COVID-19 IgG/IgM
Rapid Test Device
(Whole Blood/Serum/Plasma)

INTENDED USE
The COVID-19 IgG/IgM Rapid Test Device is an in vitro immunoassay for the direct and qualitative
detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or
plasma as an aid in the diagnosis of COVID-19.The test is for professional use only.

INTRODUCTION
Coronaviruses are a large family of viruses that are common in many different species of animals, including camels, cattle, cats, and bats.
The two highly pathogenic viruses, SARS-CoV and MERS-CoV, cause severe respiratory syndrome in humans, and the other four human coronaviruses (HCoV-NL63, HCoV-229E, HCoV-OC43 and HKU1) induce only mild upper respiratory diseases in immunocompetent hosts, although some of them can cause severe infections in infants, young children and elderly individuals.
COVID-19 is the disease associated with SARS-CoV-2, which was identified in China at the end of Coronaviruses cause respiratory and intestinal infections in animals and humans.
The virus is transmitted mainly via respiratory droplets that people sneeze, cough, or exhale. The incubation period for COVID-19 is currently estimated at between two and 14 days. Common symptoms of COVID-19 infection include fever, cough and respiratory symptoms such as shortness of breath and breathing difficulties. More serious cases develop severe pneumonia, acute respiratory distress syndrome, sepsis and septic shock that can lead to the death of the patient. People with existing chronic conditions seem to be more vulnerable to severe illness.
Detection of IgM indicates recent infection and can be used for early diagnosis of infection. IgG antibodies gradually appear and increase in the late stage of infection, and the COVID-19 IgG/IgM Rapid Test Device is a simple lateral flow immunoassay for the direct detection of anti-SARS-CoV-2 IgG/IgM antibody. It will provide a presumptive diagnosis of COVID-19.

PRINCIPLE
The COVID-19 IgG/IgM Rapid Test Device detects anti-SARS-CoV-2 IgG/IgM antibody through visual interpretation of colour development.
Anti-human IgG and anti-human IgM are used to detect specific antibodies in the human whole blood, serum, or plasma specimen. When specimen is added to the sample well, specific IgM and/or IgG antibodies, if present, will bind to the SARS-CoV-2 antigens conjugated to coloured particles on the conjugate pad. As the specimen migrates along the strip by capillary action and interacts with reagents on the membrane, the complex will be captured by anti-human IgM and/or anti-human IgG antibodies immobilised on the test region(s). Excess coloured particle are captured at the internal control region.
The presence of a red band(s) on the test region(s) indicates a positive result for the particular IgG and/or IgM antibodies, while its absence indicates a negative result. A red band at the control region (C) serves as a procedural control, indicating that membrane wicking is working.

As you can see in the video, this test is very simple to carry out, but how accurate is it..? We have been provided with clinical evidence from the manufacturers and suppliers that this product is 98.2% accurate – much closer to the perfect test than any other test we have looked at.

We have been provided with correspondence from the Medicines and Healthcare products Regulatory Agency (MHRA) that states “Legally the product can be placed on the market” and “professional use only and not for home use”. This means that we will not be selling retail to the general public – these tests can only be purchased for use by companies or organisations requiring testing and therefore, minimum purchase quantities of 5 units will apply.

UNIT COST

The cost per unit is £50+VAT (£60) – with a minimum purchase of 5 units. This includes delivery and comprehensive instructions.
If you require one of our registered nurses to attend your premises (subject to minimum numbers), or you would prefer to send your staff for testing at one of our clinics, the cost per unit is £60+VAT (£72) which we will discount to £50+VAT (£60) if booked as an extra to other medical tests.

ORDERING

We are just a phone call away from taking your order.