Performance Characteristics of a High-Throughput Automated Transcription-Mediated Amplification Test for SARS-CoV-2 Detection
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Abstract
The COVID-19 pandemic caused by the new SARS-CoV-2 coronavirus has imposed severe challenges on laboratories in their effort to achieve sufficient diagnostic testing capability for identifying infected individuals. In this study, we report the analytical and clinical performance characteristics of a new, high-throughput, fully automated nucleic acid amplification test system for the detection of SARS-CoV-2. The assay utilizes target capture, transcription-mediated amplification, and acridinium ester-labeled probe chemistry on the automated Panther system to directly amplify and detect two separate target sequences in the open reading frame 1ab (ORF1ab) region of the SARS-CoV-2 RNA genome.
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SciScore for 10.1101/2020.07.06.20143719: (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 not detected. 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:Limitations of this study include the small number of clinical specimens available for testing, and the absence of discordant result resolution by testing with a third assay. The paired specimen testing (NS and OP) included …
SciScore for 10.1101/2020.07.06.20143719: (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 not detected. 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:Limitations of this study include the small number of clinical specimens available for testing, and the absence of discordant result resolution by testing with a third assay. The paired specimen testing (NS and OP) included only 35 patients (14 of which were positive). The specimens that were included did span a typical clinical titer range for the virus (SARS-CoV-2 RT-PCR Ct values ranged from 14.5 to 37.1). Additional clinical data should be collected to more fully assess and compare performance between these sample types. In summary, the SARS-CoV-2 TMA assay is highly sensitive and specific and provides an automated high-throughput testing solution for large-scale diagnostic testing for the virus. The assay system is able to process and generate results for > 1,000 samples per day enabling medical centers, reference laboratories and public health laboratories to efficiently process and analyze very high volumes of specimens for the detection of SARS-CoV-2 RNA (18).
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.
- No funding statement was detected.
- No protocol registration statement was detected.
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