Evaluation of Rapid Diagnostic Test Performance

Rapid diagnostic tests are used for the determination of binary qualitative results not only uniquely in nonhospital-based but also in hospital-based tests. Principally, in developing countries, rapid diagnostic tests are the primary option since tests to be used in medical laboratories are discarded due to the higher cost. The test’s performance is evaluated to assure that the chance of results to be false is clinically acceptable. Therefore, the diagnostic accuracy of results (diagnostic sensitivity and specificity) is assessed to guarantee the safety of postclinical decision. The statistical approach requires that representative samplings of the populations of infected and healthy individuals are tested. The area under the receiver-operating characteristic (ROC) curve is a complementary measurement using the same samplings. It represents the diagnostic accuracy in a single outcome. When samplings with known diagnostics are unavaila‐ ble, samplings with known outcomes from a comparative test are used to determine the agreement of results. However, this approach is secondary, due to diagnostic accura‐ cy to be unmeasurable. The seronegative period is another critical measurement that allows determining an individual biological bias during a period where results of an infected individual are false-negatives due to seroconversion. The claimed require‐ ments should be defined for diagnostic accuracy and agreement outcomes. A spread‐ sheet is used to estimate the results considering the absolute value and the 95% confidence interval.