scholarly journals A novel approach for evaluating antibodies against SARS-CoV-2 using menstrual blood collected from sanitary napkins before and after vaccination and evaluation of the visual napkin score

Author(s):  
Hiromitsu Shirasawa ◽  
Yukiyo Kumazawa ◽  
Shiori Kushima ◽  
Ayaka Fujishima ◽  
Wataru Sato ◽  
...  

Abstract BackgroundAlthough saliva, whole blood, serum, plasma, urine, and feces have been used as specimens for SARS-CoV-2 antigen and antibody tests, menstrual blood has not been reported to date. Unlike invasive blood collection methods, menstrual blood collected non-invasively from participants can be used to evaluate the presence of antibodies against SARS-CoV-2. The purpose of our report is to show an association between menstrual blood and the presence of neutralizing antibodies acquired via mRNA vaccination and the usefulness of menstrual blood as a sample type for detecting SARS-CoV-2 antibodies, considering the volume of blood in sanitary napkins as visual napkin score (VNS).MethodsIn this study, we collected one napkin each from 40 participants visiting the outpatient gynecology clinic of our university hospital with no symptoms related to COVID-19 and attempted to collect their menstrual blood from the napkins. In 5 of 40 participants, menstrual blood was collected after at least one dose of mRNA vaccination. For this study, the maximum volume of menstrual blood collected was set as 980 μl. In addition, the classification of napkins based on the VNS was set, with level 1 being the lowest percentage of blood on the napkin (0–20%) and level 5 being the highest category (80–100%), according to the consensus of two researchers. We have evaluated used four different antibody testing kits using menstrual blood for detecting IgG and IgM.FindingsThe mean amount of menstrual blood collected from the 40 participants' sanitary napkins was 364 ± 372 μl; higher VNS indicated more menstrual blood collected. Statistically, VNS 3 or higher resulted in significantly higher menstrual blood collection than VNS 1 (p<0.01). With VNS 1, the collection of menstrual blood was complicated, and antibody test kits could not be tested for all eight participants. On the other hand, 31 of 32 participants (96.9%) with VNS 2 or higher could be tested with one or more antibody test kits. For all testing kits, 100% of tests with menstrual blood had a positive control line, and all participants who tested positive for IgG and IgM had received a COVID-19 mRNA vaccine. In the five participants after mRNA vaccination, only two of the four testing kits were all positive for IgG.InterpretationWe have, for the first time, evaluated antibodies against SARS-CoV-2 in menstrual blood collected from sanitary napkins with several antibody test kits. We found that if more than 20% of the napkin area has menstrual blood on it, sufficient menstrual blood can be collected for antibody testing. We also confirmed that menstrual blood collected from a sanitary napkin could be used to detect antibody after mRNA COVID-19 vaccination. We believe that our results are a pioneering effort that has not been reported previously and will lead to better public health and development of wearable devices.FundingThere are no conflicts of interest to disclose for this study.

Diagnostics ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. 2193
Author(s):  
Bo Kyeung Jung ◽  
Jung Yoon ◽  
Joon-Yong Bae ◽  
Jeonghun Kim ◽  
Man-Seong Park ◽  
...  

Rapid and accurate measurement of SARS-CoV-2 neutralizing antibodies (nAbs) can aid in understanding the development of immunity against COVID-19. This study evaluated the diagnostic performance of a rapid SARS-CoV-2 nAb detection test called the BZ COVID-19 nAb test BZ-nAb (BZ-nAb; BioZentech). Using the 90% plaque-reduction neutralization test (PRNT-90) as a reference, 104 serum specimens collected from COVID-19-positive and -negative patients were grouped into 40 PRNT-90-positive and 64 PRNT-90-negative specimens. The performance of the BZ-nAb was compared with that of the cPass surrogate virus neutralization test (cPass sVNT; Genscript). The BZ-nAb showed a sensitivity ranging from 92.5%–95.0% and specificity ranging from 96.9%–100%, whereas cPass sVNT showed a sensitivity of 100% (95% confidence interval (CI) 90.5%–100%) and specificity of 98.4% (95% CI, 91.6%–100%). The dilution factor obtained with PRNT-90 showed a stronger correlation with the percent inhibition of cPass sVNT (r = 0.8660, p < 0.001) compared with the test and control line ratio (T/C ratio) of the BZ-nAb (r = −0.7089, p < 0.001). An almost perfect agreement was seen between the BZ-nAb and cPass sVNT results, with a strong negative correlation between the BZ-nAb T/C ratio and cPass sVNT percent inhibition (r = −0.8022, p < 0.001). In conclusion, the diagnostic performance of the BZ-nAb was comparable to that of the cPass sVNT, although the BZ-nAb had a slightly lower sensitivity.


2020 ◽  
Author(s):  
Arantxa Valdivia ◽  
Ignacio Torres ◽  
Victor Latorre ◽  
Clara Frances-Gomez ◽  
Josep Ferrer ◽  
...  

Purpose: Assessment of commercial SARS-CoV-2 immunoassays for their capacity to provide reliable information on sera neutralizing activity is an emerging need. We evaluated the performance of two commercially-available lateral flow immunochromatographic assays (LFIC) (Wondfo SARS-CoV-2 Antibody test and the INNOVITA 2019-nCoV Ab test) in comparison with a SARS-CoV-2 neutralization pseudotyped assay for COVID-19 diagnosis in hospitalized patients, and investigate whether the intensity of the test band in LFIC associates with neutralizing antibody (NtAb) titers. Patients and Methods: Ninety sera were included from 51 patients with moderate to severe COVID-19. A green fluorescent protein (GFP) reporter-based pseudotyped neutralization assay (vesicular stomatitis virus coated with SARS-CoV-2 spike protein) was used. Test line intensity was scored using a 4-level scale (0 to 3+). Results: Overall sensitivity of LFIC assays was 91.1% for the Wondfo SARS-CoV-2 Antibody test, 72.2% for the INNOVITA 2019-nCoV IgG, 85.6% for the INNOVITA 2019-nCoV IgM and 92.2% for the NtAb assay. Sensitivity increased for all assays in sera collected beyond day 14 after symptoms onset (93.9%, 79.6%,93.9% and 93.9%, respectively). Reactivities equal to or more intense than the positive control line (≥2+) in the Wondfo assay had a negative predictive value of 100% and a positive predictive value of 96.4% for high NtAb50 titers (≥1/160). Conclusions: Our findings support the use of LFIC assays evaluated herein, particularly the Wondfo test, for COVID-19 diagnosis. We also find evidence that these rapid immunoassays can be used to predict high SARS-CoV-2-S NtAb50 titers.


2021 ◽  
Author(s):  
Hiromitsu Shirasawa ◽  
Yukiyo Kumazawa ◽  
Shiori Kushima ◽  
Ayaka Fujishima ◽  
Wataru Sato ◽  
...  

Abstract Peripheral blood is mainly used for SARS-CoV-2 antibody testing. We evaluated menstrual blood, which can be collected noninvasively from sanitary napkins, as a specimen type for antibody testing. We also evaluated the visual napkin score and examined the relationship between the amount of menstrual blood collected. We tested napkins from 40 participants; 77.5% of samples could be tested with the antibody testing kits. In 35 unvaccinated participants, there were no IgG or IgM positive results. In five vaccinated participants, IgG was positive in 100% of samples and IgM was positive in 60%. Four antibody test kits were used in this study. The results also differed depending on the antigen targeted by each antibody. The evaluation of antibodies using menstrual blood from napkins might have public health applications in the future as napkins could be developed into wearable monitoring sensors.


Healthcare ◽  
2021 ◽  
Vol 9 (9) ◽  
pp. 1124
Author(s):  
Christopher C. Lamb ◽  
Fadi Haddad ◽  
Christopher Owens ◽  
Alfredo Lopez-Yunez ◽  
Marion Carroll ◽  
...  

Background: COVID-19 antibody testing has been shown to be predictive of prior COVID-19 infection and an effective testing tool. The CLUNGENE® SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette was evaluated for its utility to aide healthcare professionals. Method: Two studies were performed by using the CLUNGENE® Rapid Test. (1) An expanded Point-of-Care (POC) study at two clinical sites was conducted to evaluate 99 clinical subjects: 62 positive subjects and 37 negative subjects were compared to RT-PCR, PPA, and NPA (95% CI). Sensitivity was calculated from blood-collection time following symptom onset. (2) A cross-reactivity study was performed to determine the potential for false-positive results from other common infections. Results: The specificity of subjects with confirmed negative COVID-19 by RT-PCR was 100% (95% CI, 88.4–100.0%). The sensitivity of subjects with confirmed positive COVID-19 by RT-PCR was 96.77% (95% CI, 88.98–99.11%). In the cross-reactivity study, there were no false-positive results due to past infections or vaccinations unrelated to the SARS-CoV-2 virus. Conclusion: There is a need for a rapid, user-friendly, and inexpensive on-site monitoring system for diagnosis. The CLUNGENE® Rapid Test is a useful diagnostic test that provides results within 15 min, without high-complexity laboratory instrumentation.


2008 ◽  
Vol 20 (6) ◽  
pp. 735-743 ◽  
Author(s):  
Ramon M. Molina ◽  
Wayne Chittick ◽  
Eric A. Nelson ◽  
Jane Christopher-Hennings ◽  
Raymond R. R. Rowland ◽  
...  

Three assays were evaluated for their ability to detect antibodies against Porcine reproductive and respiratory syndrome virus (PRRSV) in porcine muscle transudate (“meat juice”) samples. Samples were derived from 91 pigs inoculated with PRRSV isolate VR-2332 and 46 age-matched controls. Serum and muscle ( Musculus longissimus dorsi) samples were collected from randomly selected animals euthanized at ∼14-day intervals from 28 to 202 days postinoculation. Serum samples were assayed at a dilution of 1:40, and muscle transudate samples were assayed at 5 dilutions (1:2, 1:5, 1:10, 1:20, 1:40) using a commercial PRRSV antibody enzyme-linked immunosorbent assay (ELISA). In addition, muscle transudate samples were tested using an indirect fluorescent antibody test (IFAT) at 5 dilutions (1:2, 1:5, 1:10, 1:20, 1:40). Attempts to assay muscle transudate samples for neutralizing antibodies using a modified fluorescent focus neutralization assay were unsuccessful. Receiver operator characteristic (ROC) curve analyses were used to estimate cutoff thresholds and the associated diagnostic sensitivities and specificities for ELISA and IFAT at each dilution. For ELISA, muscle transudate samples at the ROC-optimized cutoffs were >95% sensitive and 100% specific at each dilution. At a cutoff dilution of ≥1:5, the IFAT diagnostic sensitivity and specificity of muscle transudate was estimated at 63.3% and 100%, respectively. These findings validated the use of muscle transudate samples in PRRSV surveillance programs based on ELISA antibody testing.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Amelia E. Sancilio ◽  
Richard T. D’Aquila ◽  
Elizabeth M. McNally ◽  
Matthew P. Velez ◽  
Michael G. Ison ◽  
...  

AbstractThe spike protein of SARS-CoV-2 engages the human angiotensin-converting enzyme 2 (ACE2) receptor to enter host cells, and neutralizing antibodies are effective at blocking this interaction to prevent infection. Widespread application of this important marker of protective immunity is limited by logistical and technical challenges associated with live virus methods and venous blood collection. To address this gap, we validated an immunoassay-based method for quantifying neutralization of the spike-ACE2 interaction in a single drop of capillary whole blood, collected on filter paper as a dried blood spot (DBS) sample. Samples are eluted overnight and incubated in the presence of spike antigen and ACE2 in a 96-well solid phase plate. Competitive immunoassay with electrochemiluminescent label is used to quantify neutralizing activity. The following measures of assay performance were evaluated: dilution series of confirmed positive and negative samples, agreement with results from matched DBS-serum samples, analysis of results from DBS samples with known COVID-19 status, and precision (intra-assay percent coefficient of variation; %CV) and reliability (inter-assay; %CV). Dilution series produced the expected pattern of dose–response. Agreement between results from serum and DBS samples was high, with concordance correlation = 0.991. Analysis of three control samples across the measurement range indicated acceptable levels of precision and reliability. Median % surrogate neutralization was 46.9 for PCR confirmed convalescent COVID-19 samples and 0.1 for negative samples. Large-scale testing is important for quantifying neutralizing antibodies that can provide protection against COVID-19 in order to estimate the level of immunity in the general population. DBS provides a minimally-invasive, low cost alternative to venous blood collection, and this scalable immunoassay-based method for quantifying inhibition of the spike-ACE2 interaction can be used as a surrogate for virus-based assays to expand testing across a wide range of settings and populations.


2021 ◽  
pp. 003335492110181
Author(s):  
Richard J. Martino ◽  
Kristen D. Krause ◽  
Marybec Griffin ◽  
Caleb LoSchiavo ◽  
Camilla Comer-Carruthers ◽  
...  

Objectives Lesbian, gay, bisexual, transgender, or queer and questioning (LGBTQ+) people and populations face myriad health disparities that are likely to be evident during the COVID-19 pandemic. The objectives of our study were to describe patterns of COVID-19 testing among LGBTQ+ people and to differentiate rates of COVID-19 testing and test results by sociodemographic characteristics. Methods Participants residing in the United States and US territories (N = 1090) aged ≥18 completed an internet-based survey from May through July 2020 that assessed COVID-19 testing and test results and sociodemographic characteristics, including sexual orientation and gender identity (SOGI). We analyzed data on receipt and results of polymerase chain reaction (PCR) and antibody testing for SARS-CoV-2 and symptoms of COVID-19 in relation to sociodemographic characteristics. Results Of the 1090 participants, 182 (16.7%) received a PCR test; of these, 16 (8.8%) had a positive test result. Of the 124 (11.4%) who received an antibody test, 45 (36.3%) had antibodies. Rates of PCR testing were higher among participants who were non–US-born (25.4%) versus US-born (16.3%) and employed full-time or part-time (18.5%) versus unemployed (10.8%). Antibody testing rates were higher among gay cisgender men (17.2%) versus other SOGI groups, non–US-born (25.4%) versus US-born participants, employed (12.6%) versus unemployed participants, and participants residing in the Northeast (20.0%) versus other regions. Among SOGI groups with sufficient cell sizes (n > 10), positive PCR results were highest among cisgender gay men (16.1%). Conclusions The differential patterns of testing and positivity, particularly among gay men in our sample, confirm the need to create COVID-19 public health messaging and programming that attend to the LGBTQ+ population.


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Benoît Misset ◽  
Eric Hoste ◽  
Anne-Françoise Donneau ◽  
David Grimaldi ◽  
Geert Meyfroidt ◽  
...  

Abstract Background The COVID-19 pandemic reached Europe in early 2020. Convalescent plasma is used without a consistent evidence of efficacy. Our hypothesis is that passive immunization with plasma collected from patients having contracted COVID-19 and developed specific neutralizing antibodies may alleviate symptoms and reduce mortality in patients treated with mechanical ventilation for severe respiratory failure during the evolution of SARS-CoV-2 pneumonia. Methods We plan to include 500 adult patients, hospitalized in 16 Belgian intensive care units between September 2020 and 2022, diagnosed with SARS-CoV-2 pneumonia, under mechanical ventilation for less than 5 days and a clinical frailty scale less than 6. The study treatment will be compared to standard of care and allocated by randomization in a 1 to 1 ratio without blinding. The main endpoint will be mortality at day 28. We will perform an intention to treat analysis. The number of patients to include is based on an expected mortality rate at day 28 of 40 percent and an expected relative reduction with study intervention of 30 percent with α risk of 5 percent and β risk of 20 percent. Discussion This study will assess the efficacy of plasma in the population of mechanically ventilated patients. A stratification on the delay from mechanical ventilation and inclusion will allow to approach the optimal time use. Selecting convalescent plasmas with a high titer of neutralizing antibodies against SARS-CoV-2 will allow a homogeneous study treatment. The inclusion in the study is based on the consent of the patient or his/her legal representative, and the approval of the Investigational Review Board of the University hospital of Liège, Belgium. A data safety monitoring board (DSMB) has been implemented. Interim analyses have been planned at 100, 2002, 300 and 400 inclusions in order to decide whether the trail should be discontinued prematurely for ethical issues. We plan to publish our results in a peer-reviewed journal and to present them at national and international conferences. Funding and registration The trial is funded by the Belgian Health Care Knowledge Center KCE # COV201004 Trial registration Clinicaltrials.gov registration number NCT04558476. Registered 14 September 2020—Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04558476


Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 1628-1628
Author(s):  
Caroline Mayeur-Rousse ◽  
Julien Guy ◽  
Laurent Miguet ◽  
Sabrina Bouyer ◽  
Franck Genevieve ◽  
...  

Abstract CD180 is a Toll-Like Receptor homolog strongly expressed on normal human B-cells and involved in innate immune responses. Previous proteomic analyses on microparticles derived from mature B-cell neoplasms allowed us to identify CD180 as a marker of marginal zone lymphomas (MZL)(Miguet, Leukemia, 2013). Using flow cytometry on blood samples we showed that this protein is lost or underexpressed at the plasma membrane for almost all B-cell lymphomas except MZL. In order to confirm its clinical relevance, we conducted a prospective multicenter flow cytometry study in 5 French University Hospital laboratories, on behalf of the GEIL. Blood or bone marrow samples from 236 patients were studied (20 normal controls ; 74 chronic lymphocytic leukemia (CLL); 21 mantle cell lymphoma (MCL); 42 lymphoplasmacytic lymphoma (LPL); 13 follicular lymphoma (FL) ; 58 MZL, 14 of which with numerous villous lymphocytes; 8 hairy cell leukemia (HCL)). Analyses were performed either on FACSCanto II (BD Biosciences, 3 centers) or on Navios (Beckman Coulter, 2 centers) instruments. Harmonization process was performed using Rainbow beads (Spherotech). For the CLL group, CD180 Median fluorescence (MdFI) in each center was not significantly different (Anova test, p>0.05). Instruments’ harmonization was therefore effective enough to obtain similar data from all centres. In the whole cohort, CD180 was significantly less expressed in the group of lymphomas -including CLL, MCL, LPL and FL- than in controls (Mann-Whitney test, p<0.05). Conversely, in the group of MZL and HCL, CD180 MdFI was not different from those of controls (Mann-Whitney test, p>0.05) but significantly higher than in CLL, MCL, LPL and FL (Mann-Whitney test, p<0.0001). Distinction between MZL and lymphomas with numerous villous lymphocytes was possible (Mann-Whitney test, p=0.0012) but not between MZL and HCL. ROC curve analysis determined a CD180 MdFI threshold of 1800 which allow the positive diagnosis of MZL with a sensitivity of 77% and specificity of 92%. These results underline the efficiency of CD180 as a single positive and robust marker for MZL diagnosis, and confirm that between centers and between instruments harmonization is largely feasible in routine practice as published recently (Solly F et al. Cytomery part A, 2013). It should be emphasized that among the group of lymphomas with intense expression of CD180, all interestingly originating from the spleen, those with numerous villous lymphocytes display the highest expression. We described for the first time in this study the strong positivity of CD180 in HCL. Anti-CD180 antibody may be included in diagnosis combination markers in order to improve the diagnosis of chronic B-cell malignancies Disclosures No relevant conflicts of interest to declare.


2020 ◽  
Vol 3 (3) ◽  
pp. 17-26
Author(s):  
Quenum K ◽  
Fatigba Oh ◽  
Houndje Yp ◽  
Tchegnonsi C ◽  
Alihonou T ◽  
...  

Introduction The extra dural hematoma is a blood collection between the cranial vault and the dura mater. It is a neurosurgical emergency whose statistical data are poorly known in the Republic of Benin. Objective The aims of this study are to assess epidemiology, therapeutic and outcome of traumatic extra dural hematomas for children admitted to the surgical department of CHUD-B/A from 2012 to 2017. Methods This was a cross-sectional, descriptive and retrospective study over a period from January 1st, 2012 to December 31st, 2017. Results One hundred and seventy-eight cases of children aged between 0-15 years were examined for brain traumatic injury. Twenty-seven 27 (15.2%) cases of extra dural hematomas were retained. The most represented age group was between 11-15 years with a frequency of 42.1%. The male sex was more represented (78.9%). Road traffic accidents were the main aetiology (57.9%). 52.6% had a mild head injury, 26.3% had a moderate head injury and 21.1% had a severe head injury. On brain scan the frequently observed location was temporo-parietal (31.6%). Acute anemia was observed in 16 children. Seventeen children were operated on. The operation involved evacuation of extra dural hematoma by cranial bone flap with suspension of the dura mater. There were no deaths. Conclusion The availability of brain CT makes the diagnosis of extra dural hematoma easier. Its management is neurosurgical with a favourable post-operative evolution in all cases in this series.


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