Why It’s Critical For Ships To Screen Crew For COVID-19 BEFORE Boarding To Fulfill New EU & IMO Guidelines

 

Because ships are at high risk of COVID-19 infection in port during crew changes, the EU & IMO recently issued urgent new guidelines requiring ships to implement pre-boarding screening of seafarers to help combat the escalating problem. The effect of an outbreak on a ship would be catastrophic in business and human terms. No-one wants a medevac, major diversion or let alone a preventable death to deal with, on top of everything else they’ve got on at the moment.

Compared to workplaces in most other industries, ships crew are subject to increased risks from COVID-19 due to being confined in small spaces for extended periods of time in close proximity to other people. Furthermore, given the overwhelming dominance of male seafarers, and the fact that studies1 in Italy and Spain have shown approximately twice as many men as women die from COVID-19 as men, the dangers are intensified.

As we learn more about this disease there’s an increasing knowledge bank that shows a high proportion of infected people who are highly contagious, show no symptoms:

  • A study2 into the outbreak on cruise ship Diamond Princess estimated that 20.6% – 39.9% of cases were asymptomatic
  • According to the CDC, ~25% of cases show no symptoms.
  • A study3 of the infected Japanese evacuees from Wuhan showed that 41.6% were asymptomatic
  • An article8 in the British Medical Journal reports that four-fifths of cases are asymptomatic!

According to McKinsey4, studies in China & Singapore report that asymptomatic transmission may account for ~50% of cases. As China begins to return to work and daily life, they still experience small outbreaks and new cases. It’s widely accepted that the asymptomatic carriers are those who contribute largely to the ongoing spread – often referred to as the “super spreaders”.  This is why testing is being widely introduced as the best practice to adopt, to prevent spread. South Korea did so well at controlling the COVID-19 outbreak because they immediately began testing hundreds of thousands of asymptomatic people.

Therefore, without extensive pre-boarding screening, it’s impossible to know whether new asymptomatic crew are bringing COVID-19 onboard and infecting the whole ships’ crew.

European Commission “Guidelines on protection of health, repatriation and travel arrangements for seafarers, passengers and other persons on board ships” 8th April 20205

So, it’s beyond doubt there’s a significant possibility that asymptomatic yet highly contagious new crew (who have the disease) could board and infect the whole of ships’ crew. This is a key reason behind the European Commission publishing new guidelines centred around protecting the health of seafarers and introducing new requirements for the pre-boarding screening of crew.

Key paragraphs of the text are extracted below:

  1. In line with the advice referred to in paragraph 3, the primary option to ensure that seafarers at risk of infection with COVID-19 can start their duties should be testing before embarking. 
  1. For seafarers with suspected infections and mild symptoms, testing should be performed in the next port of call and all crew members should have access to adequate medical care. As part of this, the person or persons in question should be evacuated and receive adequate medical care. If one person on board is suspected to be infected with COVID-19, all crew members should observe a 14-day quarantine, either onboard or land. This should be waived if the test of the crew member with the suspected infection is negative or after the quarantined crew member tests negative for COVID-19.

These guidelines follow similar directives issued by the International Maritime Organisation contained within IMO Circular Letter No.4204/Add.4 “ICS Coronavirus (COVID-19) Guidance for ship operators for the protection of the health of seafarers” 5th March 20206

 “All ships are advised to…. implement pre-boarding screening’

The new guidelines make it mandatory for ships to provide a declaration of health of all crew members, before being allowed to enter port. Going forward, every vessel’s ship master will be required to relay this information in advance:

  1. Total number of persons on board (both crew and passengers 
  2. Number of persons infected with COVID-19
  3. Number of persons suspected to be infected with COVID-19

Only ships who have the diagnostic tools to test onboard will be able to satisfy these requirements.

It’s therefore critical that vessel operators consider how to BOTH protect against infection getting on their ships AND contain any outbreak if/when it occurs. Clearly, crew change represents the highest risk of introducing an infected/contagious person on board.

Currently, there are two principal types of commercially viable test for occupational screening crew – antigen testing and antibody testing. Both kinds of tests help masters make decisions about measures to prevent and potentially contain an outbreak onboard.

Antigen tests which are often referred to as PCR tests, directly detect the virus itself using swabs from the nose and throat and have a high accuracy rate. The swab is then sent to an accredited laboratory for testing with results typically available within 1-3 days/ The International Maritime Health Association (IMHA) in April recommended7 the use of PCR tests antigen tests stating:

“If possible test every seafarer with respiratory symptoms with a throat swab (PCR) to identify if they have COVID-19.”

Furthermore, the IMO6 stated that, “Any person on board that may have been in contact with a suspected case should be…. Asked to remain onboard until laboratory [antigen] results of the suspect case are available”

Antibody tests reveal if you have been exposed to the virus, and your body has developed antibodies. They involve an affordable finger prick blood test and a small cassette onto which a drop of blood is placed, buffer solution added, and results read in just 10-15 minutes.

The new crew about to board can be categorised as follows:

  1. Totally free from any infection and never previously infected
  2. Totally free from any infection and recovered from previous infection
  3. Infected, without symptoms and within the widely accepted median 5-day incubation period
  4. Infected, past the incubation period and with symptoms
  5. Infected, past the incubation period & without symptoms
  6. With symptoms but not infected with COVID 19 (common cold)
  7. Relapsed/reactivated cases – scientists are studying this concept as ‘relapsed’ patients increase

Category 1 – subjects are of no concern and a confirmatory test will give some peace of mind to such crew & colleagues. Both types of test will likely show a negative result.

Category 2 – subjects are worthy to identify using the tests, as it’s generally recognised that these people will have developed immunity, although there remains scientific discussion on this subject as we learn more about Covid-19. PCR antigen tests will likely be negative whilst antibody tests will likely be positive. Category 2 crew members if identified, could be allocated to assist/care for any crew members that become infected whilst onboard.

Guidelines from the World Health Organisation10 recommended that a clinically recovered COVID-19 patient should test negative for the virus twice, with tests conducted at least 24 hours apart. Antigen PCR tests are the critical test for this scenario.

Category 3 – only PCR antigen tests will detect subjects carrying the virus within the 5-day incubation period – these are expensive, and results take at least 1 day to be received. Antibody tests would be negative for this category. The IMHA7 policy guidance states, “Testing a person with no symptoms by a throat swab (PCR) is never indicated. Testing asymptomatic people [using PCR] is a waste of valuable resources”

It’s therefore important for ships to anticipate the potential for category 3 subjects and define a screening strategy to mitigate any risks – see later. It’s highly recommended that ALL CREW ARE RE-TESTED 5 days after crew change to diagnose any who’ve progressed from category 3 to categories 5 see below. On-board instant antibody tests offer utility value in this scenario.

Antibody tests detect the presence of immunoglobulins which are produced by white blood cells as an immune response to viruses.  Immunoglobulin M (IgM) is the first antibody to be made by the body to fight a new infection. IgM rises within the first week of infection AFTER the incubation period and is detectable after 3-5 days. At this time the subject has the disease and is highly infectious. They may or may not be showing symptoms.  The IgG immunoglobulin, which is more abundant appears later, signally that antibodies are present which are responsible for longer term immunity.  But again, the subject may or may not show symptoms.

Dr. Deborah Birx, the response coordinator for the White House coronavirus task force, has called antibody tests “critical” in the response to the pandemic.

The below figure explains the important role antibody screening tests can play in preventing COVID-19 outbreaks on ships.

CoronaSafe - Changes of Antibodies Levels

For Category 4 ‘Infected and symptomatic’ subjects, it’s unlikely (but possible) that crew will turn up for work with symptoms given the plethora of advice and guidance issued. A possible scenario is that they leave home without symptoms and develop them whilst travelling to the embarkation point. Antigen & antibody tests combined with a health questionnaire and forehead thermometer will provide conclusive diagnosis and result in refusal to board and isolation.

Anticipating infected and symptomatic crew to reveal themselves AFTER crew change and during a voyage, IMHA7 & IMOpolicy guidance respectively is clear:

“If possible test every seafarer with respiratory symptoms with a throat swab (PCR) to identify if they have COVID-19.”

“Any person on board that may have been in contact with a suspected case should be…. Asked to remain onboard until laboratory [antigen] results of the suspect case are available”

So, it’s important for ship operators to start making arrangements for international access to PCR and antibody tests and issue their ships with throat swabs to allow testing to be done as soon as a possible case arises.

Category 5 is the most significant risk – those crew members who are infected (i.e. have the disease) and are highly contagious, but without symptoms. Such subjects left undiagnosed (i.e. without pre-screening) would board and spread the infection to fellow crew, whilst being totally oblivious.  Antibody tests have good utility value to diagnose this category of the subject with 97% clinical specificity.

Research by McKinsey & Company (COVID-19: Briefing materials 3rd April 20204) concludes that “Antibody tests are currently the best method for detecting asymptomatic cases”

Prof Ashley Woodcock9, Associate Dean for Clinical Affairs and Professor of Respiratory Medicine, University of Manchester, and Clinical Director for Respiratory Medicine, University Hospital of South Manchester commented8:

“Currently the ‘stick’ test [antibody test] will be invaluable as POC diagnosis. If positive, then the patient can immediately be triaged.  False positives are rare.  There may be 5% false negatives (IgM may not have yet gone up), but this can be checked in patients with the syndrome by re-testing”

For Category 6 subjects who are symptomatic but not Covid-19 infected (e.g common cold) as in category 4, it’s unlikely (but possible) they’ll turn up for work with symptoms given the plethora of advice and guidance issued. A possible scenario is that they leave home without symptoms but develop them whilst travelling to the embarkation point. Antigen & antibody tests combined with health questionnaire and forehead thermometer will provide a diagnosis and leave the decision to board in the hands of a medical professional.

For category 7 subjects, on-going periodic antibody testing on-board would help to diagnose their re-activation from category 2.

CONCLUSION

As in society at large, combined antigen and antibody testing has a crucial role to play in the global shipping industry to help prevent or contain covid-19 outbreaks on ships to keep global trade flowing.

PCR antigen tests with results taking 1-3 days to be available are recommended by IMHA and IMO to diagnose symptomatic cases.

A prime use case for 10-minute point of care (POC) antibody tests on ships is catching the category 5 subjects (infected but asymptomatic) who in the absence of testing, would board and infect other crew. The referenced studies show there’s a high proportion (huge range 20.6% – 80% across the studies) of asymptomatic cases with the McKinsey4 study suggesting that asymptomatic transmission may account for ~50% of cases.

Antibody tests offer further value in re-testing crew after 5-7 days (or thereafter) to catch those in category 3 (infected, without symptoms and within the incubation period) who progress to category 5. Similarly, those in category 1 (totally free from any infection and never previously infected) that get infected and progress to category 5.

The 3rd utility value of anti-body tests for ship’s crew is knowing-boarding who’s recovered from Covid-19 and likely immune, to assist with any who subsequently test positive during voyage.

The 4th utility value is the ability to instantly test crew during voyage who become ill with diseases sharing similar symptoms e.g cough, fever, who are NOT infected with Covid-19

The overwhelming conclusion from the scientific and medical community is that antigen and antibody tests are critical to the global exit and recovery strategy from the disease. The eminent medical opinion concludes combining the antibody test AND the PCR swab taken from the patient gives a 98.6% detection rate within the first 5.5 days of infections.

CoronaSafeTM  Screening Tests From Martek

To assist ship operators to comply with these important new guidelines and help protect vessels from an outbreak of COVID-19, Martek has launched CoronaSafeTM crew screening combining antigen and antibody testing to deliver the most effective testing protocol possible.

From just a single drop of blood, CoronaSafeTM finger prick antibody screening test will detect IgM antibodies within 5-7 days of infection and is particularly useful to detect infections amongst subjects who show no symptoms and would otherwise embark undetected. CoronaSafeTM has been proven in extensive clinical trials of 570 patients during the recent outbreak to deliver >95% accurate diagnosis of COVID-19.

The test is approved and certified by the European Union as meeting the safety, quality & performance requirements of European Standard IVDD 98/79/EC the highest standard applicable for these devices. It’s also in widescale use by authorities/corporations in Japan, China, Germany, Poland, Indonesia and is formally certified/approved by CFDA, Philippines FDA Singapore Health Sciences Authority.

Globally we’re seeing widescale adoption of antibody tests to help return society to normal with mass testing being recently implemented in New York, Munich and by commercial operators such as Emirates airline, who are screening passengers before boarding some flights.

CoronaSafe+TM is a highly sensitive respiratory PCR test which provides detection of COVID-19 in a simple swab test. The PCR test detects the genetic information of the virus, the RNA. This presence is only possible if the virus is present and someone is actively infected, even in the earliest of stages.

Major Corporations & health practitioners worldwide, are rushing to adopt these tests to help control the spread of this deadly virus, with demand rising rapidly as the crisis deepens.

To learn more click here

 

REFERENCES

  1. British Medical Journal blog
  2. Study into the outbreak on cruise ship Diamond Princess estimated that 20.6% – 39.9% of cases were asymptomatic
  3. Study of the infected Japanese evacuees from Wuhan
  4. McKinsey Covid-19 Briefing
  5. European Commission “Guidelines on protection of health, repatriation and travel arrangements for seafarers, passengers and other persons on board ships” 8th April 2020
  6.  IMO Circular Letter No.4204/Add.4 “ICS Coronavirus (COVID-19) Guidance for ship operators for the protection of the health of seafarers” 5th March 2020
  1. International Maritime Health Association “Testing seafarers on Covid-19” 2 April 2020
  1. British Medical Journal article
  2.  Expert comment on testing
  3. WHO Guidelines

 

The tests are further certified to the following additional International Standards:

  • ISO 14971 Standard for the application of risk management to medical devices.
  • ISO 13485 Medical Devices QMS certified manufacturer.
  • EN 13975 Sampling procedure requirements for acceptance testing of finished in vitro diagnostic medical device.
  • ISO 18113-2 Requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for professional use.
  • ISO 18113-4 Requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing.
  • BS EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing.

Author – Paul Luen, CEO