Table 1.

Diagnostic parameters analyzed during the development and clinical validation

Diagnostic parameter	Definition
Analytical sensitivity/limit of detection	Lowest concentration of the analyte that can be reliably detected by the assay.
Analytical specificity	Ability of the assay of not cross‐reacting with other pathogens.
Clinical sensitivity	Probability the test is positive when the infection is present.
Clinical specificity	Probability the test is negative when the infection is absent.
Positive likelihood ratio	Ratio between the probability of an infected person testing positive and the probability of an uninfected person testing positive.
Negative likelihood ratio	Ratio between the probability of an infected person testing negative and the probability of an uninfected person testing negative.
Positive predictive value (PPV)	Probability that the pathogen is present when the test result is positive.
Negative predictive value (NPV)	Probability that the pathogen is absent when the test result is negative.
Repeatability	Agreement between results of replicates of a sample both within and between runs of the same test in the same laboratory.
Reproducibility	Agreement between results of patient specimens assayed in different laboratories.
Robustness	Ability of the test to remain unaffected by minor variations that may occur during the testing process.
Accuracy	Overall probability that the patient is correctly diagnosed by the test.