I'd add that administering a test that the manufacturer has stipulated for use by children under the age of 4 to a child over that age goes against the terms of the Certificate of CLIA Waiver that your lab is operating under. Per CMS, "it is not acceptable for you to make changes to the current instructions provided with the test system. This could change the 'intended use' of the test system as approved by FDA and result in a test that is
no longer waived." This means "your laboratory is subject to an inspection and additional CLIA requirements," and the test results themselves could lead to "inaccurate results that may result in a misdiagnosis or delay in proper treatment of a patient." See
https://www.cms.gov/Regulations-and...IA/downloads/HowObtainCertificateofWaiver.pdf