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 |
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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
Advanced neoplasia: NR
CRC: 67.8
Advanced neoplasia: NR
CRC: 61
Advanced neoplasia: NR |
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
Yes |
No
Yes
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
2.1 |
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.
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