Reliability of serological tests for COVID-19: comparison of three immunochromatography test kits for SARS-CoV-2 antibodies

Fujigaki, Hidetsugu; Takemura, Masao; Osawa, Michiko; Sakurai, Aki; Nakamoto, Kentaro; Seto, Kazuto; Fujita, Takashi; Hata, Tadayoshi; Akiyama, Hidehiko; Doi, Yohei

doi:10.1016/j.heliyon.2020.e04929

Cited by 18 publications

(12 citation statements)

References 18 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In a recent study, the specificity for the SD Biosensor-IgG and the specificity for the Alltest-IgG were both 99.0% while that for the SD Biosensor-IgM and that for the Alltest-IgM were both 98.0%. 18 This suggests that there are no differences in false positivity between the SD Biosensor and the ALLTest.…”

Section: Discussionmentioning

confidence: 95%

“…On the other hand, IgG tests seem to be more reliable because of small variance as well as higher specificity and sensitivity. 18 – 20 …”

Section: Discussionmentioning

confidence: 99%

“…On the other hand, IgG tests seem to be more reliable because of small variance as well as higher specificity and sensitivity. [18][19][20] While the merit of the present study lies in effective estimation of multiple serodiagnostics using a minimum number of clinical subjects, it also, in turn, reflect the limitations of the present study including imprecise estimates due to heterogeneity in the timing for sampling at which results were obtained, as well as a small number of patients and samples. To address the concerns, basic, laboratory and epidemiological findings should be accumulated relevantly to diagnostics and therapeutics.…”

Section: Zhao Et Al Reported Antibody Detection One Daymentioning

confidence: 94%

See 2 more Smart Citations

Evaluation of the usability of various rapid antibody tests in the diagnostic application for COVID-19

et al. 2021

View full text Add to dashboard Cite

Background The usability of laboratory tests related to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is critically important for the world undergoing the COVID-19 pandemic. The present study aimed to assess the diagnostic usability of rapid tests for the detection of antibody against SARS-CoV-2 through comparison of their results with the results of reverse transcription polymerase chain reaction (RT-PCR) test for the detection of SARS-CoV-2 genomic RNA and with the results of a quantitative test for antibody detection. Methods Serum samples were collected from 18 patients undergoing RT-PCR testing for SARS-CoV-2. Twelve patients were RT-PCR positive while six were negative. A quantitative test based on chemiluminescent immunoassay and three rapid tests based on immunochromatography were performed to detect anti-SARS-CoV-2 IgG and IgM. Results All the antibody tests exhibited poor sensitivity at the timing of initial RT-PCR diagnosis. IgG responses occurring prior to or simultaneously with IgM responses were observed through not only the quantitative test but also the three rapid tests. Based on concordance with the quantitative test results, the large variance among the three rapid tests was revealed. Conclusions All antibody tests were unsatisfactory to replace RT-PCR for the early diagnosis of COVID-19. Rapid antibody tests as well as a quantitative antibody test were useful in the assessment of immune responses in COVID-19. The obvious variance among the three rapid tests suggested limited accuracy and difficult standardization. Diagnostic usability of rapid antibody tests for COVID-19 should be investigated rigorously.

show abstract

Section: Discussionmentioning

confidence: 95%

“…On the other hand, IgG tests seem to be more reliable because of small variance as well as higher specificity and sensitivity. 18 – 20 …”

Section: Discussionmentioning

confidence: 99%

Section: Zhao Et Al Reported Antibody Detection One Daymentioning

confidence: 94%

See 1 more Smart Citation

Evaluation of the usability of various rapid antibody tests in the diagnostic application for COVID-19

et al. 2021

View full text Add to dashboard Cite

show abstract

“…Meanwhile, countless efforts pursued optimizing detection and diagnosis methods at point-of-care (POC) facilities and as self-detection kits, such as Lateral Flow Immunochromatographic Assay Strips (LFICS) for COVID-19 ( Alpdagtas et al 2020 ; Yüce et al 2021 ). Unlike gene-targeting tests, the sensitivity of rapid immunochromatographic test (ICT) kits is dependent on the time past infection ( Fujigaki et al 2020 ). Mandatorily, 10-15 days past infection are essential to provide enough time for the viral immune-response to produce a measurable amount of IgM and IgG SARS-CoV-2 recognizing antibodies ( Fujigaki et al 2020 ).…”

Section: Introductionmentioning

confidence: 99%

Aptamer-based electrochemical biosensor for rapid detection of SARS-CoV-2: Nanoscale electrode-aptamer-SARS-CoV-2 imaging by photo-induced force microscopy

Abrego-Martínez

Jafari

Chergui

et al. 2022

Biosensors and Bioelectronics

121

View full text Add to dashboard Cite

Rapid, mass diagnosis of the coronavirus disease 2019 (COVID-19) is critical to stop the ongoing infection spread. The two standard screening methods to confirm the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are polymerase chain reaction (PCR), through the RNA of the virus, and serology by detecting antibodies produced as a response to the viral infection. However, given the detection complexity, cost and relatively long analysis times of these techniques, novel technologies are urgently needed. Here, we report an aptamer-based biosensor developed on a screen-printed carbon electrode platform for rapid, sensitive, and user-friendly detection of SARS-CoV-2. The aptasensor relies on an aptamer targeting the receptor-binding domain (RBD) in the spike protein (S-protein) of the SARS-CoV-2. The aptamer immobilization on gold nanoparticles, and the presence of S-protein in the aptamer-target complex, investigated for the first time by photo-induced force microscopy mapping between 770 and 1910 cm -1 of the electromagnetic spectrum, revealed abundant S-protein homogeneously distributed on the sensing probe. The detection of SARS-CoV-2 S-protein was achieved by electrochemical impedance spectroscopy after 40 min incubation with several analyte concentrations, yielding a limit of detection of 1.30 pM (66 pg/mL). Moreover, the aptasensor was successfully applied for the detection of a SARS-CoV-2 pseudovirus, thus suggesting it is a promising tool for the diagnosis of COVID-19.

show abstract

“…The copyright holder for this preprint this version posted July 22, 2021. ; https://doi.org/10.1101/2021.07. 19.21260728 doi: medRxiv preprint 7 results (14,15). Also, to monitor the efficacy of a vaccine by measuring antibodies against SARS-CoV-2 in the clinical laboratory, it is necessary to measure antibodies that are highly correlated with the serum neutralizing activity.…”

Section: Introductionmentioning

confidence: 99%

Antibody responses to BNT162b2 vaccination in Japan: Monitoring vaccine efficacy by measuring IgG antibodies against the receptor binding domain of SARS-CoV-2

Fujigaki

Yamamoto

Koseki

et al. 2021

Preprint

Self Cite

View full text Add to dashboard Cite

BACKGROUND: To fight severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes coronavirus disease 2019 (COVID-19), mass vaccination has begun in many countries. To investigate the usefulness of a serological assay to predict vaccine efficacy, we analyzed the levels of IgG, IgM, and IgA against the receptor binding domain (RBD) of SARS-CoV-2 in the sera from BNT162b2 vaccinated individuals in Japan. METHODS: This study included 219 individuals who received two doses of BNT162b2. The levels of IgG, IgM, and IgA against RBD were measured by enzyme-linked immunosorbent assay before and after the first and second vaccination, respectively. The relationship between antibody levels and several factors including age, gender, and hypertension were analyzed. Virus-neutralizing activity in sera was measured to determine the correlation with the levels of antibodies. A chemiluminescent enzyme immunoassay (CLEIA) method to measure IgG against RBD was developed and validated for the clinical setting. RESULTS: The levels of all antibody isotypes were increased after vaccination. Among them, RBD-IgG was dramatically increased after the second vaccination. The IgG levels in females were significantly higher than in males. There was a negative correlation between age and IgG levels in males. The IgG levels significantly correlated with the neutralizing activity. The CLEIA assay measuring IgG against RBD showed a reliable performance and a high correlation with neutralizing activity. CONCLUSIONS: Monitoring of IgG against RBD is a powerful tool to predict the efficacy of SARS-CoV-2 vaccination and provides useful information in considering a personalized vaccination strategy for COVID-19.

show abstract

Reliability of serological tests for COVID-19: comparison of three immunochromatography test kits for SARS-CoV-2 antibodies

Cited by 18 publications

References 18 publications

Evaluation of the usability of various rapid antibody tests in the diagnostic application for COVID-19

Evaluation of the usability of various rapid antibody tests in the diagnostic application for COVID-19

Aptamer-based electrochemical biosensor for rapid detection of SARS-CoV-2: Nanoscale electrode-aptamer-SARS-CoV-2 imaging by photo-induced force microscopy

Antibody responses to BNT162b2 vaccination in Japan: Monitoring vaccine efficacy by measuring IgG antibodies against the receptor binding domain of SARS-CoV-2

Contact Info

Product

Resources

About