Regulation of Laboratory Developed Tests

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Scope of Reviews

Molecular Microbiology-nucleic acid amplification assays

http://www.wadsworth.org/labcert/TestApproval/forms/M

icrobiology_NAAT_Checklist.pdf

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Scope of Reviews Molecular Microbiology-nucleic acid amplification assays http://www.wadsworth.org/labcert/TestApproval/forms/M icrobiology_NAAT_Checklist.pdf

Scope of Reviews Molecular Microbiology-nucleic acid amplification assays Information Reviewed: •standard operating procedure manual (SOPM) •test requisitions and reports •pertinent literature references •summary of validation studies and supporting data •plans for carrying out proficiency testing

Page 1 and 2: Regulation of Laboratory Developed
Page 3 and 4: Wadsworth Center Clinical Laborator
Page 5 and 6: Part 58-1.10(g) of 10 NYCRR Assay A
Page 7 and 8: Assay Approval In the past 10 years
Page 9: Scope of Reviews Comprehensive Test
Page 13 and 14: Scope of Reviews Molecular Microbio
Page 15 and 16: Scope of Reviews Molecular Microbio
Page 17 and 18: Scope of Reviews Molecular Microbio
Page 19 and 20: Inter-assay reproducibility Scope o
Page 21 and 22: Assay Verification Scope of Reviews
Page 23 and 24: Scope of Reviews Molecular Microbio

Regulation of Laboratory Developed Tests

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