Illinois Statutes Chapter 410. Public Health § 240/3.4. Adrenoleukodystrophy

(1) the development and validation of a reliable methodology for screening newborns for ALD using dried blood spots and quality assurance testing methodology for such test or the approval of a test for ALD using dried blood spots by the federal Food and Drug Administration;

(2) the availability of any necessary reagents for such test;

(3) the establishment and verification of relevant and appropriate performance specifications as defined under the federal Clinical Laboratory Improvement Amendments and regulations thereunder for Federal Drug Administration-cleared or in-house developed methods, performed under an institutional review board approved protocol, if required;

(4) the availability of quality assurance testing and comparative threshold values for ALD;

(5) the acquisition and installment by the Department of the equipment necessary to implement the initial pilot and statewide volume of screening tests for ALD;

(6) the establishment of precise threshold values ensuring defined disorder identification for ALD;

(7) the authentication of pilot testing achieving each milestone described in items (1) through (6) of this Section for ALD; and

(8) the authentication of achieving the potential of high throughput standards for statewide volume of ALD concomitant with each milestone described in items (1) through (6) of this Section.