CP Specification

Used to further subset the cell population identified in CPTEST based on the use of additional marker(s) that define a sublineage. The value in CPSBMRKS is used in combination with values in CPTEST and CPCELSTA to fully describe the cell population being measured. As such, it is an essential component of the full test name.

For example, three unnamed sublineages of monocytes have been identified as: CCR2+CD16-, CCR2-CD16+, and CCR2+CD16+. Whereas the entire monocyte cell population can be defined as CD14+ cells, the additional CCR2 and CD16 markers are used to differentiate one sublineage from another. As none of these sublineages have been given names, they are only known by the CCR2 and CD16 marker combinations. By associating the CPTEST value of "Monocytes Sub" with, for example, a value of "CCR2+CD16-" in CPSBMRKS, the full test is defined to be the CCR2+CD16- monocyte subpopulation.

A textual description of a subset of the cell population identified in CPTEST based on a particular functional and/or biological state (e.g., "ACTIVATED", "PROLIFERATING", "SENESCENT"). When populated, the values in CPCELSTA and CPSMRKS, in combination with the values in CPTEST and CPSBMRKS, fully describe the cell population being measured.

Identifies the marker(s) or indicator(s) used to define the cell state (i.e., the value in CPCELSTA).

For example, when Ki67 expression is used to determine that a cell population is in a proliferating state (i.e., CPCELSTA value="PROLIFERATING"), the value "Ki67+" in CPCSMRKS indicates that positive expression of Ki67 was used to define the population as proliferating. Similarly, a value of "Ki67-" in CPCSMRKS would indicate that lack of expression of Ki67 defined the "NON-PROLIFERATING" cell state in CPCELSTA. The CPCSMRKS value is useful for quickly determining which marker(s) were used to classify (i.e., operationally define) a cell population based on a functional/biological state.

Identifies any planned condition imposed by the assay system on the specimen at the time the test is performed. --TSTCND is generally used to distinguish between two or more records where the same assay is performed under varying (as opposed to fixed) conditions, usually for the purpose of making a comparison. For example, when the same assay (identified in --TEST) is performed under stimulated and non-stimulated conditions, the --TSTCND variable is used distinguish between the records.

The textual description of the agent, if applicable, used to impose the condition identified in CPTSTCND. For example, records might be produced for the same assay run under stimulating (CPTSTCND value = "STIMULATED") conditions produced by different stimulating agents (e.g., phorbol myristate acetate, concanavalin A, PHA-P, TNF-alpha, Ionomycin, candida antigen).

The textual description of the agent that is binding to the entity in the CPTEST variable. The CPBDAGNT variable is used to indicate that there is a binding relationship between the entities in the CPTEST and CPBDAGNT variables, regardless of direction.

The binding agent may be, but is not limited to, a test article; a portion of a test article; a substance related to a test article; an endogenous molecule; an allergen; an infectious agent; or a reagent (e.g., primary antibody) that confers the binding specificity for the measurement defined in CPTEST when it is needed to uniquely identify the test.

Identifies the antibody clone (e.g., supplier-provided catalog name) used to confer specificity for the binding agent specified in CPBDAGNT.

The text string identifying the full set of markers/indicators used by the laboratory to operationally define the complete test based on the combination of CPTEST, CPSBMRKS, and CPCELSTA. Because laboratories often use different markers/indicators to identify a cell population, the relationship between a named cell population in CPTEST (as combined with CPSBMRKS and CPCELSTA values) and the set of markers used to identify that population is many-to-one. To ensure nuances important for accurately interpreting the data are accounted for and which arise from the use of different sets of markers, it is necessary to operationally define the test in terms of the complete set of markers/indicators used to perform that test.

The sponsor-defined name assigned to a gate. Gates are electronic (i.e., a device setting or software-defined) boundaries set by a user to virtually parse a specimen into discrete populations based on a set of defined characteristics (e.g., presence, absence, or intensity of expression of various markers; physical size; internal complexity or granularity). Gates are used to constrain data collection or analysis to a specific cell population or region of interest within the specimen.

The text string identifying the set of parameters and the order in which they are applied to define the gating strategy. In practice, a series of 2-dimensional sub-gates based on different cell characteristics (i.e., markers/indicators/physical properties) are most often combined until the cell population of interest is sufficiently resolved (i.e., electronically isolated) from other cell populations contained within the specimen.

For complex analyses, differences in gating strategies can produce subtle differences in results obtained for a test. To ensure nuances important for accurately interpreting the data are accounted for and which arise from the use of different gating strategies, it is often necessary to qualify the test in terms of the gating strategy. For some purposes, however, and at the discretion of the sponsor, only the ultimate or penultimate gate is identified. When specifying the gating strategy in CPGATDEF, each sub-gate should be listed in the order it was applied and separated from the next sub-gate using the pipe/vertical line ("|") character.

Sponsor's description of a test. The variable is intended to contain highly structured test description metadata used by a sponsor to unambiguously define (label) a test. Such values generally reside in a sponsor/laboratory test metadata repository. CPSPTSTD is not intended for unstructured (spontaneous) free text.

An example of appropriate usage is when it is necessary to include identifying information for a target cell population on which a test is conducted when the target population is not part of the test name, e.g., tests for quantitative expression of a particular marker on a specific cell population.

Sponsor-defined textual description used to group tests run together as part of a test panel. Can be used with --GRPID to ensure that relationships between associated tests are accurately identified.

Classifies the scale of the original result value with respect to whether the result is quantitative, ordinal, nominal, or narrative.

Classifies the kind of result (i.e., property type) originally reported for the test. Examples: "NUMBER CONCENTRATION", "NUMBER FRACTION", "RATIO".

Used to indicate the type of collected summary result. This includes source summary results collected on a CRF or provided by an external vendor (e.g., central lab). If the summary result is derived using individual source data records, this summary result should be represented in ADaM. If a sponsor has both a collected summary result and a derived summary result, the collected summary result should be represented in SDTM and the derived summary result should be represented in ADaM.