scholarly journals Evaluation of the Roche SARS-CoV-2 Rapid Antibody Test in samples from vaccinated individuals

Author(s):  
Eva Urlaub ◽  
Johannes Hayer

Objective The study aimed to establish the performance of the SARS-CoV-2 Rapid Antibody Test (IgG and IgM) and the Elecsys® Anti-SARS-CoV-2 S assay in vaccinated individuals. Methods A panel of serum samples from Boca Biolistics was utilized to assess antibodies following vaccination, consisting of samples drawn prior to vaccination, after the first dose, or at least 14 days after the second dose of Moderna mRNA-1273 or Pfizer-BioNTech BNT162b2 COVID-19 vaccines. Agreement between the two methods was measured and stratified by test evaluator and assay lot. Results Agreement between the SARS-CoV-2 Rapid Antibody Test (IgG) and Elecsys Anti-SARS-CoV-2 S assay qualitative measurements at the different assessment points for both mRNA-1273 and BNT162b2 ranged between 97.06% (95% confidence interval [CI] 84.67, 99.93) to 100% (95% CI 82.35, 100). Agreement of the SARS-CoV-2 Rapid Antibody Test (IgG) with the Elecsys Anti-SARS-CoV-2 S assay was not highly influenced by either lot or evaluator. There was a medium-to-strong correlation between the semi-quantitative SARS-CoV-2 Rapid Antibody Test (IgG) result and quantitative Elecsys Anti-SARS-CoV-2 S assay in samples taken after both doses of the vaccines, with higher intensity bands being associated with higher total anti-S antibody titer (mRNA-1273, p=0.0019; BNT162b2, p<0.0001). Conclusion Semi-quantitative SARS-CoV-2 Rapid Antibody Test (IgG) and quantitative Elecsys Anti-SARS-CoV-2 S assay correlated well, suggesting that the SARS-CoV-2 Rapid Antibody Test (IgG) is helpful in understanding the immune response post-vaccination. The current data support the use of the SARS-CoV-2 Rapid Antibody Test (IgG) in the vaccinated population.

Author(s):  
Mehal Churiwal ◽  
Kelly D. Lin ◽  
Salman Khan ◽  
Srijana Chhetri ◽  
Meredith S. Muller ◽  
...  

Point-of-care (POC) tests to detect SARS-CoV-2 antibodies offer quick assessment of serostatus after natural infection or vaccination. We compared the field performance of the BioMedomics COVID-19 IgM/IgG Rapid Antibody Test against an ELISA in 303 participants enrolled in a SARS-CoV-2 household cohort study. The rapid antibody test was easily implemented with consistent interpretation across 14 users in a variety of field settings. Compared with ELISA, detection of seroconversion lagged by 5 to 10 days. However, it retained a sensitivity of 90% (160/177, 95% confidence interval [CI] 85–94%) and specificity of 100% (43/43, 95% CI 92–100%) for those tested 3 to 5 weeks after symptom onset. Sensitivity was diminished among those with asymptomatic infection (74% [14/19], 95% CI 49–91%) and early in infection (45% [29/64], 95% CI 33–58%). When used appropriately, rapid antibody tests offer a convenient way to detect symptomatic infections during convalescence.


Folia Medica ◽  
2019 ◽  
Vol 61 (4) ◽  
pp. 572-578
Author(s):  
Denitsa T. Tsaneva-Damyanova ◽  
Liliya I. Ivanova ◽  
Silviya N. Pavlova ◽  
Svetlana B. Todorova ◽  
Tsvetelina K. Popova

Introduction: Hepatitis B virus (HBV) is one of the most significant human pathogens responsible for a huge number of acute and chronic liver infectious diseases worldwide. Aim: To find the duration of post-vaccination immune response in individuals allocated to five age groups from 6 months to 20 years. Materials and methods: All tested subjects were born between 1999 and 2018 and therefore covered by the compulsory vaccination program against hepatitis B. For the serological marker anti-HBs Ab we investigated 449 serum samples taken from ambulatory people and patients of St Marina University Hospital in Varna. Results: A positive antibody response (anti-HBs Ab > 10 mIU/ml) was reported in 79.7% (n = 51) of the group of subjects up to one year old, in 70.0% (n = 196) of the subjects in the age range 1 year/1 month to 15 years, and in 39.3% (n = 33) of the subjects 15 years/1 month to 20 years old. Female sex had a better post-vaccination response than male sex with statistically significant relationship between sex and anti-HBs Ab titer (&chi;2 = 24.76, p <0.01). Conclusions: Regardless of the mass immunization against HBV in Bulgaria, the relative share of chronic HBV infections does not show a downward trend. Therefore, it is very important to study the duration of the post-vaccination immune response by demonstrating the anti-HBs antibodies and to apply a booster dose from the vaccine if needed.


2021 ◽  
Vol 0 ◽  
pp. 1-10
Author(s):  
Tuphan Kanti Dolai ◽  
Ankita Sen

The coronavirus disease-19 (COVID-19) caused by the SARS-CoV-2 virus, is now an ongoing pandemic. First detected in December 2019 at Wuhan, China, this disease has now spread to all parts of the world. COVID-19 may affect anyone, without regard for age, sex, or underlying disease condition. Patients with benign or malignant diseases when affected, usually have a more severe outcome than people without comorbidities. Increasing one’s immunity by vaccination against COVID-19 will help to improve the disease outcomes of COVID-19 in patients who already have some underlying disease. The live-attenuated or killed and recombinant viral protein vaccines currently available can elicit both humoral and cellular immunities. However, in immunocompromised patients (either due to the disease pathology or treatment-related immunosuppression), immune response may not be as effective as expected. Depending on the underlying disease pathogenesis, the patient may not be able to mount an adequate immune response post-vaccination. However, in view of the severe risks posed by COVID-19 disease, vaccination is of utmost importance. This review aims at understanding the importance of SARS-CoV-2 vaccination in patients with hematological disorders, and also aims to understand the side effects which arise post-SARS-CoV-2 vaccination. We have tried to ascertain the best way to vaccinate patients with hematological disorders.


Author(s):  
W. Shahzad ◽  
B. Zameer ◽  
S. H. Sanghi ◽  
S. Hussain ◽  
N. Mustafa

Haemorrhagic septicaemia (HS) caused by Pasteurella multocida serotype B:2 is an economically important disease of cattle and buffalo, causes heavy economic losses due to sudden death of animals in developing countries like Pakistan. In this country, animals are vaccinated by alum (adjuvant) precipitated vaccine twice a year. Immunity induced through this prophylactic measure lasts for 3-4 months only. Two new HS oil based vaccines were prepared by using two new oil adjuvants such as Eolane-150 and Eolane-170. The ratio of bacterial antigen and oil adjuvants was 1:1 while bacterial dry weight was adjusted to 2 mg/ml. The addition of enrichments and aeration resulted in dense bacterial growth of Pasteurella multocida. Both new vaccines passed sterility, safety and potency tests as per OIE, 2017. Active and passive Mouse Protection Tests were performed to evaluate its potency. Indirect Haem-Agglutination (IHA) test was conducted on serum samples of two rabbits, groups each of which was vaccinated with HS oil based vaccines adjuvanted with Eolane-150 and Eolane-170. IHA indicated that immune response was higher (GMT=32) initially on 45th day to 75th day post vaccination and then declined (GMT=16) in the rabbits vaccinated with HS vaccine adjuvanted with Eolane-150, while protective immune response remained constant (GMT=16) up to ninety days post vaccination in the rabbits vaccinated with HS vaccine adjuvanted with Eolane-170. Vaccines were easy to inject with no side effects, including swelling at the injection site and longer protection as well. That would hopefully motivate the livestock owners and farmers to use this new product to protect their animals against this fatal HS disease.


2021 ◽  
Author(s):  
Alexey A. Komissarov ◽  
Inna V. Dolzhikova ◽  
Grigory A. Efimov ◽  
Denis Y. Logunov ◽  
Olga Mityaeva ◽  
...  

AbstractDespite the measures taken worldwide, COVID-19 pandemic still progresses. While efficient antiviral drugs are not yet widely available, vaccination is the best option to control the infection rate. Although this option is obvious in case of COVID-19–naïve individuals, it is still unclear when individuals who have recovered from a previous SARS-CoV-2 infection should be vaccinated and whether the vaccination raises immune responses against the coronavirus and its novel variants. Here we measured the dynamics of the antibody and T-cell responses, as well as virus neutralizing activity (VNA) in serum against two SARS-CoV-2 variants, B.1.1.1 and B.1.617.2, among 84 individuals with different COVID-19 status who were vaccinated with Sputnik Light vaccine. We showed that vaccination of individuals previously exposed to the virus considerably boosts the existing immune response. In these individuals, RBD-specific IgG titers and VNA in serum were already elevated on the 7th day after vaccination, while COVID-19–naïve individuals developed the antibody response and VNA mainly 21 days post–vaccination. Additionally, we found a strong correlation between RBD-specific IgG titers and VNA in serum, and according to these data vaccination may be recommended if the RBD-specific IgG titers drop to 142.7 BAU/mL or below. In summary, the results of the study demonstrate that vaccination is beneficial both for COVID-19–naïve and recovered individuals, especially since it raises serum VNA against the B.1.617.2 variant – one of four the SARS-CoV-2 variants of concern.


2021 ◽  
Author(s):  
Alex Dulovic ◽  
Barbora Kessel ◽  
Manuela Harries ◽  
Matthias Becker ◽  
Julia Ortmann ◽  
...  

AbstractBackgroundWhile SARS-CoV-2 vaccinations were successful in decreasing COVID-19 caseloads, recent increases in SARS-CoV-2 infections have led to questions about duration and quality of the subsequent immune response. While numerous studies have been published on immune responses triggered by vaccination, these often focused on the initial peak response generated in specific population subgroups (e.g. healthcare workers or immunocompromised individuals) and have often only examined the effects of one or two different immunisation schemes.Methods and FindingsWe analysed serum samples from participants of a large German seroprevalence study (MuSPAD) who had received all available vaccines and dose schedules (mRNA-1273, BNT162b2, AZD1222, Ad26.CoV2S.2 or a combination of AZD1222 plus either mRNA-1273 or BNT162b2). Antibody titers against various SARS-CoV-2 antigens and ACE2 binding inhibition against SARS-CoV-2 wild-type and the Alpha, Beta, Gamma and Delta variants of concern were analysed using a previously published multiplex immunoassay MULTICOV-AB and an ACE2-RBD competition assay. Among the different vaccines and their dosing regimens, homologous mRNA-based or heterologous prime-boost vaccination produced significantly higher antibody responses than vector-based homologous vaccination. Ad26.CoV2S.2 performance was significantly reduced, even compared to AZD1222, with 91.67% of samples being considered non-responsive forACE2 binding inhibition. mRNA-based vaccination induced a higher ratio of RBD- and S1-targeting antibodies than vector-based vaccination, which resulted in an increased proportion of S2-targeting antibodies. Previously infected individuals had a robust immune response once vaccinated, regardless of which vaccine they received. When examining antibody kinetics post-vaccination after homologous immunisation regimens, both titers and ACE2 binding inhibition peaked approximately 28 days post-vaccination and then decreased as time increased.ConclusionsAs one of the first and largest population-based studies to examine vaccine responses for all currently available immunisation schemes in Germany, we found that homologous mRNA or heterologous vaccination elicited the highest immune responses. The high percentage of non-responders for Ad26.CoV2.S requires further investigation and suggests that a booster dose with an mRNA-based vaccine may be necessary. The high responses seen in recovered and vaccinated individuals could aid future dose allocation, should shortages arise for certain manufacturers. Given the role of RBD- and S1-specific antibodies in neutralising SARS-CoV-2, their relative over-representation after mRNA vaccination may explain why mRNA vaccines have an increased efficacy compared to vector-based formulations. Further investigation on these differences will be of particular interest for vaccine development and efficacy, especially for the next-generation of vector-based vaccines.


Author(s):  
Yoshifumi Uwamino ◽  
Masatoshi Wakui ◽  
Wataru Aoki ◽  
Toshinobu Kurafuji ◽  
Emmy Yanagita ◽  
...  

Background: The usability of laboratory tests related to SARS-CoV-2 is critically important for the world undergoing the COVID-19 pandemic. The present study aimed to assess diagnostic usability of rapid tests for detection of antibody against SARS-CoV-2 through comparison of their results with results of RT-PCR test for detection of SARS-CoV-2 genomic RNA and with results of a quantitative test for antibody detection. Methods: Serum samples were collected from eighteen 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 early diagnosis of COVID-19. Rapid antibody tests as well as a quantitative antibody test were useful in 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.


2004 ◽  
Vol 24 (4) ◽  
pp. 199-202 ◽  
Author(s):  
Alessandro Pelegrine Minho ◽  
Roberta Lemos Freire ◽  
Odilon Vidotto ◽  
Solange Maria Gennari ◽  
Elizabete Marangoni Marana ◽  
...  

The study determined the sensitivity and specificity of the indirect fluorescent antibody test (IFAT) and modified agglutination test (MAT) for anti-Toxoplasma gondii antibody detection by analyzing sera from 46 experimentally infected pigs. Values for sensitivity were 95.7% (confidence interval 95%: 84.0-99.2%) and for specificity 97.8% (confidence interval 95%: 87.0-99.9%) in both tests. There was an optimum agreement of results between IFAT and MAT evidenced by a Kappa test of 0.86. These results validate these tests for the detection of T. gondii infection in pigs. IFAT and MAT despite methodologies with different characteristics and readings have similar accuracy in pig serum samples.


2021 ◽  
Author(s):  
Ali Ozturk ◽  
Taylan Bozok ◽  
Tugce Simsek Bozok

AbstractBackgroundThe coronavirus disease 2019 (COVID-19) continues to spread around the world. Therefore, rapid, simpler, and more accurate diagnostic tests are urgently needed to diagnose the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection. The purpose of this study was to evaluate the SARS-CoV-2 IgM/ IgG rapid antibody test results in symptomatic patients with COVID-19 and their chest computed tomography (CT) data.MethodsA total of 320 patients admitted to our hospital for different durations due to COVID-19 were included in the study. Serum samples were obtained within 0 to 7 days from COVID-19 patients confirmed by RT-PCR and chest CT scan. According to the SARS-CoV-2 RT-PCR results, the patients included in the study were divided into two groups: PCR positive group (n=46), and PCR negative group (n=274).ResultsOf the 320 COVID-19 serum samples, IgM, IgG, and IgM/IgG were detected in 9.4%, 3.1%, and 17.8% within one week respectively. IgG/IgM antibodies were not detected in 69.7% of the patients. In the study, it was determined that 249 (77.8%) of 320 patients had positive chest CT scans. Four (5.6%) of 100 patients with negative chest CT scan had IgM positive and 2 (2.8%) had both IgM/ IgG positive. IgM was detected in 23 (9.2%), IgG in 1 (0.4%) and IgM/IgG in 35 (14%) of chest CT scan positive patients. The rate of CT findings in patients with antibody positivity (n=97) was found to be significantly higher than those with antibody negativity.ConclusionsThe results of the present study show the accurate and equivalent performance of serological antibody assays and chest CT in detecting SARS-CoV-2 0 to 7 days from the onset of COVID19 symptoms. When the RT-PCR is not available, we believe that the combination of immunochromatographic test and chest CT scan can increase diagnostic sensitivity for COVID-19.


2021 ◽  
Vol 9 (4) ◽  
pp. 703
Author(s):  
Deborah Vargas ◽  
Eva Vallejos-Vidal ◽  
Sebastián Reyes-Cerpa ◽  
Aarón Oyarzún-Arrau ◽  
Claudio Acuña-Castillo ◽  
...  

Piscirickettsia salmonis, the etiological agent of the Salmon Rickettsial Septicemia (SRS), is one the most serious health problems for the Chilean salmon industry. Typical antimicrobial strategies used against P. salmonis include antibiotics and vaccines, but these applications have largely failed. A few years ago, the first attenuated-live vaccine against SRS (ALPHA JECT LiVac® SRS vaccine) was released to the market. However, there is no data about the agents involved in the activation of the immune response induced under field conditions. Therefore, in this study we evaluated the expression profile of a set of gene markers related to innate and adaptive immunity in the context of a cellular response in Atlantic salmon (Salmo salar) reared under productive farm conditions and immunized with a live-attenuated vaccine against P. salmonis. We analyzed the expression at zero, 5-, 15- and 45-days post-vaccination (dpv). Our results reveal that the administration of the attenuated live SRS LiVac vaccine induces a short-term upregulation of the cellular-mediated immune response at 5 dpv modulated by the upregulation of ifnα, ifnγ, and the cd4 and cd8α T cell surface markers. In addition, we also registered the upregulation of il-10 and tgfβ. Altogether, the results suggest that a balanced activation of the immune response took place only at early times post-vaccination (5 dpv). The scope of this short-term upregulation of the cellular-mediated immune response against a natural outbreak in fish subjected to productive farm conditions deserves further research.


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