CliniExperts successfully helped in getting approval of Edinburgh Genetics Colloidal Gold Immunoassay and Whole Blood Collection kits for testing COVID-19.The pre-approved COVID-19 testing kits by the Medicines and Healthcare Products Regulatory Agency (MHRA, UK) are now also approved by the Central Drugs Standard Control Organization (CDSCO) and validated by Indian Council of Medical Research (ICMR).
India is touching its peak in numbers of COVID-19 cases daily, making it critical to increase testing rapidly. Diagnostic companies worldwide are constantly manufacturing COVID-19 kits for mass testing and further prevention of the coronavirus. COVID-19 is a very infectious disease caused by the SARS-CoV-2 virus. It spreads easily between people like the common cold or ‘flu. Most people diagnosed with COVID-19 have a mild to moderate respiratory illness, and even some may have no symptoms (asymptomatic infection). Others experience severe symptoms and need intensive care. The immune mechanism of people who have COVID-19 already responds to infection by developing proteins in their blood that can attack the virus (antibodies). The tests developed to detect antibodies in peoples’ blood might show whether they currently have COVID-19 or have had it previously. Accurate and precise testing allows identification of people who might need treatment, or isolation to prevent the spread of infection.
Recently, CliniExperts successfully helped in getting approval of Edinburgh Genetics Colloidal Gold Immunoassay and Whole Blood Collection kits for testing COVID-19.The pre- approved COVID-19 testing kits by the Medicines and Healthcare Products Regulatory Agency (MHRA, UK) are now also approved by the Central Drugs Standard Control Organization (CDSCO) and validated by Indian Council of Medical Research (ICMR). SARS- CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit is a rapid immunochromatographic test (ICT). Edinburgh COVID-19 kits are used for qualitative detection of Corona virus 2019 IgM and IgG antibodies in human serum, plasma or whole blood. Clinically with over 1 million patients tested all over the world. In a study at Hubei Provincial Centre for Disease Control and Prevention for the detection of COVID-19, the Edinburg kits are used. The blood samples were collected from clinically diagnosed COVID-19 patients in Wuhan, the sensitivity of the test was 98.43% and specificity was 99.31%.
The separate Whole Blood Collection kit comes with a capillary sampler, lancet, Eppendorf with buffer solution, alcohol pad, band-aid, and cotton bud. This kit can be conveniently used with the Edinburgh Genetics COVID-19 Colloidal Gold Immunoassay Testing Kit, IgG/IgM Combined.
Edinburgh Genetics COVID-19 Colloidal Gold Immunoassay Testing Kit, IgG/IgM Combined
Contains:
Test Cassette
One test cassette contains dried reagents with stabilizers Colloidal gold- labeled novel coronavirus antigen, Mouse anti-human IgG monoclonal antibody, Mouse anti-human IgM monoclonal antibody
Edinburgh Genetics Whole Blood Collection kit Contains Capillary sampler, Lancet, Eppendorf with buffer solution, Alcohol pad, Band-aid and Cotton bud.
This kit is used to qualitatively detect IgG and IgM antibodies of the COVID-19 novel coronavirus in human serum, whole blood, or plasma in vitro.
Edinburgh Genetics Colloidal Gold Immunoassay Testing Kit, IgG/IgM combined, is based on immunochromatography.
The test card contains
(a) Colloidal gold-labelled recombinant novel coronavirus antigen and quality control antibody colloidal gold marker.
(b) Two detection lines (G and M lines) and one quality control line (C) fixed on a nitrocellulose membrane. M is fixed with monoclonal anti-human IgM antibody for detecting the novel coronavirus IgM antibody. G is fixed with monoclonal anti-human IgG antibody for detecting the novel coronavirus IgG antibody. The quality control antibody is fixed on the C line.
The product can only be used to detect the IgG and IgM antibodies of the novel coronavirus in human whole blood, plasma, or serum. It is only for qualitative testing. Moreover, the specific content of each indicator must be measured using other quantitative methodologies.
An efficient and experienced team of CliniExperts helped in the faster approval of Edinburgh Genetics Colloidal Gold Immunoassay and Whole Blood Collection kits for testing COVID-19.
Navigating Software as a Medical Device regulation involves addressing varying global standards, including risk-based classifications...
The future of Software as a Medical Device will see breakthroughs in Artificial Intelligence-based diagnostics, personalised treatments, and remote monitoring...
Software as a Medical Device refers to software applications designed for medical purposes, such as diagnosis, treatment, or monitoring, without being part of a physical device...
Please feel free to talk to us if you have any questions. We endeavour to answer within 24 hours.