scholarly journals Remote fingerstick blood collection for SARS-CoV-2 antibody testing

2020 ◽  
Author(s):  
Wilfredo F. Garcia-Beltran ◽  
Tyler E. Miller ◽  
Grace Kirkpatrick ◽  
Andrea Nixon ◽  
Michael G. Astudillo ◽  
...  
Keyword(s):  
High Throughput ◽  
Large Scale ◽  
Dynamic Range ◽  
Venous Blood ◽  
Blood Collection ◽  
Antibody Testing ◽  
Antibody Assay ◽  
Serum Samples ◽  
Blood Draw ◽  
Serological Tests

ABSTRACTThe rapid worldwide spread of SARS-CoV-2 infection has propelled the accelerated development of serological tests that can detect anti-SARS-CoV-2 antibodies. These have been used for studying the prevalence and spread of infection in different populations, helping establish a recent diagnosis of COVID-19, and will likely be used to confirm humoral immunity after infection or vaccination. However, nearly all lab-based high-throughput SARS-CoV-2 serological assays require a serum sample from venous blood draw, limiting their applications and scalability. Here, we present a method that enables large scale SARS-CoV-2 serological studies by combining self or office collection of fingerprick blood with a volumetric absorptive microsampling device (Mitra, Neoteryx, LLC) with a high-throughput electrochemiluminescence-based SARS-CoV-2 total antibody assay (Roche Elecsys, Roche Diagnostics, Inc.) that is EUA approved for use on serum samples and widely used by clinical laboratories around the world. We found that the Roche Elecsys assay has a high dynamic range that allows for accurate detection of SARS-CoV-2 antibodies in serum samples diluted 1:20 as well as contrived dried blood extracts. Extracts of dried blood from Mitra devices acquired in a community seroprevalence study showed near identical sensitivity and specificity in detection of SARS-CoV-2 antibodies as compared to neat sera using predefined thresholds for each specimen type. Overall, this study affirms the use of Mitra dried blood collection device with the Roche Elecsys SARS-CoV-2 total antibody assay for remote or at-home testing as well as large-scale community seroprevalence studies.

scholarly journals Remote fingerstick blood collection for SARS-CoV-2 antibody testing

2020 ◽  
Author(s):  
Wilfredo F. Garcia-Beltran ◽  
Tyler E. Miller ◽  
Grace Kirkpatrick ◽  
Andrea Nixon ◽  
Michael G. Astudillo ◽  
...  
Keyword(s):  
High Throughput ◽  
Large Scale ◽  
Dynamic Range ◽  
Rapid Development ◽  
Venous Blood ◽  
Blood Collection ◽  
Antibody Assay ◽  
Serum Samples ◽  
Blood Draw ◽  
Serological Tests

ABSTACT The rapid worldwide spread of severe acute respiratory system coronavirus 2 (SARSCoV-2) infection has propelled the rapid development of serological tests that can detect anti-SARS-CoV-2 antibodies. These have been used for studying the prevalence and spread of infection in different populations, helping establish a recent diagnosis of coronavirus disease 2019 (COVID-19), and will likely be used to confirm humoral immunity after infection or vaccination. However, nearly all lab-based high-throughput SARS-CoV-2 serological assays require a serum sample from venous blood draw, limiting their applications and scalability. Here, we present a method that enables large scale SARS-CoV-2 serological studies by combining self or office collection of fingerprick blood with a volumetric absorptive microsampling device (Mitra, Neoteryx, LLC) with a high-throughput electrochemiluminescence-based SARS-CoV-2 total antibody assay (Roche Elecsys, Roche Diagnostics, Inc.) that is emergency use authorization (EUA) approved for use on serum samples and widely used by clinical laboratories around the world. We found that the Roche Elecsys assay has a high dynamic range that allows for accurate detection of SARS-CoV-2 antibodies in serum samples diluted 1:20 as well as contrived dried blood extracts. Extracts of dried blood from Mitra devices acquired in a community seroprevalence study showed near identical sensitivity and specificity in detection of SARS-CoV-2 antibodies as compared to neat sera using predefined thresholds for each specimen type. Overall, this study affirms the use of Mitra dried blood collection device with the Roche Elecsys SARS-CoV-2 total antibody assay for remote or at-home testing as well as large-scale community seroprevalence studies.

scholarly journals A Single Drop of Fingerstick Blood for Quantitative Antibody Response Evaluation After SARS-CoV-2 Vaccination

2021 ◽  
Author(s):  
Jinwei Du ◽  
Dayu Zhang ◽  
Hannah May ◽  
Yulia Loginova ◽  
Eric Chu ◽  
...  
Keyword(s):  
Large Scale ◽  
Venous Blood ◽  
Vaccine Dose ◽  
Neutralizing Antibody ◽  
Cost Effective ◽  
Quantitative Detection ◽  
Single Drop ◽  
Antibody Testing ◽  
Igg Antibody ◽  
Blood Draw

Among several COVID vaccines that have been approved, the Moderna and Pfizer-BioNTech vaccines are mRNA vaccines that are safe and highly effective at preventing COVID-19 illness. Studies have demonstrated that neutralizing antibody responses elicited by these vaccines correlate strongly with antibodies measured by immunoassays such as ELISA. To monitor the antibody level duration of vaccine-induced immune responses in vaccinated population, cost-effective and easily implementable antibody testing methodologies are urgently needed. In this study, we evaluated the feasibility of using a single drop of fingerstick blood collected with flocked swabs for a high-throughput and quantitative anti-SARS-CoV-2 spike (S1) IgG antibody immunoassay. A total of 50 voluntary subjects participated and donated fingerstick blood samples before and after receiving the Moderna mRNA vaccine. Among all individuals tested, no anti-SARS-CoV-2 S1 IgG antibody was detected before vaccination and on day 7 after receiving the first vaccine dose. On day 14 after the first dose, a significant amount of anti-SARS-CoV-2 S1 IgG antibody was detected in all participants samples. By the end the third week from the first dose, the median anti-SARS-CoV-2 S1 IgG concentration increased to 44.9 ug/mL. No anti-SARS-CoV-2 nucleocapsid (N) protein IgG antibody was detected in any of the participants during the study period, indicating that the anti-SARS-CoV-2 S1 IgG assay is specific for the mRNA vaccine induced antibodies. Comaprison of venous blood plasma and fingerstick blood for anti-SARS-CoV-2 S1 IgG shown a higher correlation. Furthermore, the fingerstick blood dried swab samples are stable for at least 4 days. In summary, we demonstrated that a single drop of fingerstick blood collected with flocked swab can be used for quantitative detection and monitoring of anti-SARS-CoV-2 spike IgG responses after receiving COVID-19 vaccination. This testing platform does not require venous blood draw and can be easily implemented for large scale antibody testing in vaccinated populations.

scholarly journals Evaluation of Multiplex-Based Antibody Testing for Use in Large-Scale Surveillance for Yaws: a Comparative Study

2016 ◽  
Vol 54 (5) ◽  
pp. 1321-1325 ◽  
Author(s):  
Gretchen M. Cooley ◽  
Oriol Mitja ◽  
Brook Goodhew ◽  
Allan Pillay ◽  
Patrick J. Lammie ◽  
...  
Keyword(s):  
High Throughput ◽  
Large Scale ◽  
Protein A ◽  
Antibody Testing ◽  
The Past ◽  
Country Level ◽  
Current Infection ◽  
Specific Reactivity ◽  
Global Eradication ◽  
Multiplex Bead

WHO has targeted yaws for global eradication by 2020. The program goals are to interrupt the transmission in countries where yaws is endemic and to certify countries as yaws free where yaws was endemic in the past. No new rapid plasmin reagin (RPR) seroreactivity in young children is required for certification of elimination at a country level. We sought to evaluate whether antibody responses to specific treponemal antigens measured in a high-throughput multiplex bead array (MBA) assay differentiate past versus current infection and whether a nontreponemal lipoidal antigen test can be incorporated into the MBA. Serum and dried blood spot specimens collected for yaws surveillance projects in Ghana, Vanuatu, and Papua New Guinea (PNG) were run on MBA to measure antibodies against recombinant p17 (rp17) and treponemal membrane protein A (TmpA) treponemal antigens. Results were compared to standard treponemal laboratory (TPPA or TPHA [TPP(H)A]) and quantitative RPR test data. Of 589 specimens, 241 were TPP(H)A+/RPR+, 88 were TPP(H)A+/RPR−, 6 were TPP(H)A−/RPR+, and 254 were negative for both tests. Compared to TPP(H)A, reactive concordance of rp17 was 93.7%, while reactive concordance of TmpA was only 81.9%. TmpA-specific reactivity showed good correlation with RPR titers (R2= 0.41;P< 0.0001). IgG responses to the lipoidal antigen used in RPR testing (cardiolipin) were not detected in the MBA. Our results suggest that TmpA can be used as a treponemal antigen marker for recent or active infection and potentially replace RPR in a high-throughput multiplex tool for large-scale yaws surveillance.

scholarly journals Low Seroprevalence of SARS-CoV-2 in Rhode Island Blood Donors Determined using Multiple Serological Assay Formats

2020 ◽  
Author(s):  
Daniel J Nesbitt ◽  
Daniel Jin ◽  
Joseph W Hogan ◽  
Philip A Chan ◽  
Melissa J Simon ◽  
...  
Keyword(s):  
Public Health ◽  
Severe Acute Respiratory Syndrome ◽  
Rhode Island ◽  
High Throughput ◽  
Blood Donors ◽  
Health Policies ◽  
Antibody Testing ◽  
Serological Tests ◽  
Public Health Policies ◽  
Seropositive Rate

Epidemic projections and public health policies addressing Coronavirus disease (COVID)-19 have been implemented without data reporting on the seroconversion of the population since scalable antibody testing has only recently become available. We measured the percentage of severe acute respiratory syndrome- Coronavirus-2 (SARS-CoV-2) seropositive individuals from 2,008 blood donors drawn in the state of Rhode Island (RI). We utilized multiple antibody testing platforms, including lateral flow immunoassays (LFAs), enzyme-linked immunosorbent assays (ELISAs) and high throughput serological assays (HTSAs). We report than an estimated seropositive rate of RI blood donors of approximately 0.6% existed in April-May of 2020. These data imply that seroconversion, and thus infection, is likely not widespread within this population. Daily new case rates peaked in RI in late April 2020. We conclude that IgG LFAs and HTSAs are suitable to conduct seroprevalence assays in random populations. More studies will be needed using validated serological tests to improve the precision and report the kinetic progression of seroprevalence estimates.

scholarly journals Validation of dried blood spot sample modifications to two commercially available COVID-19 IgG antibody immunoassays

Bioanalysis ◽  
2020 ◽  
Author(s):  
Theodore T Zava ◽  
David T Zava
Keyword(s):  
Venous Blood ◽  
Dried Blood Spot ◽  
Blood Collection ◽  
Igg Antibodies ◽  
Antibody Testing ◽  
Igg Antibody ◽  
Nucleocapsid Proteins ◽  
Antibody Assays ◽  
Finger Stick ◽  
Blood Spot

Aim: Coronavirus disease 2019 antibody testing often relies on venous blood collection, which is labor-intensive, inconvenient and expensive compared with finger-stick capillary dried blood spot (DBS) collection. The purpose of our work was to determine if two commercially available anti-severe acute respiratory syndrome coronavirus 2 enzyme-linked immunosorbent assays for IgG antibodies against spike S1 subunit and nucleocapsid proteins could be validated for use with DBS. Materials & methods: Kit supplied reagents were used to extract DBS, and in-house DBS calibrators were included on every run. Results: Positive/negative concordance between DBS and serum was 100/99.3% for the spike S1 subunit assay and 100/98% for the nucleocapsid assay. Conclusion: Validation of the DBS Coronavirus disease 2019 IgG antibody assays demonstrated that serum and DBS can produce equivalent results with minimal kit modifications.

scholarly journals Development and Standardization of a High-Throughput Multiplex Immunoassay for the Simultaneous Quantification of Specific Antibodies to Five Respiratory Syncytial Virus Proteins

mSphere ◽  
2019 ◽  
Vol 4 (2) ◽  
Author(s):  
Rutger M. Schepp ◽  
Cornelis A. M. de Haan ◽  
Deidre Wilkins ◽  
Hans Layman ◽  
Barney S. Graham ◽  
...  
Keyword(s):  
Respiratory Syncytial Virus ◽  
High Throughput ◽  
Large Scale ◽  
Dynamic Range ◽  
Valuable Insight ◽  
Conformational Structure ◽  
Multiplex Immunoassay ◽  
Rsv Infection ◽  
Syncytial Virus ◽  
Antibody Levels

ABSTRACT Human respiratory syncytial virus (RSV) is a major cause of severe respiratory disease in (premature) newborns and causes respiratory illness in the elderly. Different monoclonal antibody (MAb) and vaccine candidates are in development worldwide and will hopefully become available within the near future. To implement such RSV vaccines, adequate decisions about immunization schedules and the different target group(s) need to be made, for which the assessment of antibody levels against RSV is essential. To survey RSV antigen-specific antibody levels, we developed a serological multiplex immunoassay (MIA) that determines and distinguishes antibodies against the five RSV glycoproteins postfusion F, prefusion F, Ga, Gb, and N simultaneously. The standardized RSV pentaplex MIA is sensitive, highly reproducible, and specific for the five RSV proteins. The preservation of the conformational structure of the immunodominant site Ø of prefusion F after conjugation to the beads has been confirmed. Importantly, good correlation is obtained between the microneutralization test and the MIA for all five proteins, resulting in an arbitrarily chosen cutoff value of prefusion F antibody levels for seropositivity in the microneutralization assay. The wide dynamic range requiring only two serum sample dilutions makes the RSV-MIA a high-throughput assay very suitable for (large-scale) serosurveillance and vaccine clinical studies. IMPORTANCE In view of vaccine and monoclonal development to reduce hospitalization and death due to lower respiratory tract infection caused by RSV, assessment of antibody levels against RSV is essential. This newly developed multiplex immunoassay is able to measure antibody levels against five RSV proteins simultaneously. This can provide valuable insight into the dynamics of (maternal) antibody levels and RSV infection in infants and toddlers during the first few years of life, when primary RSV infection occurs.

scholarly journals Rapid, Simple, Quantitative, and Highly Sensitive Antibody Detection for Lyme Disease

2010 ◽  
Vol 17 (6) ◽  
pp. 904-909 ◽  
Author(s):  
Peter D. Burbelo ◽  
Alexandra T. Issa ◽  
Kathryn H. Ching ◽  
Jeffrey I. Cohen ◽  
Michael J. Iadarola ◽  
...  
Keyword(s):  
Lyme Disease ◽  
Dynamic Range ◽  
Independent Set ◽  
Antibody Responses ◽  
Peptide Sequence ◽  
Antibody Detection ◽  
Enzyme Linked Immunosorbent Assay ◽  
Characteristic Analysis ◽  
Serum Samples ◽  
Serological Tests

ABSTRACT There is currently a need for improved serological tests for the diagnosis and monitoring of Lyme disease, an infection caused by Borrelia burgdorferi. In the present study, we evaluated luciferase immunoprecipitation systems (LIPSs) for use for profiling of the antibody responses to a panel of B. burgdorferi proteins for the diagnosis of Lyme disease. Initially, serum samples from a cohort of patients and controls (n = 46) were used for training and were profiled by the use of 15 different B. burgdorferi antigen constructs. For the patient sera, the antibody responses to several B. burgdorferi antigens, including VlsE, flagellin (FlaB), BmpA, DbpA, and DbpB, indicated that the antigens had high levels of immunoreactivity. However, the best diagnostic performance was achieved with a synthetic protein, designated VOVO, consisting of a repeated antigenic peptide sequence, VlsE-OspC-VlsE-OspC, Analysis of an independent set of serum samples (n = 139) used for validation showed that the VOVO LIPS test had 98% sensitivity (95% confidence interval [CI], 93% to 100%; P < 0.0001) and 100% specificity (95% CI, 94% to 100%; P < 0.0001). Similarly, the C6 peptide enzyme-linked immunosorbent assay (ELISA) also had 98% sensitivity (95% CI, 93% to 100%; P < 0.0001) and 98% specificity (95% CI, 90% to 100%; P < 0.0001). Receiver operating characteristic analysis revealed that the rates of detection of Lyme disease by the LIPS test and the C6 ELISA were not statistically different. However, the VOVO LIPS test displayed a wide dynamic range of antibody detection spanning over 10,000-fold without the need for serum dilution. These results suggest that screening by the LIPS test with VOVO and other B. burgdorferi antigens offers an efficient quantitative approach for evaluation of the antibody responses in patients with Lyme disease.

Order of blood draw: Opinion Paper by the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase (WG-PRE)

2017 ◽  
Vol 55 (1) ◽  
pp. 27-31 ◽  
Author(s):  
Michael Cornes ◽  
Edmée van Dongen-Lases ◽  
Kjell Grankvist ◽  
Mercedes Ibarz ◽  
Gunn Kristensen ◽  
...  
Keyword(s):  
Working Group ◽  
Clinical Chemistry ◽  
Venous Blood ◽  
Laboratory Medicine ◽  
European Federation ◽  
Blood Collection ◽  
Sample Collection ◽  
Blood Draw ◽  
Preanalytical Phase ◽  
Analytical Phase

AbstractIt has been well reported over recent years that most errors within the total testing process occur in the pre-analytical phase (46%–68.2%), an area that is usually outside of the direct control of the laboratory and which includes sample collection (phlebotomy). National and international (WHO, CLSI) guidelines recommend that the order of draw of blood during phlebotomy should be blood culture/sterile tubes, then plain tubes/gel tubes, then tubes containing additives. This prevents contamination of sample tubes with additives from previous tubes that could cause erroneous results. There have been a number of studies recently looking at whether order of draw remains a problem with modern phlebotomy techniques and materials, or it is an outdated practice followed simply because of historical reasons. In the following article, the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase (EFLM WG-PRE) provides an overview and summary of the literature with regards to order of draw in venous blood collection. Given the evidence presented in this article, the EFLM WG-PRE herein concludes that a significant frequency of sample contamination does occur if order of draw is not followed during blood collection and when performing venipuncture under less than ideal circumstances, thus putting patient safety at risk. Moreover, given that order of draw is not difficult to follow and knowing that ideal phlebotomy conditions and protocols are not always followed or possible, EFLM WG-PRE supports the continued recommendation of ensuring a correct order of draw for venous blood collection.

scholarly journals Self-sampling of capillary blood for serological testing of SARS-CoV-2 by COVID-19 IgG ELISA

2020 ◽  
Author(s):  
Lottie Brown ◽  
Rachel Louise Byrne ◽  
Alice Fraser ◽  
Sophie I Owen ◽  
Ana I Cubas Atienzar ◽  
...  
Keyword(s):  
Large Scale ◽  
Venous Blood ◽  
Dried Blood Spots ◽  
Capillary Blood ◽  
Blood Collection ◽  
Serological Testing ◽  
Perfect Agreement ◽  
Blood Samples ◽  
Large Scale Testing ◽  
Feasible Alternative

Serological testing is emerging as a powerful tool to progress our understanding of COVID-19 exposure, transmission and immune response. Large-scale testing is limited by the need for in-person blood collection by staff trained in venepuncture. Capillary blood self-sampling and postage to laboratories for analysis could provide a reliable alternative. Two-hundred and nine matched venous and capillary blood samples were obtained from thirty nine participants and analysed using a COVID-19 IgG ELISA to detect antibodies against SARS-CoV-2. Thirty seven out of thirty eight participants were able to self-collect an adequate sample of capillary blood (≥50 μl). Using plasma from venous blood collected in lithium heparin as the reference standard, matched capillary blood samples, collected in lithium heparin-treated tubes and on filter paper as dried blood spots, achieved a Cohen′s kappa coefficient of >0.88 (near-perfect agreement). Storage of capillary blood at room temperature for up to 7 days post sampling did not affect concordance. Our results indicate that capillary blood self-sampling is a reliable and feasible alternative to venepuncture for serological assessment in COVID-19.

scholarly journals Low Seroprevalence of SARS-CoV-2 in Rhode Island Blood Donors Determined Using Multiple Serological Assay Formats

2020 ◽  
Author(s):  
Daniel J. Nesbitt ◽  
Daniel P. Jin ◽  
Joseph W. Hogan ◽  
Philip A Chan ◽  
Melissa J Simon ◽  
...  
Keyword(s):  
Public Health ◽  
Severe Acute Respiratory Syndrome ◽  
Statistical Method ◽  
Rhode Island ◽  
High Throughput ◽  
Blood Donors ◽  
Health Policies ◽  
Antibody Testing ◽  
Serological Tests ◽  
Public Health Policies

Abstract Background: Epidemic projections and public health policies addressing Coronavirus disease (COVID)-19 have been implemented without data reporting on the seroconversion of the population since scalable antibody testing has only recently become available. Methods: We measured the percentage of severe acute respiratory syndrome- Coronavirus-2 (SARS-CoV-2) seropositive individuals from 2,008 blood donors drawn in the state of Rhode Island (RI). We utilized multiple antibody testing platforms, including lateral flow immunoassays (LFAs), enzyme-linked immunosorbent assays (ELISAs) and high throughput serological assays (HTSAs). To estimate seroprevalence, we utilized the Bayesian statistical method to adjust for sensitivity and specificity of the commercial tests used.Results: We report than an estimated seropositive rate of RI blood donors of approximately 0.6% existed in April-May of 2020. Daily new case rates peaked in RI in late April 2020. We found HTSAs and LFAs were positively correlated with ELISA assays to detect antibodies specific to SARS-CoV-2 in blood donors. Conclusions: These data imply that seroconversion, and thus infection, is likely not widespread within this population. We conclude that IgG LFAs and HTSAs are suitable to conduct seroprevalence assays in random populations. More studies will be needed using validated serological tests to improve the precision and report the kinetic progression of seroprevalence estimates.

Sign in / Sign up

Export Citation Format

Share Document