Comparison study of commercial COVID-19 RT-PCR kits propose an approach to evaluate their performances

  1. Hana Krismawati
  2. Caroline Mahendra
  3. Annabelle Hartanto
  4. Muhammad Fajri Rokhmad
  5. Semuel Sandi
  6. Astrid Irwanto

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Abstract

With the increasing number of COVID-19 cases in Indonesia, scalable and high-throughput diagnostic testing is essential nationwide. Currently, RT-PCR has been the preferred method of viral detection and many manufacturers offer commercial kits for routine clinical diagnostics. In response to the incoming of various kits, there is a need to assess their performance and compatibility of use in clinical laboratories. Kit characteristics impact the testing workflow of these laboratories and some factors can render a kit to perform sub-optimally, leading to false results that are misleading for public safety. Here, we evaluated six commercial kits that are predominantly distributed to appointed testing facilities across Indonesia. Their performance was assessed based on their ease of use, availability, robustness and accuracy for scalable testing in a manual set-up. Our findings demonstrated that all six kits are suitable for use in routine diagnostics, but their considerations for use may vary according to different use-cases. To better guide considerations in procurement of kits, our study provided a systematic approach for laboratories to assess the performance of new incoming kits.

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  1. ScreenIT

    SciScore for 10.1101/2021.01.20.21250143: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: All six can be found on the list of kits recommended by the Indonesian Committee of COVID-19 Task Force(7), and their respective specifications derived from their manufacturer’s Instructions For Use (IFU) can be found in Tables 1 and 2.
    Consent: Ethical Clearance: This study was approved for ethical clearance by the Health Research Ethics Committee of National Institute of Health Research and Development and expedited with waiver of informed consent.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    No key resources detected.

    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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    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 scite Reference Check: We found no unreliable references.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  2. Version published to 10.1101/2021.01.20.21250143v1 on medRxiv