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. 2022 Jun 6;6(6):CD009276.
doi: 10.1002/14651858.CD009276.pub2.

Guaiac-based faecal occult blood tests versus faecal immunochemical tests for colorectal cancer screening in average-risk individuals

Esmée J Grobbee #  1 , Pieter HA Wisse #  1 , Eline H Schreuders  1 , Aafke van Roon  2 , Leonie van Dam  1 , Ann G Zauber  3 , Iris Lansdorp-Vogelaar  4 , Wichor Bramer  5 , Sarah Berhane  6 , Jonathan J Deeks  6 , Ewout W Steyerberg  4 , Monique E van Leerdam  1 , Manon Cw Spaander  1 , Ernst J Kuipers  1
Affiliations

Guaiac-based faecal occult blood tests versus faecal immunochemical tests for colorectal cancer screening in average-risk individuals

Esmée J Grobbee et al. Cochrane Database Syst Rev. .

Abstract

Background: Worldwide, many countries have adopted colorectal cancer (CRC) screening programmes, often based on faecal occult blood tests (FOBTs). CRC screening aims to detect advanced neoplasia (AN), which is defined as CRC or advanced adenomas. FOBTs fall into two categories based on detection technique and the detected blood component: qualitative guaiac-based FOBTs (gFOBTs) and faecal immunochemical tests (FITs), which can be qualitative and quantitative. Screening with gFOBTs reduces CRC-related mortality.

Objectives: To compare the diagnostic test accuracy of gFOBT and FIT screening for detecting advanced colorectal neoplasia in average-risk individuals.

Search methods: We searched CENTRAL, MEDLINE, Embase, BIOSIS Citation Index, Science Citation Index Expanded, and Google Scholar. We searched the reference lists and PubMed-related articles of included studies to identify additional studies.

Selection criteria: We included prospective and retrospective studies that provided the number of true positives, false positives, false negatives, and true negatives for gFOBTs, FITs, or both, with colonoscopy as reference standard. We excluded case-control studies. We included studies in which all participants underwent both index test and reference standard ("reference standard: all"), and studies in which only participants with a positive index test underwent the reference standard while participants with a negative test were followed for at least one year for development of interval carcinomas ("reference standard: positive"). The target population consisted of asymptomatic, average-risk individuals undergoing CRC screening. The target conditions were CRC and advanced neoplasia (advanced adenomas and CRC combined).

Data collection and analysis: Two review authors independently screened and selected studies for inclusion. In case of disagreement, a third review author made the final decision. We used the Rutter and Gatsonis hierarchical summary receiver operating characteristic model to explore differences between tests and identify potential sources of heterogeneity, and the bivariate hierarchical model to estimate sensitivity and specificity at common thresholds: 10 µg haemoglobin (Hb)/g faeces and 20 µg Hb/g faeces. We performed indirect comparisons of the accuracy of the two tests and direct comparisons when both index tests were evaluated in the same population.

Main results: We ran the initial search on 25 June 2019, which yielded 63 studies for inclusion. We ran a top-up search on 14 September 2021, which yielded one potentially eligible study, currently awaiting classification. We included a total of 33 "reference standard: all" published articles involving 104,640 participants. Six studies evaluated only gFOBTs, 23 studies evaluated only FITs, and four studies included both gFOBTs and FITs. The cut-off for positivity of FITs varied between 2.4 μg and 50 µg Hb/g faeces. For each Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2 domain, we assessed risk of bias as high in less than 20% of studies. The summary curve showed that FITs had a higher discriminative ability than gFOBTs for AN (P < 0.001) and CRC (P = 0.004). For the detection of AN, the summary sensitivity of gFOBTs was 15% (95% confidence interval (CI) 12% to 20%), which was significantly lower than FITs at both 10 μg and 20 μg Hb/g cut-offs with summary sensitivities of 33% (95% CI 27% to 40%; P < 0.001) and 26% (95% CI 21% to 31%, P = 0.002), respectively. Results were simulated in a hypothetical cohort of 10,000 screening participants with 1% CRC prevalence and 10% AN prevalence. Out of 1000 participants with AN, gFOBTs missed 850, while FITs missed 670 (10 μg Hb/g cut-off) and 740 (20 μg Hb/g cut-off). No significant differences in summary specificity for AN detection were found between gFOBTs (94%; 95% CI 92% to 96%), and FITs at 10 μg Hb/g cut-off (93%; 95% CI 90% to 95%) and at 20 μg Hb/g cut-off (97%; 95% CI 95% to 98%). So, among 9000 participants without AN, 540 were offered (unnecessary) colonoscopy with gFOBTs compared to 630 (10 μg Hb/g) and 270 (20 μg Hb/g) with FITs. Similarly, for the detection of CRC, the summary sensitivity of gFOBTs, 39% (95% CI 25% to 55%), was significantly lower than FITs at 10 μg and 20 μg Hb/g cut-offs: 76% (95% CI 57% to 88%: P = 0.001) and 65% (95% CI 46% to 80%; P = 0.035), respectively. So, out of 100 participants with CRC, gFOBTs missed 61, and FITs missed 24 (10 μg Hb/g) and 35 (20 μg Hb/g). No significant differences in summary specificity for CRC were found between gFOBTs (94%; 95% CI 91% to 96%), and FITs at the 10 μg Hb/g cut-off (94%; 95% CI 87% to 97%) and 20 μg Hb/g cut-off (96%; 95% CI 91% to 98%). So, out of 9900 participants without CRC, 594 were offered (unnecessary) colonoscopy with gFOBTs versus 594 (10 μg Hb/g) and 396 (20 μg Hb/g) with FITs. In five studies that compared FITs and gFOBTs in the same population, FITs showed a higher discriminative ability for AN than gFOBTs (P = 0.003). We included a total of 30 "reference standard: positive" studies involving 3,664,934 participants. Of these, eight were gFOBT-only studies, 18 were FIT-only studies, and four studies combined both gFOBTs and FITs. The cut-off for positivity of FITs varied between 5 µg to 250 µg Hb/g faeces. For each QUADAS-2 domain, we assessed risk of bias as high in less than 20% of studies. The summary curve showed that FITs had a higher discriminative ability for detecting CRC than gFOBTs (P < 0.001). The summary sensitivity for CRC of gFOBTs, 59% (95% CI 55% to 64%), was significantly lower than FITs at the 10 μg Hb/g cut-off, 89% (95% CI 80% to 95%; P < 0.001) and the 20 μg Hb/g cut-off, 89% (95% CI 85% to 92%; P < 0.001). So, in the hypothetical cohort with 100 participants with CRC, gFOBTs missed 41, while FITs missed 11 (10 μg Hb/g) and 11 (20 μg Hb/g). The summary specificity of gFOBTs was 98% (95% CI 98% to 99%), which was higher than FITs at both 10 μg and 20 μg Hb/g cut-offs: 94% (95% CI 92% to 95%; P < 0.001) and 95% (95% CI 94% to 96%; P < 0.001), respectively. So, out of 9900 participants without CRC, 198 were offered (unnecessary) colonoscopy with gFOBTs compared to 594 (10 μg Hb/g) and 495 (20 μg Hb/g) with FITs. At a specificity of 90% and 95%, FITs had a higher sensitivity than gFOBTs.

Authors' conclusions: FITs are superior to gFOBTs in detecting AN and CRC in average-risk individuals. Specificity of both tests was similar in "reference standard: all" studies, whereas specificity was significantly higher for gFOBTs than FITs in "reference standard: positive" studies. However, at pre-specified specificities, the sensitivity of FITs was significantly higher than gFOBTs.

PubMed Disclaimer

Conflict of interest statement

EG has no interests to disclose.

PW has no interests to disclose.

ES has no interests to disclose.

AR has no interests to disclose.

LD has no interests to disclose.

AZ has no interests to disclose.

IL was involved in a published overview paper on risk‐based CRC screening in The International Journal of Cancer and participated in The BMJ Rapid Recommendations on CRC screening.

WB has no interests to disclose.

SB has no interests to disclose.

JD has a Cochrane Diagnostic Test Accuracy (DTA) Editorial role but was not involved in the editorial process. JD was involved in published opinions in medical journals, the public press, broadcast, and social media relevant to the interventions in the work: eight podcasts, including Talk Evidence (BMJ), More or Less (Radio 4), Inside Science (Radio 4), and The Newscast (Radio 4); five opinion pieces in The Guardian, UnHerd and The BMJ; and numerous television, radio and mainstream media interviews giving substantial coverage of scientific issues related to test evaluation for COVID‐19. JD presented evidence to the House of Lords Select Committee, and the All Parliamentary Party Investigation on COVID‐19, and wrote two invited editorials on COVID‐19 for The BMJ.

ES received payment for a book: Clinical Prediction Models.

ML has no interests to disclose.

MS has no interests to disclose.

EK has no interests to disclose.

Figures

1
1
Flow diagram of search and included studies
2
2
Studies using "reference standard: all". Risk of bias and applicability concerns graph: review authors' judgements about each domain presented as percentages across studies
3
3
Studies using "reference standard: all". Risk of bias and applicability concerns summary: review authors' judgement about each domain for each included study
4
4
Studies using "reference standard: positive". Risk of bias and applicability concerns graph: review authors' judgements about each domain presented as percentages across included studies
5
5
Studies using "reference standard: positive". Risk of bias and applicability concerns summary: review authors' judgement about each domain for each included study
6
6
Forest plot of gFOBT and FIT ("reference standard: all") for advanced neoplasia. For all FITs, a cut‐off of 10 µg Hb/g faeces was used, unless this cut‐off was unavailable.
7
7
Summary curve using the HSROC model for gFOBT and FIT ("reference standard: all") including multiple cut‐offs for advanced neoplasia. Scale of individual study points is based on sample size
8
8
"Reference standard: all" gFOBT versus FIT (cut‐off 10 ug Hb/g) for AN
9
9
"Reference standard: all" gFOBT versus FIT (cut‐off 20 ug Hb/g) for AN
10
10
Forest plot of gFOBT and FIT ("reference standard: all") for colorectal cancer. For all FITs, a cut‐off of 10 µg Hb/g faeces was used, unless this cut‐off was unavailable
11
11
Summary curve using the HSROC model for gFOBT and FIT ("reference standard: all") including multiple cut‐offs for colorectal cancer. Scale of individual study points is based on sample size
12
12
"Reference standard: all" gFOBT versus FIT (cut‐off 10 ug Hb/g) for CRC
13
13
"Reference standard: all" gFOBT versus FIT (cut‐off 20 ug Hb/g) for CRC
14
14
Linked‐HSROC curve of studies ("reference standard: all") with outcome advanced neoplasia (including: Brenner 2012, Brenner 2013 and Haug 2011 combined, Graser 2009, Hoepffner 2006, Park 2010). Scale of individual study points is based on sample size
15
15
Forest plot of gFOBT and FIT ("reference standard: positive") for colorectal cancer. For all FITs, a cut‐off of 10 µg Hb/g faeces was used, unless this cut‐off was unavailable
16
16
Summary curve using the HSROC model for gFOBT and FIT ("reference standard: positive") including multiple cut‐offs for colorectal cancer. Scale of individual study points is based on sample size
1
1. Test
"Reference standard: all" gFOBT AN
2
2. Test
"Reference standard: positive" gFOBT CRC
3
3. Test
"Reference standard: all" FIT10 AN
4
4. Test
"Reference standard: all" FIT20 AN
5
5. Test
"Reference standard: all" gFOBT CRC
6
6. Test
"Reference standard: all" FIT CRC
7
7. Test
"Reference standard: all" FIT10 CRC
8
8. Test
"Reference standard: all" FIT20 CRC
9
9. Test
"Reference standard: all" gFOBT_Hemoccult_II_AN
10
10. Test
"Reference standard: all" gFOBT_Hemoccult_Sensa_AN
11
11. Test
"Reference standard: all" gFOBT_Hemoccult_II_CRC
12
12. Test
"Reference standard: all" gFOBT_Hemoccult_Sensa_CRC
13
13. Test
"Reference standard: all" gFOBT_Hemoccult_AN
14
14. Test
"Reference standard: all" FIT_Iatro_Hemcheck_CRC
15
15. Test
"Reference standard: all" FIT AN
16
16. Test
"Reference standard: all" gFOBT_Hemoccult_CRC
17
17. Test
"Reference standard: all" FIT_OC_Sensor_50_AN
18
18. Test
"Reference standard: all" FIT_OC_Sensor_50_CRC
19
19. Test
"Reference standard: all" FIT_OC_Sensor_100_AN
20
20. Test
"Reference standard: all" FIT_OC_Sensor_100_CRC
21
21. Test
"Reference standard: all" FIT_OC_Light_50_AN
22
22. Test
"Reference standard: all" FIT_OC_Light_100_AN
23
23. Test
"Reference standard: all" FIT_OC_Light_100_CRC
24
24. Test
"Reference standard: all" FIT_OC_Light_50_CRC
25
25. Test
"Reference standard: all" FIT_OC_Sensa_100_CRC
26
26. Test
"Reference standard: all" FIT_OC_Sensa_50_CRC
27
27. Test
"Reference standard: all" FIT_OC_Sensa_100_AN
28
28. Test
"Reference standard: all" FIT_OC_Sensa_50_AN
29
29. Test
"Reference standard: all" FIT_OC_Micro_50_AN
30
30. Test
"Reference standard: all" FIT_ELISA_Immunodiagnostik
31
31. Test
"Reference standard: all" FIT_RIDASCREEN_50_AN
32
32. Test
"Reference standard: all" FIT_RIDASCREEN_50_CRC
33
33. Test
"Reference standard: all" FIT_RIDASCREEN_100_AN
34
34. Test
"Reference standard: all" FIT_RIDASCREEN_100_CRC
35
35. Test
"Reference standard: all" FIT_OC_Hemodia_AN
36
36. Test
"Reference standard: all" FIT_OC_Hemodia_CRC
37
37. Test
"Reference standard: positive" FIT CRC
38
38. Test
"Reference standard: positive" FIT_OC_Hemodia_CRC
39
39. Test
"Reference standard: positive" FIT 50 CRC
40
40. Test
"Reference standard: positive" FIT 100 CRC
41
41. Test
"Reference standard: positive" gFOBT_Hemoccult_II_CRC
42
42. Test
"Reference standard: positive" gFOBT_Hemoccult_Sensa_CRC
43
43. Test
"Reference standard: positive" FIT_OC‐Micro_CRC
44
44. Test
"Reference standard: positive" gFOBT_Hemoccult_CRC
45
45. Test
"Reference standard: positive" FIT_OC_Sensor_CRC
46
46. Test
"Reference standard: positive" FIT_Hemeselect_CRC
47
47. Test
"Reference standard: positive" FIT_Magstream_CRC
48
48. Test
"Reference standard: positive" gFOBT_Hema‐screen_CRC
49
49. Test
"Reference standard: positive" FIT_HM‐Jack_CRC
50
50. Test
"Reference standard: positive" FIT_Monohaem_CRC
51
51. Test
"Reference standard: all" FIT_OCHEMCHECK_100_CRC
52
52. Test
"Reference standard: all" FIT_OCHEMCHECK_100_AN
53
53. Test
"Reference standard: all" FIT_Hemosure_50_AN
54
54. Test
"Reference standard: all" FIT_Hemosure_50_CRC
55
55. Test
"Reference standard: all" FIT_FOBGold_AN
56
56. Test
"Reference standard: all" FIT_FOBGold_CRC
57
57. Test
"Reference standard: all" FIT_InvernessClearview_AN
58
58. Test
"Reference standard: all" FIT_InvernessClearview_CRC
59
59. Test
"Reference standard: all" FIT_AlereClearview_AN
60
60. Test
"Reference standard: all" FIT_AlereClearview_CRC
61
61. Test
"Reference standard: all" FIT_ Quidel _QuickVue_AN
62
62. Test
"Reference standard: all" FIT_ Quidel _QuickVue_CRC
63
63. Test
"Reference standard: all" FIT_ImmoCARE‐C_AN
64
64. Test
"Reference standard: all" FIT_ImmoCARE‐C_CRC
65
65. Test
"Reference standard: all" gFOBT_HemoCARE_AN
66
66. Test
"Reference standard: all" gFOBT_hemoCARE_CRC
67
67. Test
"Reference standard: positive" FIT_167ug_CRC
68
68. Test
"Reference standard: positive" FIT_250ug_CRC
69
69. Test
"Reference standard: all" FIT_OC_Micro_50_CRC
70
70. Test
"Reference standard: all" FIT_OC_Micro_100_AN
71
71. Test
"Reference standard: all" FIT_OC_Micro_100_CRC
72
72. Test
"Reference standard: positive" gFOBT_Hemofec_CRC
73
73. Test
"Reference standard: all" Linked‐ROC FIT AN
74
74. Test
"Reference standard: all" Linked‐ROC gFOBT AN
75
75. Test
"Reference standard: positive" FIT_OC_FIT_FIT‐CHEK_CRC
76
76. Test
"Reference standard: positive" FIT_FOBGOLD
77
77. Test
"Reference standard: all" linked‐ROC gFOBT CRC
78
78. Test
"Reference standard: all" linked‐ROC all FIT CRC
79
79. Test
"Reference standard: positive" linked‐ROC gFOBT CRC
80
80. Test
"Reference standard: positive" linked‐ROC all FIT CRC
See this image and copyright information in PMC

Comment in

References

References to studies included in this review

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Graser 2009 {published data only}
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Itoh 1996 {published data only}
    1. Itoh M, Takahashi K, Nishida H, Sakagami K, Okubo T.Estimation of the optimal cut off point in a new immunological faecal occult blood test in a corporate colorectal cancer screening programme. Journal of Medical Screening 1996;3(2):66-71. - PubMed
Jensen 2016 {published and unpublished data}
    1. Jensen CD, Corley DA, Quinn VP, Doubeni CA, Zauber AG, Lee JK, et al.Fecal immunochemical test program performance over 4 rounds of annual screening: a retrospective cohort study. Annals of Internal Medicine 2016;164(7):456-63. - PMC - PubMed
Juul 2018 {published data only}
    1. Juul JS, Andersen B, Laurberg S, Carlsen AH, Olesen F, Vedsted P.Differences in diagnostic activity in general practice and findings for individuals invited to the Danish screening programme for colorectal cancer: a population-based cohort study. Scandinvian Journal of Primary Health Care 2018;36(3):281-90. - PMC - PubMed
Kapidzic 2017 {published data only}
    1. Kapidzic A, Van Roon AH, Van Leerdam ME, Van Vuuren AJ, Van Ballegooijen M, Lansdorp-Vogelaar I, et al.Attendance and diagnostic yield of repeated two-sample faecal immunochemical test screening for colorectal cancer. Gut 2017;66(1):118-23. - PubMed
Khalid‐de Bakker 2011 {published data only}
    1. Khalid-de Bakker CA, Jonkers DM, Sanduleanu S, Bruïne AP, Meijer GA, Janssen JB, et al.Test performance of immunologic fecal occult blood testing and sigmoidoscopy compared with primary colonoscopy screening for colorectal advanced adenomas. Cancer Prevention Research 2011;4(10):1563-71. - PubMed
Kim 2017 {published data only}
    1. Kim NH, Lee MY, Park JH, Park DI, Sohn CI, Choi K, et al.A combination of fecal immunochemical test results and iron deficiency anemia for detection of advanced colorectal neoplasia in asymptomatic men. Yonsei Medical Journal 2017;58(5):910-7. - PMC - PubMed
Kronborg 1987 {published data only}
    1. Kronborg O, Fenger C, Søndergaard O, Pedersen KM, Olsen J.Initial mass screening for colorectal cancer with fecal occult blood test. A prospective randomized study at Funen in Denmark. Scandinavion Journal of Gastroenterology 1987;2(6):677-86. - PubMed
Launoy 2005 {published data only}
    1. Launoy GD, Bertrand HJ, Berchi C.Evaluation of an immunochemical fecal occult blood test with automated reading in screening for colorectal cancer in a general average‐risk population. International Journal of Cancer 2005;115(3):493-96. - PubMed
Levi 2011a {published data only}
    1. Levi Z, Birkenfeld S, Vilkin A, Bar-Chana M, Lifshitz I, Chared M, et al.A higher detection rate for colorectal cancer and advanced adenomatous polyp for screening with immunochemical fecal occult blood test than guaiac fecal occult blood test, despite lower compliance rate. A prospective, controlled, feasibility study. International Journal of Cancer 2011;128(10):2415-24. - PubMed
Levi 2011b {published data only}
    1. Levi Z, Birkenfeld S, Vilkin A, Bar-Chana M, Lifshitz I, Chared M, et al.A higher detection rate for colorectal cancer and advanced adenomatous polyp for screening with immunochemical fecal occult blood test than guaiac fecal occult blood test, despite lower compliance rate. A prospective, controlled, feasibility study. International Journal of Cancer 2011;128(10):2415-24. - PubMed
Levy 2014a {published and unpublished data}
    1. Levy BT, Bay C, Xu Y, Daly JM, Bergus G, Dunkelberg J, et al.Test characteristics of faecal immunochemical tests (FIT) compared with optical colonoscopy. Journal of Medical Screening 2015;21(3):133-43. - PMC - PubMed
Levy 2014b {published data only}
    1. Levy BT, Bay C, Xu Y, Daly JM, Bergus G, Dunkelberg J, et al.Test characteristics of faecal immunochemical tests (FIT) compared with optical colonoscopy. Journal of Medical Screening 2015;21(3):133-43. - PMC - PubMed
Levy 2014c {published data only}
    1. Levy BT, Bay C, Xu Y, Daly JM, Bergus G, Dunkelberg J, et al.Test characteristics of faecal immunochemical tests (FIT) compared with optical colonoscopy. Journal of Medical Screening 2015;21(3):133-43. - PMC - PubMed
Levy 2014d {published data only}
    1. Levy BT, Bay C, Xu Y, Daly JM, Bergus G, Dunkelberg J, et al.Test characteristics of faecal immunochemical tests (FIT) compared with optical colonoscopy. Journal of Medical Screening 2015;21(3):133-43. - PMC - PubMed
Liebermann 2001 {published data only}
    1. Lieberman DA, Harford WV, Ahnen DJ, Provenzale D, Sontag SJ, Schnell TG, et al.One-time screening for colorectal cancer with combined fecal occult-blood testing and examination of the distal colon. New England Journal of Medicine 2001;345(8):555-60. - PubMed
McNamara 2014 {published data only}
    1. McNamara D, Leen R, Seng-Lee C, Shearer N, Crotty P, Neary P, et al.Sustained participation, colonoscopy uptake and adenoma detection rates over two rounds of the Tallaght-Trinity College colorectal cancer screening programme with the faecal immunological test. European Journal of Gastroenterology and Hepatology 2014;26(12):1415-21. [PMID: ] - PubMed
Nakama 1996 {published data only}
    1. Nakama H, Kamijo N, Abdul Fattah AS, Zhang B.Validity of immunological faecal occult blood screening for colorectal cancer: a follow up study. Journal of Medical Screening 1996;3(2):63-5. - PubMed
Nakama 2000 {published data only}
    1. Nakama H, Zhang B, Fattah AS, Zhang X.Colorectal cancer in iron deficiency anemia with a positive result on immunochemical fecal occult blood. International Journal of Colorectal Disease 2000;15(5-6):271-4. - PubMed
Nakazato 2006 {published and unpublished data}
    1. Nakazato M, Yamano H, Matsushita H, Sato K, Fujita K, Yamanaka Y, et al.Immunologic fecal occult blood test for colorectal cancer screening. Japan Medical Association Journal 2006;49:203-7.
Omata 2011 {published data only}
    1. Omata F, Shintani A, Isozaki M, Masuda K, Fujita Y, Fukui T.Diagnostic performance of quantitative fecal immunochemical test and multivariate prediction model for colorectal neoplasms in asymptomatic individuals. European Journal of Gastroenterology and Hepatology 2011;23(11):1036-41. - PubMed
Paimela 2010 {published data only}
    1. Paimela H, Malila N, Palva T, Hakulinen T, Vertio H, Jarvinen H.Early detection of colorectal cancer with faecal occult blood test screening. British Journal of Surgery 2010;97(10):1567-71. - PubMed
Parente 2013 {published data only}
    1. Parente F, Boemo C, Ardizzoia A, Costa M, Carzaniga P, Ilardo A, et al.Outcomes and cost evaluation of the first two rounds of a colorectal cancer screening program based on immunochemical fecal occult blood test in northern Italy. Endoscopy 2013;45(1):27-34. - PubMed
Park 2010 {published data only}
    1. Park DI, Ryu S, Kim YH, Lee SH, Lee CK, Eun CS, et al.Comparison of guaiac-based and quantitative immunochemical fecal occult blood testing in a population at average risk undergoing colorectal cancer screening. American Journal of Gastroenterology 2010;105(9):2017-25. - PubMed
Parra‐Blanco 2010 {published data only}
    1. Parra-Blanco A, Gimeno-Garcia AZ, Quintero E, Nicolas D, Moreno SG, Jimenez A, et al.Diagnostic accuracy of immunochemical versus guaiac faecal occult blood tests for colorectal cancer screening. Journal of Gastroenterology 2010;45(7):703-12. - PubMed
Paszat 2016 {published data only}
    1. Paszat L, Sutradhar R, Tinmouth J, Baxter N, Rabeneck L.Interval colorectal cancers following guaiac fecal occult blood testing in the Ontario ColonCancerCheck Program. Canadian Journal of Gastroenterology and Hepatology 2016;2016:[6 p.]. - PMC - PubMed
Ribbing Wilen 2019 {published data only}
    1. Ribbing Wilen H, Blom J, Hoijer J, Andersson G, Lowbeer C, Hultcrantz R.Fecal immunochemical test in cancer screening - colonoscopy outcome in FIT positives and negatives. Scandinavian Journal of Gastroenterology 2019;54(3):303-10. - PubMed
Robinson 1996 {published data only}
    1. Robinson MH, Marks CG, Farrands PA, Bostock K, Hardcastle JD.Screening for colorectal cancer with an immunological faecal occult blood test: 2-year follow-up. British Journal of Surgery 1996;83(4):500-1. - PubMed
Sieg 2002 {published data only}
    1. Sieg A, Wirth A, Luthgens K, Schmidt-Gayk H.Six years of screening for colorectal neoplasms with an immunological fecal occult hemoglobin test. Verdauungskrankheiten 2002;20:114-7.
Siripongpreeda 2016 {published data only}
    1. Siripongpreeda B, Mahidol C, Dusitanond N, Sriprayoon T, Muyphuag B, Sricharunrat T, et al.High prevalence of advanced colorectal neoplasia in the Thai population: a prospective screening colonoscopy of 1,404 cases. BMC Gastroenterology 2016;16:101. - PMC - PubMed
Sohn 2005 {published data only}
    1. Sohn DK, Jeong SY, Choi HS, Lim SB, Huh JM, Kim DH, et al.Single immunochemical fecal occult blood test for detection of colorectal neoplasia. Cancer Research and Treatment 2005;37(1):20-3. - PMC - PubMed
Steele 2009 {published data only}
    1. Steele RJ, McClements PL, Libby G, Black R, Morton C, Birrell J, et al.Results from the first three rounds of the Scottish demonstration pilot of FOBT screening for colorectal cancer. Gut 2009;58(4):530-5. - PubMed
Sung 2003 {published data only}
    1. Sung JJ, Chan FK, Leung WK, Wu JC, Lau JY, Ching J, et al.Screening for colorectal cancer in Chinese: comparison of fecal occult blood test, flexible sigmoidoscopy, and colonoscopy. Gastroenterology 2003;124(3):608-14. - PubMed
Van Roon 2013 {published data only}
    1. Van Roon AH, Goede SL, Van Ballegooijen M, Van Vuuren AJ, Looman CW, Biermann K, et al.Random comparison of repeated faecal immunochemical testing at different intervals for population-based colorectal cancer screening. Gut 2013;62(3):409-15. [PMID: ] - PubMed
Wong 2014 {published data only}
    1. Wong MC, Ching JY, Chan VC, Shum JP, Lam TY, Luk AK, et al.Should prior FIT results be incorporated as an additional variable to estimate risk of colorectal neoplasia? A prospective study of 5,813 screening colonoscopies. PloS One 2014;9(12):e114332. - PMC - PubMed
Wu 2014 {published data only}
    1. Wu T, Kuo K, Wu Y, Lin K.Diagnostic accuracy of a single qualitative immunochemical fecal occult blood test coupled with physical measurements. Chinese Medical Journal 2014;127(24):4164-70. - PubMed
Zorzi 2018 {published and unpublished data}
    1. Zorzi M, Hassan C, Capodaglio G, Narne E, Turrin A, Baracco M, et al.Divergent long-term detection rates of proximal and distal advanced neoplasia in fecal immunochemical test screening programs: a retrospective cohort study. Annals of Internal Medicine 2018;169(9):602-9. - PubMed

References to studies excluded from this review

Allison 1996 {published data only}
    1. Allison JE, Tekawa IS, Ransom LJ, Adrain AL.A comparison of fecal occult-blood tests for colorectal-cancer screening. New England Journal of Medicine 1996;334(3):155-9. - PubMed
Brenner 2010a {published data only}
    1. Brenner G, Faure H, Reinholz J.Comparison of the guaiac-based test (g-FOBT) and the immunochemical test (i-FOBT) with the results of the screening colonoscopy in an asymptomatic population. Verdauungskrankheiten 2010;28.
Brenner 2010b {published data only}
    1. Brenner H, Haug U, Hundt S.Sex differences in performance of fecal occult blood testing. American Journal of Gastroenterology 2010;105(11):2457-64. - PubMed
Brenner 2014 {published data only}
    1. Brenner H, Hoffmeister M, Birkner B, Stock C.Diagnostic performance of guaiac-based fecal occult blood test in routine screening: state-wide analysis from Bavaria, Germany. American Journal of Gastroenterology 2014;109(3):427-35. - PubMed
Castiglione 1996 {published data only}
    1. Castiglione G, Zappa M, Grazzini G, Mazzotta A, Biagini M, Salvadori P, et al.Immunochemical vs guaiac faecal occult blood tests in a population-based screening programme for colorectal cancer. British Journal of Cancer 1996;74(1):141-4. - PMC - PubMed
Castiglione 2000 {published data only}
    1. Castiglione G, Zappa M, Grazzini G, Rubeca T, Turco P, Sani C, et al.Screening for colorectal cancer by faecal occult blood test: comparison of immunochemical tests. Journal of Medical Screening 2000;7(1):35-7. - PubMed
Chiu 2015 {published data only}
    1. Chiu HM, Chen SL, Yen AM, Chiu SY, Fann JC, Lee YC, et al.Effectiveness of fecal immunochemical testing in reducing colorectal cancer mortality from the One Million Taiwanese Screening Program. Cancer 2015;121(18):3221-9. - PMC - PubMed
Crotta 2004 {published data only}
    1. Crotta S, Castiglione G, Grazzini G, Valle F, Mosconi S, Rosset R.Feasibility study of colorectal cancer screening by immunochemical faecal occult blood testing: results in a northern Italian community. European Journal of Gastroenterology and Hepatology 2004;16(1):33-7. - PubMed
Cubiella 2014 {published data only}
    1. Cubiella J, Castro I, Hernandez V, Gonzalez-Mao C, Rivera C, Iglesias F, et al.Diagnostic accuracy of fecal immunochemical test in average- and familial-risk colorectal cancer screening. United European Gastroenterology Journal 2014;2(6):522-9. [PMID: ] - PMC - PubMed
Cummings 1986 {published data only}
    1. Cummings KM, Michalek A, Tidings J, Herrera L, Mettlin C.Results of a public screening program for colorectal cancer. New York State Journal of Medicine 1986;86(2):68-72. - PubMed
Dancourt 2008 {published data only}
    1. Dancourt V, Lejeune C, Lepage C, Gaillaird MC, Meny B, Faivre J.Immunochemical faecal occult blood tests are superior to guaiac-based tests for the detection of colorectal neoplasms. European Journal of Cancer 2008;44(15):2254-8. - PubMed
Elferink 2018 {published data only}
    1. Elferink MA, Toes-Zoutendijk E, Vink GR, Lansdorp-Vogelaar I, Meijer GA, Dekker E, et al.National population screening for colorectal carcinoma in the Netherlands: results of the first years since the implementation in 2014. Nederlands Tijdschrift voor Geneeskunde 2018;162:D2283. - PubMed
Faivre 2012 {published data only}
    1. Faivre J, Dancourt V, Denis B, Dorval E, Piette C, Perrin P, et al.Comparison between a guaiac and three immunochemical faecal occult blood tests in screening for colorectal cancer. European Journal of Cancer 2012;48(16):2969-76. - PubMed
Fraser 2006 {published data only}
    1. Fraser CG, Matthew CM, Mowat NA, Wilson JA, Carey FA, Steele RJ.Immunochemical testing of individuals positive for guaiac faecal occult blood test in a screening programme for colorectal cancer: an observational study. Lancet Oncology 2006;7(2):127-31. - PubMed
Gies 2018 {published data only}
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Hardcastle 1996 {published data only}
    1. Hardcastle JD, Chamberlain JO, Robinson MH, Moss SM, Amar SS, Balfour TW, et al.Randomised controlled trial of faecal-occult-blood screening for colorectal cancer. Lancet 1996;348(9040):1472-7. - PubMed
Hoff 2004 {published data only}
    1. Hoff G, Grotmol T, Thiis-Evensen E, Bretthauer M, Gondal G, Vatn MH.Testing for faecal calprotectin (PhiCal) in the Norwegian Colorectal Cancer Prevention trial on flexible sigmoidoscopy screening: comparison with an immunochemical test for occult blood (FlexSure OBT). Gut 2004;53(9):1329-33. - PMC - PubMed
Hol 2010 {published data only}
    1. Hol L, Van Leerdam ME, Van Ballegooijen M, Van Vuuren AJ, Van Dekken H, Reijerink JC, et al.Screening for colorectal cancer: randomised trial comparing guaiac-based and immunochemical faecal occult blood testing and flexible sigmoidoscopy. Gut 2010;59(1):62-8. - PubMed
Hundt 2009 {published data only}
    1. Hundt S, Haug U, Brenner H.Comparative evaluation of immunochemical fecal occult blood tests for colorectal adenoma detection. Annals of Internal Medicine 2009;150(3):162-9. - PubMed
Jørgensen 2002 {published data only}
    1. Jørgensen OD, Kronborg O, Fenger C.A randomised study of screening for colorectal cancer using faecal occult blood testing: results after 13 years and seven biennial screening rounds. Gut 2002;50(1):29-32. - PMC - PubMed
Ko 2003 {published data only}
    1. Ko CW, Dominitz JA, Nguyen TD.Fecal occult blood testing in a general medical clinic: comparison between guaiac-based and immunochemical-based tests. American Journal of Medicine 2003;115(2):111-4. - PubMed
Libby 2018 {published data only}
    1. Libby G, Fraser CG, Carey FA, Brewster DH, Steele RJ.Occult blood in faeces is associated with all-cause and non-colorectal cancer mortality. Gut 2018;67(12):2116-23. - PMC - PubMed
Mandel 1993 {published data only}
    1. Mandel JS, Bond JH, Church TR, Snover DC, Bradley GM, Schuman LM, et al.Reducing mortality from colorectal cancer by screening for fecal occult blood. New England Journal of Medicine 1993;328(19):1365-71. - PubMed
Mandel 2000 {published data only}
    1. Mandel JS, Church TR, Bond JH, Ederer F, Geisser MS, Mongin SJ, et al.The effect of fecal occult-blood screening on the incidence of colorectal cancer. New England Journal of Medicine 2000;343(22):1603-7. - PubMed
Oort 2010 {published data only}
    1. Oort FA, Terhaar Sive Droste JS, Van der Hulst RW, Van Heukelem HA, Loffeld RJ, Wesdorp IC, et al.Colonoscopy-controlled intra-individual comparisons to screen relevant neoplasia: faecal immunochemical test vs. guaiac-based faecal occult blood test. Alimentary Pharmacology and Therapeutics 2010;31(3):432-9. - PubMed
Quintero 2012 {published data only}
    1. Quintero E, Castells A, Bujanda L, Cubiella J, Salas D, Lanas Á, et al.Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening. New England Journal of Medicine 2012;366(8):697-706. - PubMed
Scholefield 2002 {published data only}
    1. Scholefield JH, Moss S, Sufi F, Mangham CM, Hardcastle JD.Effect of faecal occult blood screening on mortality from colorectal cancer: results from a randomised controlled trial. Gut 2002;50(6):840-4. - PMC - PubMed
Steele 2013 {published data only}
    1. Steele RJ, McDonald PJ, Digby J, Brownlee L, Strachan JA, Libby G, et al.Clinical outcomes using a faecal immunochemical test for haemoglobin as a first-line test in a national programme constrained by colonoscopy capacity. United European Gastroenterology Journal 2013;1(3):198-205. - PMC - PubMed
Van Rossum 2008 {published data only}
    1. Van Rossum LG, Van Rijn AF, Laheij RJ, Van Oijen MG, Fockens P, Van Krieken HH, et al.Random comparison of guaiac and immunochemical fecal occult blood tests for colorectal cancer in a screening population. Gastroenterology 2008;135(1):82-90. - PubMed
Winawer 1980 {published data only}
    1. Winawer SJ, Andrews M, Flehinger B, Sherlock P, Schottenfeld D, Miller DG.Progress report on controlled trial of fecal occult blood testing for the detection of colorectal neoplasia. Cancer 1980;45(12):2959-64. - PubMed
Zorzi 2011 {published data only}
    1. Zorzi M, Fedato C, Grazzini G, Stocco FC, Banovich F, Bortoli A, et al.High sensitivity of five colorectal screening programmes with faecal immunochemical test in the Veneto Region, Italy. Gut 2011;60(7):944-9. - PubMed

References to studies awaiting assessment

Cheng 2021 {published data only}
    1. Cheng WC, Chen PJ, Kang JW, Chen WY, Sheu BS.Age, male sex, smoking and metabolic syndrome as risk factors of advanced colorectal neoplasia for fecal immunochemical test negative patients. Journal of the Formosan Medical Association 2021;S0929-6646(21)00240-0.:Online ahead of print.. - PubMed

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