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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 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.

About the Authors

M. Yu. Dmitryukova
NextBio LLC
Russian Federation

Marina Yu. Dmitryukova – PhD (Biol.), Senior Researcher. RSCI SPIN-code: 3021-2553

8 Polimernaya Str., Moscow 111394

A. A. Golod
NextBio LLC
Russian Federation

Anastasia A. Golod – Junior Development Specialist

8 Polimernaya Str., Moscow 111394

M. E. Senina
NextBio LLC
Russian Federation

Maria E. Senina – Director, Research and Production Complex. RSCI SPIN-code: 6122-0490

8 Polimernaya Str., Moscow 111394

A. E. Gushchin
Moscow Scientific and Practical Center of Dermatovenerology and Cosmetology; InterLabService LLC
Russian Federation

Aleksandr E. Gushchin – PhD (Biol.), Leading Researcher; Founder. RSCI SPIN-code: 3496-6893

17 Leninskiy Ave, Moscow 119071
20/13 bldg 2 Sadovnicheskaya Str., Moscow 115035


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For citations:

Dmitryukova M.Yu., Golod A.A., Senina M.E., Gushchin A.E. Clinical study of real-time polymerase chain reaction test kit for SARS-CoV-2 ribonucleic acids detection. FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2022;15(2):230-236. (In Russ.)

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ISSN 2070-4909 (Print)
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