ABSTRACT
Humanity has been continuously threatened by epidemics and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has shown greater epidemic potential. According to the World Health Organization, measures such as rapid diagnosis, immediate isolation, and precautionary contact tracing are key tools of epidemic control. The method of detection or testing is critical in this epidemiological control, where SARS-CoV-2-positive cases are increasingly growing, leading to community infection. Immunochromatographic test kits have been described for the diagnosis of various infectious diseases because of their rapid scalability, convenient use, and prompt validation. The benefits of the immunochromatographic test kits include evaluation of the sample in approximately 20 minutes, lower cost per sample, and simple directions to use. Such test kits are composed of an uncut sheet structure that is protein conjugated, labeled with markers, and reagents coated in a nitrocellulose membrane. The need for thorough vetting is a major concern for the Central Drugs Standard Control Organization, Indian Council of Medical Research and other regulators, as more businesses are rushing to produce serologic test kits for SARS-CoV-2 worldwide. Initial reports of 86%−89% sensitivity and 84.2%–98.6% specificity were reported for these kits. Nonetheless, many national reports show variability in test accuracy significantly among various commercial suppliers. The virus’s more recent mutated strains (B.1.1.7, B.1.617, and B.1.351) have also raised concerns about their detectability using these test kits. In India, manufacturers are developing rapid test kits to detect SARS-CoV-2 by importing pre-antigen or antibody-coated uncut sheets from vendors and then cutting them into strips. Such sheets also have problems with specificity and are expensive. The possibility of developing kits with an indigenous protein coating and conjugation to detect antigens and antibodies needs to be explored by Indian researchers. This communication describes techniques to develop precise rapid test kits for detecting SARS-CoV-2. © 2021
ABSTRACT
Over the last two decades, various Immune assays utilizing gold nanoparticles have been developed that can be habituated to study the antigen-antibody identification, especially for infectious diseases (e.g.SARS-CoV-2) diagnosis. These gold nanoparticle-labeled immunochromatographic assays have been utilized for developing biosensors and provide a captivating denotes for performing bioassays on-field. These tests are very sensitive and sometimes engender nonspecific results that lead to diagnostic errors. Therefore, scientists are fascinated by examining the reliability of these test kits. Such test kits are composed in uncut sheet structures after protein conjugation labeled with markers (mostly AuNPs) and nitrocellulose membrane (NCM) coating.In most countries and in India for the easy & expeditious production in current situation of global virus pendamic, the rapid test kits are manufactured after purchasing an un-cut sheet from vendors and are assembled to compose final the test kits after cutting to pieces. Often it is perceived that there is very little information provided or available about these un-cut sheets. Due to the specific antigen – antibody-protein design and stability, these sheets often have specific efficiency issues. To develop a better rapid test kit, not only is the manufacturer's pre-un-cut sheet evaluation is very crucial, but it is also necessary to monitor the essential quality attributes during sheet cutting & scale-up to maintain the potency of the kits. Herein, we are including, all the critical quality variables or factors to be considered during kits assembly to enhance the reliability of the kits and to evade regulatory scrutiny. © 2020 Innovare Academics Sciences Pvt. Ltd. All rights reserved.