Implementation and evaluation of a novel real-time multiplex assay for SARS-CoV-2: in-field learnings from a clinical microbiology laboratory
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SciScore for 10.1101/2020.06.03.20117267: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding Prior to commencement of clinical testing the reference laboratory also provided a blinded quality assessment panel containing a dilution series of samples of standard culture medium spiked in duplicate with gamma-irradiated culture supernatants of a SARS-CoV-2 isolate, described previously 16. Power Analysis not detected. Sex as a biological variable not 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: We detected the …SciScore for 10.1101/2020.06.03.20117267: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding Prior to commencement of clinical testing the reference laboratory also provided a blinded quality assessment panel containing a dilution series of samples of standard culture medium spiked in duplicate with gamma-irradiated culture supernatants of a SARS-CoV-2 isolate, described previously 16. Power Analysis not detected. Sex as a biological variable not 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: We detected the following sentences addressing limitations in the study:Although a limitation of our study is the single-site design, we provide robust validation data for a testing platform that is widely used across Australia, and has also been used in the United States and the United Kingdom 29. In this rapidly evolving pandemic, where standard regulatory requirements for the introduction of new assays have been replaced by emergency authorizations in many countries, including Australia, it is critical that laboratories share their post-market validation experiences, as the consequences of widespread introduction of a sub-optimal assay for SARS-CoV-2 are profound. COVID-19 has placed unprecedented demands on clinical microbiology laboratories. In conjunction with the public health units, clinical microbiology laboratories were part of the first ‘wave’ of response to this pandemic 30. Subsequent waves will relate to clinical management, critical care and end of life support for those affected by this disease 31-33. In Australia, containment and preparedness measures, particularly international travel restrictions, allowed time for clinical microbiology laboratories to review diagnostic assays, develop workflows and implement testing prior to the surge in demand. Here we share our pragmatic ‘in-field’ experience, and encourage other laboratories to follow suit.
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.
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