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Innovacon Flipcard Fecal Occult Blood Test Device

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Last Updated: 18 January 2022

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General | Latest Info

Policy Grade: Effective 02 / 06 / 2013: Active Policy but No schedule for regular literature reviews and updates. Immunochemical Fecal Occult Blood Tests are proposed for Colorectal Cancer Screening as alternative to Guaiac-base FOBT. IFOBT does not have dietary or drug restrictions prior sample collection, and possibly simpler sampling instructions, WHICH May LEAD to higher patient compliance. Colorectal cancers and some adenomas often bleed periodically. Consequently, small amount of blood on stool in absence of other explanatory conditions is marker for Neoplasia. Immunochemical Fecal Occult Blood Tests are used for Colorectal Cancer Screening by employing antibodies to detect globin portion of human hemoglobin in stool. Because globin is degrade during passage through upper gastrointestinal tract, IFOBT is specific for bleeding that is limited to colon and rectum. Guaiac Fecal Occult Blood Testing has been standard test used for Screening but requires complicated dietary and drug restrictions prior to testing and sampling instructions may limit patient compliance. IFOBTs offer testing without dietary or drug restrictions and May offer sampling instructions. IFOBTs approved by US Food and Drug Administration for marketing in United States are InSure, Instant-View, immoCARE, and MonoHaem Tests require sample collection from 1 stool, 2 stools, or 3 stools. Test formats for several iFOBTs minimal processing and involve developing Test strip WITH controls and reading color reaction. In case of InSure IFOBT, all tests are developed by Quest Diagnostic Laboratories through exclusive arrangement. For InSure, dry stool specimen is not require, and sample may be collected by brushing surface of stool while in toilet bowl water WHICH may be more reasonable for patient. Number Of Additional IFOBTs Have Been Cleared Through FDA 510 Process. Some of these include Hema-Screen Specific, innovacon Flipcard Fecal Occult Blood Test, OC Auto Micro Test, FlexSure OBT, TECO Rapid FOB Card Test, QuickVue and InSure II. In addition, iScreen FOB is noted to be cleared by FDA and waived Under Clinical Laboratory Improvement Amendments, thus available for point-of-Care Testing. Immunoassay / Fecal Occult Blood Tests, for routine physical examination and in Screening for Colorectal Cancer or other sources of lower gastrointestinal bleeding may be considered medically necessary. Also refer to medical 447 Preventive Care Services Under Healthcare Reform for additional information. For health Care compliant plans, mandate provision of Services may apply. Please verify routine and screening benefits coverage for each contract. Per American Cancer Society, Colorectal Cancer is third most common cancer in both men and women. Screening for Colorectal Cancer in persons who at Average Risk for developing Colorectal Cancer should begin at age 50. Earlier and more frequent screening has been recommended for risk individuals. Currently available Screening methods for Colorectal Cancer include Occult Blood Test, Fecal Immunochemical Test, flexible sigmoidoscopy, double-contrast barium enema or gold standard colonoscopy.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Analytes Measured/Detected and Complexity:

CLIA legislation passed by Congress in 1988 was established to ensure accuracy, reliability, and timeliness of patient test results regardless of where test was perform. 17 FOBTs, both waive and complexity, are classified as class II devices. Waive tests are simple laboratory examinations and procedures that insignificant risk of erroneous result. 17 To perform waived tests, healthcare provider needs to have CLIA Certificate of Waiver. Moderate complexity tests have to be analyzed in certified pathology Laboratory. Class indicate intended use of device and risk device poses to patients, with class I being least risk and class III greatest risk. For class II tests, 510 applications to are required for clearance and then marketing. All certified pathology Laboratories are required to participate in PT program for all analytes they Test For. Centers For Medicare Medicaid Services, through CLIA, regulate approximately 252 000 Laboratory entities where FOBTs are analyze. 18 FDA requires 510 applications to be submitted prior marketing and selling of FOBTs. 510 must FOBT is substantially equivalent to device already legally market. Application submitters must compare their FOBT one or more similarly marketed devices to support their substantial equivalency claims. FDA then determines if data provides supports claim of substantial equivalence and categorizes FOBT as new device, substantially equivalent for marketing in United States, or as device modification. List on 510 are predicated device names and numbers, which indicate device is safe and effective / substantially equivalent to its predicate. Contrary to what one might see on company websites, FDA does not approve any FOBTs, but provides clearance after review 510 application.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Incidence, prevalence, survival

Schistosomiasis is neglect tropical disease caused by trematode parasites of genus Schistosoma. These parasites infect some 207 million worldwide, particularly in sub-Saharan Africa. 1 Globally, it estimated that schistosomiasis is responsible for 280 000 deaths per year and loss of 1. 53 million disability-adjust life years. 2 3 However, this latter figure is likely to be underestimated because schistosomiasis can cause variety of subtle and hidden morbidities that are difficult to capture within this metric and hard to measure directly in communities in which schistosomiasis is endemic. In sub-Saharan Africa, intestinal form of schistosomiasis is largely attributable to Schistosoma mansoni and causes spectrum of pathologic changes caused by detrimental reactions to eggs, produced by female worms, that have become trapped in host tissues. 2 For example, intestinal morbidity diarrhea, abdominal pain, intestinal granulomas and fibrosis, polyps and microulcerations, and colonic obstruction in extreme cases. 4-10 Perforation of intestinal mucosa by S. Mansoni eggs and colorectal polyps can cause release of blood into bowel, resulting in blood in feces and anemia if infections are heavy. 4 5 today, mass chemotherapy using anthelminthic drug praziquantel acts as cornerstone of all national schistosomiasis control programs. Up until now, main of these programs has been control of morbidity associated with schistosomiasis, rather than infections per se. 11 As consequence, school age children have been particularly target for mass chemotherapy because they are believed to have highest infection intensities and to respond to PZQ with greater reductions in morbidity. 12 However, it is becoming clear that younger children less than six years of age can also infected and treated safely with PZQ. 13 14 Despite fact that focus of national programs is on morbidity reduction, monitoring and evaluation of these programs is largely dependent on measuring infection intensities as proxy for morbidity. Thus, field-applicable morbidity markers are essential for defining initial disease burden and monitoring impact of preventive chemotherapy. Fecal occult blood, which refers to cryptic blood in feces, has been used for number of years as marker of intestinal pathologic changes, particularly in association with colorectal cancer. Number Of Point-of-care Tests Have Been Develop, 15 And, As Such, They Are Simple To Use And Provide Results In Minutes. Studies in Brazil, Zimbabwe, and Philippines using guaiac-base for detection of FOB have demonstrated positive correlation between FOB and intensity of S. Mansoni or S. Japonicum infection. 16-18 More recently, we reported strong association between FOB and S. Mansoni in baseline surveys of cohort of young children and their mothers. We then propose that FOB tests could used for measuring morbidity associated with intestinal schistosomiasis but further study of longitudinal dynamics is needed. 19 to extend this line of inquiry, 19 we have follow-up children in cohort for one year, investigating dynamics of FOB in face of preventive chemotherapy.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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