Evidence map›Paper›PMID 32536002›Full record

ArticleTransboundary and emerging diseases2021

Pitfalls in SARS-CoV-2 PCR diagnostics.

Kerstin Wernike, Markus Keller, Franz J Conraths, Thomas C Mettenleiter, Martin H Groschup, Martin Beer

Abstract read
In one paragraph

Article in Transboundary and emerging diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

36 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Guideline
  3. Trial
  4. Review
  5. Article
  6. Article
  7. The Role of Surveillance Inspections in Reducing False-Positives of SARS-CoV-2 Omicron Variants during the COVID-19 Epidemic.The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale · 2023
    Article
  8. Comparative Analysis ofDiagnostics (Basel, Switzerland) · 2022
    Article
  9. Article
  10. Article
  11. A pandemic guided by the SARS-CoV-2 PCR test: What should the clinician know?South African family practice : official journal of the South African Academy of Family Practice/Primary Care · 2022
    Article
  12. Article
  13. Article
  14. Gene editing and its applications in biomedicine.Science China. Life sciences · 2022
    Review
  15. Review
  16. Article
  17. Article
  18. Article
  19. Article
  20. Clinical laboratory evaluation of COVID-19.Clinica chimica acta; international journal of clinical chemistry · 2021
    Review
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

6 authors.

Kerstin WernikeFriedrich-Loeffler-Institut, Greifswald-Insel Riems, Germany.ORCID https://orcid.org/0000-0001-8071-0827
Markus KellerFriedrich-Loeffler-Institut, Greifswald-Insel Riems, Germany.
Franz J ConrathsFriedrich-Loeffler-Institut, Greifswald-Insel Riems, Germany.
Thomas C MettenleiterFriedrich-Loeffler-Institut, Greifswald-Insel Riems, Germany.
Martin H GroschupFriedrich-Loeffler-Institut, Greifswald-Insel Riems, Germany.ORCID https://orcid.org/0000-0003-0215-185X
Martin BeerFriedrich-Loeffler-Institut, Greifswald-Insel Riems, Germany.ORCID https://orcid.org/0000-0002-0598-5254

Funding

intramural funding of the German Federal Ministry of Food and Agriculture provided to the Friedrich-Loeffler-InstitutOpen access funding enabled and organized by Projekt DEAL.
6 · The paper itself

Abstract

To combat the COVID-19 pandemic, millions of PCR tests are performed worldwide. Any deviation of the diagnostic sensitivity and specificity will reduce the predictive values of the test. Here, we report the occurrence of contaminations of commercial primers/probe sets with the SARS-CoV-2 target sequence of the RT-qPCR as an example for pitfalls during PCR diagnostics affecting diagnostic specificity. In several purchased in-house primers/probe sets, quantification cycle values as low as 17 were measured for negative control samples. However, there were also primers/probe sets that displayed very low-level contaminations, which were detected only during thorough internal validation. Hence, it appears imperative to pre-test each batch of reagents extensively before use in routine diagnosis, to avoid false-positive results and low positive predictive value in low-prevalence situations. As such, contaminations may have happened more widely, and COVID-19 diagnostic results should be re-assessed retrospectively to validate the epidemiological basis for control measures.

Indexed as

PandemicsSARS-CoV-2BenchmarkingCOVID-19COVID-19 TestingDNA PrimersEquipment ContaminationGermanyHumansReal-Time Polymerase Chain ReactionSensitivity and SpecificityDNA PrimerscontaminationcoronavirusCOVID-19diagnosticspoolingreal-time PCRswab

Identifiers

PMID32536002
PMCPMC7323359

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.