Evidence map›Paper›PMID 32485157›Full record

ArticleClinica chimica acta; international journal of clinical chemistry2020

Diagnostic performances and thresholds: The key to harmonization in serological SARS-CoV-2 assays?

Mario Plebani, Andrea Padoan, Davide Negrini, Benedetta Carpinteri, Laura Sciacovelli

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinica chimica acta; international journal of clinical chemistry, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 3 pooled it
2.7field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 3 syntheses or guidelines pooled it, 108 citations in OpenAlex.

  1. Pooled it
  2. COVID-19 associated brain/spinal cord lesions and leptomeningeal enhancement: A meta-analysis of the relationship to CSF SARS-CoV-2.Journal of neuroimaging : official journal of the American Society of Neuroimaging · 2021
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  18. Low risk of reinfections and relation with serological response after recovery from the first wave of COVID-19.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2021
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Mario PlebaniDepartment of Laboratory Medicine, University Hospital of Padova, Italy; Department of Medicine-DIMED, University of Padova, Italy. Electronic address: www.mario.plebani@unipd.it.
Andrea PadoanDepartment of Laboratory Medicine, University Hospital of Padova, Italy; Department of Medicine-DIMED, University of Padova, Italy.
Davide NegriniDepartment of Medicine-DIMED, University of Padova, Italy.
Benedetta CarpinteriDepartment of Medicine-DIMED, University of Padova, Italy.
Laura SciacovelliDepartment of Laboratory Medicine, University Hospital of Padova, Italy.
University of Padua · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe evaluation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) specific antibody (Ab) assay performances is of the utmost importance in establishing and monitoring virus spread in the community. In this study focusing on IgG antibodies, we compare reliability of three chemiluminescent (CLIA) and two enzyme linked immunosorbent (ELISA) assays.

methodsSera from a total of 271 subjects, including 64 reverse transcription-polymerase chain reaction (RT-PCR) confirmed SARS-CoV-2 patients were tested for specific Ab using Maglumi (Snibe), Liaison (Diasorin), iFlash (Yhlo), Euroimmun (Medizinische Labordiagnostika AG) and Wantai (Wantai Biological Pharmacy) assays. Diagnostic sensitivity and specificity, positive and negative likelihood ratios were evaluated using manufacturers' and optimized thresholds.

resultsOptimized thresholds (Maglumi 2 kAU/L, Liaison 6.2 kAU/L and iFlash 15.0 kAU/L) allowed us to achieve a negative likelihood ratio and an accuracy of: 0.06 and 93.5% for Maglumi; 0.03 and 93.1% for Liaison; 0.03 and 91% for iFlash. Diagnostic sensitivities and specificities were above 93.8% and 85.9%, respectively for all CLIA assays. Overall agreement was 90.3% (Cohen's kappa = 0.805 and SE = 0.041) for CLIA, and 98.4% (Cohen's kappa = 0.962 and SE = 0.126) for ELISA.

conclusionsThe results obtained indicate that, for CLIA assays, it might be possible to define thresholds that improve the negative likelihood ratio. Thus, a negative test result enables the identification of subjects at risk of being infected, who should then be closely monitored over time with a view to preventing further viral spread. Redefined thresholds, in addition, improved the overall inter-assay agreement, paving the way to a better harmonization of serologic tests.

Indexed as

BetacoronavirusAdolescentAdultAgedAged, 80 and overChildCoronavirus InfectionsCOVID-19Enzyme-Linked Immunosorbent AssayFemaleHumansMaleMiddle AgedPandemicsPneumonia, ViralReproducibility of ResultsAntibodiesClinical performancesCOVID-19SARS-CoV-2

Identifiers

PMID32485157
PMCPMC7261100
OpenAlexW3031733179

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.