Clinical study of real-time polymerase chain reaction test kit for SARS-CoV-2 ribonucleic acids detection
Objective: development and validation of a reverse transcription polymerase chain reaction (RT-PCR) test kit for SARS-CoV-2 ribonucleic acids (RNA) qualitative detection adapted for using with automated station for RNA extraction.Material and methods. Assessment of clinical performance was carried o...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | Russian |
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IRBIS LLC
2022-07-01
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| Series: | Фармакоэкономика |
| Subjects: | |
| Online Access: | https://www.pharmacoeconomics.ru/jour/article/view/696 |
| _version_ | 1797878897363124224 |
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| author | M. Yu. Dmitryukova A. A. Golod M. E. Senina A. E. Gushchin |
| author_facet | M. Yu. Dmitryukova A. A. Golod M. E. Senina A. E. Gushchin |
| author_sort | M. Yu. Dmitryukova |
| collection | DOAJ |
| description | Objective: development and validation of a reverse transcription polymerase chain reaction (RT-PCR) test kit for SARS-CoV-2 ribonucleic acids (RNA) qualitative detection adapted for using with automated station for RNA extraction.Material and methods. Assessment of clinical performance was carried out on biological samples (nasal and oropharyngeal swabs and sputum) obtained during the diagnostic procedure. The presence of novel coronavirus RNA was established using a reference kit. Sensitivity was evaluated on standard SARS-CoV-2 sample (EDX SARS-CoV-2 Standard, Bio-Rad Laboratories, USA).Results. Presence of SARS-CoV-2 RNA is detected by two genome regions. Sensitivity determined by testing SARS-CoV-2 standard was 250 copies/ml. Coefficient of variation during the testing of samples with the concentration of 104 copies/ml did not exceed 5% in different conditions. Diagnostic sensitivity against reference test was 100% (95% confidence interval (CI) 95.6–100) for nasal and oropharyngeal swabs and 100% (95% CI 94.8–100) for sputum. Diagnostic specificity was 100% (95% CI 95.6–100) for nasal and oropharyngeal swabs and 100% (95% CI 94.8–100) for sputum. The turnaround time for test from RNA extraction till obtaining results was about 3 hours when testing 96 samples using automated stations for RNA extraction.Conclusion. Using the kit together with automated station for RNA extraction will increase laboratory testing capacity in pandemic conditions. |
| first_indexed | 2024-04-10T02:39:20Z |
| format | Article |
| id | doaj.art-b7260f499fa64887a1de90be0709df2b |
| institution | Directory Open Access Journal |
| issn | 2070-4909 2070-4933 |
| language | Russian |
| last_indexed | 2024-04-10T02:39:20Z |
| publishDate | 2022-07-01 |
| publisher | IRBIS LLC |
| record_format | Article |
| series | Фармакоэкономика |
| spelling | doaj.art-b7260f499fa64887a1de90be0709df2b2023-03-13T07:48:18ZrusIRBIS LLCФармакоэкономика2070-49092070-49332022-07-0115223023610.17749/2070-4909/farmakoekonomika.2022.111394Clinical study of real-time polymerase chain reaction test kit for SARS-CoV-2 ribonucleic acids detectionM. Yu. Dmitryukova0A. A. Golod1M. E. Senina2A. E. Gushchin3NextBio LLCNextBio LLCNextBio LLCMoscow Scientific and Practical Center of Dermatovenerology and Cosmetology; InterLabService LLCObjective: development and validation of a reverse transcription polymerase chain reaction (RT-PCR) test kit for SARS-CoV-2 ribonucleic acids (RNA) qualitative detection adapted for using with automated station for RNA extraction.Material and methods. Assessment of clinical performance was carried out on biological samples (nasal and oropharyngeal swabs and sputum) obtained during the diagnostic procedure. The presence of novel coronavirus RNA was established using a reference kit. Sensitivity was evaluated on standard SARS-CoV-2 sample (EDX SARS-CoV-2 Standard, Bio-Rad Laboratories, USA).Results. Presence of SARS-CoV-2 RNA is detected by two genome regions. Sensitivity determined by testing SARS-CoV-2 standard was 250 copies/ml. Coefficient of variation during the testing of samples with the concentration of 104 copies/ml did not exceed 5% in different conditions. Diagnostic sensitivity against reference test was 100% (95% confidence interval (CI) 95.6–100) for nasal and oropharyngeal swabs and 100% (95% CI 94.8–100) for sputum. Diagnostic specificity was 100% (95% CI 95.6–100) for nasal and oropharyngeal swabs and 100% (95% CI 94.8–100) for sputum. The turnaround time for test from RNA extraction till obtaining results was about 3 hours when testing 96 samples using automated stations for RNA extraction.Conclusion. Using the kit together with automated station for RNA extraction will increase laboratory testing capacity in pandemic conditions.https://www.pharmacoeconomics.ru/jour/article/view/696novel coronavirus infectionsars-cov-2covid-19ribonucleic acidsrnapolymerase chain reactionpcr |
| spellingShingle | M. Yu. Dmitryukova A. A. Golod M. E. Senina A. E. Gushchin Clinical study of real-time polymerase chain reaction test kit for SARS-CoV-2 ribonucleic acids detection Фармакоэкономика novel coronavirus infection sars-cov-2 covid-19 ribonucleic acids rna polymerase chain reaction pcr |
| title | Clinical study of real-time polymerase chain reaction test kit for SARS-CoV-2 ribonucleic acids detection |
| title_full | Clinical study of real-time polymerase chain reaction test kit for SARS-CoV-2 ribonucleic acids detection |
| title_fullStr | Clinical study of real-time polymerase chain reaction test kit for SARS-CoV-2 ribonucleic acids detection |
| title_full_unstemmed | Clinical study of real-time polymerase chain reaction test kit for SARS-CoV-2 ribonucleic acids detection |
| title_short | Clinical study of real-time polymerase chain reaction test kit for SARS-CoV-2 ribonucleic acids detection |
| title_sort | clinical study of real time polymerase chain reaction test kit for sars cov 2 ribonucleic acids detection |
| topic | novel coronavirus infection sars-cov-2 covid-19 ribonucleic acids rna polymerase chain reaction pcr |
| url | https://www.pharmacoeconomics.ru/jour/article/view/696 |
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