Development and Evaluation of AccuPower COVID-19 Multiplex Real-Time RT-PCR Kit and AccuPower SARS-CoV-2 Multiplex Real-Time RT-PCR Kit for SARS-CoV-2 Detection in Sputum, NPS/OPS, Saliva and Pooled Samples
This article has been Reviewed by the following groups
Listed in
- Evaluated articles (ScreenIT)
Abstract
Rapid and accurate detection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is essential for the successful control of the current global COVID-19 pandemic. The real-time reverse transcription polymerase chain reaction (Real-time RT-PCR) is the most widely used detection technique. This research describes the development of two novel multiplex real-time RT-PCR kits, AccuPower ® COVID-19 Multiplex Real-Time RT-PCR Kit (NCVM) specifically designed for use with the ExiStation ™48 system (comprised of ExiPrep ™48 Dx and Exicycler ™96 by BIONEER, Korea) for sample RNA extraction and PCR detection, and AccuPower ® SARS-CoV-2 Multiplex Real-Time RT-PCR Kit (SCVM) designed to be compatible with manufacturers’ on-market PCR instruments. The limit of detection (LoD) of NCVM was 120 copies/mL and the LoD of the SCVM was 2 copies/μL for both the Pan-sarbecovirus gene and the SARS-CoV-2 gene. The AccuPower ® kits demonstrated high precision with no cross reactivity to other respiratory-related microorganisms. The clinical performance of AccuPower ® kits was evaluated using the following clinical samples: sputum and nasopharyngeal/oropharyngeal swab (NPS/OPS) samples. Overall agreement of the AccuPower ® kits with a Food and Drug Administration (FDA) approved emergency use authorized commercial kit (STANDARD™ M nCoV Real-Time Detection kit, SD BIOSENSOR, Korea) was above 95% (Cohen’s kappa coefficient ≥ 0.95), with a sensitivity of over 95%. The NPS/OPS specimen pooling experiment was conducted to verify the usability of AccuPower ® kits on pooled samples and the results showed greater than 90% agreement with individual NPS/OPS samples. The clinical performance of AccuPower ® kits with saliva samples was also compared with NPS/OPS samples and demonstrated over 95% agreement (Cohen’s kappa coefficient > 0.95). This study shows the BIONEER NCVM and SCVM assays are comparable with the current standard confirmation assay and are suitable for effective clinical management and control of SARS-CoV-2.
Article activity feed
-
-
SciScore for 10.1101/2021.11.21.21264927: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Ethics Statement and Sample Collection: Myongji Hospital Institutional Review Board (IRB) approved the use of surplus clinical samples for the NPS/OPS specimen-pooling (IRB No.: MJH 2020-12-028) and clinical performance evaluation (IRB No.: MJH 2020-12-029) tests.
Consent: Kangwon National University Hospital IRB approved the use of saliva and NPS/OPS samples for the clinical performance testing of the AccuPower® kits (IRB No.: KNUH-2021-03-014), which were either surplus samples or de-identified patient samples drawn after informed consent (Fig 1).
Field Sample Permit: Saliva samples were collected and stored using the Saliva Collection Kit (BIONEER, Korea), which was developed to …SciScore for 10.1101/2021.11.21.21264927: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Ethics Statement and Sample Collection: Myongji Hospital Institutional Review Board (IRB) approved the use of surplus clinical samples for the NPS/OPS specimen-pooling (IRB No.: MJH 2020-12-028) and clinical performance evaluation (IRB No.: MJH 2020-12-029) tests.
Consent: Kangwon National University Hospital IRB approved the use of saliva and NPS/OPS samples for the clinical performance testing of the AccuPower® kits (IRB No.: KNUH-2021-03-014), which were either surplus samples or de-identified patient samples drawn after informed consent (Fig 1).
Field Sample Permit: Saliva samples were collected and stored using the Saliva Collection Kit (BIONEER, Korea), which was developed to collect, transport, and preserve saliva specimens for extraction of human genomic DNA, bacterial genomic DNA, and viral DNA/RNA for disease detection.Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources The MUSCLE alignment was generated by multiple sequence alignment and viewed in Jalview. MUSCLEsuggested: (MUSCLE, RRID:SCR_011812)Jalviewsuggested: (Jalview, RRID:SCR_006459)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 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.
-