COVID-19 Coronavirus Antibody Rapid Test

Spectral Diagnostics, a subsidiary of Spectral Pharmaceuticals have launched a new blood test to detect antibodies in blood to confirm current or past exposure to coronavirus (Covid-19), giving a result within 15 minutes. This is one of the world’s first rapid tests that identifies both early and late antibody markers in human finger-prick blood samples that are generated by the body as a result of Covid-19 infection (IgG and IgM).

The antibodies, which are normally present during the middle and final stages of infection, may remain in the body after the exposure. It will help clinicians to determine past exposure to Covid-19 even if a patient no longer exhibits symptoms.

Our focus is to continue research in order to understand the possibility of re-occurrence of SARS-CoV-2 in other forms and to improve the diagnostic tests to fight the pandemic not only now but in the future.

Principles of the test

There are currently two main pathways for Covid-19 diagnosis. The first is by detecting presence of the virus itself by RT-PCR analysis using a sample from a nasopharyngeal swab. The other is by detecting the body’s immune response to the virus, i.e. presence of IgG and IgM antibodies in the blood.

The Spectral diagnostics COVID-19 Rapid Test is based on detection of IgM and IgG antibodies to SARS-CoV-2 virus. The specimens can be either whole blood (obtained from a finger prick), serum or plasma.

Spectral Pharma Covid-19 Diagnisis Flowchart

The test cassette contains recombinant SARS-CoV-2 antigen. When a specimen is added to the sample well of the cassette, any IgM or IgG antibodies present will bind to the conjugate forming antigen-antibody complexes. This mixture moves along the membrane to the test region. If the sample specimen is from someone who is positive for coronavirus then coloured lines will appear at the corresponding IgG/IgM test lines.

There is a control line which should be coloured, indicating a correct volume of buffer reagent and specimen has been used and the procedure has been carried out correctly. If no line appears next to the control region then the test is invalid and will have to be repeated.

How it works

1. Prick finger using a lancet.
2. Add one drop of blood to the sample well using the pipette.

3. Place 2–3 drops of buffer in the sample well
4. Read results after 15 minutes.

Interpretation of Results

Negative

IgG Positive

IgM Positive

IgG/IgM Positive

INVALID RESULT

Interpretation and Clinical Significance

Covid-19 disease progression determines which type of diagnostic test is the most suitable. The graph below shows how the body responds after Covid-19 infection and progression.

Specific IgM antibodies become detectable 3-5 days after symptoms appear. The COVID-19 Rapid Test will provide meaningful results when symptoms have been present for at least 3 days, which is approximately 7-10 days after infection. It is important to note that a person infected may be asymptomatic or display very mild symptoms.

The table below explains how the different test results can be interpreted:

processed new

Spectral Diagnostics Rapid Coronavirus (Covid-19) Testing Kit

  • CE marked in line with EU regulations
  • Conform to Essential Principles for Safety & Performance, Medical Devices IVD Directive 98/79/EC]
  • EN ISO 15223-1:2016, EN ISO 13485:2016, EN ISO 14971:2012 and EN 62304:2006 Certificates of Quality Management
  • In Vitro Diagnostic Device Directive (IVDD)

Accuracy

  • Relative Specificity: 100%
  • Relative sensitivity (11-24 days post infection): 97.1%
  • Overall accuracy: 99.2%

For Businesses

Screening is vital. Recent studies suggest that a high percentage of patients show no or few clinical symptoms. At this time these easy-to-administer COVID-19 Rapid Test Kits have been CE Certified for Healthcare Professional use only, for example a doctor, pharmacist, nurse, occupational Health personnel etc.
Screening your team will give everyone from the individual staff member to your customers the peace of mind and assurance that they can continue to work safely.

Benefits of the instant Covid-19 test

  • Can Screen Anywhere – no lab required.
  • Results in 15 Minutes
  • Significant time and cost-saving over lab methods
  • Up to 99.2% accuracy
  • Relative sensitivity: 97.1% – accuracy in identifying IgM in positive samples.
  • Peace of Mind – know whether you have the virus to plan accordingly

Spectral Diagnostics Rapid Coronavirus (Covid-19) testing kit

Mixing Instructions

Using the scoop provided in the tin, add the recommended quantity into a dry, empty container.

Using the scoop provided in the tin, add the recommended quantity into a dry, empty container.

Add the liquid into the container containing the powder and stir rapidly with a fork or spoon for 10 seconds or until dissolved.

Leave to stand for a few minutes until desired thickness level has been reached.

Leave to stand for a few minutes until desired thickness level has been reached.

Leave to stand for a few minutes until desired thickness level has been reached.

More information

For more information on the test and where to purchase it from,email us contact@spectralpharma.com or send us a message using the contact form.

99.6% (IgG) detection accuracy and 97.8% (IgM) detection accuracy

Sensitivity: 96.88%
Specificity: 100%,
false positive rate: 0%
false negative rate: 3.12%
Total conformity rate: 99%

ProductFormatPIP CodeEANCase Size
Osmosip Clear & Thick

133g Tin
(with 1.2g scoop)

4096947506066934000312

Osmosip Clear & Thick is ACBS approved, FSMP and Listed in section XV of drug tariff.

Spectral Diagnostics, a subsidiary of Spectral Pharmaceuticals have launched a new blood test to detect antibodies in blood to confirm current or past exposure to coronavirus (Covid-19), giving a result within 10 minutes. This is one of the world’s first rapid tests that identifies both early and late antibody markers in human finger-prick blood samples that are generated by the body as a result of Covid-19 infection (IgG and IgM).

The antibodies, which are normally present during the middle and final stages of infection, may remain in the body after the exposure. It will help clinicians to determine past exposure to Covid-19 even if a patient no longer exhibits symptoms.

Our focus is to continue research in order to understand the possibility of re-occurrence of SARS-CoV-2 in other forms and to improve the diagnostic tests to fight the pandemic not only now but in the future.