Report in English with a Dutch summary (KCE reports 45A)

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62 Screening for Colorectal Cancer KCE reports vol.45 that have not contacted toilet bowl water ( dry specimen collection ); specimens are then smeared on test cards that need to be developed afterwards. Nearly all FOBT manufacturers make analytical sensitivity claims (in vitro detection limits). The analytical sensitivity of a test represents the smallest amount of substance that can accurately be measured in a biological sample. Examples of these sensitivity claims from manufacturers product sheets are listed in Table 12. Table 12: in vitro detection limits of commercially available FOBTs Product Type Manufacturer In vitro detection limits Hemoccult® * Hemoccult® II * guaiac 50% at 300 µg Hb/gm feces Hemoccult® SENSA® * Hemoccult II® SENSA® * guaiac 75% at 300 µg Hb/gm feces Hemoccult® ICT (immuno) ** immuno Beckman Coulter Inc. ~30 µg human Hb/gm feces FlexSure® OBT ** immuno 300 µg human Hb/gm feces Magstream HemSp ® ** immuno 300 µg human Hb/gm feces Instant-View® FOBT II immuno Alpha Scientific Desings 50 µg human Hb/gm *** Inc. feces InSure® ** immuno Enterix, Inc. 50 µg human Hb/gm feces ImmoCARE® ** ColonCARE® ** immuno Care Products, Inc. 30 µg human Hb/gm feces HemeSelect® ** Immudia HemSp ® ** immuno Fujirebio (Japan) immuno 300 µg human Hb/gm feces OC-Hemodia® ** immuno Eiken Chemical (Japan) 40 µg human Hb/gm feces MonoHaem® ** Nihon Pharmaceuticals ~1 - 2 mg Hb/gm feces immuno (Japan) Chemicon International, Inc. Sure Vue® * guaiac Fisher Scientific Co. Inc. 10 mg Hb/gm feces Coloscreen® ES * guaiac Helena Laboratories Inc. ~ 0,3 mg Hb/gm feces Sure Vue® ES * guaiac Fisher Scientific Co. Inc. ~ 0,3 mg Hb/gm feces HemaPrompt® * guaiac Aerscher Diagnostics Inc. 2 mg Hb/gm feces Hemostick®**** immuno Ventec S.A. (Belgium) ~ 100 µg human Hb/gm feces Actim Fecal Blood®***** immuno Medix Biochemica (FN) 25-50 µg human Hb/gm faeces Hemoccult® and Hemoccult II® are similar except for card design; Hemoccult® is now discontinued. Sources: * http://www.hemoccultfobt.com/healthcare/health_products.htm ** Blue Cross and Blue Shield Association http://www.bsbs.com *** http://www.meditechinternational.com/instant_cancerCE.html **** Ventec S.A. Av. Du Pré Aily 10, 4031 Angleur - tel: 04/361 42 32 ***** Lucron Bioproducts B.V.B.A. Willemsdorp 2 B-9840 De Pinte The observation that colorectal neoplasms and polyps do not bleed continuously has been the basis for the standard testing procedure for guaiac tests, whereby two samples of fecal matter are applied to the test kit on three consecutive days, leading to 6 samples to be studied. Hemoccult II slides come

KCE reports vol.45 Screening for Colorectal Cancer 63 in an all in patient kit with 3 double windowed specially prepared, stabilized guaiac test cards, 6 stool spatulae and a vial with hydrogen peroxide developer. They are designed for patients to easily collect serial specimens at home from bowel movements over three days. After the patient prepares the Hemoccult II test, it may be returned in person or by mail to the laboratory, hospital or medical office for development and interpretation. Hemoccult II Sensa is a guaiac based but more sensitive and more readable test than Hemoccult II. However, there is no consensus on the number of those samples that need to be positive to call the test round positive. Different trials used different positivity thresholds, inevitably leading to different test characteristics in terms of sensitivity and specificity. Although gFOBT can in theory detect bleeding from any part of the alimentary tract, it is somewhat more selective for the large bowel over the upper gastrointestinal tract. False positives can occur with gFOBTs as a result of dietary factors and ingestion of certain medications. Non-human hemoglobins from meat, other dietary components with peroxidase activity (e.g., radishes, turnips, broccoli, spinach, ), and bleeding due to medications (e.g., salicylates) may give false-positive results, whereas an excess of vitamin C may give falsenegative results 270. Therefore, dietary and drug restrictions are often recommended prior to sampling (table 13), although there is little evidence that these precautions are required 195. Moreover, there are concerns whether such restriction also reduces the probability that patients will complete the test 206, thus endangering optimal patient adherence to the screening program. Table 13: Recommended drug and diet guidelines with guaiac FOBTs Drug Guidelines For seven days before and during the stool collection period, avoid non-steroidal antiinflammatory drugs such as ibuprofen, indomethacin, naproxen or aspirin (more than one adult aspirin a day) as well as corticosteroids, phenylbutazone, reserpine, anticoagulants, anti-metabolites, and cancer chemotherapeutic drugs. Acetaminophen can be taken as needed. For three days before and during the stool collection period, avoid vitamin C in excess of 250 mg a day from supplements, and citrus fruits and juices. Avoid alcohol in excess and the application of antiseptic preparations containing iodine (povidone/iodine mixture) Diet Guidelines For three days before and during stool collection period, avoid red meats (beef, lamb and liver). Eat a well balanced diet including fibre such as bran cereals, fruits and vegetables, but avoid radishes, turnips, broccoli, spinach, citrus fruits and juices. Source: http://www.hemoccultfobt.com/docs/PI_HOS_462489.E-web.pdf Some reports suggest that delaying development of Hemoccult cards for at least three days will decrease the number of false positives caused by plant peroxidases and obviate the need for diet restriction of fruits and vegetables 254. In their position paper on the interpretation and follow-up of FOBTs, Ransohoff and Lang 195 argue that any person with a positive result who did not restrict diet or medications pre-test should still undergo diagnostic work-up, rather than resubmitting repeat FOBTs after diet and medication restrictions. Likewise, the American Cancer Society likewise states that there is no justification for repeating fecal occult blood test in response to an initial positive finding 56.

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