Agreement of the Point of Care Test (POCT) Boditech iCHROMA™ COVID-19 IgG Antibody Assay with the Abbott Architect SARS-CoV-2 IgG Antibody Assay: An Advanced Study Approach
“…It also identified 100% of the negative control samples, as negative, with a consistent index range of 00.00. The range of the index estimated in s NIBSC positive control sample was 19.50-29.00, interestingly the index range observed in patient samples was between 22.8 and 74.6, indicating that the NIBSC positive control was within the range of the lower levels seen in clinical samples [13].Another study demonstrated the kinetics for the first 27 days post onset of infection in a mildly infected subject [14]. In this report, the kinetics of the Boditech iCHROMA FIA Covid-19 IgG assay was studied in: (i) a mildly infected subject who was followed up for 100 days post infection, (ii) 30 patients who were infected with Covid-19 at 3 time points (10-18 days, 20-28 days and 40-90 days) post infection, (iii) 12 vaccinated subjects (not previously infected and previously infected).…”
Section: Introductionmentioning
confidence: 72%
“…Covid-19 Infected subject (Day 1-100 post infection): Blood samples had been taken from a subject who suffered mild symptoms confirmed by PCR and antigen tests on day 1,2, 3,4,5,6,7,8,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26…”
Background: Coronavirus disease 2019 (COVID-19) is an emerging threat affecting millions of people worldwide. This study aims to assess the serologic profiles and time kinetics of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in patients with COVID-19 using the Boditech iCHROMA fluorescence immunoassay (FIA) method. Methods: Samples were collected from 43 subjects and analyzed for IgG antibodies against SARS-CoV-2 using the Boditech iCHROMA FIA. The iCHROMA processes the signal using a cut off index of 0.9 – 1.1, results <0.9 are interpreted as negative, results between 0.9 and 1.1 are interpreted as indeterminate and results >1.1 are interpreted as positive. Longitudinal samples were collected on days between day 1- day 100 post onset of symptoms in 1 subject, single samples collected on days 40-90 post infection in 30 subjects, and single samples collected at 3 time points (pre vaccination, 8-18 days post vaccination and 20-28 days post vaccination) collected from 12 subjects non-infected and previously infected. Results: The Covid-19 IgG concentration was detected (positive and cut off index above 1.1) on day 11 and remained consistently elevated for another 100 days of measurement in the sera of the single infected subject. The IgG cut off indices between day 20 and 100 ranged between 26.8 and 46.7, with a mean of 36.5. In the sera of the 30 patients infected with Covid-19 collected 40 – 90 days post infection, IgG antibodies were detected in all the samples. The IgG cut off indices ranged between 14.0 and 32.60, with a mean of 20.65. Of the twelve subjects who were vaccinated, eight had not been previously infected, while 4 had been previously infected. All 4 (100%) previously infected subjects seroconverted by the first time point (8-18 days post vaccination), whilst only 1/8 (12.5%) of the non-infected subjects seroconverted by the first time point (8-18 days post vaccination). By the second time point (20 - 28 days post vaccination), 2/12 subjects (17%) had failed to seroconvert, whilst 10/12 (83%) of the subjects had seroconverted. In addition, a previously infected subject whose IgG antibodies had dropped to a very low-level, after receiving the first dose of vaccination his IgG antibodies had gone back to his previous antibody levels at the first time point (8-18 days post vaccination). Conclusion: The Boditech iCHROMA FIA method for antibody testing is useful in detecting SARS-CoV-2 in a variety of situations at different time points but has its limitations with regards to determining the difference between previously infected and vaccinated individuals.
“…It also identified 100% of the negative control samples, as negative, with a consistent index range of 00.00. The range of the index estimated in s NIBSC positive control sample was 19.50-29.00, interestingly the index range observed in patient samples was between 22.8 and 74.6, indicating that the NIBSC positive control was within the range of the lower levels seen in clinical samples [13].Another study demonstrated the kinetics for the first 27 days post onset of infection in a mildly infected subject [14]. In this report, the kinetics of the Boditech iCHROMA FIA Covid-19 IgG assay was studied in: (i) a mildly infected subject who was followed up for 100 days post infection, (ii) 30 patients who were infected with Covid-19 at 3 time points (10-18 days, 20-28 days and 40-90 days) post infection, (iii) 12 vaccinated subjects (not previously infected and previously infected).…”
Section: Introductionmentioning
confidence: 72%
“…Covid-19 Infected subject (Day 1-100 post infection): Blood samples had been taken from a subject who suffered mild symptoms confirmed by PCR and antigen tests on day 1,2, 3,4,5,6,7,8,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26…”
Background: Coronavirus disease 2019 (COVID-19) is an emerging threat affecting millions of people worldwide. This study aims to assess the serologic profiles and time kinetics of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in patients with COVID-19 using the Boditech iCHROMA fluorescence immunoassay (FIA) method. Methods: Samples were collected from 43 subjects and analyzed for IgG antibodies against SARS-CoV-2 using the Boditech iCHROMA FIA. The iCHROMA processes the signal using a cut off index of 0.9 – 1.1, results <0.9 are interpreted as negative, results between 0.9 and 1.1 are interpreted as indeterminate and results >1.1 are interpreted as positive. Longitudinal samples were collected on days between day 1- day 100 post onset of symptoms in 1 subject, single samples collected on days 40-90 post infection in 30 subjects, and single samples collected at 3 time points (pre vaccination, 8-18 days post vaccination and 20-28 days post vaccination) collected from 12 subjects non-infected and previously infected. Results: The Covid-19 IgG concentration was detected (positive and cut off index above 1.1) on day 11 and remained consistently elevated for another 100 days of measurement in the sera of the single infected subject. The IgG cut off indices between day 20 and 100 ranged between 26.8 and 46.7, with a mean of 36.5. In the sera of the 30 patients infected with Covid-19 collected 40 – 90 days post infection, IgG antibodies were detected in all the samples. The IgG cut off indices ranged between 14.0 and 32.60, with a mean of 20.65. Of the twelve subjects who were vaccinated, eight had not been previously infected, while 4 had been previously infected. All 4 (100%) previously infected subjects seroconverted by the first time point (8-18 days post vaccination), whilst only 1/8 (12.5%) of the non-infected subjects seroconverted by the first time point (8-18 days post vaccination). By the second time point (20 - 28 days post vaccination), 2/12 subjects (17%) had failed to seroconvert, whilst 10/12 (83%) of the subjects had seroconverted. In addition, a previously infected subject whose IgG antibodies had dropped to a very low-level, after receiving the first dose of vaccination his IgG antibodies had gone back to his previous antibody levels at the first time point (8-18 days post vaccination). Conclusion: The Boditech iCHROMA FIA method for antibody testing is useful in detecting SARS-CoV-2 in a variety of situations at different time points but has its limitations with regards to determining the difference between previously infected and vaccinated individuals.
“…Manufacturer declares 95.8% sensitivity and 97.0% specificity for iCHROMA™ COVID-19 Ab, and 91.9% sensitivity and 100.0% specificity for COVID-19 nAb test. There are comparative data on iCHROMA™COVID-19 IgG Ab with the Abbott Architect SARS-CoV-2 IgG assay showing an overall agreement of 95%, with a sensitivity of 100% and a specificity of 90% of the iCHROMA™ COVID-19 IgG antibody assay(23).…”
Objectives: Understanding immune response is critical for control of COVID-19 pandemic. However, recent studies show that vaccine-induced humoral immunity may not be long-lasting and weaker in SARS-CoV-2 variants of concern.Methods: In May 2021, 253 self-nominated persons were tested for antibodies against SARS-CoV-2 in 1 to 104 days (mean 41, median 28) after two doses of Moderna and Pfizer-BioNTech vaccines in the city of Brno, Czechia. Two point-of-care iCHROMA™ II immunofluorescence assays were used: COVID-19 Ab against mix of SARS-CoV-2 nucleocapsid and spike proteins (IgG Ab); and COVID-19 nAb against S1-RBD protein (nAb). Results were analysed in relation to gender, age, vaccine, and past COVID-19 disease.Results: Antibodies nAb were detectable in 92.9% (95% CI: 89.7-96.0) of vaccinees. We observed statistically insignificant decrease of positive results from 93.9% (95% CI: 89.5-98.3) and 97.0% (95% CI: 92.8-100.0) in the first and second month after vaccination, respectively, to 91.7% (95% CI: 83.8-99.5) and 78.3% (95% CI: 61.4-95.1) in the third and fourth month, respectively. Quantitative results showed decreasing level of nAb in both genders, age groups and vaccines. Higher levels of nAb were found in younger age group and in COVID-19 convalescents. IgG Ab showed little dynamics in time.Conclusions: We found robust humoral response after vaccination with mRNA vaccines, however, decreasing nAb levels suggest that vaccineinduced humoral immunity is rapidly waning. This finding is relevant for adjustment of vaccination strategies with regard to inclusion of booster dose(s).
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