Evidence map›Paper›PMID 33930425›Full record

ArticleClinica chimica acta; international journal of clinical chemistry2021

Evaluation of 32 rapid tests for detection of antibodies against SARS-CoV-2.

Mette C Tollånes, Pål A Jenum, Helene Kierkegaard, Eirik Abildsnes, Roar Magne Bævre-Jensen, Anne C Breivik, Sverre Sandberg

Open access · greenAbstract read
In one paragraph

Article in Clinica chimica acta; international journal of clinical chemistry, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.7field-weighted citation impact, top 29% 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

6 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Lateral Flow Immunoassays for SARS-CoV-2.Diagnostics (Basel, Switzerland) · 2022
    Review
  6. Article
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

7 authors at 6 institutions in 3 countries.

Mette C TollånesNorwegian Organization for Quality Improvement of Laboratory Examinations, Haraldsplass Deaconess Hospital, Bergen, Norway; Department of Global Public Health and Primary Care, University of Bergen, Norway. Electronic address: mette.tollanes@noklus.no.
Pål A JenumNorwegian Organization for Quality Improvement of Laboratory Examinations, Haraldsplass Deaconess Hospital, Bergen, Norway.
Helene KierkegaardLillebælt Hospital, Denmark.
Eirik AbildsnesKristiansand Municipality, Norway.
Roar Magne Bævre-JensenVestre Viken Hospital Trust, Norway.
Anne C BreivikNorwegian Organization for Quality Improvement of Laboratory Examinations, Haraldsplass Deaconess Hospital, Bergen, Norway.
Sverre SandbergNorwegian Organization for Quality Improvement of Laboratory Examinations, Haraldsplass Deaconess Hospital, Bergen, Norway; Department of Global Public Health and Primary Care, University of Bergen, Norway; Department of Medical Biochemistry and Pharmacology, Haukeland University Hospital, Bergen, Norway.
Haraldsplass Diakonale Sykehus · NODeaconess Hospital · USHaukeland University Hospital · NOKristiansand Municipality · NOLillebaelt Hospital · DKVestre Viken Hospital Trust · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo evaluate the analytical performance of 32 rapid tests for detection of antibodies against coronavirus SARS-CoV-2. MATERIALS AND

methodsWe used at total of 262 serum samples (197 pre-pandemic and 65 convalescent COVID-19), and three criteria to evaluate the rapid tests under standardized and optimal conditions: (i) Immunoglobulin G (IgG) specificity "good" if lower limit of the 95% confidence interval was ≥ 97.0%, "acceptable" if point estimate was ≥ 97.0%, otherwise "not acceptable". (ii) IgG sensitivity "good" if point estimate was ≥ 90.0%, "acceptable" if ≥ 85.0%, otherwise "not acceptable". (iii) User-friendliness "not acceptable" if complicated to perform or difficult to read result, otherwise "good". We also included partial evaluations of three automated immunoassay systems.

resultsSensitivity and specificity varied considerably; IgG specificity between 90.9% (85.9-94.2) and 100% (97.7-100.0), and IgG sensitivity between 53.8% (41.9-65.4) and 98.5% (91.0-100.0). Combining our evaluation criteria, none of the 28 rapid tests that detected IgG had an overall performance considered "good", seven tests were considered "acceptable", while 21 tests were considered "not acceptable". Four tests detected only total antibodies and were not given an overall evaluation. IgG sensitivity and/or specificity of the automated immunoassays did not exceed that of many rapid tests.

conclusionWhen prevalence is low, the most important analytical property is a test's IgG specificity, which must be high to minimize false positive results. Out of 32 rapid tests, none had a performance classified as "good", but seven were classified as "acceptable".

Indexed as

COVID-19SARS-CoV-2Antibodies, ViralHumansImmunoassayImmunoglobulin MPandemicsSensitivity and SpecificityAntibodies, ViralImmunoglobulin MAnalytical performanceAntibody detectionCOVID-19 serological testingCOVID-19 testingPoint-of-careRapid testsSARS-CoV-2User-friendliness

Identifiers

PMID33930425
PMCPMC8078036
OpenAlexW3157798688

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.