Analysis of clinical specimens to obtain information about the health of a patient.

Data Element

Information from the submission form

Test Kit Unique Identifier

Uniquely identifies the type of test (at minimum by using test name and manufacturer (similar to the make and model of a car)) that was used to obtain the Test Result Value. It is a device identifier and should be referenced using Device Identifiers (DI), when available. The DI is contained within the unique device identifier (UDI), created by manufacturer (Manufacturer requests UDI issuance, then provides DI, or can be pulled from GUDID database (


APHL Comments on ISA 2022

In order to better support the use of lab results from different laboratories in a patient’s record, research or for public health use for tests that are not harmonized against an international standard, this data element is essential to understanding equivalence of results and APHL supports inclusion of this data element in the Laboratory class of USCDI V4

Level 2 Data Element: Test Kit Unique Identifier

While valuable, IMO questions the capability of ONC certified HIT to store and exchange the Level 2 Data Element detailed in this submission While many of these data elements are implemented in CLIA for routine exchange between labs and state, tribal, local, or territorial (STLT) public health agencies, we request that this submission be reviewed thoroughly for implementation in ONC certified HIT.

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