COVID-19 IgG/IgM Rapid Test

Published on 16/03/2020

PRIMA Lab SA supports healthcare personnel during Coronavirus emergency

covid-19

COVID-19 IgG/IgM Rapid Test is a CE Certified immunochromatographic assay for the qualitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies against COVID-19 in human whole blood, serum or plasma specimens. For professional in vitro diagnostic use only.
An immunoglobulin test measures the level of certain immunoglobulins, or antibodies, in the blood. Antibodies are proteins made by the immune system to fight microorganisms, such as bacteria, viruses and toxins. The IgG is the most abundant type of antibody and it is found in all body fluids and protects against bacterial and viral infections. The IgM, which is found mainly in blood and lymph fluid, is the first antibody to be made by the body to fight a new infection.

Who should use the COVID-19 Rapid Test?

This is a test dedicated to healthcare professionals, in order to help them in the on-site diagnosis of COVID-19:
- high Sensitivity and Specificity standards, when compared to a PCR methodology
- safe and accurate results in just 10 minutes
- easy to use and to read, without the aim of a laboratory

Coronavirus: what is it?

Early January 2020, a novel coronavirus (COVID-19) was identified as the infectious agent causing an outbreak of viral pneumonia in Wuhan, China, where the first cases were identified in December 2019.
Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, mammals and birds and they cause respiratory, enteric, hepatic and neurologic diseases. As it can be read on the website of CDC, Centers for Disease Control and Prevention, there are seven species of coronavirus able to cause disease in humans. Four species - 229E, OC43, NL63 and HKU1 - are prevalent and typically cause common cold symptoms in immunocompetent health individuals. Other two - the Severe Acute Respiratory Syndrome Coronavirus (SARS-COV) and the Middle East Respiratory Syndrome Coronavirus (MERS-COV) - are of zoonotic origin (i.e. they are transmitted from animals to humans) and have shown a higher mortality than others. The last one, SARS-CoV-2, is the one that cause the outbreak of coronavirus 2019, or COVID-19.

COVID-19 has spread so quickly to more than 150 countries around the world during the first months of 2020 - the real time situation on JHU CSSE website - that on the 11th of March, 2020 Dr Tedros Adhanom Ghebreyesus, General Director of World Health Organization, has declared the state of pandemic after the increasing of cases outside China.
Thereafter, Dr Hans Henri P. Kluge, WHO Regional Director for Europe, briefed the Europe’s Standing Committee of the Regional Committee on the rapid escalation of COVID-19 in the European Region, placing it at the centre of this pandemic, after the many new cases found daily in this area - read the full article at this link.

Symptoms associated to COVID-19

Common signs of infection include respiratory symptoms, fever and cough. In more severe cases, the infection can cause pneumonia, severe acute respiratory syndrome, kidney failure and even death. These symptoms may appear after 2-14 days after exposure, 5 days on average.

Symptoms Coronavirus Cold Flu
Symptoms range from mild to severe Gradual onset of symptoms Abrupt onset of symptoms
Fever Common Rare Common
Fatigue Sometimes Sometimes Common
Cough Common (usually dry) Mild Common (usually dry)
Sneezing No Common No
Aches and pains Sometimes Common Common
Runny or stuffy nose Rare Common Sometimes
Sore throat Sometimes Common Sometimes
Diarrhea Rare No Sometimes for children
Headaches Sometimes Rare Common
Shortness of breath Sometimes No No

If you experience these symptoms, you should call your doctor or the emergency number provided in your country and follow the instructions. Do not leave your home or go to health care facilities without first following the instructions of health care professionals.

On this occasion, many digital companies have worked to develop software and applications that can support both healthcare professionals and general users who need information and assistance about the COVID-19 outbreak. These include Apps dedicated to the COVID-19 emergency, Health-Bot and consulting services provided by Microsoft, Ask Sophie and GYANT for the symptoms control.

How to prevent infection?

At the moment there is no vaccine to protect from the outbreak of the disease, so the best way to prevent a possible infection is to avoid contact with the virus itself. This generally spreads person-to-person, especially if in close contact (about one meter away) and through respiratory droplets (coughing or sneezing).
It is also possible that some infections may occur during the incubation period of the virus, before the infected subject shows symptoms. It is therefore recommended to keep a safe distance in all cases.

The main recommendations to prevent the spread of infection include:
1) Regularly wash your hands with soap and water for at least 20 seconds, especially if you come into contact with public places or after coughing, sneezing or blowing your nose. Use a hand sanitizer containing at least 60% alcohol if soap and water are not immediately available. Avoid touching your eyes, nose and mouth with unclean hands;
2) Cover your nose and mouth with a handkerchief when coughing and sneezing, or do it inside your elbow. Throw the handkerchief away and wash your hands immediately;
3) Avoid close contact with anyone showing symptoms of respiratory illness. If you have to assist a patient, use a mask if he does not wear one.
It is also useful to clean and disinfect any frequently touched surfaces, such as: counters, tabletops, doorknobs, bathroom fixtures, toilets, phones, keyboards, tablets, and bedside tables.

China: an example to follow

At the beginning of 2020 the world watched China struggle against the inexorable spread of COVID-19 among its population. Two months later, the situation is definitely different: in just two weeks China has managed to stabilize and progressively reduce the number of infections thanks to a massive testing operation and quarantine, strictly respected by all Chinese people.
Today, while cases in the rest of the world are constantly increasing, China is heading towards a positive leveling of contagions. The goal of the Chinese strategy is Flatten the curve of pandemic. As can be read from the article in Our World in Data, this strategy is based on a few main aspects, with the aim of lowering the spread rate of the epidemic: on the main axes of the graph below are highlighted (y) the number of daily cases and (x) the time since the outbreak of a specific country. The yellow curve indicates the development of the pandemic without the use of measures that can reduce infections (i. e. quarantining, smart-working,social distancing, closing schools and other institutions); the violet curve, on the other hand, represents the development of the pandemic with the use of early restrictive measures. The dividing line is the capacity of each country's healthcare system (determined by the number of doctors, nurses, beds and intensive care units available - variable in the event of an epidemic, as healthcare workers may be ill or in quarantine).

Flatten the curve

The graph clearly represents the reason why taking early countermeasures is fundamental during an epidemic: by lowering the rate of infection it is possible to dilute the disease over time and thus also the involvement of the healthcare system, which can assist a greater number of patients if spread over a long period of time, rather than condensed into a very short one.

How does the COVID-19 Rapid Test work?

Early disease diagnosis is essential both to prevent ill people from rapidly infecting large numbers of the population, and to be able to receive treatment and tackle with the disease. Today, however, the tests carried out are still insufficient to deal effectively with the pandemic: in many cases, infected subjects do not undergo the swab because they suffer from mild symptoms; while, in many other circumstances, the capacity of many countries to perform COVID-19 tests is still very low.
Since today the diagnosis has been made using a technique called Polymerase Chain Reaction (or PCR). This involves duplication of DNA/RNA in the laboratory, allowing exponential growth of the filament in just over an hour. In this way it is possible to isolate and study any trait of DNA/RNA from a biological sample. The PCR methodology is part of the official protocol indicated by the WHO, as it allows to detect the presence of the virus even during the incubation period, when the RNA copies of the virus present in the infected are too few to be detected by other methods.

Especially during particular emergency situations it is very important that the devices used by the medical personnel, both during the preliminary phase and also in a subsequent monitoring step, are rapid and accurate. PRIMA Lab SA offers a useful tool to receive results of your patients’ health status, without the help of specialized laboratories and without further lack of time, resources and energy: this is COVID-19 IgG/IgM Rapid Test. The device is a qualitative membrane based lateral flow immunochromatographic assay for the detection of IgG and IgM antibodies to COVID-19 in whole blood, serum or plasma specimen.

Instructions for Use
A) Collect the blood sample:
1. Whole blood (fingerstick and venous sampling): Fill the blood collecting pipette and transfer 20μL of whole blood sample into the sample well of the test cassette. As an alternative to the blood collecting pipette, 20μL of sample from venous sampling can be dispensed with a laboratory micropipette.
2. Serum and plasma: Transfer 10μL of sample to the sample well with a laboratory micropipette.

covid-19 rapid test sample collection

B) Apply two drops of diluent to the sample well, approximately 80μL, then wait for 10 minutes and then read the results. The results are valid for up to 20 minutes after adding the diluent. Beyond 20 minutes the results should not be considered.

covid-19 rapid test execution

Write to info@primahometest.com for further information

Results interpretation

Positive IgG/IgM Results: Three coloured lines appear at the C (Control), IgG and IgM signs. This means that the subject is COVID-19 positive and needs immediate assistance. Contact the COVID-19 emergency reference number in your country and follow the instructions.

Positive IgG Results: Two coloured lines appear at the C (Control) and IgG signs, none at the IgM one. This means that the subject tested has been previously exposed to COVID-19, possibly without symptoms. Contact the COVID-19 emergency reference number for your country and follow the instructions.

Positive IgM Results: Two coloured lines appear at the C (Control) and IgM signs, none at the IgG sign. This means that the subject is positive to COVID-19 and needs immediate assistance. Contact the COVID-19 emergency reference number for your country and follow the instructions.

Negative Results: A coloured line appears at the C (Control) sign and none at the IgG and IgM ones. This means that the subject is negative to COVID-19. If the individual has come into contact with infected persons during the recent period, re-test within 5 days.

covid-19 rapid test results

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