Comparative sensitivity evaluation for 122 CE-marked rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021

  1. Heinrich Scheiblauer
  2. Angela Filomena
  3. Andreas Nitsche
  4. Andreas Puyskens
  5. Victor M Corman
  6. Christian Drosten
  7. Karin Zwirglmaier
  8. Constanze Lange
  9. Petra Emmerich
  10. Michael Müller
  11. Olivia Knauer
  12. C Micha Nübling

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Abstract

Numerous CE-marked SARS-CoV-2 antigen rapid diagnostic tests (Ag RDT) are offered in Europe, several of them with unconfirmed quality claims.

Aim

We performed an independent head-to-head evaluation of the sensitivity of SARS-CoV-2 Ag RDT offered in Germany.

Methods

We addressed the sensitivity of 122 Ag RDT in direct comparison using a common evaluation panel comprised of 50 specimens. Minimum sensitivity of 75% for panel specimens with a PCR quantification cycle (Cq) ≤ 25 was used to identify Ag RDT eligible for reimbursement in the German healthcare system.

Results

The sensitivity of different SARS-CoV-2 Ag RDT varied over a wide range. The sensitivity limit of 75% for panel members with Cq ≤ 25 was met by 96 of the 122 tests evaluated; 26 tests exhibited lower sensitivity, few of which failed completely. Some RDT exhibited high sensitivity, e.g. 97.5 % for Cq < 30.

Conclusions

This comparative evaluation succeeded in distinguishing less sensitive from better performing Ag RDT. Most of the evaluated Ag RDT appeared to be suitable for fast identification of acute infections associated with high viral loads. Market access of SARS-CoV-2 Ag RDT should be based on minimal requirements for sensitivity and specificity.

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  1. Version published to 10.2807/1560-7917.es.2021.26.44.2100441
  2. ScreenIT

    SciScore for 10.1101/2021.05.11.21257016: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Ethicsnot detected.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Cell Line Authenticationnot detected.

    Table 2: Resources

    Experimental Models: Cell Lines
    SentencesResources
    Furthermore, presence of infectious virus detectable by propagation in Vero cell culture was determined for the individual pools.
    Vero
    suggested: CLS Cat# 605372/p622_VERO, RRID:CVCL_0059)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    A limitation of the study is its spot check nature since it cannot address variations between different batches of the same product, or variations between different test locations (see also the tandem publication of Puyskens et al). In conclusion, by using the same panel for a large number of different SARS-CoV-2 Ag RDT we were able to evaluate the comparative performance of the different tests under the same conditions. The evaluation panel proved to be accurate for sensitivity differentiation of SARS-CoV-2 Ag RDTs, distinguishing better performing from less suitable tests. The continuation of the comparative evaluation is needed cope with the rapidly growing market of SARS-CoV-2 Ag RDT. Since the panel has now been exhausted, we will continue the evaluation with a new set of samples with similar features, accurately calibrated against its predecessor.

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

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  3. Version published to 10.1101/2021.05.11.21257016v1 on medRxiv