Regulation/Guidelines

CliniExperts Aided The Faster Approval Of Edinburgh Genetics Colloidal Gold Immunoassay And Whole Blood Collection COVID-19 Kits

  • 2nd September, 2020
CliniExperts aided the faster approval of Edinburgh Genetics Colloidal Gold Immunoassay and Whole Blood Collection COVID-19 kits

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%.

Edinburgh Genetics Colloidal Gold Immunoassay COVID-19 kits

  • Detects IgG and IgM antibodies simultaneously
  • Only requires a small drop of blood
  • Test results can be available in ten minutes
  • No additional instrument required
  • Kits can be stored at room temperature and very easy to transport because of their small sizes.

Edinburgh Genetics Whole Blood Collection kit

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.

What are the components of Edinburgh Genetics COVID-19 testing Combi Pack?

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.

How to use COVID-19 Edinburgh Genetics Colloidal Gold Immunoassay and
Whole Blood Collection kits?

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.

What is the test procedure of Edinburgh Genetics COVID-19 testing kit?

  • In fingerpick whole blood sample method, use a capillary sampler to collect 20μL of blood.
  • In the serum/plasma sample, collect 20μL plasma or serum samples, respectively.
  • Add the sample into 60μL of buffer solution, recap and shake sample to mix thoroughly.
  • Now, remove the cap of the buffer solution and dispense 2-3 drops into the test cassette sample well with the capillary sampler’s help.
  • Allow the test to run for about 10 minutes. Read the results through the detection window and comparing to the guidance below. Test results are invalid that have run over 15 minutes.

Warnings and Precautions while using the kits:

  1. Do not open the pouch of the kit until ready to use. The test should be used immediately within one hour after opening the sealed cassette pouch.
  2. It is better to test on a level surface at room temperature. Always remember to use appropriate PPE.

How is the sample for testing prepared?

  • The product is suitable for human serum, plasma, or whole blood samples (capillary or venous) and also with samples prepared by commonly used anticoagulants (EDTA, heparin, sodium citrate)
  • Storage of serum and plasma samples can be done at 2-8°C for 5 days. Store the samples at -20°C and avoid repeated freeze/thaw cycles,if long-term storage of serum or plasma samples is required.
  • Storage of samples in refrigerator or frozen storage should be slowly returned to room temperature (15-30° C) and stirred before testing.
  • Before testing when particulates are clearly visible in the sample the precipitate should be removed by centrifugation. It is best to collect fresh samples and test immediately. Storage of anticoagulated whole blood samples can be done at 2-8°C for 7days.

Key Specifications of the Edinburgh COVID-19 Kit

  • The Kit carries a CE mark with certification of COVID-19 testing. The procedural control is included within the test
  • The test is done by fingerstick whole blood or venous whole blood
  • Performance of the Edinburgh testing kit-Sensitivity 98.00% and Specificity 99.00%. Storage 2° – 25°C
  • Long Shelf Life – 18 months
  • Storage- The reagent should be stored away from sunlight at room temperature (2° to 25°C). After opening, the container should be kept away from light after being opened.
  • Edinburgh kits should not be freezed and used after expiry date.
  • Limitations of the testing kit

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.

References:

  1. COVID-19 Immunoassay Antibodies. Available at: https://www.eggenetics.com/edinburgh- genetics-covid-19-immunoassay-testing-kits/ .Accessed on: 8 th August, 2020.