Keeping ahead of Covid-19 testing options in Italy

covid-19 testing update

For one who wishes to be compliant with the rules and up to date on Covid-19 in Italy, finding trusted sources is not an easy task. With news running wild in all directions, steady information sources are much needed.

Our team at DoctorsinItaly has chosen to rely on the Technical-Scientific Committee of the National Emergency Management Agency, at the Presidency of the Council. 

Periodic updates are issued by the Committee in the form of Circulars of the Ministry of Health. 

We have collected the most relevant information regarding testing options for Covid-19 from these sources, and will be updating the article as news becomes available.

What types of tests are available for coronavirus?

There are two common types of tests that are used for diagnostic purposes and for monitoring of coronavirus: the swab test and the blood test.

There are different methodological approaches to each of these testing strategies, but this categorization can help make sense of the alternatives in layman’s terms.

What is the swab tests for coronavirus?

The so called “swab test”, which is a RT-PCR test looking for viral RNA, is performed on a nose/throat swab sample.

It is used to detect the presence of an infection, and it can only detect the virus during the infection. This means it cannot detect whether a person was infected and then subsequently recovered.

If you have flu-like symptoms or signs of a respiratory infection, this is the test you need to do to diagnose if you have Covid-19 or not.

The test transcribes and replicates RNA traces present in a biological sample, allowing to detect the virus even when the viral load is low.

This test can be used on people who have signs of infection, and on those who have no symptoms at all.

What is the serological test, or blood test for Covid-19?

The blood test for Covid-19 is used to identify a person who has been exposed to the virus and has developed specific antibodies. 

This type of test for coronavirus is currently available at some private labs and it can be done by anyone who requests it. 

However, before running to your closest lab, you may want to know why Lazio’s regional health councillor Alessio D’Amato has expressed his utter contempt for those who offer this test, as much as to define them “criminals” for having people pay 150 euro for this test (original article in Italian).

First of all, this test is not useful for acute cases, such as patients who have developed symptoms, nor it can be used to rule out an infection. If you have been sneezing and can’t get tested through the official health centres, this test won’t help you either.

Serology tests are blood-based tests that can be used to identify whether people have been exposed to a particular pathogen by looking at their immune response and identifying specific antibodies. They all focus on proteins made by your immune system in response to an infection. The immune system keeps you healthy by producing antibodies, particles that destroy foreign invaders, such as viruses, by attaching to the antigens and deactivating them. 

If your blood contains antibodies that are specific to Covid-19, it means that your system has responded to its presence, thus you have been in contact with the virus.

Serology testing for SARS-CoV-2 is at increased demand in order to better quantify the number of cases of COVID-19, including those that may be asymptomatic or have recovered, and inform public health policies. 

The rapid tests for Covid-19, used to find IgM and IgG antibodies, can verify that a person has been infected, but it cannot confirm what is their current status. 

rapid test result options
Possible results of a rapid test (RDT)

Specifically, a positive serology test for coronavirus would confirm the presence of specific antibodies, showing that the subject has been infected. However, this is not sufficient to understand if the person is still infected and contagious, or if they have overcome the disease and are no longer contagious.

A negative result, on the other hand, is even more uncertain: it may mean that the person is healthy and has not been in contact with the virus, or it could mean that the person is currently infected, but has not yet developed a detectable quantity of antibodies.

For this reason, serology tests cannot substitute the swab test used for diagnosing an ongoing infection and they cannot be used on subjects with symptoms to identify their status. 

So why are these tests even done, you may ask.

From the perspective of public health authorities, policymakers, and researchers, it makes a lot of sense to get a more accurate estimate of how many people have been infected with Covid-19.

Additionally, if herd immunity were to be possible this kind of test could prove very useful to detect all those who have the antibodies and can be considered immune.

A word of caution is in order here: there is no proof that those who have been infected are immune and cannot be infected again. At the current state of our knowledge of this new virus, this is simply a possibility. 

Another shortcoming of the serology test is that it may show false positive results due to cross-reaction to similar viral strains, such as other common types of coronavirus. A person may result positive and be considered immune, while having actually had a different type of infection.

[April 9th update] On April 8th, 2020, Lazio Region has issued an official communication, authorising private centres to offer blood tests for Covid-19 at a regulated fee of €45.  

Labs used to set the fee at their discretion, but as this led to speculation by some labs and unfair pricing imposed on worried citizens, the Region defined a price cap and, even more importantly, requested that all centres clearly inform patients of the shortcomings of the test and its real clinical value.

A list of serology tests approved in USA

[April 22nd update]

The test performed on blood, can be used as an additional investigation to the direct research of SARS-Cov-2 in the respiratory tract, in patients without disease symptoms (asymptomatic), to further contribute to prevent the transmission of the virus.

What is the Covid-19 blood test for?

The test is used to determine whether a SARS-Cov-2 infection has occurred. This infection, in fact, may have occurred without any symptom or with mild symptoms you may not have given importance. It’s a way to find out if you have had the infection without knowing. The test can give useful indications about a possible contact of the patient with the virus, by measuring IgM and IgG in the blood.

What happens when IgM and IgG are both negative?

The test is able to detect infections that occurred within 10 days preceding the moment of detection. In the current state of knowledge the window period of SARS-Cov-2 is estimated in 10 days from the presumed infection. A negative result therefore cannot exclude that there is no current infection, as the patient may still be in the 10-day window period. 

What happens when only the IgM are positive?

If the IgM result is positive (therefore in the report the IgM are indicated as “positive”) the patient must be able to access the confirmation test for Covid-19 (swab), in agreement with the NHS doctor or local health authorities.

In any case, the positive result of the IgM cannot give indications on the course of the infection.

What happens when IgG are positive and IgM negative?

If the IgG result is positive (therefore in the report the IgG are indicated as “positive”) it means that the patient is likely to have recovered from Covid-19 infection, but in any case it is recommend an assessment with a doctor.

When to take the test?

The test can be always performed, except in the presence of symptoms (as indicated by the Ministry of Health, for example fever, flu syndrome, cough, breathlessness, etc.). In this case the swab test is the most appropriate and it is recommended to contact the local health authorities, to obtain the appropriate evaluation and adequate assistance.

When to repeat the test?

If the IgM and IgG in the report are indicated as “negative”, the test has to be repeated 7 days after the first sampling. 

Can the test give “wrong” answers?

Like any other test, there is a possibility that the test will produce false positives or false negatives. The tests in use at most reputable laboratories are marked CE-IVD but there is still paucity of data to estimate the sensitivity  of this new test. 

How could the test provide “wrong” answers?

Case 1: IgM could be negative because the test was  performed too early, during the window period.

Case 2: IgG could be positive due to a different type of Coronavirus (there are several in nature), very “similar” to SARS-COV-2. 

What is the use of a positive IgG result?

Given that a false positive is a rare occurrence, this test remains important for the prevention of transmission of viruses, epidemiologically, to map the territory and protect a given population, determining the relationship between people who developed antibodies and people who haven’t yet developed them.

Are all blood tests for Covid-19 the same?

There are 2 types of tests: qualitative and quantitative. Initially most labs use the qualitative one, which just informs about presence or absence of antibodies. Amidst Coronavirus emergency, qualitative test is simpler, faster and allows to take the correct actions. At the end of the emergency, if it will be very likely more useful to switch to a quantitative test, which measures the exact concentration of IgG in the blood. 

That is the theory, although in practice we don’t know how people might react to reinfection with SARS-CoV-2 nor the length of time that someone might remain immune for.

Where can you get tested for Covid-19 in Italy?

The swab test for SARS-CoV-2 is not available for commercial use and is only done at public healthcare facilities specifically dedicated to this. 

There is currently a limited number of labs which are authorised to run the swab test for Covid-19, that have the appropriate instruments and trained professionals, and which follow specific procedures to comply with the very strict guidelines for bio-containment. 

These labs are usually part of large public hospitals and run at their maximum capacity in the most affected areas. To ease the pressure on Covid-19 labs, the Regional Health Authority has defined a list of supporting centers which can also run the swab tests under the coordination of the authorised labs.

However, you cannot go to any of these labs to get a swab test, unless it is requested for you by a hospital or a doctor in accordance with the latest guidelines.

On April 3rd the Ministry of Health issued Circular 11715 to update the rules to be applied for testing priority, and how healthcare professionals should determine if a person is eligible for a test.

Because the reagent used to run the swab test for coronavirus is limited and it also needs to be used also to detect other important infections, Public Health Authorities, in accordance with guidelines defined by the European Commission and the World Health Organisation (WHO) are working to optimise the use of swab tests, to avoid running out.

The strategy used by the Health Authorities includes setting precise prioritisation rules on when to run the test and when it is not necessary – even if it might be beneficial.

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Who can get tested for Covid-19?

The test is run only when requested by a doctor or a hospital in accordance with Ministerial Circular 11715 issued on April 3rd 2020. Here are the key points of the document.

To be eligible for priority testing, a subject must who fall into one of these groups:

  • Patients who are hospitalised with severe acute respiratory infection (SARI), so that the appropriate treatment and bio-containment measures can be taken
  • Patients who are hospitalised or reside in a nursing home, as they are the most vulnerable to severe complications
  • Healthcare workers who are at highest risk of infection, including paramedics, technicians and emergency assistance personnel, to reduce the risk of spreading the disease and protect their own health
  • Subjects who are most fragile due to age or presence of other disease, such as pulmonary disease, cancer, cardiovascular disease, kidney or liver disease, hypertension, diabetes, or compromised immune system who show signs of a respiratory infection
  • Those who exhibit symptoms and reside in closed communities, such as prisons, in order to detect early the onset of sites of infection and proceed with isolation and containment measures.

 

For anyone who is not in this group, the need for a test is evaluated case-by-case by healthcare professionals of the public health authority. 

If you believe you need to be tested, call the dedicated phone number for your region (see list below), or 1500. You will undergo a triage via phone and, if appropriate, a swab collection will be planned – either at a hospital, at your home, or at a drive-through collection site. 

In case of severe symptoms or urgent need, call 112 or 118 for emergency assistance.

You might be eligible for testing if, for example, you have influenza-like illness, or if you have been in close contact with someone who has resulted positive. 

A close contact is currently considered worth testing when it occurs within 48 hours of the onset of the first symptoms, or for 14 days after – see Ministerial Circular 9774 issued on March 20th 2020.

Regional Covid-19 phone numbers

Basilicata: 800 99 66 88 
Calabria: 800 76 76 76
Campania: 800 90 96 99
Emilia-Romagna: 800 033 033
Friuli Venezia Giulia: 800 500 300
Lazio: 800 11 88 00
Liguria: 800 938 883
Lombardia: 800 89 45 45
Marche: 800 93 66 77
Piemonte800 19 20 20 or 
800 333 444

Provincia autonoma di Trento: 800 867 388
Provincia autonoma di Bolzano: 800 751 751
Puglia: 800 713 931
Sardegna: 800 311 377
Sicilia: 800 45 87 87
Toscana: 800 55 60 60
Umbria: 800 63 63 63
Val d’Aosta: 800 122 121
Veneto: 800 462 340

Food for thought

It goes without saying that, though the current guidelines for testing priority are approved by the WHO, these may change as new knowledge becomes available and strategies are redefined. 

There is much discussion within the scientific community on how likely are people without symptoms to spread the disease. With SARS and MERS-CoV the risk of transmission before exhibiting symptoms was considered low. 

However, evidence suggests that Covid-19 is contagious even when symptoms are not present in the carrier, therefore seemingly healthy people can transmit the virus. 

 These carriers are commonly divided into three categories: 

  • pre-symptomatic, or those who do not have symptoms yet but will develop illness a few of days later
  • asymptomatic, or those who never develop symptoms
  • post-symptomatic, or those who recover after the illness but remain contagious

While post-symptomatic individuals fall into the mandatory self-quarantine as defined by the recent decrees, the pre-symptomatic and asymptomatic may well be among those who go to the supermarket, or work as a cashier, or carry your food at home.

In Milan and Lombardia region it is now mandatory to wear a surgical mask – or a piece of clothing as a substitute – every time one leaves the apartment, even if you do not have any symptoms (see article in Italian). 

The masks are meant not so much to protect you from getting infected, but rather to reduce the chance that you spread the virus, in case you have it and don’t know it.

Universal use of face mask outdoors, until a vaccine (or a novel treatment) becomes available, may reduce community spreading by asymptomatic individuals and will be very likely adopted in every country. For this to be possible, mask manufacturing capacity will have to ramp up until sufficient units become available for public use.

It may, also, become appropriate to define new rules for testing priority, to include all the essential workers who cannot stay at home, since they may well be – unknowingly – among the silent carriers.

Still got doubts?

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DoctorsinItaly Team

This article was written, curated, and updated by the DoctorsinItaly team, as part of our efforts to share relevant and current information on health and wellness related topics, as well as on life as an expat or traveler in Italy.

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