Analytical and Clinical Evaluation of “AccuPower SARS-CoV-2 Multiplex RT-PCR kit (Bioneer, South Korea)” and “Allplex 2019-nCoV Assay (Seegene, South Korea)” for SARS-CoV-2 RT-PCR Diagnosis: Korean CDC EUA as a Quality Control Proxy for Developing Countries

Freire‐Paspuel, Byron; García-Bereguiaín, Miguel Angel

doi:10.3389/fcimb.2021.630552

Cited by 41 publications

(34 citation statements)

References 16 publications

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“…Among them, Allplex™ 2019-nCoV Assay kit (Seegene, Seoul, Republic of Korea) is a qRT-PCR-based COVID-19 diagnostic kit and has received the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) and the Korean Ministry of Food and Drug Safety (KMFDS) EUA approval (Lai et al 2021 ). In the previous study, the Allplex™ 2019-nCoV Assay kit (Seegene, Seoul, Republic of Korea) showed high performance in sensitivity as a result of confirming clinical performance by applying KCDC qRT-PCR protocol as a gold standard (Freire-Paspuel and Garcia-Bereguiain 2021 ). Therefore, currently in Korea, the Allplex™ 2019-nCoV Assay kit (Seegene, Seoul, Republic of Korea) is typically used for the COVID-19 diagnosis.…”

Section: Introductionmentioning

confidence: 84%

Diagnostic evaluation of qRT-PCR-based kit and dPCR-based kit for COVID-19

et al. 2021

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Background Coronavirus disease of 2019 (COVID-19) is well known as a fatal disease, first discovered at Wuhan in China, ranging from mild to death, such as shortness of breath and fever. Early diagnosis of COVID-19 is a crucial point in preventing global prevalence. Objective We aimed to evaluate the diagnostic competency and efficiency with the Allplex™ 2019-nCoV Assay kit and the Dr. PCR 20 K COVID-19 Detection kit, designed based on the qRT-PCR and dPCR technologies, respectively. Methods A total of 30 negative and 20 COVID-19 positive specimens were assigned to the diagnostic test by using different COVID-19 diagnosis kits. Diagnostic accuracy was measured by statistical testing with sensitivity, specificity, and co-efficiency calculations. Results Comparing both diagnostic kits, we confirmed that the diagnostic results of 30 negative and 20 positive cases were the same pre-diagnostic results. The diagnostic statistics test results were perfectly matched with value (1). Cohen’s Kappa coefficient was demonstrated that the given kits in two different ways were “almost perfect” with value (1). In evaluating the detection capability, the dilutional linearity experiments substantiate that the Dr. PCR 20 K COVID-19 Detection kit could detect SARS-CoV-2 viral load at a concentration ten times lower than that of the Allplex™ 2019-nCoV Assay kit. Conclusions In this study, we propose that the dPCR diagnosis using LOAA dPCR could be a powerful method for COVID-19 point-of-care tests requiring immediate diagnosis in a limited time and space through the advantages of relatively low sample concentration and small equipment size compared to conventional qRT-PCR. Supplementary Information The online version contains supplementary material available at 10.1007/s13258-021-01162-4.

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Section: Introductionmentioning

confidence: 84%

Diagnostic evaluation of qRT-PCR-based kit and dPCR-based kit for COVID-19

et al. 2021

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“…A previous study presented the LoD of AccuPower ® kits without the appropriate number of replications, using quantified specimens RNA for the test [ 18 ]. On the contrary, in this study, The LoD test was performed with 20 replicates, which is recommended in the CLSI guideline, using SARS-CoV-2 verification panel and SARS-Related Coronavirus 2.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2022

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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.

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“…The false positive samples were tested with an additional RT-PCR protocol and reconfirmed as a true negative. These samples were also negative for other COVID RT-PCR target i.e., SARS-CoV-2 virus genome, E-gene, N-gene and RdRp gene [ 31 , 32 ].…”

Section: Discussionmentioning

confidence: 99%

“…A total of 380 individuals were enrolled where 230 (60.5%) were male with the median (IQR) age 33 (27)(28)(29)(30)(31)(32)(33)(34)(35)(36)(37)(38)(39)(40)(41)(42) and 150 (39.5%) were female with the median age 32.5 (25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35)(36)(37)(38)(39)(40)(41)(42). There was no significant difference between median age (p = 0.26).…”

Section: Enrollmentmentioning

confidence: 99%

Clinical Evaluation of a New Antigen-Based COVID-19 Rapid Diagnostic Test from Symptomatic Patients

et al. 2021

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Accurate diagnosis at the right moment is the prerequisite for treatment of any disease. Failure to correctly diagnose a disease can result in highly detrimental effects, unmistakably a crucial factor during the COVID-19 pandemic. RT-PCR is the gold standard for COVID-19 detection while there are other test procedures available, such as LAMP, X-Ray, and ELISA. However, these tests are expensive, require sophisticated equipment and a highly trained workforce, and multiple hours or even days are often required to obtain the test results. A rapid and cheap detection system can thus render a solution to the screening system on a larger scale and be added as an aid to the current detection processes. Recently, some rapid antigen-based COVID-19 tests devices have been developed and commercialized. In this study, we evaluated the clinical performance of a new rapid detection device (OnSite® COVID-19 Ag Rapid Test by CTK Biotech Inc., Poway, CA, USA) on COVID-19 symptomatic patients (n = 380). The overall sensitivity and specificity were 91.0% (95% CI: 84.8–95.3%) and 99.2% (95% CI: 97.1–99.9), against gold standard RT-PCR. The kit was capable of detecting patients even after 06 days of onset of symptoms and the sensitivity can be maximized to 98% in samples with an average RT-PCR Ct ≤ 26.48, demonstrating a high potential of the kit for clinical diagnosis of symptomatic patients in healthcare facilities.

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Analytical and Clinical Evaluation of “AccuPower SARS-CoV-2 Multiplex RT-PCR kit (Bioneer, South Korea)” and “Allplex 2019-nCoV Assay (Seegene, South Korea)” for SARS-CoV-2 RT-PCR Diagnosis: Korean CDC EUA as a Quality Control Proxy for Developing Countries

Cited by 41 publications

References 16 publications

Diagnostic evaluation of qRT-PCR-based kit and dPCR-based kit for COVID-19

Diagnostic evaluation of qRT-PCR-based kit and dPCR-based kit for COVID-19

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

Clinical Evaluation of a New Antigen-Based COVID-19 Rapid Diagnostic Test from Symptomatic Patients

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