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Table 1. Summary of Newer Fecal Test Studies
| Study, Year (Reference); Patients, n; Study Quality | Gold Standard | Additional FOBT Tested or Threshold for Occult Blood Detection, ng/mL | Duration of Fecal Sample Collection, d |
|---|---|---|---|
| Magstream (Fujirebio, Tokyo) | |||
| Morikawa et al., 2005 44; 21,805; fair | Colonoscopy for all patients | 20 | 1 |
| Launoy et al., 200542; 7421; fair | Registry follow-up for screen-negative patients; colonoscopy for screen-positive patients | >20 >50 >75 |
2 |
| Allison et al., 199639; 8104; fair | Registry follow-up for screen-negative patients; colonoscopy for screen-positive patients | HemeSelect (Magstream) Hemoccult SENSA Hemoccult SENSA/HemeSelect Hemoccult II |
3 |
| OC-Hemodia (Eiken Chemical Co., Tokyo) | |||
| Cheng et al., 200240; 7411; fair | Colonoscopy for all patients | 3 | |
| Itoh et al., 199641; 27 860; fair |
Registry follow-up for screen-negative patients; colonoscopy for screen-positive patients | 1 | |
| Levi et al., 200743; fair | Colonoscopy for all patients | 3 | |
| FlexSure OBT (Hemoccult ICT, Beckman Coulter, Fullerton, California) | |||
| Allison et al., 2007a 38; 5841; good | Colonoscopy for screen-positive patients or flexible sigmoidoscopy for screen-negative patients | FlexSure Hemoccult SENSA FlexSure/Hemoccult SENSA |
3 |
| Monohaem (Millipore, Billerica, Massachusetts) | |||
| Nakama et al., 1999 45; 4611; fair | Colonoscopy for all patients | 1 2 3 |
|
| Nakama et al., 1996 46,b; 3365; fair | Registry follow-up for screen-negative patients; colonoscopy for screen-positive patients | 1-y follow-up 2-y follow-up 3-y follow-up |
1 |
| Faecal DNA | |||
| Imperiale et al., 2004 47; 4404; fair | Colonoscopy for all patients, but test accuracy limited to those selected for fecal DNA testing | Fecal DNA testing done only in subsample based on histopathologic and colonoscopic results (n = 2507) Hemoccult II |
Whole-stool (30-g) sample 3 |
Table 1 (continued)
| Study, Year (Reference); Patients, n; Study Quality | Test Positivity Rate (%) | Sensitivity (95% CI), % | Specificity, % | FDA Approved | Available in U.S. Market |
|---|---|---|---|---|---|
| Magstream (Fujirebio, Tokyo) | |||||
| Morikawa et al., 2005 44; 21 805; fair | 5.6 | CRC: 65.8 Advanced neoplasia: 27.1 Adenoma ≥ 10 mm: 20.0 |
CRC: 94.6 Advanced neoplasia: 95.1 Adenoma ≥ 10 mm: NR |
No | No |
| Launoy et al., 200542; 7421; fair | 5.8 3.1 2.0 |
CRC: 85 |
CRC: 94 Advanced neoplasia: NR CRC: 97 Advanced neoplasia: NR CRC: 98 Advanced neoplasia: NR |
No | No |
| Allison et al., 199639; 8104; fair | 5.9 13.6 3.0 2.5 |
CRC: 68.8 Polyp ≥10 mm: 66.7 CRC: 79.4 Polyp ≥10 mm: 68.6 CRC: 65.6 Polyp ≥10 mm: 50.0 CRC: 37.1 Polyp ≥10 mm: 30.8 |
CRC: 94.4 Polyp ≥10 mm: 95.2 CRC: 86.7 Polyp ≥10 mm: 87.5 CRC: 97.3 Polyp ≥10 mm: 97.9 CRC: 97.7 Polyp ≥10 mm: 98.1 |
Yes Yes |
No Yes |
| OC-Hemodia (Eiken Chemical Co., Tokyo) | |||||
| Cheng et al., 200240; 7411; fair | 9.2 | CRC: 87.5 Advanced neoplasia: 48.4 |
CRC: 91.0 Advanced neoplasia: 91.3 |
Yes (OC-Auto Micro 80, Polymedco, Cortlandt Manor, NY) |
Yes |
| Itoh et al., 199641; 27,860; fair | 5.3 | CRC: 86.5 | CRC: 94.9 | No | No |
| Levi et al., 200743; fair | 18.8 | CRC: 66.7 Advanced neoplasia: 55.6 |
CRC: 83.1 Advanced neoplasia: 91.9 |
No | No |
| FlexSure OBT (Hemoccult ICT, Beckman Coulter, Fullerton, California) | |||||
| Allison et al., 2007a 38; 5841; good | 3.2 10.1 |
CRC: 81.8 Adenoma ≥ 10 mm: 29.5 CRC: 64.3 Adenoma ≥ 10 mm: 41.3 CRC: 64.3 Adenoma ≥10 mm: 22.8 |
CRC: 96.9 Adenoma ≥ 10 mm: 97.3 CRC: 90.1 Adenoma ≥10 mm: 90.6 CRC: 98.1 Adenoma ≥10 mm: 98.4 |
Yes Yes |
Yes Yes |
| Monohaem (Millipore, Billerica, Massachusetts) | |||||
| Nakama et al., 1999 45; 4611; fair | NR NR NR |
CRC: 55.6 Adenoma: 30.1 CRC: 83.3 Adenoma: 50.7 CRC: 88.9 Adenoma: 54.8 |
CRC and adenoma: 97.1 CRC and adenoma: 96.0 CRC and adenoma: 93.9 |
Yes | No |
| Nakama et al., 1996 46,b; 3365; fair | 4.7 | CRC: 90.9 CRC: 83.3 CRC: 71.4 |
CRC: 95.6 | Yes | No |
| Faecal DNA | |||||
| Imperiale et al., 2004 47; 4404; fair | 8.2 5.8 |
CRC: 51.6 (34.8-68.0) Advanced adenoma: 15.1 (12.0-19.0) CRC: 12.9 (5.1-28.9) Advanced adenoma: 10.7 (8.0-14.0) |
Minor polyps: 92.4 No polyps: 94.4 Minor polyps: 95.2 No polyps: 95.2 |
No Yes |
Yes Yes |
CRC = colorectal cancer; FDA = U.S. Food and Drug Administration; FOBT = fecal occult blood testing; NR = not reported.
a. Left-sided tumors only.
b. Sensitivity and specificity of
small adenomas or polyps of unknown size are found in the full evidence table25.
USPSTF Program Office |
