A dried blood spot protocol for high throughput analysis of SARS-CoV-2 serology based on the Roche Elecsys anti-N assay

Beyerl, Jessica; Rubio-Acero, Raquel; Castelletti, Noemi; Paunović, Ivana; Kroidl, Inge; Khan, Zohaib Nisar; Bakuli, Abhishek; Tautz, Andreas; Oft, Judith; Höelscher, Michael; Wieser, Andreas

doi:10.1016/j.ebiom.2021.103502

Cited by 27 publications

(27 citation statements)

References 13 publications

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“…We previously showed a high sensitivity and specificity of the Elecsys ® Anti-SARS-CoV-2 assay (Roche) used in this sero-study [ 5 ]. For the follow-up, we developed and carefully validated a semi-automated protocol using self-sampled DBS for SARS-CoV-2 serology [ 7 ]. This approach facilitates field work to a very considerable extent and thus, makes studies with a higher frequency of follow-ups more feasible.…”

Section: Discussionmentioning

confidence: 99%

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From first to second wave: follow-up of the prospective COVID-19 cohort (KoCo19) in Munich (Germany)

Radon

Bakuli²,

Pütz

et al. 2021

BMC Infect Dis

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Background In the 2nd year of the COVID-19 pandemic, knowledge about the dynamics of the infection in the general population is still limited. Such information is essential for health planners, as many of those infected show no or only mild symptoms and thus, escape the surveillance system. We therefore aimed to describe the course of the pandemic in the Munich general population living in private households from April 2020 to January 2021. Methods The KoCo19 baseline study took place from April to June 2020 including 5313 participants (age 14 years and above). From November 2020 to January 2021, we could again measure SARS-CoV-2 antibody status in 4433 of the baseline participants (response 83%). Participants were offered a self-sampling kit to take a capillary blood sample (dry blood spot; DBS). Blood was analysed using the Elecsys® Anti-SARS-CoV-2 assay (Roche). Questionnaire information on socio-demographics and potential risk factors assessed at baseline was available for all participants. In addition, follow-up information on health-risk taking behaviour and number of personal contacts outside the household (N = 2768) as well as leisure time activities (N = 1263) were collected in summer 2020. Results Weighted and adjusted (for specificity and sensitivity) SARS-CoV-2 sero-prevalence at follow-up was 3.6% (95% CI 2.9–4.3%) as compared to 1.8% (95% CI 1.3–3.4%) at baseline. 91% of those tested positive at baseline were also antibody-positive at follow-up. While sero-prevalence increased from early November 2020 to January 2021, no indication of geospatial clustering across the city of Munich was found, although cases clustered within households. Taking baseline result and time to follow-up into account, men and participants in the age group 20–34 years were at the highest risk of sero-positivity. In the sensitivity analyses, differences in health-risk taking behaviour, number of personal contacts and leisure time activities partly explained these differences. Conclusion The number of citizens in Munich with SARS-CoV-2 antibodies was still below 5% during the 2nd wave of the pandemic. Antibodies remained present in the majority of SARS-CoV-2 sero-positive baseline participants. Besides age and sex, potentially confounded by differences in behaviour, no major risk factors could be identified. Non-pharmaceutical public health measures are thus still important.

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Section: Discussionmentioning

confidence: 99%

“…Compared to full blood samples, sensitivity of the DBS method was 99.2% and specificity 98.7%. Details of the laboratory methods are described in [ 7 ].…”

Section: Methodsmentioning

confidence: 99%

From first to second wave: follow-up of the prospective COVID-19 cohort (KoCo19) in Munich (Germany)

Radon

Bakuli²,

Pütz

et al. 2021

BMC Infect Dis

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“…For the DABA, the absence of normal levels of serum protein in the first incubation would be expected to increase the off-rate during antibody binding, substantially reducing sensitivity as we observed. We note with interest the recent publication by Beyerl et al, who described a sensitivity of 99.2% using the Roche DABA assay, achieved by a substantial redesign of the assay cut-off for DBS eluates 27 .…”

Section: Discussionmentioning

confidence: 92%

Simple, sensitive, specific self-sampling assay secures SARS-CoV-2 antibody signals in sero-prevalence and post-vaccine studies

Khan

Rosadas

Katsanovskaja

et al. 2022

Sci Rep

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At-home sampling is key to large scale seroprevalence studies. Dried blood spot (DBS) self-sampling removes the need for medical personnel for specimen collection but facilitates specimen referral to an appropriately accredited laboratory for accurate sample analysis. To establish a highly sensitive and specific antibody assay that would facilitate self-sampling for prevalence and vaccine-response studies. Paired sera and DBS eluates collected from 439 sero-positive, 382 sero-negative individuals and DBS from 34 vaccine recipients were assayed by capture ELISAs for IgG and IgM antibody to SARS-CoV-2. IgG and IgM combined on DBS eluates achieved a diagnostic sensitivity of 97.9% (95%CI 96.6 to 99.3) and a specificity of 99.2% (95% CI 98.4 to 100) compared to serum, displaying limits of detection equivalent to 23 and 10 WHO IU/ml, respectively. A strong correlation (r = 0.81) was observed between serum and DBS reactivities. Reactivity remained stable with samples deliberately rendered inadequate, (p = 0.234) and when samples were accidentally damaged or ‘invalid’. All vaccine recipients were sero-positive. This assay provides a secure method for self-sampling by DBS with a sensitivity comparable to serum. The feasibility of DBS testing in sero-prevalence studies and in monitoring post-vaccine responses was confirmed, offering a robust and reliable tool for serological monitoring at a population level.

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“…If necessary, the sensitivity of DBS analysis with the Elecsys anti-SARS-CoV-2 S assay could be improved by working with other instruments to enable the use of lower volumes. Recent work showed that a 60 µL volume was sufficient with a Cobas e801 to work with DBS [22]. The initial volume of dried blood could also be increased by using other quantitative/volumetric DBS specimens allowing collection of 20 µL or 30 µL per spot (e.g., Tasso M-20 from TASSO Inc., Mitra from Neoteryx).…”

Section: Discussionmentioning

confidence: 99%

“…DBS by finger prick is well tolerated, and auto-sampling worked well with our cohort of volunteers. Beyerl et al performed high-scale monitoring of anti-SARS-CoV-2 antibodies in volunteers with DBS and reported that 4465/4471 of unsupervised home sampling DBS cards (99.87%) could be analyzed [22], thus showing that it is a viable strategy to obtain samples even from untrained individuals. The DBS device used in this study was also successfully used in a large test of auto-sample collection evaluation in Stockholm (878 individual Capitainer cards).…”

Section: Discussionmentioning

confidence: 99%

Use of Quantitative Dried Blood Spots to Evaluate the Post-Vaccination Level of Neutralizing Antibodies against SARS-CoV-2

Marchand

Roulland

Semence

et al. 2021

Life

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To combat the COVID-19 pandemic, vaccines against SARS-CoV-2 are now given to protect populations worldwide. The level of neutralizing antibodies following the vaccination will evolve with time and vary between individuals. Immunoassays quantifying immunoglobulins against the viral spike (S) protein in serum/plasma have been developed, but the need for venous blood samples could limit the frequency and scale of control in populations. The use of a quantitative dried blood spot (DBS) that can be self-collected would simplify this monitoring. The objective of this study was to determine whether a quantitative DBS device (Capitainer qDBS 10 µL) could be used in combination with an Elecsys anti-SARS-CoV-2 S immunoassay from Roche to follow the development and persistence of anti-S antibodies. This objective was carried out through two clinical studies. The first study investigated 14 volunteers who received two doses of the Comirnaty (Pfizer) vaccine. The levels of anti-S antibodies and the progression over time post-vaccination were studied for three months. The level of produced antibodies varied between subjects, but a similar trend was observed. The anti-S antibodies were highly stimulated by the second dose (×100) and peaked two weeks later. The antibody levels subsequently decreased and three months later were down to 65%. DBS proved to be sufficiently sensitive for use in evaluating the immune status against SARS-CoV-2 over a prolonged time. The second cohort was composed of 200 random patients from a clinical chemistry department in Stockholm. In this cohort, we had no information on previous COVID-19 infections or vaccination. Nevertheless, 87% of the subjects had anti-S immunoglobulins over 0.8 U/mL, and the bias between plasma and DBS proved to be variable, as was also seen in the first vaccination study.

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A dried blood spot protocol for high throughput analysis of SARS-CoV-2 serology based on the Roche Elecsys anti-N assay

Cited by 27 publications

References 13 publications

From first to second wave: follow-up of the prospective COVID-19 cohort (KoCo19) in Munich (Germany)

From first to second wave: follow-up of the prospective COVID-19 cohort (KoCo19) in Munich (Germany)

Simple, sensitive, specific self-sampling assay secures SARS-CoV-2 antibody signals in sero-prevalence and post-vaccine studies

Use of Quantitative Dried Blood Spots to Evaluate the Post-Vaccination Level of Neutralizing Antibodies against SARS-CoV-2

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