Tutorial: statistical methods for the meta-analysis of diagnostic test accuracy studies

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2023, Volume and Issue: 61(5), P. 777 - 794

Published: Jan. 19, 2023

This tutorial shows how to perform a meta-analysis of diagnostic test accuracy studies (DTA) based on 2 × table available for each included primary study. First, univariate methods sensitivity and specificity are presented. Then the use logistic regression models with without random effects e.g. is described. Diagnostic odds ratios (DOR) then introduced combine into one single measure assess publication bias. Finally, bivariate using exact binomial likelihood describe within-study variability normal distribution between-study presented as method choice. Based this model summary receiver operating characteristic (sROC) curves constructed logit-true positive rate (TPR) over logit-false (FPR). Also it demonstrated necessary calculations freely software R. As an example DTA Procalcitonin marker sepsis

Language: Английский

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Diagnostic accuracy of non-invasive SARS-CoV-2 screening tests: a national prospective analysis

Research Square (Research Square), Journal Year: 2025, Volume and Issue: unknown

Published: March 11, 2025

Background Providing non-invasive, accurate and affordable SARS-CoV-2 tests represents a public health priority, to better control viral circulation while protecting healthcare workers. Saliva is robust alternative nasopharyngeal (NP) swab, but there heterogeneity in collection pre-analytical methods. Methods Relying on national COVID-19 Public Health Programme, we prospectively recruited 3,488 symptomatic asymptomatic adults attending the Monaco community centre for NP RT-PCR testing from February 2021-2023. was concomitantly obtained with either buccal swab or an oral sponge (OS) analysed by assay fully automated electrochemiluminescent enzyme immunoassays (ECLIA) rapid antigen test (RAT). Results Sensitivity of varied according previous infection, vaccination, presence symptoms, it remained around 95% OS RT-PCR. Specificity approached 100% OS-RT PCR. The RAT sensitivity 66.9% 69.1% comparing assays rose 71% 97% case high load (Ct<25), respectively. Conclusions sampling saliva using showed accuracy amongst non-symptomatic adults, including identification negative swabs. This method allows self-collection without any prior conditions patient nor laboratory step. ECLIA presents throughput at moderate cost could be relevant mass screening strategy settings where diagnostic capacity limited. Our findings encompassed latest omicron subvariants, such as BA.4&5 XBB series.

Language: Английский

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Fujirebio Lumipulse SARS-CoV-2 antigen immunoassay: pooled analysis of diagnostic accuracy

Diagnosis, Journal Year: 2022, Volume and Issue: 9(2), P. 149 - 156

Published: March 15, 2022

Abstract We provide here a pooled analysis of accuracy Fujirebio Lumipulse SARS-CoV-2 Antigen chemiluminescent immunoassay for diagnosing acute infections. An electronic search was conducted in Scopus and Medline with the keywords “Lumipulse” AND “antigen” “SARS-CoV-2” or “COVID-19”, up to January 21, 2022, identifying clinical investigations (minimum sample size ≥100) where diagnostic G Ag tested against reference molecular techniques. All studies which allowed construct 2 × table were included analysis. A final number 21 studies, totalling 17,648 nasopharyngeal 8538 saliva specimens, finally included. The sensitivity specificity swabs 0.80 (95%CI, 0.78–0.81) 0.98 0.97–0.98), respectively, whilst area under curve agreement 0.980 0.973–0.986) 94.9%, respectively. In twelve used fixed 1.34 pg/mL currently recommended manufacturer’s threshold, remained unvaried. samples, 0.75 0.71–0.75) 1.00 0.99–1.00), 0.976 0.969–0.984) 98.4%, five 0.67 conclusion, assay demonstrates good specificity, thus representing valuable complementary integrative option testing current pandemic.

Language: Английский

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Ad interim recommendations for diagnosing SARS-CoV-2 infection by the IFCC SARS-CoV-2 variants working group

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2022, Volume and Issue: 60(7), P. 975 - 981

Published: April 22, 2022

Abstract This document, endorsed by the IFCC Working Group on SARS-CoV-2 Variants, aims to update previous indications for diagnosing acute infection, taking into consideration evidence that has emerged after origin and spread of new lineages sub-lineages virus characterized mutated genetics altered biochemical, biological clinical characteristics. These encompass use different diagnostic strategies in specific settings, such as high risk infection (symptomatic patients), low (asymptomatic subjects) at hospital admission/contact tracing, testing asymptomatic subjects, epidemiologic surveys and/or population screening, along with tentative identification SARS-CoV-2.

Language: Английский

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Evaluation of a high-sensitivity SARS-CoV-2 antigen test on the fully automated light-initiated chemiluminescent immunoassay platform

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2023, Volume and Issue: 61(6), P. 1123 - 1130

Published: Jan. 19, 2023

Abstract Objectives To describe a high-sensitivity SARS-CoV-2 antigen test that is based on the fully automated light-initiated chemiluminescent immunoassay (LiCA ® ), and to validate its analytical characteristics clinical agreement detecting infection against reference molecular test. Methods Analytical performance was validated detection limits were determined using different types of nucleocapsid protein samples. 798-pair anterior nasal swab specimens collected from hospitalized patients asymptomatic screening individuals. Agreement between LiCA real-time reverse transcription polymerase chain reaction (rRT-PCR) evaluated. Results Repeatability within-lab precision 1.6–2.3%. The C 5 ∼C 95 interval −5.1–4.6% away 50 . Detection in average (SD) 325 (±141) U/mL national panel, 0.07 (±0.04) TCID /mL active viral cultures, 0.27 (±0.09) pg/mL recombinant proteins 1.07 (±1.01) inactivated suspensions, respectively. detected median 374-fold (IQR 137–643) lower levels than comparative rapid tests. As rRT-PCR method, overall sensitivity specificity be 97.5% (91.4–99.7%) 99.9% (99.2–100%), Total both methods 99.6% (98.7–99.9%) with Cohen’s kappa 0.98 (0.96–1). A positive rate 100% (95.4–100%) obtained as Ct≤37.8. Conclusions system provides an exceptionally platform for swabs. assay may have high potential use large-scale population surveillance COVID-19 alternative

Language: Английский

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Photoinduced Electrochemiluminescence Immunoassays

Analytical Chemistry, Journal Year: 2024, Volume and Issue: 96(45), P. 18262 - 18268

Published: Nov. 1, 2024

Optimization of electrochemiluminescence (ECL) immunoassays is highly beneficial for enhancing clinical diagnostics. A major challenge the improvement operation conditions required bead-based using typical [Ru(bpy)3]2+/tri-n-propylamine (TPrA) system. In this study, we report a heterogeneous immunoassay based on near-infrared photoinduced ECL, which facilitates imaging and quantitative analysis [Ru(bpy)3]2+-modified immunobeads at low anodic potential. The photovoltage generated by photoanode under light promotes oxidation processes electrode/electrolyte interface, thus considerably lowering onset potential both TPrA ECL emission. anti-Stokes shift between excitation (invisible to human eyes) visible emitted results in clear stable signal from immunobeads. addition, it offers possibility site-selective photoexcitation process. This approach not only meets performance traditional accuracy but also additional benefits lower requirements enhanced stability, providing new perspective optimization commercial immunoassays.

Language: Английский

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Evaluation of a laboratory-based high-throughput SARS-CoV-2 antigen assay

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2022, Volume and Issue: 60(9), P. 1478 - 1485

Published: June 14, 2022

Abstract Objectives Antigen tests are an essential part of SARS-CoV-2 testing strategies. Rapid antigen easy to use but less sensitive compared nucleic acid amplification (NAT) and suitable for large-scale testing. In contrast, laboratory-based high-throughput immunoanalyzers. Here we evaluated the diagnostic performance Siemens Healthineers (CoV2Ag) assay. Methods a public test center, from 447 individuals anterior nasal swab specimens as well nasopharyngeal were collected. The collected in sample inactivation medium measured using CoV2Ag by RT-PCR. Additionally, 9,046 obtained screening purposes tertiary care hospital analyzed positive results confirmed NAT. Results total, 234/447 (52.3%) participants center SARS-CoV-2-RNA. Viral lineage B1.1.529 was dominant during study. Sensitivity specificity assay 88.5% (95%CI: 83.7–91.9%) 99.5% (97.4–99.9%), respectively. increased 93.7% (97.4–99.9%) 98.7% with cycle threshold values <30 <25, Out hospitalized patients, 21 (0.2%) determined false-positive confirmatory Conclusions Using tubes containing is very specific highly detection including variant. low prevalence settings confirmation SARS-CoV-2-RNA recommended.

Language: Английский

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LumiraDX SARS-CoV-2 Antigen Test for Diagnosing Acute SARS-CoV-2 Infection: Critical Literature Review and Meta-Analysis

Diagnostics, Journal Year: 2022, Volume and Issue: 12(4), P. 947 - 947

Published: April 11, 2022

We present here a critical literature review and meta-analysis on the accuracy of LumiraDX SARS-CoV-2 Antigen Test for diagnosing acute infection. An electronic search was conducted in Scopus Medline databases using keywords “LumiraDX” AND “COVID-19” OR “SARS-CoV-2”, without date (i.e., up to 1 February 2022) or language restrictions, detecting clinical studies where diagnostic compared with reference molecular methods. All rates true positive, negative, false positive negative cases were available constructing 2 × table providing pooled estimates sensitivity, specificity included analysis. The study accordance PRISMA (preferred reporting items systematic reviews meta-analyses) checklist. Eleven (n = 8527 samples) could be our analysis, while five additional documents provided data but not extracted construction table. sensitivity 0.86 (95%CI, 0.84–0.88) 0.99 0.98–0.99), respectively, area under summary receiver operating characteristic curve 0.974 0.965–0.983) agreement 96.8% 96.4–97.1%), kappa statistics 0.87 0.85–0.88). In conclusion, performance would allow conclusion that it may seen as reliable alternative testing rapid preliminary screening infections.

Language: Английский

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Clinical Chemistry and Laboratory Medicine celebrates 60 years – narrative review devoted to the contribution of the journal to the diagnosis of SARS-CoV-2

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2022, Volume and Issue: 61(5), P. 811 - 821

Published: Nov. 23, 2022

This review is an integral part of the special issue for 60 years journal Clinical Chemistry and Laboratory Medicine (CCLM). The aim to highlight role clinical laboratory since emergence "severe acute respiratory syndrome coronavirus 2" (SARS-CoV-2), which causes Coronavirus disease 2019 (COVID-19), with focus on contribution in generating knowledge SARS-CoV-2 diagnosis. As October 30, 2022, a total 186 CCLM publications were dedicated COVID-19. Of importance, major International Federation (IFCC) guidelines related diagnosis COVID-19 published CCLM. Between early-2020 late represented around 27% all articles CCLM, highlighting willingness editorial board help field order better describe diagnose this new emerging disease. First launched 1963 under name "Zeitschrift für Klinische Chemie", Journal was entirely devoted chemistry strict sense. various topics relation including its diagnosis, impact biochemical or hematological measures, as well biosafety perfect example that shows has greatly diversified over time.

Language: Английский

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Diagnostic accuracy of the ultrasensitive S-PLEX SARS-CoV-2 N electrochemiluminescence immunoassay

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2022, Volume and Issue: 60(6), P. e121 - e124

Published: March 14, 2022

To the Editor, We read with interest recent article of Ren et al. [1], who described accuracy an ultrasensitive electrochemiluminescence immunoassay for saliva-based Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) nucleocapsid protein (N) detection based on S-PLEX platform (S-PLEX SARS-CoV-2 N Kit; Meso Scale Discovery, Rockville, MD, United States).This method has been specifically developed detecting and quantifying antigen in a variety human specimens, including serum, plasma, saliva nasopharyngeal swabs (NPS).Briefly, either 96-Well SECTOR or QuickPlex plates coated streptavidin binding biotin-conjugated capture anti-SARS-CoV-2 antibodies

Language: Английский

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