Evaluation of Rapid Diagnostic Test Performance

Abstract

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 unavailable, samplings with known outcomes from a comparative test are used to determine the agreement of results. However, this approach is secondary, due to diagnostic accuracy 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 requirements should be defined for diagnostic accuracy and agreement outcomes. " spreadsheet is used to estimate the results considering the absolute value and the % confidence interval.

A multi‐center evaluation of TECHNOSCREEN® ADAMTS‐13 activity assay as a screening tool for detecting deficiency of ADAMTS‐13

“…The samples used encompassed a full spread of ADAMTS‐13 levels, including levels below and close to the 0.1 IU/mL threshold, and levels between that value and the lower limits of local reference ranges. All of the samples tested were from clinically relevant patients in whom TTP formed part of the differential diagnosis, or were from patients with established TTP at different stages of the disease and treatment, including acute presentation, thereby reducing spectrum bias 20 . As the screening test is read qualitatively to generate semiquantitative interpretations, it was not considered necessary or entirely feasible to calculate a reference range from a set of normal donors.…”

“…The goal of rapid tests is to expedite a clinical decision, so erroneous binary results can have a directly adverse effect. According to current good laboratory practice, rapid diagnostic test results should not be final results 20 and the TECHNOSCREEN ® ADAMTS‐13 activity manufacturer recommends in its literature that deficiency of ADAMTS‐13 activity identified in the screening tool should be confirmed with a quantitative assay. In terms of potential effects on immediate clinical decision making, the results on the 22 misclassified samples are revealing.…”

Accuracy of Dongjui analyzer for reducing the number of unnecessary urine cultures in an outpatient setting

“…1. The AUC for leukocyte counts was 0.753 (95% Cl, 0.642 to 0.862), compared with 0.581 (95% Cl, 0.438 to 0.725) for bacteria; showing acceptable discrimination power for UTI only for urine leukocyte count with a Dongjui DJ-8602 urinary sediment and chemistry analyzer (Table 2) [8].…”

“…Many manufacturers have developed fully automated, integrated urine analyzers [7]. Automated urinalyzers as a screening system to rule out UTI are evaluated by their diagnostic sensitivity, specificity, accuracy, and area under receiver-operating-characteristic (ROC) curve [8]. Some authors suggest that certain analyzers are controversial to screen urine for UTI [2,5].…”

Verification and validation of the anti-PD-L1 antibody, Clone 22C3on a laboratory-developed test

“…The results were analysed using positive per cent agreement (PPA), negative per cent agreement (NPA) and the overall per cent agreement (OPA) with the PD-L1 Autostainer Link 48 designated as the standard. The relevant formulae are as follows: OPA true0a+dN, PPA = true0aa+c, NPA = true0db+d 20…”