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 and simultaneous detection of immunoglobulin G and M antibodies against SARS-CoV-2 in human whole blood, serum or plasma specimens. For professional use only.

Who should use the Test?

COVID-19 IgG/IgM Rapid Test is dedicated to healthcare professionals with the aim to support them in the COVID-19 emergency management, receiving quick answers about the health status of their patients:
- 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

How does the Test work?

An early disease diagnosis is fundamental: nowadays, the positivity of a subject to SARS-CoV-2 virus is confirmed by a nose-pharyngeal swab, subsequently analyzed with a molecular biology technique called PCR - Polymerase Chain Reaction. This technique involves the duplication of 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 RNA from a biological sample.

PCR methodology, as part of the official protocol indicated by the WHO, is the main reference system for in vitro diagnostic devices aimed at identifying the COVID-19 pathology.

COVID-19 IgG/IgM Rapid Test by PRIMA Lab SA showed an excellent concordance with the PCR method, obtaining a combined Sensitivity of 95%. The Test, as antibody detector, is useful from 5 to 14 days after the onset of symptoms, i.e. after the initial incubation phase of the virus. It has been demonstrated in several clinical studies that the average immune response against SARS-CoV-2 virus develops within 14 days after the onset of symptoms, as demonstrated in Long et al.

The Test is a qualitative membrane based lateral flow immunochromatographic assay for the detection of IgG and IgM antibodies against SARS-CoV-2 in whole blood, serum or plasma specimen. A diluent buffer is used to dilute the sample and favor sample flow along the test strip. The Test combines IgG and IgM components, corresponding to two lines on the test strip positioned in the test cassette. During testing the immunoglobulins IgG and IgM, possibly present in the specimen, react with the reagents and the nanoparticles in the Test. Then, the mixture chromatographically migrates upward in the strip membrane by capillary action, interacting with the two test line regions resulting in the appearance of a coloured line, if the specimen contains IgM and/or IgG antibodies to SARS-CoV-2. Otherwise, no coloured line will appear in either test regions, indicating a negative result. To serve as a procedural control, a coloured line will always appear in the control region, indicating that the test procedure has been performed properly and that test components and reagents have operated as intended.

Vitamin D & COVID-19

sars-covid-2

In recent months several studies have suggested a link between lower vitamin D values and higher risk in contracting a severe form of COVID-19.
This possible link could be due to the well-characterized role in calcium and phosphate balance that vitamin D has, affecting bone growth and turnover. Moreover, low vitamin D status is also associated with other non-communicable diseases and with increased susceptibility to infectious disease; notably, upper respiratory tract infections. A growing body of circumstantial evidence now also specifically links outcomes of COVID-19 and vitamin D status. SARS-CoV-2, the virus responsible for COVID-19, emerged and started its spread in the Northern hemisphere at the end of 2019 (winter), when levels of 25-hydroxyvitamin D are at their lowest. A brief report by D’Avolio et al., analyzing 107 patients in Switzerland, has shown that lower levels of 25(OH)D – the pre-hormone used to determine a patient's vitamin D status - were linked with SARS-CoV-2 positive patients, above all in males over 70 years old.

In a cross-sectional analysis across Europe, COVID-19 mortality was significantly associated with vitamin D status in different populations. The most vulnerable group for COVID–19 is also the one that has the most deficit in vitamin D, the older population.

In a 2017 study, Martineau AR et al. concluded in a meta-analysis that vitamin D supplementation was safe and protective against acute respiratory tract infections. They described that patients who were severe vitamin D deficient experienced the most benefit. For all these reasons, we believe it is important to check the values of Vitamin D, above all in the older family members, in particular men over 70 years.

Please write to info@primahometest.com for more info

Symptoms associated to COVID-19

Coronavirus disease, or COVID-19, is a potentially fatal infection caused by the presence of the SARS-CoV-2 virus. Person-to-person transmission of COVID-19 has led to the isolation of patients who have subsequently been given various treatments.

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 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 and have shown a higher mortality than others.

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.

Coronavirus: how to protect yourself and prevent infection

There is no vaccine to protect from the outbreak of the disease at the moment, 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 and through respiratory droplets (coughing or sneezing). The most frequent way of transmission of the disease is represented by the breath droplets of infected people via:
- saliva (coughing and sneezing)
- hands, e.g. touching the nose, eyes and mouth with the hands not yet washed
- direct personal contacts
In rare cases the infection can also occur through fecal contamination. 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.
Studies are underway to better understand how the virus is transmitted.

The main recommendations to prevent the spread of infection include:
1) Regularly wash your hands with soap and water for at least 20 seconds. Use a hand sanitizer containing at least 60% alcohol if soap and water are not immediately available;
2) Cover your nose and mouth with a handkerchief when coughing and sneezing, or do it inside your elbow;
3) Avoid close contact with anyone showing symptoms of respiratory illness.
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.

Publications

COVID-19 IgG/IgM Rapid Test has been used in several clinical studies at various European research centres and hospitals, resulting in the following publications:

- “SARS-CoV-2 seroprevalence trends in healthy blood donors during the COVID-19 Milan outbreak”, by L. Valenti et al., Submitted to Eurosurveillance, (medRxiv preprint doi: https://doi.org/10.1101/2020.05.11.20098442).
The aim of this study was to examine the seroprevalence of SARS-CoV-2 infection in healthy asymptomatic adults, the risk factors, and laboratory correlates in the Milan metropolitan area. The seroprevalence was detected with a lateral flow immunoassay, detecting anti-nucleocapsid antibodies to SARS-CoV-2. Participants included a random sample of blood donors since the start of the outbreak (February 24th to April 8th 2020, n=789).
Results show that at the start of the outbreak, the overall seroprevalence of SARS-CoV-2 was 4.6% (2.3 to 7.9; P<0.0001 vs. 120 historical controls). During the study period characterized by a gradual implementation of social distancing measures, there was a progressive increase in seroprevalence to 7.1% (4.4 to 10.8), due to a rise in IgG+ to 5% (2.8 to 8.2; P=0.004 ) but not of IgM+ (P=NS).
In conclusion the study suggests that the SARS-CoV-2 infection was already circulating in Milan at the outbreak start, with up to 10% of healthy individuals having evidence of seroconversion;

- “Rapid antibody testing for SARS-Cov-2 in asymptomatic and paucisymptomatic healthcare professionals in Hematology and Oncology units identifies undiagnosed infections" by P. Corradini et al, Hemasphere (2020) 4:3(e408). http://dx.doi.org/10.1097/.
The aim of the study was to detect the prevalence of occult infections at the Hemat-Onc department of the Milano National Cancer Institute. These undocumented cases are likely to represent a real threat for patients, colleagues and also family contacts.
Preliminary data from the Italian Society of Hematology suggest that also in the hematology and bone marrow transplantation setting, mortality for COVID-19 infected patients, seems at least 30%. Thus, stringent control measures in Hemat-Onc units are of utmost importance to keep them COVID-free.
Participants included asymptomatic and paucisymptomatic workers (doctors, nurses, paramedics and staff members) and the serology status was checked with a lateral-flow immunoassay detecting the presence of anti-nucleocapsid antibodies to SARS-CoV-2. The presence of viral RNA was searched by reverse transcription polymerase chain reaction (RT-PCR) in NPS (nasopharyngeal swab) of seropositive cases only.
Results have shown that the prevalence of asymptomatic/paucisymptomatic healthcare workers in the Hemat-Onc Units at the Milano National Cancer Institute with a positive serology is 9.4% and that 31.8% of them had a confirmed diagnosis of COVID-19 by RT-PCR of SARS CoV- 2 RNA in NPS.

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