Among these, α- and β-CoVs mainly infect mammals, while δ- and γ-CoVs infect birds. Alpha-coronavirus (α-CoV), beta-coronavirus (β-CoV), gamma-coronavirus (γ-CoV), and delta-coronavirus (δ-CoV) are the four genera of coronaviruses in the subfamily Orthocoronavirinae. The pandemic outbreak of COVID-19 was caused by SARS-CoV-2, which belongs to the Coronaviridae family in the order Nidovirales and the subfamily of Orthocoronavirinae. PathShodh’s current production capacity is about one lakh tests per month, and we can scale this up further by augmenting the manufacturing infrastructure,” Kumar said.ACE2 Angiotensin Converting Enzyme 2 ARDS Acute Respiratory Distress Syndrome AuNIs Gold Nanoislands AuNPs Gold Nanoparticles BALF Bronchoalveolar lavage fluid CDC Centers for Disease control and Prevention CLIA Chemiluminescence Enzyme Immunoassay COVID-19 Coronavirus disease-19 CRISPR Clustered Regularly Interspaced Short Palindromic Repeats CSAb SARS-CoV spike S1 subunit protein antibody CT Computed Tomography ELISA Enzyme Linked Immunosorbent Assay EUA Emergency Use Authorization FDA Food and Drug Administration Gr-FET Graphene-Field Effect Transistor ICG Immunochromatographic strip ICMR Indian Council of Medical Research Kd Equilibrium dissociation constant LAMP Loop-mediated Isothermal Amplification LFIA Lateral Flow Immunoassay LOD Limit of Detection LSPR Localized Surface Plasmon Resonance MERS-CoV Middle East Respiratory Syndrome Coronavirus NIV Non-invasive Ventilation NP Nasopharyngeal Nt nucleotides ORF Open Reading Frame PPT Plasmonic Photothermal RBD Receptor Binding Domain RdRp RNA Dependent RNA Polymerase rRT-PCR Real-Time Reverse Transcriptase-Polymerase Chain Reaction RT-LAMP reverse transcription LAMP SARS-CoV-2/2019-nCoV Severe Acute Respiratory Syndrome Coronavirus 2 sgmRNA subgenomic mRNA SPR Surface Plasma Resonance WHO World Health Organization
“We plan to deploy the product in the market in the next couple of weeks.
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PathShodh has received the license to manufacture the test for sale from the Central Drugs Standard Control Organisation (CDSCO).
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The technology also includes on-board memory to store more than one lakh real-time test results, touch screen display, rechargeable battery, Bluetooth connectivity to smartphone and cloud storage, capabilities to map the patient data to Aadhar number and the possibility of connecting test data through APIs to Aarogya Setu. The results are automatically displayed by the handheld reader. This platform interfaces with disposable test strips and immunoreceptors specific to Covid-19 antibodies. The test uses a Lab-on-Palm platform called “anuPathTM” which has also been developed by PathShod.
The technique will also play a big role in elucidating seroconversion response to Covid-19 vaccines, and thereby play a supporting role in vaccination programmes in the future,” explained Professor Navakanta Bhat, Dean, Centre for Nano Science and Engineering (CeNSE), IISc, who is also the co-founder of PathShodh Healthcare. “The capability to quantify the Covid-19 antibody concentration will be crucial in estimating the declining antibody response over time and hence its possible impact on immunity against recurrence of infection. IISc added that PathShodh’s technique, which is protected through US and Indian patent applications, is a major departure from the qualitative rapid antibody tests in the market, which are primarily based on the lateral flow ELISA technique. It can work with venous or capillary (finger-prick) whole blood samples as well as serum samples.” Vinay Kumar, CEO and co-founder of PathShodh said that “This novel technology can detect Covid-19 antibodies all the way down to the nanomolar concentration. Hence, those antibody tests which target the S1 spike protein are more representative of an immune response against infection compared to those that target the Nucleocapsid (N) protein.
The S1 protein has a Receptor Binding Domain (RBD) which latches on to the host cell’s ACE2 receptors before infection. Invented by PathShodh Healthcare, a start-up incubated at the Society for Innovation and Development (SID) at the Indian Institute of Science (IISc), the test can measure the electrochemical redox activity of IgM and IgG antibodies specific to the Sars-CoV-2 Spike Glycoprotein (S1). The test can determine levels of Covid-prompted IgM and IgG antibodies. Researchers at the Indian Institute of Science (IISc) have made a breakthrough development of a semi-quantitative electrochemical ELISA test for Covid-19.
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