Test Classifications

 

Analytical tests offered by UnityPoint Health - Des Moines are classified according to the FDA status of the test kit or reagent and to their usage. A test is classified as either FDA cleared, approved, or exempt, or as a laboratory developed test (LDT). Where appropriate, analytical test listings contain a statement regarding the test classification, test development, and performance characteristics of the test.

The U.S. Food and Drug Administration (FDA) reviews and approves tests for "In Vitro Diagnostic Use." Clinical diagnostic tests that do not have FDA clearance or approval must meet validated performance specifications as required by Clinical Laboratory Improvement Amendment of 1988 (CLIA).   Where appropriate, the following statement is appended to test results, "This test was developed, and its performance characteristics determined by UnityPoint Health - Des Moines. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes."   

To identify tests, UnityPoint Health - Des Moines uses the following categories:  

Standard

For tests that use a standard method, which is universally applied across laboratories and has an established record of reliability and clinical validity.

FDA

For tests that use an in vitro diagnostic (IVD) that has been cleared or approved by the FDA.  

Modified FDA

For tests that use an FDA approved/cleared/exempt IVD that has been modified from the manufacturer's instructions.  

Laboratory Developed Test (LDT)

For tests developed and validated by UnityPoint Health - Des Moines. 

Analyte Specific Reagent (ASR)

For tests using a manufacturer labeled Analyte Specific Reagent (ASR) as the reagent providing the specificity of the assay. 

Research Use Only (RUO)

For tests using a manufacturer labeled Research Use Only as the reagent providing the specificity of the assay. 

Emergency Use Authorization (EUA)

For tests that use an IVD authorized by the FDA for Emergency Use.