Screening The Program screening test 3.1 Measured test performance demonstrates a high degree of characteristics demonstrate: accuracy for the early detection of high validity, colorectal cancer and advanced requisite test specificity and adenomas in the target screening sensitivity, population. positive predictive and negative predictive value, consistent with international evidence and where possible, Australian population The screening test and its analysis clinical trials. are effective, safe and acceptable; 3.2 The screening test is included in and effective screening is the Australian Register of Therapeutic supported by appropriate program Goods. design 3.3 The screening test is monitored to ensure that it is performing within the parameters provided by the test manufacturer and agreed by the Program. 3.4 Program policy and design supports optimised test performance. 3.5. Emerging technologies for population screening are monitored and evaluated (as required) by Health. The screening test instructions are 3.6 The screening test instructions, suitable for the eligible population including sample temperature stability, and varying literacy levels. postage instructions and consent are simple and clear. 3.7 The screening test instructions are supported by a pathology helpline that provides and accurate information and support and access to interpreting services. 3.8 The screening test instructions are available in different languages. 3.9 Alternative instruction formats are available for people with low literacy levels. 3.10 Suitability of the screening test instructions are evaluated regularly for * QRA 3 incorporates care’ acceptability by identified eligible ‘usual and Program operation participant groups.
Screening The screening test and its analysis are effective, safe and acceptable; and effective screening is supported by appropriate program design * QRA 3 incorporates ‘usual care’ and Program operation The Program screening test demonstrates a high degree of accuracy for the early detection of colorectal cancer and advanced adenomas in the target screening population. 3.1 Measured test performance characteristics demonstrate: high validity, requisite test specificity and sensitivity, positive predictive and negative predictive value, consistent with international evidence and where possible, Australian population clinical trials. 3.2 The screening test is included in the Australian Register of Therapeutic Goods. 3.3 The screening test is monitored to ensure that it is performing within the parameters provided by the test manufacturer and agreed by the Program. 3.4 Program policy and design supports optimised test performance. 3.5. Emerging technologies for population screening are monitored and evaluated (as required) by Health. The screening test instructions are suitable for the eligible population and varying literacy levels. 3.6 The screening test instructions, including sample temperature stability, postage instructions and consent are simple and clear. 3.7 The screening test instructions are supported by a pathology helpline that provides and accurate information and support and access to interpreting services. 3.8 The screening test instructions are available in different languages. 3.9 Alternative instruction formats are available for people with low literacy levels. 3.10 Suitability of the screening test instructions are evaluated regularly for acceptability by identified eligible participant groups.