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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  
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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