Merging microfluidics with luminescence immunoassays for urgent point-of-care diagnostics of COVID-19

Yuan, Huijuan; Chen, Peng; Wan, Chao; Li, Yiwei; Liu, Bi‐Feng

doi:10.1016/j.trac.2022.116814

Cited by 14 publications

(10 citation statements)

References 389 publications

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“…Оценка последних важна на разных этапах течения COVID-19, а также при оценке эффективности вакцинации. ИФА сохраняет свою актуальность в диагностике коронавирусной инфекции, в частности, в связи со своей относительно высокой скоростью проведения, что реализуется и в новых тест-системах для прикроватной диагностики (point-of-care), где также определяют IgM и IgG к SARS-CoV-2 [3,7,8]. Взаимодействие вируса SARS-CoV-2 с клеткой-мишенью человеческого организма опосредовано S-белком, в частности, его RBD-доменом [9][10][11].…”

Section: Discussionunclassified

“…Основным подходом к определению иммуноглобулинов в биологических жидкостях человека является неконкурентный иммуноферментный анализ (ИФА) [3]. В настоящий момент в России наличие у гражданина иммунитета к SARS-CoV-2 подтверждается официально по факту проведенной вакцинации и/или ревакцинации, при постановке в медучреждении официального диагноза COVID-19 с внесением сведений о выздоровлении в регистр больных COVID-19, при положительном результате теста на IgG к SARS-CoV-2 в сертифицированных лабораториях, а также в случае поло-ОРИГИНАЛЬНОЕ ИССЛЕДОВАНИЕ https://doi.org/10.17816/clinpract163553 жительного теста полимеразной цепной реакции на SARS-CoV-2.…”

Section: обоснованиеunclassified

“…При значении индекса авидности <30% считали, что IgG к RBD антигену SARS-CoV-2 в анализируемом образце обладают низкой, при 30-50%средней, при >50% -высокой авидностью. По результатам ИФА с использованием набора «SARS-CoV-2-IgG-ИФА-БЕСТ» суммарный уровень IgG был выше во всех группах в сравнении с контрольной: медиана значения КП IgG составила 6,48 (Min-Max 0,29-14,85), 9,96 (3,86), 15,13 (3,60-18,61) для переболевших, вакцинированных, переболевших и вакцинированных и 0,08 (0,06-0,29) для контроля (p=0,001, p <0,001 и p <0,001 соответственно). Таким образом, наи-более высокий уровень суммарных IgG у вакцинированных лиц, перенесших COVID-19 (p=0,012 и р <0,001 в сравнении с перенесшими инфекцию и вакцинированными соответственно).…”

Section: описание медицинского вмешательстваunclassified

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Clinical laboratory diagnostics of antibodies to SARS-CoV-2: from a QR code to the reality

Shansky

Gospodarik

Komarova

et al. 2023

Journal of Clinical Practice

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Background: The immune response to SARS-CoV-2 includes the production of specific immunoglobulins to protein antigens of SARS-CoV-2. Depending on the type and level of immunoglobulins, it is possible to assess the stage of the disease and evaluate the effectiveness of vaccination. The main approach to the determination of immunoglobulins to SARS-CoV-2 in human biological fluids is enzyme-linked sorbent immunoassay. Its data, in particular, are used to issue an electronic COVID-19 certificate with a QR code. However, the qualitative and quantitative composition of immunoglobulins for a QR code is not officially regulated. Aim: measuring the immunoglobulins level in the human blood serum with different types of immunity to the new coronavirus infection (COVID-19) to select the most informative indicators of protective immunity. Methods: The study included 76 blood serum samples from male and female volunteers (age, 18 to 50 y.o.) in compliance with the ethical standards. The detection of IgA, IgM, IgG (total to different regions of SARS-CoV-2, S-protein IgG and RBD-fragment IgG), IgG avidity, and the level of the SARS-CoV-2 N-antigen was performed by enzyme-linked immunosorbent assay (ELISA) using commercially available reagent kits. Results: The indicators of the level of antibodies (both "protective" IgG and IgA of the initial phase of infection) are most pronounced in persons who have been vaccinated and have had COVID-19, and least pronounced in unvaccinated people. For recovered unvaccinated individuals, the level of total protective antibodies and IgG to the S-protein, including the RBD fragment, is the lowest; the avidity of IgG is lower than that in the other groups, too. The IgG avidity in vaccinated patients is higher than that in recovered ones. It should be noted that there were no differences in the level of both total IgG to SARS-CoV-2, to the S-protein and to the RBD-fragment of the S-protein for recovered and vaccinated individuals. Conclusion: The analysis of COVID-19 immunoglobulins indicates a different profile of the humoral immune response following vaccination and previous infection with COVID-19. To quickly assess the immune response to previous and current COVID-19 infection, as well as to detect the post-vaccination immunity, it is advisable to use the total level of IgG to SARS-CoV-2. For deeper assessment of protective immunity and production of protective antibodies, it is better to evaluate the quantitative content of IgG to the S protein and its RBD fragment. The equal level of IgA in the experimental groups indicates an ongoing interaction with SARS CoV-2 in the population. Thus, the electronic COVID-19 certificate is of little use when it is formed by only one of the indicators without taking into account the rest.

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Section: Discussionunclassified

Section: обоснованиеunclassified

Section: описание медицинского вмешательстваunclassified

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Clinical laboratory diagnostics of antibodies to SARS-CoV-2: from a QR code to the reality

Shansky

Gospodarik

Komarova

et al. 2023

Journal of Clinical Practice

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“…As these features enable more sensitive measurements and a more reliable detection of different virus variants by the same antibodies, the N protein is commonly used as a target antigen in microtiter-plate enzyme-linked immunoassays (ELISA) and lateral flow immunoassays (LFA) intended for point-of-care testing . Various other assay formats and detection schemes for the diagnosis of SARS-CoV-2 have been reviewed recently. , …”

Section: Introductionmentioning

confidence: 99%

Digital and Analog Detection of SARS-CoV-2 Nucleocapsid Protein via an Upconversion-Linked Immunosorbent Assay

et al. 2023

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The COVID-19 crisis requires fast and highly sensitive tests for the early stage detection of the SARS-CoV-2 virus. For detecting the nucleocapsid protein (N protein), the most abundant viral antigen, we have employed upconversion nanoparticles that emit short-wavelength light under near-infrared excitation (976 nm). The anti-Stokes emission avoids autofluorescence and light scattering and thus enables measurements without optical background interference. The sandwich upconversion-linked immunosorbent assay (ULISA) can be operated both in a conventional analog mode and in a digital mode based on counting individual immune complexes. We have investigated how different antibody combinations affect the detection of the wildtype N protein and the detection of SARS-CoV-2 (alpha variant) in lysed culture fluid via the N protein. The ULISA yielded a limit of detection (LOD) of 1.3 pg/mL (27 fM) for N protein detection independent of the analog or digital readout, which is approximately 3 orders of magnitude more sensitive than conventional enzyme-linked immunosorbent assays or commercial lateral flow assays for home testing. In the case of SARS-CoV-2, the digital ULISA additionally improved the LOD by a factor of 10 compared to the analog readout.

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“…However, despite promising progress, most of these POC platforms enable naked-eye qualitative detection or additional instrument-assisted quantitative detection. Thus, it is desirable to develop a low-cost, simple, instrument-free platform with quantitative visualization for POC diagnostics of SARS-CoV-2 [ 17 ].…”

Section: Introductionmentioning

confidence: 99%

Hand-powered centrifugal micropipette-tip with distance-based quantification for on-site testing of SARS-CoV-2 virus

Xia

Pang

et al. 2023

Talanta

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Merging microfluidics with luminescence immunoassays for urgent point-of-care diagnostics of COVID-19

Cited by 14 publications

References 389 publications

Clinical laboratory diagnostics of antibodies to SARS-CoV-2: from a QR code to the reality

Clinical laboratory diagnostics of antibodies to SARS-CoV-2: from a QR code to the reality

Digital and Analog Detection of SARS-CoV-2 Nucleocapsid Protein via an Upconversion-Linked Immunosorbent Assay

Hand-powered centrifugal micropipette-tip with distance-based quantification for on-site testing of SARS-CoV-2 virus

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