Pandemic diagnostic tool and accuracy of biomаtеrials for SARS-COV-2 detection


  • O.V. Obertynska Shupik National Healthcare University of Ukraine, Kyiv, Ukraine



diagnostic tool, biological material, types of biological material, nasopharyngeal smear, nasal smear, saliva, RT-PCR, SARS-CoV-2, COVID-19


Background. The new SARS-CoV-2 coronavirus pandemic continues to have an unprecedented impact on the social aspects of society and the world economy. To prevent and control the transmission of COVID-19, infection monitoring, there is a constant need for high-performance technologies to identify the pathogen or its markers. An important tool and the gold standard of today in the diagnosis of coronavirus disease (COVID-19) are molecular genetic technologies, namely the method of polymerase chain reaction with reverse transcription (RT-PCR) to detect markers of ribonucleic acid (RNA) SARS-CoV-2) in samples of different types of biological material, from the most probable sites of the human body available for selection. The biological material of nasal smears (NS), saliva (SS) was studied, although reliable data on their accuracy of use are limited. To do this, we studied the diagnostic value and accuracy of the collected samples of different biological material: nasopharynx/nose /saliva (NPS/NS/SS). Materials and methods. Thirty patients were included after a positive test for SARS-CoV 2 RT-PCR in NPS samples in accordance with the current order № 662 of the Ministry of Health of Ukraine "Guidelines" Procedure for collection, transportation and storage of material for polymerase chain reaction", WHO guidelines for collection, processing and testing of clinical specimens on COVID-19. In comparison with this recommended test method, NPS/NS/SS samples were tested using an automated portable ExiStation 48 detection system (Bioneer Corporation, South Korea) to investigate the feasibi­lity and usefulness of the ExiStation method. 48 and the difference between the types of biological sample samples, specificity and sensitivity were calculated, and three to five samples were taken from each patient over a total study period of 6 to 9 days. Results. 171 sets of NPS/NS/SS samples were selected, of which 122 tested positive for COVID-19 by RT-PCR from NPS biological material. In general, the concordance ratio for biological material types was 82.0%/68.2%/50.4% for NPS/NS/SS samples (ExiStation 48 system); however, for samples collected on the 9th day after the onset of the disease (66 negative and three positive samples), the corresponding figures were 91.7%/80.0%/65.2%. Overall sensitivity estimates were 100.0%/67.5%/37.5% for NPS/NS/SS samples (ExiStation 48 system). For samples up to 7 days after the onset of the disease, the values were 98.0%/84.4%/64.6%. Conclusions. Biological material of samples taken from the lower nasal passage (insert the tip of the tampon into the nostril 2-3 cm from the nostril, touching the anterior nasal cavity and mucous membrane) NS are more reliable than SS samples, and can be an alternative to biological samples NPS collected and delivered in the transport medium for viruses with a lysing component. Therefore, the biological material of the samples taken from the anterior nasal cavity in a special transport medium with a lysing component may be recommended for RT-PCR studies for the diagnosis of COVID-19 during an epidemic or rise in SARS for differential diagnosis.


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How to Cite

Obertynska, O. (2022). Pandemic diagnostic tool and accuracy of biomаtеrials for SARS-COV-2 detection. Health of Society, 10(6), 193–200.