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.