Appendix B:
Laboratory Developed Tests
(AXB)
Laboratory Developed Tests
The US Food and Drug Administration (FDA) defines Laboratory Developed Tests
(LDTs) as “a class of in vitro diagnostics that are manufactured, including being
developed and validated, and offered, within a single laboratory.”
Historically, the components of LDTs were individually regulated by the FDA as
Analyte Specific Reagents (ASRs) or other specific or general reagents. Today, many
LDTs use complex elements and sophisticated technologies that may not be FDA-
regulated. Because the FDA does not actively regulate them, LDTs that have not been
properly validated for their intended use can result in missed diagnoses, wrong
diagnoses, and failure to receive appropriate treatment for patients.
Laboratories performing LDTs are currently regulated by the Clinical Laboratory
Improvement Amendments of 1988 (CLIA '88) by both proficiency and quality control
testing requirements.
For laboratories performing LDTs, follow the standards listed in the Molecular Biology
column of the Standards Applicability Grid (SAG), in addition to the following:
■ DC.02.01.05
■ DC.02.01.07
■ EC.02.04.05
■ HR.01.02.03, EP 4
■ QSA.02.04.01
■ QSA.02.10.01, EP 6
■ QSA.02.10.01, EP 7
■ QSA.02.10.03
■ QSA.04.01.01
■ QSA.04.02.01
■ QSA.04.03.01
■ QSA.04.04.01
Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
CAMLAB Update 1, July 2024 AXB – 1
E-dition July 1, 2024, Release
◤Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing
■ QSA.04.05.01
■ QSA.04.06.01
■ QSA.09.01.01
■ QSA.09.02.01
■ QSA.09.03.01
■ QSA.09.03.03
■ QSA.09.03.05
■ QSA.09.04.01
■ QSA.09.05.01
■ QSA.09.06.01
■ QSA.09.07.01
■ QSA.09.07.03
■ QSA.17.01.01
■ QSA.17.01.03
■ QSA.17.02.01
■ QSA.21.01.01
■ QSA.21.02.01
■ QSA.21.03.01
■ QSA.21.04.01
Shading indicates a change effective July 1, 2024, unless otherwise noted in the What's New.
AXB – 2 CAMLAB Update 1, July 2024
E-dition July 1, 2024, Release
