Dataset Information

Sensitivity, Specificity and Predictive Values of Molecular and Serological Tests for COVID-19: A Longitudinal Study in Emergency Room.

ABSTRACT: BACKGROUND:We assessed the sensitivity, specificity and positive and negative predictive value (PPV and NPV) of molecular and serological tests for the diagnosis of SARS-CoV-2 infection. METHODS:A total of 346 patients were enrolled in the emergency room. We evaluated three Reverse Transcriptase-real time PCRs (RT-PCRs) including six different gene targets, five serologic rapid diagnostic tests (RDT) and one ELISA. The final classification of infected/non-infected patients was performed using Latent Class Analysis combined with clinical re-assessment of incongruous cases. RESULTS:Out of these, 24.6% of patients were classified as infected. The molecular test RQ-SARS-nCoV-2 showed the highest performance with 91.8% sensitivity, 100% specificity, 100.0% PPV and 97.4% NPV respectively. Considering the single gene targets, S and RdRp of RQ-SARS-nCoV-2 had the highest sensitivity (94.1%). The in-house RdRp presented the lowest sensitivity (62.4%). The specificity ranged from 99.2% for in-house RdRp and N2 to 95.0% for E. The PPV ranged from 97.1% of N2 to 85.4% of E and the NPV from 98.1% of S to 89.0% of in-house RdRp. All serological tests had < 50% sensitivity and low PPV and NPV. VivaDiag IgM (RDT) had 98.5% specificity, with 84.0% PPV, but 24.7% sensitivity. CONCLUSION:Molecular tests for SARS-CoV-2 infection showed excellent specificity, but significant differences in sensitivity. Serological tests have limited utility in a clinical context.

SUBMITTER: Bisoffi Z

PROVIDER: S-EPMC7555224 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Sensitivity, Specificity and Predictive Values of Molecular and Serological Tests for COVID-19: A Longitudinal Study in Emergency Room.

Bisoffi Zeno Z Pomari Elena E Deiana Michela M Piubelli Chiara C Ronzoni Niccolò N Beltrame Anna A Bertoli Giulia G Riccardi Niccolò N Perandin Francesca F Formenti Fabio F Gobbi Federico F Buonfrate Dora D Silva Ronaldo R Silva Ronaldo R

Diagnostics (Basel, Switzerland) 20200903 9

<h4>Background</h4>We assessed the sensitivity, specificity and positive and negative predictive value (PPV and NPV) of molecular and serological tests for the diagnosis of SARS-CoV-2 infection.<h4>Methods</h4>A total of 346 patients were enrolled in the emergency room. We evaluated three Reverse Transcriptase-real time PCRs (RT-PCRs) including six different gene targets, five serologic rapid diagnostic tests (RDT) and one ELISA. The final classification of infected/non-infected patients was per ...[more]

PMID: 32899333

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Project description:BackgroundMachine learning (ML) can be an effective tool to extract information from attribute-rich molecular datasets for the generation of molecular diagnostic tests. However, the way in which the resulting scores or classifications are produced from the input data may not be transparent. Algorithmic explainability or interpretability has become a focus of ML research. Shapley values, first introduced in game theory, can provide explanations of the result generated from a specific set of input data by a complex ML algorithm.MethodsFor a multivariate molecular diagnostic test in clinical use (the VeriStrat® test), we calculate and discuss the interpretation of exact Shapley values. We also employ some standard approximation techniques for Shapley value computation (local interpretable model-agnostic explanation (LIME) and Shapley Additive Explanations (SHAP) based methods) and compare the results with exact Shapley values.ResultsExact Shapley values calculated for data collected from a cohort of 256 patients showed that the relative importance of attributes for test classification varied by sample. While all eight features used in the VeriStrat® test contributed equally to classification for some samples, other samples showed more complex patterns of attribute importance for classification generation. Exact Shapley values and Shapley-based interaction metrics were able to provide interpretable classification explanations at the sample or patient level, while patient subgroups could be defined by comparing Shapley value profiles between patients. LIME and SHAP approximation approaches, even those seeking to include correlations between attributes, produced results that were quantitatively and, in some cases qualitatively, different from the exact Shapley values.ConclusionsShapley values can be used to determine the relative importance of input attributes to the result generated by a multivariate molecular diagnostic test for an individual sample or patient. Patient subgroups defined by Shapley value profiles may motivate translational research. However, correlations inherent in molecular data and the typically small ML training sets available for molecular diagnostic test development may cause some approximation methods to produce approximate Shapley values that differ both qualitatively and quantitatively from exact Shapley values. Hence, caution is advised when using approximate methods to evaluate Shapley explanations of the results of molecular diagnostic tests.

Project description:BackgroundSerological screening tests play a crucial role to diagnose gambiense human African trypanosomiasis (gHAT). Presently, they preselect individuals for microscopic confirmation, but in future "screen and treat" strategies they will identify individuals for treatment. Variability in reported specificities, the development of new rapid diagnostic tests (RDT) and the hypothesis that malaria infection may decrease RDT specificity led us to evaluate the specificity of 5 gHAT screening tests.MethodsDuring active screening, venous blood samples from 1095 individuals from Côte d'Ivoire and Guinea were tested consecutively with commercial (CATT, HAT Sero-K-SeT, Abbott Bioline HAT 2.0) and prototype (DCN HAT RDT, HAT Sero-K-SeT 2.0) gHAT screening tests and with a malaria RDT. Individuals with ≥ 1 positive gHAT screening test underwent microscopy and further immunological (trypanolysis with T.b. gambiense LiTat 1.3, 1.5 and 1.6; indirect ELISA/T.b. gambiense; T.b. gambiense inhibition ELISA with T.b. gambiense LiTat 1.3 and 1.5 VSG) and molecular reference laboratory tests (PCR TBRN3, 18S and TgsGP; SHERLOCK 18S Tids, 7SL Zoon, and TgsGP; Trypanozoon S2-RT-qPCR 18S2, 177T, GPI-PLC and TgsGP in multiplex; RT-qPCR DT8, DT9 and TgsGP in multiplex). Microscopic trypanosome detection confirmed gHAT, while other individuals were considered gHAT free. Differences in fractions between groups were assessed by Chi square and differences in specificity between 2 tests on the same individuals by McNemar.ResultsOne gHAT case was diagnosed. Overall test specificities (n = 1094) were: CATT 98.9% (95% CI: 98.1-99.4%); HAT Sero-K-SeT 86.7% (95% CI: 84.5-88.5%); Bioline HAT 2.0 82.1% (95% CI: 79.7-84.2%); DCN HAT RDT 78.2% (95% CI: 75.7-80.6%); and HAT Sero-K-SeT 2.0 78.4% (95% CI: 75.9-80.8%). In malaria positives, gHAT screening tests appeared less specific, but the difference was significant only in Guinea for Abbott Bioline HAT 2.0 (P = 0.03) and HAT Sero-K-Set 2.0 (P = 0.0006). The specificities of immunological and molecular laboratory tests in gHAT seropositives were 98.7-100% (n = 399) and 93.0-100% (n = 302), respectively. Among 44 reference laboratory test positives, only the confirmed gHAT patient and one screening test seropositive combined immunological and molecular reference laboratory test positivity.ConclusionsAlthough a minor effect of malaria cannot be excluded, gHAT RDT specificities are far below the 95% minimal specificity stipulated by the WHO target product profile for a simple diagnostic tool to identify individuals eligible for treatment. Unless specificity is improved, an RDT-based "screen and treat" strategy would result in massive overtreatment. In view of their inconsistent results, additional comparative evaluations of the diagnostic performance of reference laboratory tests are indicated for better identifying, among screening test positives, those at increased suspicion for gHAT.Trial registrationThe trial was retrospectively registered under NCT05466630 in clinicaltrials.gov on July 15 2022.

Dataset Information

Sensitivity, Specificity and Predictive Values of Molecular and Serological Tests for COVID-19: A Longitudinal Study in Emergency Room.

Publications

Sensitivity, Specificity and Predictive Values of Molecular and Serological Tests for COVID-19: A Longitudinal Study in Emergency Room.

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