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clinical specificity (for newborn screening) the proportion of newborns in the screened population who do not have the target disease and who have negative screening results NOTE 1: The clinical disease must be defined by criteria independent of the test under consideration; NOTE 2: The term “clinical specificity” (United States) is equivalent to “diagnostic specificity” (Europe); NOTE 3: Specificity = d / (b + d), for which b = false-positive screening results and d = true-negative screening results; see table in screening outcome; NOTE 4: “Clinical specificity” is not the same as “analytical specificity”; NOTE 5: See positive predictive value. Alternate Term: diagnostic specificity Project: NBS11, NBS09, NBS10, NBS12 Source: Newborn Screening Glossary
| clinical specificity the ability of a test under study to give a negative result for subjects not having the disease in question or the ability of the test to correctly identify the absence of the disease at a particular decision threshold (ie, a negative result and idenification of patients who do not have a disease) (Centers for Disease Control and Prevention. Diagnostic Sensitivity and Specificity Job Aid. Accessed 12 April 2023. https://www.cdc.gov/labtraining/docs/job_aids/additional_resources/Sensitivity_and_Specificity_Final_5_23_2022_508.pdf) NOTE 1: Also known as diagnostic specificity (positive predictive value); NOTE 2: Clinical specificity refers to the assay’s ability to discriminate subjects who do not have the condition or disease from those who have the condition or disease; NOTE 3: It is the fraction of clinically true-negative classifications divided by the sum of clinically true-negative plus clinically false-positive classifications; NOTE 4: In laboratory testing, the ability of a test to give a negative result for patients who do not have the disease or condition for which they are being tested. It is measured as the ratio of negative tests to the total number of tests in those who do not have the disease or condition, and expressed as a percentage; NOTE 5: The term “clinical specificity” (United States) is equivalent to “diagnostic specificity” (Europe). Alternate Term: diagnostic specificity (positive predictive value) Project: I/LA28, MM20, MM26
| clinical specificity the proportion of patients who do not have a specified clinical disorder whose test results are negative or within the defined decision limit NOTE 1: The term clinical specificity (United States) is equivalent to diagnostic specificity (Europe); NOTE 2: Proportion of truly nondiseased persons who are so identified by the screening test. It is a measure of the probability of correctly identifying a nondiseased person with a screening test. Specificity = d / (b + d) where b = a false-positive result and d = a true-negative result; NOTE 3: Also referred to as “diagnostic specificity” (proportion of truly nondiseased persons who are so identified by the screening test); NOTE 4: Clinical specificity is measured as the ratio of negative test results in individuals without the target condition and is often expressed as a percentage; NOTE 5: The condition or characteristic of interest must be defined by criteria independent of the test under consideration. Alternate Term: diagnostic specificity Project: MM07, H62
| diagnostic specificity the ability of a test to give a negative result for patients who do not have the disease or condition for which they are being tested NOTE: It is measured as the ratio of negative tests to the total number of tests in those that do not have the disease or condition and is expressed as a percentage. Project: M55
| diagnostic specificity the ability of a measurement procedure to give a negative result for subjects who do not have the disease or condition for which they are being measured NOTE: In the context of EP33, diagnostic specificity refers to the ability of a delta check rule to correctly exclude patient samples that do not have identification or integrity issues, and correctly exclude samples from patients who do not have clinically important changes in their conditions. Project: EP33
| diagnostic specificity the proportion of subjects who do not have a specified clinical disorder (or condition of interest) whose test results are negative or within the defined decision limit NOTE 1: It is the fraction of clinically true-negative classifications divided by the sum of clinically true-negative plus clinically false-positive classifications; NOTE 2: This term is equivalent to the US term “clinical specificity”; NOTE 3: In laboratory testing, the ability of a test to give a negative result for patients who do not have the disease or condition for which they are being tested. It is measured as the ratio of negative tests to the total number of tests in those who do not have the disease or condition and expressed as a percentage; NOTE 4: In Europe, the term “clinical” applies mostly to clinical studies of drugs, under much more stringent conditions; NOTE 5: Diagnostic sensitivity pertains to test results rather than analytical measurements; NOTE 6: For purposes of continuous glucose monitoring, diagnostic specificity refers to effectiveness of detection of the absence of hypoglycemia or hyperglycemia. Specificity = true negatives/(true negatives + false positives); NOTE 7: The probability (P) that the test is negative (T−), given that the subject being tested is disease free (D−), ie, P(T− | D−); or, the ability of a test under study to give a negative result for subjects not having the disease in question; NOTE 8: The term “clinical specificity” (United States) is equivalent to “diagnostic specificity” (Europe). Project: I/LA21, I/LA23, MM10, MM03, MM12, C50, MM17, I/LA28, H60, MM23 Related Term(s):
specificity
ability of a measurement procedure to measure solely the measurand (modified from ISO 17511) clinical specificity
the proportion of subjects who do not have a specified clinical disorder whose test results are negative or within the defined decision limit analytical specificity
ability of a measurement procedure to determine solely the measurable quantity it purports to measure (modified from ISO 17511) specificity
ability of a test or procedure to correctly identify or quantify an entity in the presence of interfering phenomena/influence quantities; the ability of a measurement procedure to measure solely the measurand
| diagnostic specificity as used in CLSI document I/LA02, the ability of a test to correctly identify samples in which antinuclear antibodies are absent NOTE: Specificity for antinuclear antibodies is ideally determined by testing a panel of serum samples previously determined to be negative to antinuclear antibodies by an accepted reference method or consensus evaluation. This serum panel should reflect samples from a variety of disease states as well as normal samples. Project: I/LA02
| diagnostic specificity as used in I/LA34, the ability of a test to correctly identify samples in which allergen-specific immunoglobulin E antibody is absent; it correlates the absence of allergen-specific immunoglobulin E antibody in the serum of patients who are defined by clinical criteria and/or designated reference laboratory tests as truly not allergic NOTE: Specificity for immunoglobulin E antibody is ideally determined by testing a panel of serum samples from subjects with a negative history of allergic disease and evidence of the absence of immunoglobulin E antibody positivity by an alternative accepted method such as skin testing, provocation testing, and/or an accepted reference serology method (provided its sensitivity and specificity are known). The serum panel should reflect patients from a variety of allergic disease states relevant to that allergen specificity as positive controls as well as healthy nonatopic negative controls. Alternate Term: clinical specificity Project: I/LA34
| diagnostic specificity the ability of a measurement procedure under study to give a negative result for subjects not having the disease/target condition in question NOTE: Formerly, the term “clinical specificity” was used in CLSI documents. Project: EP19, I/LA20
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