COVID-19 IgG/IgM Rapid Test

Published on 16/03/2020

PRIMA Lab SA supports healthcare personnel during Coronavirus emergency

Covid-19 IgG/IgM Rapid Test

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.

Are you interested in buying our COVID-19 IgG/IgM Rapid Test kit? Please write to info@primahometest.com for further information.

Coronavirus: what is it?

In December 2019 a cluster of pneumonia cases of unknown aetiology was reported in Wuhan, Hubei Province, China. In January 2020, the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), belonging to the β genus, was identified as the causative agent of this first outbreak and the related disease was defined as Coronavirus Disease 2019 (COVID-19).
The initial outbreak of COVID-19 in Wuhan spread rapidly, to the extent that, on 11 March 2020, the Director General of the World Health Organization declared COVID-19 a global pandemic. Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals and birds and that cause respiratory, enteric, hepatic and neurologic diseases. As reported on the website of CDC, Centers for Disease Control and Prevention, six other species of coronavirus are known to cause disease in humans. The four prevalent species - 229E, OC43, NL63 and HKU1 - cause common cold symptoms in immunocompetent individuals. Two other strains - the Acute Severe 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 higher mortality rates than others.

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.

How to protect from the outbreak

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.

How to keep the curve flat

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 was definitely different: China managed to stabilize and progressively reduce the number of infections, thanks to a massive testing operation and a quarantine, strictly respected by all Chinese people. Flatten the curve of COVID-19 spreading was the main goal of this Country - China demonstrated to all the world that it is possible to fight the pandemic.

Nowadays, it is as important to understand how to keep the curve flat: while some countries have failed in their response to the pandemic, others met the challenge more successfully, by limiting the direct and the indirect impact of COVID-19. These countries have both succeeded in lowering the mortality and infection rate while containing the socio-economic impact of the pandemic.

Daily new confirmed COVID-19 cases updated on 02/09/2020

As we can see from the chart above, Our World in Data outlines that the differences between countries are substantial. Basing on these results, it is possible to divide their achievements in two different groups:

1) The countries which have monitored the outbreak from the very beginning of the pandemic or rapidly caught up after an initial outbreak. They have been able to bend the curve and bring down the number of confirmed cases, while increasing the ratio of tests to confirmed cases.

2) The countries which have tested too little if compared to the relative size of the outbreak and they still report very high daily case counts.

The first group of countries was able to bend the curve by following the guidelines given by the World Health Organization - the SRPP, Strategic Response and Preparedness Plan, complemented with the Operational Planning Guidelines to Support Country Preparedness and Report. This document is intended to be a practical guide outlining the public health and essential health services measures needed to prepare for and respond to COVID-19. It defines the priority actions to be included in country-specific preparedness and response plans, towards a fully collaborative and coordinated response to the pandemic.

Using this guidance, countries are encouraged to:
- Appoint a lead, if not done so already, to coordinate and oversee the development and/or update of the COVID‑19 national plan and the COVID‑19 multiagency plan;
- Map existing preparedness and response capacity, and identify key gaps based on the actions outlined in this document;
- Engage with national authorities and key technical and operational partners to identify appropriate coordination mechanisms, including the health cluster, and assign roles and responsibilities to address key gaps to be addressed by the COVID‑19 plans;
- Engage with local donors and existing programmes to mobilize resources and capacities to implement the COVID‑19 plans;
- Establish monitoring mechanisms based on key performance indicators to track progress, and review performance to adjust COVID‑19 plans as needed;
- Conduct regular operational reviews, and adjust the COVID‑19 response and preparedness strategies as required.

Vitamin D & COVID-19

In recent months several studies have suggested that vitamin D status may influence the severity of responses to 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.

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.

Bibliography

1. European Centre for Disease Prevention and Control, Disease background of COVID-19 (https://www.ecdc.europa.eu/en/2019-ncov-backgrounddisease)

2. WHO Director-General's opening remarks at the media briefing on COVID-19 - 11 March 2020 (https://www.who.int/dg/speeches/detail/who-directorgeneral-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020)

3. Xiao AT, Gao C, Zhang S. Profile of specific antibodies to SARSCoV-2: the first report. J Infect 2020. doi: 10.1016/j.jinf.2020.03.012

4. Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, et al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. medRxiv.2020:2020.03.02.20030189

5. Long Q-x, Deng H-j, Chen J, Hu J, Liu B-z, Liao P, et al. Antibody responses to SARS-CoV-2 in COVID-19 patients: the perspective application of serological tests in clinical practice. medRxiv. 2020:2020.03.18.20038018

6. Sethuraman N, Jeremiah SS, Ryo A. “Interpreting Diagnostic Tests for SARS-CoV-2.” JAMA. Published online May 06, 2020. DOI:10.1001/jama.2020.8259

7. Sun et al., “Kinetics of SARS-CoV-2 specific IgM and IgG responses in COVID-19 patients” Emerging Microbes & Infections, 2020, 9:1, DOI:10.1080/22221751.2020.1762515