Examining the applicability of a fieldable serological point of care serological test Biozek and Point of care molecular Fluorescent in Situ Hybridization (FISH) technology by Biotrack for the usage of decision making, containment and management of…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Obtaining knowledge on the performance of fieldable point of care testen: will
they provide reliable information on viral replication intermediars of
virusparticles and antigens.
Decision making on which type of body fluid will generate the best results
Secondary outcome
IIs the test applicable under field circumstances lacking well equiped
laboratory facilities.
Background summary
Reasoning behind the study
Since January 2020 the SARS-CoV-2 viral pandemic results in many cases of
COVID-19 worldwide, with an overall case fatality rate of about 2 %. Even
though most of the cases (80%) show mild to moderate clinical signs, about 15
% of cases deteriorate into severe illness requiring in 5 % of the cases
hospitalization in the intensive care. The (mortality)percentages do differ
between countries and local situations. The probability of a bad outcome is age
related; the older the more case fatalities are reported. Also presence of
comorbities have a significant impact on the severity of the disease.
The Dutch working conditions Act require efforts of the employer to reduce
health and safety hazards and impose risk mitigations strategies in order to
create working circumstances that are safe and will not harm (the health of) an
employee. This also includes protective measures related to infection with
pathogens. The government also has a responsibility towards her employees to
imply strategies that are contributing to the longevity and maintenance of
physical and mental health of her personnel. Personnel, that is required to
fulfill and sustain their tasks required regardless of circumstances and the
COVID-19 related difficulties. Military personnel is asked to perform anywhere
and anyhow under circumstances where laboratory facilities are minimal or
absent.
At this moment a few serological well performing point of care tests are
available for usage under field circumstances. A lot of research is ongoing but
not for this specific indication. Also, for molecular detection of the
infection a limited number of point of care tests are available but not
suitable for field conditions that require robustness and resistance against
trembling, shaking or under circumstances with limited laboratory facilities.
Therefore the health department of MOD NL has been looking for robust, simple
and user friendly fieldable equipment and methods to identify COVID-19
cases.The MOD will perform the study in cooperation with the civilian
(research) partners. Results will become accessible for both the military as
civilian community.
The working hypothesis is that both the Biozek and Biotrack COVID-19 -point of
care rapid test, will generate sufficiently reliable data that the results can
contribute to development an fine tuning of risk mitigating measures and
management.
Study objective
Examining the applicability of a fieldable serological point of care
serological test Biozek and Point of care molecular Fluorescent in Situ
Hybridization (FISH) technology by Biotrack for the usage of decision making,
containment and management of th SARS-CoV-2 infection in a (military)
population.
Study design
Prospective, observational, descriptive pilot study.
Study burden and risks
The participant has a contact moment with the main medical researcher to
discuss inclusion in the study.
Thereafter two contact moment follow with the sample team lasting about 2 time
20 minutes. It is expected that the collection of blood samples, nasopharyngeal
swabs, and saliva collection will induce slight discomfort and that saliva
collection will not.
The participant fills in ( using a data safety protected app) a questionnaire
at 3 time point, taking about 5 minutes per session. During the first, above
mentioned contact moment , the sampling team member will guide the participant
through the questions to make sure the next 2 sessions will be completed
correctly if they are filling it in on their own.
The risk involved might be hematoma development after/ during blood sampling of
slight erosion of the mucus membranes during swab sampling. The measures taken
to guarantee respecting the AVG Act should reduce the risk on data leakage to
zero or minimal risk.
For military personnel it is of utmost importance to have access to a useful,
and reliable fieldable point of care test. The need for this it urgent since it
can reduce their uncertainty or feeling of unsafety as long as they have no
information on their or their colleagues status if clinical signs develop in
their community during operations or missions.
Also commanders have a strong desire to assign in a responsible way their
personnel.
Military doctors want to have the possibility to obtain information from their
patients about the possibility that COVID-19 the cause of disease, also if
laboratory facilities are limited. Since some COVID-19 can rapidly deteriorate,
a risk assessment has to be made of disease occurs in remote locations.
If this research is not performed, the capability gaps are not filled and
only nonspecific clinical signs have to lead to decision of likelihood of a
diagnosis of COVID -19.
In conclusion, the risk for the participant is low in relation to the major
impact which validates its operformance*
Kortemolenweg 3
Doorn 3941PW
NL
Kortemolenweg 3
Doorn 3941PW
NL
Listed location countries
Age
Inclusion criteria
Group 1
• Complete set samples available as complete set from persons being samples
before the outbreak of COVID -19 (< jan 2019).
• Other respiratory viral infections well represented, including the common
corona viridae
Group 2
• Complete set samples of SARS-CoV-2 PCR RIVM positive person
• COVID-19 related clinical signs
• Inclusion of patients with minor to severe signs
• Date first clinical signs known
• Date first sampling in relation first day of illness known
Group 3-5
Military personnel volunteering to participate
Study approval by 1-MGA/013 procedure, staffing DGO for related AVG
notification and cooperation contract with * Sensorium* (see also attachment
K6.2 for details)
Group 3: Complete set samples of potentially contaminated military personnel,
with no clinical signs
• Participant has had contact with colleague or family member, roommate that
has PCR proven COVID19
• Contact was during complaint of this proven patient or in the three days
before the start of the signs
• Direct contact is defined by : minimally one working day repeated contact
within the 1,5 meter zone
• Date of sampling resulting in positive PCR of the ill contact known
• Date clinical signs of the ill contact known
Group 4: Complete set samples of potentially contaminated military personnel,
with clinical signs
• COVID -19 risk contact known
• Clinical signs participant related to COVID-19
• Date start clinical signs risk contact known ( thus moment of start clinical
signs within incubation period)
Group 5 complete set samples of military personnel in vital functions:
• Military personnel participating in a critical process and in whom potential
COVID-19 signs will severely impact the capability and performance of the
military unit or assignment.
Exclusion criteria
none
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74138.041.20 |