MOLECULAR DIAGNOSTIC LABORATORY SETUP AND MAINTENANCE FOR SARS-COV-2

An Erratum to this article was published on October 23, 2023. https://dergipark.org.tr/en/pub/jihsam/article/1379848

Abstract

Abstract Aim: Importance of laboratory diagnosis has come to the spotlight once again with the Covid-19 pandemic caused by Sars-CoV-2 and significant changes have taken place in terms of laboratory operation. A global effort has emerged when all healthcare professionals faced a biological threat. Interlaboratory collaboration and multidisciplinary approach contributed to this effort. This study aims to explain step-by-step establishment of a fully capable laboratory for Sars-CoV-2 diagnosis to support local and global fight for the COVID-19 pandemic. Methods: Several precautions were taken, and disaster plans were updated because of the changes in employee health and workload distribution. Some of these are setting up a laboratory from scratch for microorganism diagnostic tests performed in pandemic cases, measures for healthcare workers, personnel assignment planning, changes in the variety and number of tests, innovations in quality standards and the contribution of laboratories to scientific studies. Results: XXXXX Molecular Diagnostic Laboratory has become one of the laboratories in Türkiye where Sars-Cov-2 and its mutations have been studied the most with 1,710,856 samples between 01 October 2020 and 01 May 2022 since its establishment and it has become the laboratory with the highest number of equipment and technical personnel in the capital. Conclusion: This study summarizes all the phases of XXXXX Molecular Diagnostic Laboratory beginning with its establishment from the scratch and covers all the steps to render this facility fully operational. Keywords: COVID-19, laboratory disaster planning, laboratory staff, personal protective equipment, Sars-CoV-2

Keywords

• covid-19
• laboratory disaster planning,
• laboratory staff
• personal protective equipment
• Sars-CoV-2

References

1. Aberaa A, Belaya H, Zewudea A. Establishment of COVID-19 testing laboratory in resource-limited settings: challenges and prospects reported from Ethiopia. Global Health Action 2020;13(1):1841963. doi: 10.1080/16549716.2020.1841963
2. Blasco-Belled A, Tejada-Gallardo C, Fatsini-Prats M, Alsinet C. Mental health among healthcare workers during COVID-19 pandemic in Thailand. Curr Psychol.2022;1:1-12. DOI: 10.1007/s12144-022-02913-6
3. CDC 2019-Novel Coronavirus (2019-nCoV) RealTime RT-PCR Diagnostic Panel,2020. Atlanta: Centers for Disease Control and Prevention. Accessed 12 Jun 2022.
4. Chin A, Chu J, Perera M, et al. Stability of SARS-CoV-2 in different environmental conditions. Lancet Microbe.2020; 1(1):e10.
5. Clinical and Laboratory Standards Institute (CLSI). Training and competence assessment, 4th ed. CLSI guideline QMS03. Wayne, PA: Clinical and Laboratory Standards Institute, 2016.
6. COVID-19 (SARS-CoV-2 Infection) Laboratory Biosafety Guide. TR Ministry of Health, General Directorate of Health Services, Department of Examination and Diagnostic Services, Medical Laboratories Science Commission, 8 April 2020.Turkish
7. Finch TJ, Crowell A, Bhatia M, et al. Continuously updated forecasting of SARS-CoV-2 in a regional health system. Am J Manag Care. 2022;28(3):124-130. doi: 10.37765/ajmc.2022.88838.
8. Jafri L, Ahmed S, Siddiqui I. Impact of COVID-19 on laboratory professionals-A descriptive cross-sectional survey at a clinical chemistry laboratory in a developing country. Ann Med Surg (Lond). 2020;57: 70-75.

9. Linster, M., Ng, B., & Vijayan, V. (2020). COVID-19 and Beyond: Safety and Design Considerations for the Development of a Mobile Biocontainment Laboratory. Applied biosafety : journal of the American Biological Safety Association, 25(3), 169–173. https://doi.org/10.1177/1535676020943394
10. Lippi G, Plebani M. The critical role of laboratory medicine during coronavirus disease 2019 (COVID- 19) and other viral outbreaks. Clin Chem and Lab Med.2020;58(7):1063-1069.
11. Lippi G, Plebani M. Laboratory medicine resilience during coronavirus disease 2019 (COVID-19 ) pandemic. Adv Lab Med . 2020;20200035. doi:10.1515/almed-2020-0035
12. Lippi G. Current laboratory diagnostics of coronavirus disease 2019 (COVID-19). Acta Biomed. 2020;91(2):137-145.
13. Liu R, Han H, Liu F, et al. Positive rate of RT-PCR detection of SARSCoV-2 infection in 4880 cases from one hospital in Wuhan, China, from Jan to Feb 2020. Clin Chim Acta. 2020;505:172-175.
14. Ortiz M, Mario Grijalva M. Biosafety at Home: How to Translate Biomedical Laboratory Safety Precautions for Everyday Use in the Context of COVID-19. Am. J. Trop. Med. Hyg. 2020;103(2), 838–840.
15. Republic of Turkey Ministry of Health COVID-19 Information Platform. https://covid19.saglik.gov.tr/TR68720/covid-19-yetkilendirilmis-tani-laboratuvarlari listesi.html. Accessed 6 Jun 2022. Turkish
16. Sharma B, Shahanshah MF, Gupta S, Gupta V. Recent advances in the diagnosis of COVID-19: A bird's eye view. Expert Rev Mol Diagn.2021; 21(5): 475-491.
17. Tahamtan A, Ardebili A. Real-time RT-PCR in COVID-19 detection: issues affecting the results. Expert Rev Mol Diagn. 2020;20(5):453-454.
18. Tan W, Zhao X, Ma X, et al. A novel coronavirus genome identified in a cluster of pneumonia cases-Wuhan, China 2019. China CDC Weekly. 2020;2(4): 61-2.
19. van Doremalen N, Bushmaker T, Morris DH, et al. Aerosol and surface stability of SARS-CoV-2 as compared with SARS-CoV-1. N Engl J Med. 2020; 382(16), 1564-1567.
20. Waste Management in the COVID-19 Pandemic, TR Ministry of Health (2020). Accessed 6 Jun 2022.Turkish Williams TL, Potenza G, Paz Carlos M, et al. GP36-A Planning for Laboratory Operations During a Disaster; Approved Guideline. 2014; 34(19).
21. World Health Organization. Coronavirus Disease (COVID-19) Situation Report, 2022. https://www.who.int/publications/m/item/weekly-operational-update-on-covid-19. Accessed 6 Jun 2022. World Health Organization, Laboratory biosafety guidance related to coronavirus disease (COVID-19): Geneva,2020: World Health Organization. Interim Guidance; 19 May 2022. Accessed 6 Jun 2022.
22. World Health Organization. Guidance on regulations for the transport of infectious substances 2019– 2020: applicable from 1 January 2019 (No. WHO/WHE/CPI/2019.20). Geneva: World Health Organization; 2019. Accessed 6 Jun 2022.
23. World Health Organization. Rational use of personal protective equipment (PPE) for coronavirus disease (COVID-19): interim guidance, 19 March 2020 (No. WHO/2019-nCoV/IPC PPE_use/2020.2). Geneva: World Health Organization.
24. World Health Organization. Infection prevention and control during health care when coronavirus disease (COVID-19) is suspected or confirmed: interim guidance, 29 June 2020 (No. WHO/2019-nCoV/IPC/ 2020.4). Geneva: World Health Organization; 2020. Accessed 6 Jun 2022.