Multicentric evaluation of a novel point of care electrochemical ELISA platform for SARS-CoV-2 specific IgG and IgM antibody assay.

New diagnostics technologies for the efficient detection and quantification of SARS-CoV-2 antibodies are very crucial to manage the COVID-19 pandemic, especially in the context of emerging vaccination paradigms. Herein, we report on a novel point-of-care Electrochemical ELISA platform with disposable screen printed electrodes functionalized with SARS-CoV-2 Spike Glycoprotein S1, to enable fast and accurate quantitative estimation of total antibody concentration (IgG and IgM) in clinical samples. The quantification is performed with a comparison of electrochemical redox current against the current produced by the spiked monoclonal antibodies with known concentration. The assay is validated through multicentric evaluation against 3 different FDA authorized Laboratory standard techniques, using both EDTA whole blood and serum samples. We demonstrate that the proposed assay has excellent sensitivity and specificity, making it a suitable candidate for epidemiological surveys and quantification of antibodies in COVID-19 vaccination programs.

Multicentric Evaluation of a Novel Point of Care Electrochemical ELISA Platform for SARS-CoV-2 Specific IgG and IgM Antibody Assay

New diagnostics technologies for the efficient detection and quantification of SARS-CoV-2 Antibodies is very crucial to manage the COVID-19 pandemic, especially in the context of emerging vaccination paradigms. Herein, we report on a novel point-of-care Electrochemical ELISA platform with disposable screen printed electrodes functionalized with SARS-CoV-2 Spike Glycoprotein S1, to enable fast and accurate quantitative estimation of total antibody concentration (IgG and IgM) in clinical samples. The quantification is performed with a comparison of electrochemical redox current against the current produced by the spiked monoclonal antibodies with known concentration. The assay is validated through multicentric evaluation against 3 different FDA authorized Laboratory standard techniques, using both EDTA whole blood and serum samples. We demonstrate that the proposed assay has excellent sensitivity and specificity, making it a suitable candidate for epidemiological surveys and quantification of antibodies in COVID-19 vaccination programs.

Comparison of a novel immunocapture assay with standard serological methods in the diagnosis of brucellosis.

BACKGROUND: Microbiological culture methods and immunological assays currently available are technically challenging, difficult to interpret even in non-endemic areas. They are also time consuming leading to misdiagnosis, treatment delay, and severe morbidity and mortality. Therefore, the development of a simple and accurate diagnostic assay which could be performed even in small laboratories is a pressing need. This has prompted us to evaluate an assay based on the immunocapture technique in a region where brucellosis is prevalent. METHODS: The immunocapture test was evaluated for diagnostic efficacy on 211 patients with suspected brucellosis. Standard tube agglutination test (SAT), 2-mercaptoethanol (2-ME) agglutination, Coombs, immunocapture tests, and blood cultures were performed on these 211 blood samples. 190 sera belonging to healthy blood donors of endemic and non-endemic areas and 43 sera obtained from non-brucellosis patients were also subjected to SAT, 2-ME, Coombs, and immunocapture tests. A total of 15 blood cultures belonging to blood donors of endemic area and non-brucellosis cases were done. RESULTS: SAT picked up only 21 (9.9%), Coombs established the diagnosis in 69 (32.7%), while the immunocapture test confirmed the diagnosis in 76 (36%; p < 0.001)) patients with brucellosis, including 48 culture-confirmed cases. Sensitivity and specificity of the immunocapture technique were 97.29% and 97.08% respectively. SAT could not exclude the diagnosis in 55 cases as they were confirmed in most cases by the Coombs test and in all by immunocapture. CONCLUSIONS: Our results clearly show that immunocapture is superior to SAT in all stages of illness but is not significantly superior to Coombs. It also seems to be a useful tool in diagnosing a relapse. Immunocapture and Coombs tests were found to be more sensitive eliminating the ambiguity in the interpretation of the results for diagnosing brucellosis. The Coombs test is laborious, subjective in interpretation and demanding on skills. The immunocapture technique does not have the subjective reading errors, is simple to perform, and the results of the immunocapture technique seem to be reproducible. Thus we recommend the immunocapture technique especially for brucellosis-endemic countries. The Coombs, immunocapture, and 2-ME tests may also be considered useful tools in assessing treatment outcome.

Phylogenetic conservation of the stem-loop III structure of the 5' untranslated region of Hepatitis C virus RNA among natural variants in samples collected from Southern India.

The stem-loop III (SLIII) structure within the 5' untranslated region has been shown to be critical for internal initiation of translation of Hepatitis C virus (HCV). Using 'Single Strand Conformation Polymorphism (SSCP)' of the SLIII region we have investigated for natural mutations and demonstrated presence of some non-covariant changes in certain sub-domains. However, overall SLIII-RNA structure was found to be phylogenetically conserved. Additionally, by SSCP analysis we have determined the genotype of 50 HCV isolates collected from Southern India, 25 random samples were confirmed by DNA sequencing. Results showed the prevalence of genotype 1 in this part of India.

Impact of educational intervention on knowledge of mothers regarding home management of diarrhoea.

A pre and post comparison study was carried out in the field practice area of M.S. Ramaiah Medical College Bangalore, Karnataka to assess the impact of educational intervention on the knowledge of mothers of under five children on home management of diarrhoeal diseases. Sample of 225 mothers were included in the study. The study was conducted in 3 stages. Stage I--initial knowledge, attitude and practice of mothers was assessed. Stage II--one to one educational intervention was conducted and supported by audiovisual aids and live demonstration. Stage III--included post intervention knowledge, attitude and practice after 2 months and 2 years. After the educational intervention, there was significant improvement on knowledge of mothers regarding definition of diarrhoea (P < 0.001), signs of dehydration (P < 0.001), awareness of ORS solution (P < 0.001), correct preparation of ORS solution (P < 0.001), shelf-life of ORS solution (P < 0.001), seeking health care (P < 0.001) and rational drug therapy during diarrhoea (P < 0.001). McNemar test was used to find out the change in knowledge before and after the educational intervention. The overall knowledge scores improved significantly after 2 months (P < 0.001) as well as 2 years (P < 0.001) of the educational intervention. Though the proportion of mothers retaining the knowledge at the end of 2 years dropped, yet there was significant improvement (P < 0.001) when compared to the baseline study.

Acute respiratory infection in children: a survey in the rural community.

The prevalence of Acute Respiratory Infections was 7.6% in a total of 10,951 children below 5 yrs surveyed. The annual incidence was estimated to be 2.6 episodes per child. The prevalence was highest in the 6 months--2 yrs of age. Majority of the episodes were mild in nature (86.2%), while only 1.7% episodes were severe in nature. A substantial number of episodes (27.3%) did not receive any treatment. There was no association between the severity of ARI episodes and the treatment received. Registered medical practitioners were the main source of treatment. Far distance of the hospital was the reason for not receiving any treatment among untreated cases. The outcome was better in those episodes treated by a qualified MBBS doctor, as compared to other sources of treatment.

Infant feeding patterns in slums of Bangalore.

PIP: 10% of the Anganwadis population from the Bangalore Urban Block, 1055 families, were interviewed in a study of infant feeding practices, prevailing traditions and customs and the effect of urban slums. A great need for health education, nutritional education and an increase in female literacy were found in addition to improvements in the general social welfare of the families. Although breast milk and honey were commonly chosen for the 1st feeds of infants, some cases of delayed breast feeding were reported due to a superstitious belief that a mother cannot lactate before the 2nd day or that the colostrum may be harmful to the infant. Sometimes ceremonies were performed to mark the beginning of breast feeding. Despite the overall poor diet of the mothers, most of the mothers did not begin supplemental feeding until the 7-12 month period. 90.8% of the mothers were ignorant to supplementary feeding practices and had therefore started such feeding practices late. Most of the mothers were laborers who left the children to surrogates. 2 other unhealthy practices cited were the use of diluted milk and the use of unclean utensils.^ieng