X X 5. OneStep+ X X X X 6. Hemoccult® ICT X X X X X
