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      Poor sensitivity of "AccuPower SARS-CoV-2 real time RT-PCR kit (Bioneer, South Korea)"

      research-article
      ,
      Virology Journal
      BioMed Central
      SARS-CoV-2, RT-PCR, CDC, Bioneer

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          Abstract

          Background

          Several molecular kits are available for SARS-CoV-2 diagnosis, mostly lacking of proper clinical evaluation due to the emergency caused by COVID19 pandemia, particularly at developing countries like Ecuador.

          Objective

          We carried out an evaluation of the clinical performance of "AccuPower SARS-CoV-2 Real Time RT-PCR kit" (Bioneer, South Korea) for SARS-CoV-2 diagnosis using 2019-nCoV CDC EUA kit (IDT, USA) as a gold standard .

          Results

          48 clinical specimens were included on the study, 38 tested SARS-CoV-2 positive and 10 SARS-CoV-2 negative for 2019-nCoV CDC EUA kit. For "AccuPower SARS-CoV-2 Real Time RT-PCR kit", only 30 were SARS-CoV-2 positive, indicating a low clinical performance with sensitivity of 78.9%. Moreover, the limit of detection for "AccuPower SARS-CoV-2 Real Time RT-PCR kit" was estimated to be higher than 40,000 viral RNA copies/mL of sample.

          Conclusions

          Proper clinical performance evaluation studies from government agencies at developing countries should be mandatory prior to clinical use authorization of SARS-CoV-2 diagnosis kits, particularly when those kits lack of either FDA or its country of origin clinical use authorization, to prevent the distribution of low quality products that may have a negative impact of COVID19 surveillance at developing countries.

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          Most cited references2

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          US CDC Real-Time Reverse Transcription PCR Panel for Detection of Severe Acute Respiratory Syndrome Coronavirus 2

          Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified as the etiologic agent associated with coronavirus disease, which emerged in late 2019. In response, we developed a diagnostic panel consisting of 3 real-time reverse transcription PCR assays targeting the nucleocapsid gene and evaluated use of these assays for detecting SARS-CoV-2 infection. All assays demonstrated a linear dynamic range of 8 orders of magnitude and an analytical limit of detection of 5 copies/reaction of quantified RNA transcripts and 1 x 10−1.5 50% tissue culture infectious dose/mL of cell-cultured SARS-CoV-2. All assays performed comparably with nasopharyngeal and oropharyngeal secretions, serum, and fecal specimens spiked with cultured virus. We obtained no false-positive amplifications with other human coronaviruses or common respiratory pathogens. Results from all 3 assays were highly correlated during clinical specimen testing. On February 4, 2020, the Food and Drug Administration issued an Emergency Use Authorization to enable emergency use of this panel.
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            SARS-CoV-2 Viral load Assessment in Respiratory Samples

            Real-time reverse transcriptase polymerase chain reaction (rRTPCR) has been the main method for diagnosis of SARS-CoV-2 infection in the early stages of the COVID-19 pandemic. De-identified results from upper and lower respiratory samples submitted to a reference laboratory demonstrated a positivity rate of 14.9% (4,428 of 29,713 samples tested). Distribution of results by birth year cohort and specimen type suggested general consistency in mean, median and peak values but higher positivity rates in individuals born from 1964 to 1974. Female patients had a significantly lower positivity rate (P < 0.0001), although similar load mean and median values, compared to males. Overall, 15.3% (676 of 4,428 positive results) of positive results had viral loads greater than 8 log10 copies/mL, with occasional samples exceeding 10 log10 copies/mL. These results support quantitative assessment of SARS-CoV-2 viral load in patient testing and efforts to control viral transmission
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              Author and article information

              Contributors
              magbereguiain@gmail.com
              Journal
              Virol J
              Virol J
              Virology Journal
              BioMed Central (London )
              1743-422X
              14 November 2020
              14 November 2020
              2020
              : 17
              Affiliations
              GRID grid.442184.f, ISNI 0000 0004 0424 2170, One Health Research Group, , Universidad de Las Américas, ; Quito, Ecuador
              Article
              1445
              10.1186/s12985-020-01445-4
              7666399
              33189137
              fd6cc11d-d40b-43e5-b56e-c54f05b4b60d
              © The Author(s) 2020

              Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

              Funding
              Funded by: UDLA
              Categories
              Short Report
              Custom metadata
              © The Author(s) 2020

              Microbiology & Virology
              sars-cov-2,rt-pcr,cdc,bioneer
              Microbiology & Virology
              sars-cov-2, rt-pcr, cdc, bioneer

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