5. Evaluate the Sars- Cov-2 diagnostic value of quantitative antigen test
Nội dung chính của bài viết
One of the most successful strategies to halt the spread of the COVID-19 pandemic is to quickly screen by testing to identify infected individuals, leading to effectively isolating patients. However, in order to ensure the test's value, the diagnostic value must be thoroughly analyzed before using it. In this research, we used a cross-sectional descriptive study to evaluate the diagnostic efficacy of the Lumipulse G SARS-COV-2 Ag test on salivary and nasopharyngeal swab specimens. The results showed that at the manufacturer's recommended cut-off of 0.67 pg/mL, the sensitivity and specificity were 70.00% and 68.87% on saliva samples, respectively. The test's sensitivity and specificity for nasopharyngeal swab samples were 100% and 95.9%, respectively, at the 1.34 pg/mL cut-off, and it could achieve high sensitivity of 99.4% and specificity of 99.3% at the cut-off value of 17.66 pg/mL. With nasopharyngeal swab samples, we found that the Lumipulse G SARS-COV-2 Ag test achieved the WHO testing standards for the diagnosis and screening of COVID-19. The sensitive diagnostic of this test in nasopharyngeal swab samples is high even the viral load is low and higher than in saliva swab samples.
Chi tiết bài viết
Evaluate the Sars- Cov-2 diagnostic value of quantitative antigen test
Tài liệu tham khảo
2. WHO Director-General’s opening remarks at the mission briefing on COVID-19. Accessed June 12, 2022. https://www.who.int/director-general/speeches/detail/who-director-general-s-opening-remarks-at-the-mission-briefing-on-covid-19.
3. Weekly epidemiological update on COVID-19 - 27 April 2022. Accessed July 17, 2022. https://www.who.int/publications/m/item/weekly-epidemiological-update-on-covid-19---27-april-2022.
4. Thông tấn xã Việt Nam - Thống kê dịch Covid-19. Accessed July 17, 2022. https://covid19.vnanet.vn/
5. Chen N, Zhou M, Dong X, et al. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. The Lancet. 2020; 395(10223): 507-513. doi:10.1016/S0140-6736(20)30211-7.
6. Yokota I, Shane PY, Okada K, et al. A novel strategy for SARS-CoV-2 mass screening with quantitative antigen testing of saliva: a diagnostic accuracy study. Lancet Microbe. Published online May 19, 2021. doi:10.1016/S2666-5247(21)00092-6.
7. Benzigar MR, Bhattacharjee R, Baharfar M, Liu G. Current methods for diagnosis of human coronaviruses: pros and cons. Anal Bioanal Chem. 2021; 413(9): 2311-2330. doi:10.1007/s00216-020-03046-0.
8. Larremore DB, Wilder B, Lester E, et al. Test sensitivity is secondary to frequency and turnaround time for COVID-19 screening. Sci Adv. 2021; 7(1): eabd5393. doi:10.1126/sciadv.abd5393.
9. Gili A, Paggi R, Russo C, et al. Evaluation of Lumipulse® G SARS-CoV-2 antigen assay automated test for detecting SARS-CoV-2 nucleocapsid protein (NP) in nasopharyngeal swabs for community and population screening. Int J Infect Dis. 2021; 105: 391-396. doi:10.1016/j.ijid.2021.02.098.
10. Menchinelli G, Bordi L, Liotti FM, et al. Lumipulse G SARS-CoV-2 Ag assay evaluation using clinical samples from different testing groups. Clin Chem Lab Med CCLM. 2021; 59(8): 1468-1476. doi:10.1515/cclm-2021-0182.
11. Dân số Việt Nam mới nhất (2022) - cập nhật hằng ngày. DanSo.Org. Published April 21, 2017. Accessed June 12, 2022. https://danso.org/viet-nam/.
12. WHO, Germany open Hub for Pandemic and Epidemic Intelligence in Berlin. Accessed June 15, 2022. https://www.who.int/news/item/01-09-2021-who-germany-open-hub-for-pandemic-and-epidemic-intelligence-in-berlin.
13. LightMix® SarbecoV E-gene plus EAV control Kit Instruction. Roche.
14. Lumipulse® G SARS-CoV-2 Immunoreaction Catridges Package Insert.
15. Thuấn TV. Ban hành Hướng dẫn sử dụng sinh phẩm xét nghiệm nhanh kháng nguyên vi rút SARS-CoV-2:13.
16. Hirotsu Y, Maejima M, Shibusawa M, et al. Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients. Int J Infect Dis IJID Off Publ Int Soc Infect Dis. 2020; 99: 397-402. doi:10.1016/j.ijid.2020.08.029.
17. Basso D, Aita A, Padoan A, et al. Salivary SARS-CoV-2 antigen rapid detection: A prospective cohort study. Clin Chim Acta Int J Clin Chem. 2021; 517: 54-59. doi:10.1016/j.cca.2021.02.014.
18. Petonnet D, Marot S, Leroy I, et al. Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection. Diagnostics. 2022; 12(1): 104. doi:10.3390/diagnostics12010104.