Evaluation of the basic assay performance of the GeneSoc® rapid PCR testing system for detection of severe acute respiratory syndrome coronavirus 2

Autor: Hidehumi Kakizoe, Haruyo Atsumi, Kazumi Ohtagawa, Ryosuke Watanabe, Satomi Asai, Mend-Amar Ravzanaaadii, Kazuo Umezawa, Mika Doi, Hayato Miyachi, Miki Miyazawa, Atsuko Masukawa, Hirofumi Saeki
Rok vydání: 2021
Předmět:
RNA viruses
Viral Diseases
Time Factors
Coronaviruses
Microfluidics
Artificial Gene Amplification and Extension
Polymerase Chain Reaction
Biochemistry
law.invention
Geographical Locations
Medical Conditions
Japan
Limit of Detection
law
Nucleic Acids
Medicine and Health Sciences
Medicine
Sampling (medicine)
Pathology and laboratory medicine
Polymerase chain reaction
Virus Testing
Multidisciplinary
Repeatability
Medical microbiology
Infectious Diseases
Viruses
Engineering and Technology
Fluidics
SARS CoV 2
Pathogens
Viral load
Research Article
Asia
SARS coronavirus
Science
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Coefficient of variation
Research and Analysis Methods
Microbiology
Virus
Diagnostic Medicine
Humans
Molecular Biology Techniques
Molecular Biology
Reproducibility
SARS-CoV-2
business.industry
Organisms
Viral pathogens
Biology and Life Sciences
Covid 19
Reverse Transcriptase-Polymerase Chain Reaction
Virology
Microbial pathogens
People and Places
business
Zdroj: PLoS ONE, Vol 16, Iss 3, p e0248397 (2021)
PLoS ONE
ISSN: 1932-6203
Popis: In the ongoing coronavirus disease 2019 (COVID-19) pandemic, PCR has been widely used for screening patients displaying relevant symptoms. The rapid detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) enables prompt diagnosis and the implementation of proper precautionary and isolation measures for the patient. In the present study, we aimed to evaluate the basic assay performance of an innovative PCR system, GeneSoC® (Kyorin Pharmaceutical Co. Ltd., Tokyo, Japan). A total of 1,445 clinical samples were submitted to the clinical laboratory, including confirmed or suspected cases of COVID-19, from February 13 to August 31. Specimen types included nasopharyngeal swabs. The sampling was performed several times for each patient every 2–7 days. Using this system, sequences specific for SARS-CoV-2 RNA could be detected in a sample within 10–15 min using the microfluidic thermal cycling technology. Analytical sensitivity studies showed that GeneSoC® could detect the target sequence of the viral envelope and RNA-dependent RNA-polymerase (RdRp) genes at 5 and 10 copies/μL, respectively. The precision of the GeneSoC® measurements using clinical isolates of the virus at a concentration of 103 copies/μL was favorable for both the genes; within-run repeatability and between-run reproducibility coefficient of variation values were less than 3% and 2%, respectively; and the reproducibility of inter-detection units was less than 5%. Method comparison by LightCycler® 480 showed the positive and negative agreement to be 100% [(174/174) and (1271/1271), respectively]. GeneSoC® proved to be a rapid and reliable detection system for the prompt diagnosis of symptomatic COVID-19 patients and could help reduce the spread of infections and facilitate more rapid treatment of infected patients.
Databáze: OpenAIRE
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