Abstract
Coronavirus disease 2019 (COVID-19) has continued to spread globally since late 2019, representing a formidable challenge to the world’s healthcare systems, wreaking havoc, and spreading rapidly through human contact. With fever, fatigue, and a persistent dry cough being the hallmark symptoms, this disease threatened to destabilize the delicate balance of our global community. Rapid and accurate diagnosis of COVID-19 is a prerequisite for understanding the number of confirmed cases in the world or a region, and an important factor in epidemic assessment and the development of control measures. It also plays a crucial role in ensuring that patients receive the appropriate medical treatment, leading to optimal patient care. Reverse transcription-polymerase chain reaction (RT-PCR) technology is currently the most mature method for detecting viral nucleic acids, but it has many drawbacks. Meanwhile, a variety of COVID-19 detection methods, including molecular biological diagnostic, immunodiagnostic, imaging, and artificial intelligence methods have been developed and applied in clinical practice to meet diverse scenarios and needs. These methods can help clinicians diagnose and treat COVID-19 patients. This review describes the variety of such methods used in China, providing an important reference in the field of the clinical diagnosis of COVID-19.
摘要
自2019年底以来, 新型冠状病毒感染(COVID-19)继续在全球蔓延, 对世界卫生保健系统构成严峻挑战, 造成严重破坏, 并通过人类接触迅速传播. 这种疾病的主要症状是发烧、 疲劳和持续的干咳, 它威胁到我们全球社会健康系统的平衡. 快速准确诊断新冠肺炎是掌握全球或地区确诊病例数量的前提, 也是疫情评估和制定控制措施的重要因素. 同时, 这也确保患者获得合理治疗, 为患者获得最佳的护理方案发挥着至关重要的作用. 逆转录聚合酶链反应(RT-PCR)技术是目前检测病毒核酸最成熟的方法, 但它存在很多缺点. 与此同时, 分子生物学诊断、 免疫诊断、 影像学、 人工智能等多种新型冠状病毒检测方法已经开发并应用于临床, 适应不同场景和需求. 这些方法可以帮助临床医生诊断和治疗COVID-19患者. 本文总结了目前国内常用于新冠肺炎诊断的多种最新检测方法, 为新冠肺炎临床诊断提供了重要参考.
Article PDF
Similar content being viewed by others
Explore related subjects
Discover the latest articles, news and stories from top researchers in related subjects.Avoid common mistakes on your manuscript.
References
Adams SH, Park MJ, Schaub JP, et al., 2020. Medical vulnerability of young adults to severe COVID-19 illness—data from the national health interview survey. J Adolesc Health, 67(3):362–368. https://doi.org/10.1016/j.jadohealth.2020.06.025
Alqahtani MS, Abbas M, Alqahtani A, et al., 2021. A novel computational model for detecting the severity of inflammation in confirmed COVID-19 patients using chest X-ray images. Diagnostics (Basel), 11(5):855. https://doi.org/10.3390/diagnostics11050855
Al-Tawfiq JA, 2020. Asymptomatic coronavirus infection: MERS-CoV and SARS-CoV-2 (COVID-19). Travel Med Infect Dis, 35:101608. https://doi.org/10.1016/j.tmaid.2020.101608
Bai HX, Hsieh B, Xiong Z, et al., 2020. Performance of radiologists in differentiating COVID-19 from non-COVID-19 viral pneumonia at chest CT. Radiology, 296(2):E46–E54. https://doi.org/10.1148/radiol.2020200823
Bai Y, Tao XN, 2021. Comparison of COVID-19 and influenza characteristics. J Zhejiang Univ-Sci B (Biomed & Biotechnol), 22(2):87–98. https://doi.org/10.1631/jzus.B2000479
Bal A, Destras G, Gaymard A, et al., 2020. Molecular characterization of SARS-CoV-2 in the first COVID-19 cluster in France reveals an amino acid deletion in nsp2 (Asp268del). Clin Microbiol Infect, 26(7):960–962. https://doi.org/10.1016/j.cmi.2020.03.020
Bernheim A, Mei XY, Huang MQ, et al., 2020. Chest CT findings in coronavirus disease-19 (COVID-19): relationship to duration of infection. Radiology, 295(3):685–691. https://doi.org/10.1148/radiol.2020200463
Beyerl J, Rubio-Acero R, Castelletti N, et al., 2021. A dried blood spot protocol for high throughput analysis of SARS-CoV-2 serology based on the Roche Elecsys anti-N assay. eBioMedicine, 70:103502. https://doi.org/10.1016/j.ebiom.2021.103502
Bourassa L, Perchetti GA, Phung Q, et al., 2021. A SARS-CoV-2 nucleocapsid variant that affects antigen test performance. J Clin Virol, 141:104900. https://doi.org/10.1016/j.jcv.2021.104900
Brodin P, 2021. Immune determinants of COVID-19 disease presentation and severity. Nat Med, 27(1):28–33. https://doi.org/10.1038/s41591-020-01202-8
Cao YL, Jian FC, Wang J, et al., 2023. Imprinted SARS-CoV-2 humoral immunity induces convergent Omicron RBD evolution. Nature, 614(7948):521–529. https://doi.org/10.1038/s41586-022-05644-7
Chakraborty S, Chandran D, Mohapatra RK, et al., 2022. Langya virus, a newly identified Henipavirus in China-Zoonotic pathogen causing febrile illness in humans, and its health concerns: current knowledge and counteracting strategies-Correspondence. Int J Surg, 105:106882. https://doi.org/10.1016/j.ijsu.2022.106882
Chan JF, Yuan SF, Kok KH, et al., 2020. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet, 395(10223):514–523. https://doi.org/10.1016/S0140-6736(20)30154-9
Chandran D, Dhama K, Chakraborty S, et al., 2022. Monkey-pox: an update on current knowledge and research advances. J Exp Biol Agric Sci, 10(4):679–688. https://doi.org/10.18006/2022.10(4).679.688
Chau CH, Strope JD, Figg WD, 2020. COVID-19 clinical diagnostics and testing technology. Pharmacotherapy, 40(8):857–868. https://doi.org/10.1002/phar.2439
Chen XP, Hu WJ, Yang M, et al., 2021. Risk factors for the delayed viral clearance in COVID-19 patients. J Clin Hypertens (Greenwich), 23(8):1483–1489. https://doi.org/10.1111/jch.14308
Chen YJ, Shi Y, Chen Y, et al., 2020. Contamination-free visual detection of SARS-CoV-2 with CRISPR/Cas12a: a promising method in the point-of-care detection. Biosens Bioelectron, 169:112642. https://doi.org/10.1016/j.bios.2020.112642
Cheng ZJ, Shan J, 2020. 2019 Novel coronavirus: where we are and what we know. Infection, 48(2):155–163. https://doi.org/10.1007/s15010-020-01401-y
Cheng ZJ, Zhan ZQ, Xue MS, et al., 2023. Public health measures and the control of COVID-19 in China. Clin Rev Allergy Immunol, 64(1):1–16. https://doi.org/10.1007/s12016-021-08900-2
Conte C, 2021. Possible link between SARS-CoV-2 infection and Parkinson’s disease: the role of Toll-like receptor 4. Int J Mol Sci, 22(13):7135. https://doi.org/10.3390/ijms22137135
Corman VM, Landt O, Kaiser M, et al., 2020. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill, 25(3):2000045. https://doi.org/10.2807/1560-7917.ES.2020.25.3.2000045
Corman VM, Haage VC, Bleicker T, et al., 2021. Comparison of seven commercial SARS-CoV-2 rapid point-of-care antigen tests: a single-centre laboratory evaluation study. Lancet Microbe, 2(7):e311–e319. https://doi.org/10.1016/S2666-5247(21)00056-2
da Silva SJR, da Silva CTA, Guarines KM, et al., 2020. Clinical and laboratory diagnosis of SARS-CoV-2, the virus causing COVID-19. ACS Infect Dis, 6(9):2319–2336. https://doi.org/10.1021/acsinfecdis.0c00274
Dai WH, Zhang B, Jiang XM, et al., 2020. Structure-based design of antiviral drug candidates targeting the SARS-CoV-2 main protease. Science, 368(6497):1331–1335. https://doi.org/10.1126/science.abb4489
Dheda K, Ruhwald M, Theron G, et al., 2013. Point-of-care diagnosis of tuberculosis: past, present and future. Respirology, 18(2):217–232. https://doi.org/10.1111/resp.12022
Dhochak N, Singhal T, Kabra SK, et al., 2020. Pathophysiology of COVID-19: why children fare better than adults?. Indian J Pediatr, 87(7):537–546. https://doi.org/10.1007/s12098-020-03322-y
Dou YZ, Su J, Chen SX, et al., 2022. A smartphone-based three-in-one biosensor for co-detection of SARS-CoV-2 viral RNA, antigen and antibody. Chem Commun, 58(41):6108–6111. https://doi.org/10.1039/D2CC01297A
Fang YC, Zhang HQ, Xie JC, et al., 2020. Sensitivity of chest CT for COVID-19: comparison to RT-PCR. Radiology, 296(2):E115–E117. https://doi.org/10.1148/radiol.2020200432
Fang ZF, Sun BQ, Zhu AR, et al., 2021. Multiplexed analysis of circulating IgA antibodies for SARS-CoV-2 and common respiratory pathogens in COVID-19 patients. J Med Virol, 93(5):3257–3260. https://doi.org/10.1002/jmv.26829
Fitzpatrick MC, Pandey A, Wells CR, et al., 2021. Buyer beware: inflated claims of sensitivity for rapid COVID-19 tests. Lancet, 397(10268):24–25. https://doi.org/10.1016/S0140-6736(20)32635-0
Frank MG, Nguyen KH, Ball JB, et al., 2022. SARS-CoV-2 spike S1 subunit induces neuroinflammatory, microglial and behavioral sickness responses: evidence of PAMP-like properties. Brain Behav Immun, 100:267–277. https://doi.org/10.1016/j.bbi.2021.12.007
Gao JW, Wang CH, Chu YJ, et al., 2022. Graphene oxide-graphene Van der Waals heterostructure transistor biosensor for SARS-CoV-2 protein detection. Talanta, 240: 123197. https://doi.org/10.1016/j.talanta.2021.123197
Gao W, Tian JJ, Huang KL, et al., 2019. Ultrafast, universal and visual screening of dual genetically modified elements based on dual super PCR and a lateral flow biosensor. Food Chem, 279:246–251. https://doi.org/10.1016/j.foodchem.2018.12.013
Gao YP, Huang KJ, Wang FT, et al., 2022. Recent advances in biological detection with rolling circle amplification: design strategy, biosensing mechanism, and practical applications. Analyst, 147(15):3396–3414. https://doi.org/10.1039/D2AN00556E
García-Fiñana M, Buchan IE, 2021. Rapid antigen testing in COVID-19 responses: SARS-CoV-2 transmission was reduced with measures centered on rapid antigen testing. Science, 372(6542):571–572. https://doi.org/10.1126/science.abi6680
Gaugler S, Sottas PE, Blum K, et al, 2021. Fully automated dried blood spot sample handling and extraction for serological testing of SARS-CoV-2 antibodies. Drug Test Anal, 13(1):223–226. https://doi.org/10.1002/dta.2946
Gili A, Paggi R, Russo C, et al., 2021. 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, 105:391–396. https://doi.org/10.1016/jljid.202L02.098
Gill JL, Williams JW, Jackson ST, et al., 2009. Pleistocene megafaunal collapse, novel plant communities, and enhanced fire regimes in North America. Science, 326(5956):1100–1103. https://doi.org/10.1126/science.1179504
Greenwood D, Richard S, Barer M, et al., 2012. Medical Microbiology. Elsevier, Amsterdam, The Netherlands. Grubaugh ND, Ladner JT, Lemey P, et al., 2019. Tracking virus outbreaks in the twenty-first century. Nat Microbiol, 4(1):10–19. https://doi.org/10.1038/s41564-018-0296-2
Gu W, Miller S, Chiu CY, 2019. Clinical metagenomic next-generation sequencing for pathogen detection. Annu Rev Pathol, 14:319–338. https://doi.org/10.1146/annurev-pathmechdis-012418-012751
Guo M, Tao WY, Flavell RA, et al., 2021. Potential intestinal infection and faecal-oral transmission of SARS-CoV-2. Nat Rev Gastroenterol Hepatol, 18(4):269–283. https://doi.org/10.1038/s41575-021-00416-6
Harcourt J, Tamin A, Lu XY, et al., 2020. Severe acute respiratory syndrome coronavirus 2 from patient with coronavirus disease, United States. Emerg Infect Dis, 26(6):1266–1273. https://doi.org/10.3201/eid2606.200516
Hirotsu Y, Maejima M, Shibusawa M, et al., 2020. 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, 99:397–402. https://doi.org/10.1016/j.ijid.2020.08.029
Hirotsu Y, Maejima M, Shibusawa M, et al., 2021a. Prospective study of 1308 nasopharyngeal swabs from 1033 patients using the LUMIPULSE SARS-CoV-2 antigen test: comparison with RT-qPCR. Int J Infect Dis, 105:7–14. https://doi.org/10.1016/j.ijid.2021.02.005
Hirotsu Y, Sugiura H, Maejima M, et al., 2021b. Comparison of Roche and Lumipulse quantitative SARS-CoV-2 antigen test performance using automated systems for the diagnosis of COVID-19. Int J Infect Dis, 108:263–269. https://doi.org/10.1016/j.ijid.2021.05.067
Holland LA, Kaelin EA, Maqsood R, et al., 2020. An 81-nucleotide deletion in SARS-CoV-2 ORF7a identified from sentinel surveillance in Arizona (January to March 2020). J Virol, 94(14):e00711–20. https://doi.org/10.1128/JVI.00711-20
Hu XJ, Deng QY, Li JM, et al., 2020. Development and clinical application of a rapid and sensitive loop-mediated isothermal amplification test for SARS-CoV-2 infection. mSphere, 5(4):e00808–20. https://doi.org/10.1128/mSphere.00808-20
Huang L, Tian SL, Zhao WH, et al., 2020. Multiplexed detection of biomarkers in lateral-flow immunoassays. Analyst, 145(8):2828–2840. https://doi.org/10.1039/C9AN02485A
Iscove NN, Barbara M, Gu M, et al., 2002. Representation is faithfully preserved in global cDNA amplified exponentially from sub-picogram quantities of mRNA. Nat Biotechnol, 20(9):940–943. https://doi.org/10.1038/nbt729
Islam A, Sangkham S, Tiwari A, et al., 2022a. Association between global monkeypox cases and meteorological factors. Int J Environ Res Public Health, 19(23):15638. https://doi.org/10.3390/ijerph192315638
Islam A, Hasan MN, Ahammed T, et al., 2022b. Association of household fuel with acute respiratory infection (ARI) under-five years children in Bangladesh. Front Public Health, 10:985445. https://doi.org/10.3389/fpubh.2022.985445
Islam A, Hemo MK, Chopra H, et al., 2022c. Old enemy with a new face: re-emerging monkeypox disease-an update. J Pure Appl Microbiol, 16(S1):2972–2988. https://doi.org/10.22207/JPAM.16.SPL1.18
Islam A, Haque A, Rahman A, et al., 2022d. A review on measures to rejuvenate immune system: natural mode of protection against coronavirus infection. Front Immunol, 13: 837290. https://doi.org/10.3389/fimmu.2022.837290
Islam A, Ahammed T, Noor STA, 2022e. An estimation of five-decade long monkeypox case fatality rate: systematic review and meta-analysis. J Pure Appl Microbiol, 16(S1):3036–3047. https://doi.org/10.22207/JPAM.16.SPL1.16
Islam A, Rahman A, Jakariya M, et al., 2023a. A 30-day follow-up study on the prevalence of SARS-CoV-2 genetic markers in wastewater from the residence of COVID-19 patient and comparison with clinical positivity. Sci Total Environ, 858:159350. https://doi.org/10.1016/j.scitotenv.2022.159350
Islam A, Adeiza SS, Amin R, et al., 2023b. A bibliometric study on Marburg virus research with prevention and control strategies. Front Trop Dis, 3:1068364. https://doi.org/10.3389/fitd.2022.1068364
Islam A, Hossen F, Rahman A, et al., 2023c. An opinion on Wastewater-Based Epidemiological Monitoring (WBEM) with Clinical Diagnostic Test (CDT) for detecting high-prevalence areas of community COVID-19 infections. Curr Opin Environ Sci Health, 31:100396. https://doi.org/10.1016/j.coesh.2022.100396
Jakariya M, Ahmed F, Islam A, et al., 2022. Wastewater-based epidemiological surveillance to monitor the prevalence of SARS-CoV-2 in developing countries with onsite sanitation facilities. Environ Pollut, 311:119679. https://doi.org/10.1016/j.envpol.2022.119679
Kames J, Holcomb DD, Kimchi O, et al., 2020. Sequence analysis of SARS-CoV-2 genome reveals features important for vaccine design. Sci Rep, 10:15643. https://doi.org/10.1038/s41598-020-72533-2
Karp DG, Danh K, Espinoza NF, et al., 2020. A serological assay to detect SARS-CoV-2 antibodies in at-home collected finger-prick dried blood spots. Sci Rep, 10:20188. https://doi.org/10.1038/s41598-020-76913-6
Kobayashi Y, Mitsudomi T, 2013. Management of ground-glass opacities: should all pulmonary lesions with ground-glass opacity be surgically resected?. Transl Lung Cancer Res, 2(5):354–363. https://doi.org/10.3978/j.issn.2218-6751.2013.09.03
Koczula KM, Gallotta A, 2016. Lateral flow assays. Essays Biochem, 60(1):111–120. https://doi.org/10.1042/EBC20150012
Krüttgen A, Cornelissen CG, Dreher M, et al., 2021. Comparison of the SARS-CoV-2 rapid antigen test to the real star SARS-CoV-2 RT PCR kit. J Virol Methods, 288:114024. https://doi.org/10.1016/j.jviromet2020.114024
Kubina R, Dziedzic A, 2020. Molecular and serological tests for COVID-19. A comparative review of SARS-CoV-2 coronavirus laboratory and point-of-care diagnostics. Diagnostics, 10(6):434. https://doi.org/10.3390/diagnostics10060434
Kucirka LM, Lauer SA, Laeyendecker O, et al., 2020. Variation in false-negative rate of reverse transcriptase polymerase chain reaction-based SARS-CoV-2 tests by time since exposure. Ann Intern Med, 173(4):262–267. https://doi.org/10.7326/M20-1495
Kuntip N, Japrung D, Pongprayoon P, 2021. What happens when a complementary DNA meets miR-29a cancer biomarker in complex with a graphene quantum dot. ACS Appl Bio Mater, 4(12):8368–8376. https://doi.org/10.1021/acsabm.1c00943
Kurhade C, Zou J, Xia HJ, et al., 2023. Low neutralization of SARS-CoV-2 Omicron BA.2.75.2, BQ. 1.1 and XBB. 1 by parental mRNA vaccine or a BA. 5 bivalent booster. Nat Med, 29(2):344–347. https://doi.org/10.1038/s41591-022-02162-x
la Marca A, Capuzzo M, Paglia T, et al., 2020. Testing for SARS-CoV-2 (COVID-19): a systematic review and clinical guide to molecular and serological in-vitro diagnostic assays. Reprod Biomed Online, 41(3):483–499. https://doi.org/10.1016/j.rbmo.2020.06.001
Lanciotti RS, Calisher CH, Gubler DJ, et al., 1992. Rapid detection and typing of dengue viruses from clinical samples by using reverse transcriptase-polymerase chain reaction. J Clin Microbiol, 30(3):545–551. https://doi.org/10.1128/jcm.30.3.545-551.1992
Leixner G, Voill-Glaninger A, Bonner E, et al., 2021. Evaluation of the AMP SARS-CoV-2 rapid antigen test in a hospital setting. Int J Infect Dis, 108:353–356. https://doi.org/10.1016/j.ijid.2021.05.063
Li F, Ye QH, Chen MT, et al., 2021. Cas12aFDet: a CRISPR/Cas12a-based fluorescence platform for sensitive and specific detection of Listeria monocytogenes serotype 4c. Anal Chim Acta, 1151:338248. https://doi.org/10.1016/j.aca.2021.338248
Li TW, Shao YF, Fu LY, et al., 2018. Plasma circular RNA profiling of patients with gastric cancer and their droplet digital RT-PCR detection. J Mol Med, 96(1):85–96. https://doi.org/10.1007/s00109-017-1600-y
Li YY, Yang X, Zhao WA, 2017. Emerging microtechnologies and automated systems for rapid bacterial identification and antibiotic susceptibility testing. SLAS Technol, 22(6):585–608. https://doi.org/10.1177/2472630317727519
Li ZT, Yi YX, Luo XM, et al., 2020. Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis. J Med Virol, 92(9):1518–1524. https://doi.org/10.1002/jmv.25727
Liu J, Gratz J, Amour C, et al., 2016. Optimization of quantitative PCR methods for enteropathogen detection. PLoS ONE, 11(6):e0158199. https://doi.org/10.1371/journal.pone.0158199
Lv DF, Ying QM, Weng YS, et al., 2020. Dynamic change process of target genes by RT-PCR testing of SARS-CoV-2 during the course of a Coronavirus Disease 2019 patient. Clin Chim Acta, 506:172–175. https://doi.org/10.1016/j.cca.2020.03.032
Mackay IM, 2004. Real-time PCR in the microbiology laboratory. Clin Microbiol Infect, 10(3):190–212. https://doi.org/10.1111/j.1198-743X.2004.00722.x
Mahalakshmi AM, Ray B, Tuladhar S, et al., 2021. Does COVID-19 contribute to development of neurological disease?. Immun Inflamm Dis, 9(1):48–58. https://doi.org/10.1002/iid3.387
Manenti A, Maggetti M, Casa E, et al., 2020. Evaluation of SARS-CoV-2 neutralizing antibodies using a CPE-based colorimetric live virus micro-neutralization assay in human serum samples. J Med Virol, 92(10):2096–2104. https://doi.org/10.1002/jmv.25986
McDade TW, McNally EM, Zelikovich AS, et al., 2020. High seroprevalence for SARS-CoV-2 among household members of essential workers detected using a dried blood spot assay. PLoS ONE, 15(8):e0237833. https://doi.org/10.1371/journal.pone.0237833
Menchinelli G, Bordi L, Liotti FM, et al., 2021. Lumipulse G SARS-CoV-2 Ag assay evaluation using clinical samples from different testing groups. Clin Chem Lab Med, 59(8):1468–1476. https://doi.org/10.1515/cclm-2021-0182
Mercer TR, Salit M, 2021. Testing at scale during the COVID-19 pandemic. Nat Rev Genet, 22(7):415–426. https://doi.org/10.1038/s41576-021-00360-w
Metzker ML, 2010. Sequencing technologies—the next generation. Nat Rev Genet, 11(1):31–46. https://doi.org/10.1038/nrg2626
Miesse PK, Collier BB, Grant RP, 2022. Monitoring of SARS-CoV-2 antibodies using dried blood spot for at-home collection. Sci Rep, 12:5812. https://doi.org/10.1038/s41598-022-09699-4
Mina MJ, Parker R, Larremore DB, 2020. Rethinking Covid-19 test sensitivity—a strategy for containment. N Engl J Med, 383(22):e120. https://doi.org/10.1056/NEJMp2025631
Mohammadi MR, Omidi AH, Sabati H, 2022. Current trends and new methods of detection of SARS-CoV-2 infection. Cell Mol Biomed Rep, 2(3):138–150. https://doi.org/10.55705/cmbr.2022.345025.1047
Montesinos I, Gruson D, Kabamba B, et al., 2020. Evaluation of two automated and three rapid lateral flow immunoassays for the detection of anti-SARS-CoV-2 antibodies. J Clin Virol, 128:104413. https://doi.org/10.1016/j.jcv.2020.104413
Morley GL, Taylor S, Jossi S, et al., 2020. Sensitive detection of SARS-CoV-2-specific antibodies in dried blood spot samples. Emerg Infect Dis, 26(12):2970–2973. https://doi.org/10.3201/eid2612.203309
Motayo BO, Oluwasemowo OO, Olusola BA, et al., 2021. Evolution and genetic diversity of SARS-CoV-2 in Africa using whole genome sequences. Int J Infect Dis, 103: 282–287. https://doi.org/10.1016/j.ijid.2020.11.190
Muhi S, Tayler N, Hoang T, et al., 2021. Multi-site assessment of rapid, point-of-care antigen testing for the diagnosis of SARS-CoV-2 infection in a low-prevalence setting: a validation and implementation study. Lancet Reg Health West Pac, 9:100115. https://doi.org/10.1016/j.lanwpc.2021.100115
Nicol T, Lefeuvre C, Serri O, et al., 2020. Assessment of SARS-CoV-2 serological tests for the diagnosis of COVID-19 through the evaluation of three immunoassays: two automated immunoassays (Euroimmun and Abbott) and one rapid lateral flow immunoassay (NG Biotech). J Clin Virol, 129:104511. https://doi.org/10.1016/j.jcv.2020.104511
Nie JH, Li QQ, Wu JJ, et al., 2020. Establishment and validation of a pseudovirus neutralization assay for SARS-CoV-2. Emerg Microbes Infect, 9(1):680–686. https://doi.org/10.1080/22221751.2020.1743767
Oran DP, Topol EJ, 2020. Prevalence of asymptomatic SARS-CoV-2 infection: a narrative review. Ann Intern Med, 173(5):362–367. https://doi.org/10.7326/M20-3012
Oude Munnink BB, Nieuwenhuijse DF, Stein M, et al., 2020. Rapid SARS-CoV-2 whole-genome sequencing and analysis for informed public health decision-making in the Netherlands. Nat Med, 26(9):1405–1410. https://doi.org/10.1038/s41591-020-0997-y
Pan F, Ye TH, Sun P, et al., 2020. Time course of lung changes at chest CT during recovery from coronavirus disease 2019 (COVID-19). Radiology, 295(3):715–721. https://doi.org/10.1148/radiol.2020200370
Pang B, Xu JY, Liu YM, et al., 2020. Isothermal amplification and ambient visualization in a single tube for the detection of SARS-CoV-2 using loop-mediated amplification and CRISPR technology. Anal Chem, 92(24):16204–16212. https://doi.org/10.1021/acs.analchem.0c04047
Peeling RW, Olliaro PL, Boeras DI, et al., 2021. Scaling up COVID-19 rapid antigen tests: promises and challenges. Lancet Infect Dis, 21(9):e290–e295. https://doi.org/10.1016/S1473-3099(21)00048-7
Peto J, 2020. Covid-19 mass testing facilities could end the epidemic rapidly. BMJ, 368:m1163. https://doi.org/10.1136/bmj.m1163
Pumford EA, Lu JK, Spaczai I, et al., 2020. Developments in integrating nucleic acid isothermal amplification and detection systems for point-of-care diagnostics. Biosens Bioelectron, 170:112674. https://doi.org/10.1016/j.bios.2020.112674
Qiu F, Wang HJ, Zhang ZK, et al., 2020. Laboratory testing techniques for SARS-CoV-2. J Southern Med Univ, 40(2): 164–167 (in Chinese). https://doi.org/10.12122/j.issn.1673-4254.2020.02.16
Quail MA, Smith M, Coupland P, et al., 2012. A tale of three next generation sequencing platforms: comparison of Ion Torrent, Pacific Biosciences and Illumina MiSeq sequencers. BMC Genomics, 13:341. https://doi.org/10.1186/1471-2164-13-341
Rajpal S, Lakhyani N, Singh AK, et al., 2021. Using hand-picked features in conjunction with ResNet-50 for improved detection of COVID-19 from chest X-ray images. Chaos Solitons Fractals, 145:110749. https://doi.org/10.1016/j.chaos.2021.110749
Rutala WA, Weber DJ, 2017. Guideline for disinfection and sterilization in healthcare facilities, 2008. Centers for Disease Control and Prevention. https://stacks.cdc.gov/view/cdc/47378
Safiabadi Tali SH, LeBlanc JJ, Sadiq Z, et al., 2021. Tools and techniques for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)/COVID-19 detection. Clin Microbiol Rev, 34(3):e00228–20. https://doi.org/10.1128/CMR.00228-20
Sakib MH, Nishat AA, Islam MT, et al., 2021. Computational screening of 645 antiviral peptides against the receptor-binding domain of the spike protein in SARS-CoV-2. Comput Biol Med, 136:104759. https://doi.org/10.1016/j.compbiomed.2021.104759
Sandle T, 2013. Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals: Technology, Validation and Current Regulations. Woodhead Publishing Ltd., Oxford, UK.
Santiago I, 2020. Trends and innovations in biosensors for COVID-19 mass testing. ChemBioChem, 21(20):2880–2889. https://doi.org/10.1002/cbic.202000250
Shen B, Zheng Y, Zhang X, et al., 2020. Clinical evaluation of a rapid colloidal gold immunochromatography assay for SARS-CoV-2 IgM/IgG. Am J Transl Res, 12(4):1348–1354.
Shi P, Dong YQ, Yan HC, et al., 2020. Impact of temperature on the dynamics of the COVID-19 outbreak in China. Sci Total Environ, 728:138890. https://doi.org/10.1016/j.scitotenv.2020.138890
Shi R, Shan C, Duan XM, et al., 2020. A human neutralizing antibody targets the receptor-binding site of SARS-CoV-2. Nature, 584(7819):120–124. https://doi.org/10.1038/s41586-020-2381-y
Shu YL, McCauley J, 2017. GISAID: global initiative on sharing all influenza data-from vision to reality. Euro Surveill, 22(13):30494. https://doi.org/10.2807/1560-7917.ES.2017.22.13.30494
Singh J, Sharma S, Nara S, 2015. Evaluation of gold nanoparticle based lateral flow assays for diagnosis of enterobacteriaceae members in food and water. Food Chem, 170:470–483. https://doi.org/10.1016/j.foodchem.2014.08.092
Sirois M, 2014. Laboratory Procedures for Veterinary Technicians, 6th Ed. Elsevier, St. Louis, USA.
Smyrlaki I, Ekman M, Lentini A, et al., 2020. Massive and rapid COVID-19 testing is feasible by extraction-free SARS-CoV-2 RT-PCR. Nat Commun, 11:4812. https://doi.org/10.1038/s41467-020-18611-5
Soni A, Herbert C, Filippaios A, et al., 2022. Comparison of rapid antigen tests’ performance between Delta and Omicron variants of SARS-CoV-2: secondary analysis from a serial home self-testing study. Ann Intern Med, 175(12):1685–1692. https://doi.org/10.7326/M22-0760
Soto I, Zamorano-Illanes R, Becerra R, et al., 2023. A new COVID-19 detection method based on CSK/QAM visible light communication and machine learning. Sensors, 23(3):1533. https://doi.org/10.3390/s23031533
Steinman JB, Lum FM, Ho PPK, et al., 2020. Reduced development of COVID-19 in children reveals molecular checkpoints gating pathogenesis illuminating potential therapeutics. Proc Natl Acad Sci USA, 117(40):24620–24626. https://doi.org/10.1073/pnas.2012358117
Sun T, Guan J, 2020. Novel coronavirus and the central nervous system. Eur J Neurol, 27(9):e52. https://doi.org/10.1111/ene.14227
Taleghani N, Taghipour F, 2021. Diagnosis of COVID-19 for controlling the pandemic: a review of the state-of-the-art. Biosens Bioelectron, 174:112830. https://doi.org/10.1016/j.bios.2020.112830
Tan CW, Chia WN, Qin XJ, et al., 2020. A SARS-CoV-2 surrogate virus neutralization test based on antibody-mediated blockage of ACE2-spike protein-protein interaction. Nat Biotechnol, 38(9):1073–1078. https://doi.org/10.1038/s41587-020-0631-z
Tsang NNY, So HC, Ng KY, et al., 2021. Diagnostic performance of different sampling approaches for SARS-CoV-2 RT-PCR testing: a systematic review and meta-analysis. Lancet Infect Dis, 21(9):1233–1245. https://doi.org/10.1016/S1473-3099(21)00146-8
Verkhratsky A, Li Q, Melino S, et al., 2020. Can COVID-19 pandemic boost the epidemic of neurodegenerative diseases? Biol Direct, 15:28. https://doi.org/10.1186/s13062-020-00282-3
Wang CJ, Li Y, Pan YC, et al., 2022. Clinical and immune response characteristics among vaccinated persons infected with SARS-CoV-2 delta variant: a retrospective study. J Zhejiang Univ-Sci B (Biomed & Biotechnol), 23(11):899–914. https://doi.org/10.1631/jzus.B2200054
Wang R, Qian CY, Pang YA, et al., 2021. opvCRISPR: one-pot visual RT-LAMP-CRISPR platform for SARS-CoV-2 detection. Biosens Bioelectron, 172:112766. https://doi.org/10.1016/j.bios.2020.112766
Wang XN, Zhu YS, Jiang HW, et al., 2020. Detection methods of SARS-CoV-2. Chem Life, 40(8):1258–1269 (in Chinese). https://doi.org/10.13488/j.smhx.20200280
Wang YH, Dong CJ, Hu Y, et al., 2020. Temporal changes of CT findings in 90 patients with COVID-19 pneumonia: a longitudinal study. Radiology, 296(2):E55–E64. https://doi.org/10.1148/radiol.2020200843
Wang YW, Ma DD, Zhang GP, et al., 2022. An electrochemical immunosensor based on SPA and rGO-PEI-Ag-Nf for the detection of arsanilic acid. Molecules, 27(1):172. https://doi.org/10.3390/molecules27010172
Wen JQ, Cheng YF, Ling RS, et al., 2020. Antibody-dependent enhancement of coronavirus. Int J Infect Dis, 100:483–489. https://doi.org/10.1016/j.ijid.2020.09.015
Wu F, Zhao S, Yu B, et al., 2020. A new coronavirus associated with human respiratory disease in China. Nature, 579(7798):265–269. https://doi.org/10.1038/s41586-020-2008-3
Wu Q, Wu W, Chen FF, et al., 2022. Highly sensitive and selective surface plasmon resonance biosensor for the detection of SARS-CoV-2 spike S1 protein. Analyst, 147(12):2809–2818.
Xu Z, Shi L, Wang YJ, et al., 2020. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med, 8(4):420–422. https://doi.org/10.1016/S2213-2600(20)30076-X
Yadav S, Sadique MA, Ranjan P, et al., 2021. SERS based lateral flow immunoassay for point-of-care detection of SARS-CoV-2 in clinical samples. ACS Appl Bio Mater, 4(4):2974–2995. https://doi.org/10.1021/acsabm.1c00102
Yan C, Cui J, Huang L, et al., 2020. Rapid and visual detection of 2019 novel coronavirus (SARS-CoV-2) by a reverse transcription loop-mediated isothermal amplification assay. Clin Microbiol Infect, 26(6):773–779. https://doi.org/10.1016/j.cmi.2020.04.001
Yan SJ, Ahmad KZ, Warden AR, et al., 2021. One-pot pre-coated interface proximity extension assay for ultrasensitive co-detection of anti-SARS-CoV-2 antibodies and viral RNA. Biosens Bioelectron, 193:113535. https://doi.org/10.1016/j.bios.2021.113535
Yang WJ, Cao QQ, Qin L, et al., 2020. Clinical characteristics and imaging manifestations of the 2019 novel coronavirus disease (COVID-19): a multi-center study in Wenzhou city, Zhejiang, China. Journal of Infection, 80(4):388–393. https://doi.org/10.1016/j.jinf.2020.02.016
Yuan SJ, Pan Y, Xia Y, et al., 2021. Development and validation of an individualized nomogram for early prediction of the duration of SARS-CoV-2 shedding in COVID-19 patients with non-severe disease. J Zhejiang Univ-Sci B (Biomed & Biotechnol), 22(4):318–329. https://doi.org/10.1631/jzus.B2000608
Yüce M, Filiztekin E, Özkaya KG, 2021. COVID-19 diagnosis—a review of current methods. Biosens Bioelectron, 172: 112752. https://doi.org/10.1016/j.bios.2020.112752
Yue C, Song WL, Wang L, et al., 2023. ACE2 binding and antibody evasion in enhanced transmissibility of XBB. 1.5. Lancet Infect Dis, 23(3):278–280. https://doi.org/10.1016/S1473-3099(23)00010-5
Yue L, Xie TH, Yang T, et al., 2022. A third booster dose may be necessary to mitigate neutralizing antibody fading after inoculation with two doses of an inactivated SARS-CoV-2 vaccine. J Med Virol, 94(1):35–38. https://doi.org/10.1002/jmv.27334
Zava TT, Zava DT, 2021. Validation of dried blood spot sample modifications to two commercially available COVID-19 IgG antibody immunoassays. Bioanalysis, 13(1):13–28. https://doi.org/10.4155/bio-2020-0289
Zhang CY, Shi DM, Li XY, et al., 2022. Microfluidic electrochemical magnetoimmunosensor for ultrasensitive detection of interleukin-6 based on hybrid of AuNPs and graphene. Talanta, 240:123173. https://doi.org/10.1016/j.talanta.2021.123173
Zhang YM, Zhang Y, Xie KB, 2020. Evaluation of CRISPR/Cas12a-based DNA detection for fast pathogen diagnosis and GMO test in rice. Mol Breed, 40:11. https://doi.org/10.1007/s11032-019-1092-2
Zhu N, Zhang DY, Wang WL, et al., 2020. A novel coronavirus from patients with pneumonia in China, 2019. N Engl J Med, 382(8):727–733. https://doi.org/10.1056/NEJMoa2001017
Acknowledgments
This work was supported by the Emergency Key Project of Guangzhou Laboratory (No. EKPG21-30-2), China.
Author information
Authors and Affiliations
Contributions
Writing: Mingtao LIU, Jiali LYU, Xianhui ZHENG, and Zhiman LIANG. Research and paragraph contributions: Baoying LEI, Huihuang CHEN, and Yiyin MAI. Figure: Zhiman LIANG. Conceptualization and supervision: Huimin HUANG and Baoqing SUN. All authors have read and approved the final manuscript, and therefore, have full access to all the data in the study and take responsibility for the integrity and security of the data.
Corresponding authors
Ethics declarations
Mingtao LIU, Jiali LYU, Xianhui ZHENG, Zhiman LIANG, Baoying LEI, Huihuang CHEN, Yiyin MAI, Huimin HUANG, and Baoqing SUN declare that they have no conflict of interest.
This article does not contain any studies with human or animal subjects performed by any of the authors.
Rights and permissions
About this article
Cite this article
Liu, M., Lyu, J., Zheng, X. et al. Evolution of the newest diagnostic methods for COVID-19: a Chinese perspective. J. Zhejiang Univ. Sci. B 24, 463–484 (2023). https://doi.org/10.1631/jzus.B2200625
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1631/jzus.B2200625
Key words
- Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
- Coronavirus disease 2019 (COVID-19)
- Diagnosis
- Polymerase chain reaction (PCR)
- Immunoassay
- Radiography