EMBIO DIAGNOSTICS Research Lab Starters Kit User Manual
- June 8, 2024
- embio diagnostics
Table of Contents
COVBELD USER MANUAL
3 MINUTE REAL TIME DETECTION OF SARS COV-2
Intended Use
For use under the Emergency Use Authorization (EUA) only For in vitro diagnostic use
The CovBELD (CoronaVirus BELD) test is a cell-based assay that is used with
the BELD instrument intended for the qualitative detection of the S1 spike
protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab
specimens after the swabs have been added to viral transport media from
individuals who are suspected of COVID-19 by their healthcare provider.
Results are for the identification of SARS-CoV-2 S1 spike protein antigen.
Antigen is generally detectable in upper respiratory specimens during the
acute phase of infection. Positive results indicate the presence of viral
antigens, but clinical correlation with patient history and other diagnostic
information is necessary to determine infection status. Positive results do
not rule out bacterial infection or co-infection with other viruses. The agent
detected may not be the definite cause of disease.
Negative results should be treated as presumptive and confirmed with a
molecular assay, if necessary for patient management. Negative results do not
rule out COVID-19 and should not be used as the sole basis for treatment or
patient management decisions, including infection control decisions. Negative
results should be considered in the context of a patient’s recent exposures,
history and the presence of clinical signs and symptoms consistent with
COVID-19.
Sample collection and handling
SAMPLE COLLECTION
Nasal Swab Sample
To collect a nasal swab sample, carefully insert the swab into the nostril
that presents the most secretion under visual inspection. Using gentle
rotation, push the swab until resistance is met at the level of the
turbinates {less than one inch into the nostril). Rotate the swab several
times against the nasal wall then remove it from the nostril.
Nasopharyngeal Swab Sample
To collect a nasopharyngeal swab sample, carefully insert the swab into the
nostril that presents the most secretion under visual inspection. Keep the
swab near the septum floor of the nose while gently pushing the swab into the
posterior nasopharynx. Rotate the swab several times then remove it from the
nasopharynx.
SAMPLE TRANSPORT AND STORAGE
Samples should be tested as soon as possible after collection. Based on data
generated with influenza virus, nasal or nasopharyngeal swabs are stable for
up to 24-hours at room temperature or 2° to 8°C.
If transport of samples with viral transport medium {VTM) is required, minimal
dilution of the sample is recommended, as dilution may result in decreased
test sensitivity. While holding the swab, the cap from the tube. Insert the
swab into the tube and gently rotate the swab into the viral transport medium
for 23 time and remove it. Based on data generated with influenza virus, nasal
or nasopharyngeal swabs in VTM are stable for up to 72-hours at 2° to 8C.
Note: When using viral transport medium {VTM), it is important to ensure
that the VTM containing the sample is warmed to room temperature. Cold samples
can lead to erroneous or invalid results. Several minutes will be required to
bring a cold sample to room temperature.
Test procedure
All clinical samples must be at room temperature before beginning the assay.
BIOSENSOR MEASUREMENT
A. Connect the screen-printed electrode with the device and turn on the
device. Be sure that the electrodes are aligned with the connectors.
B. Turn on the bluetooth functionality and location services on your mobile
phone, open the application and login
C. Complete the informations and press Start 
D. Press the search command and connect the application to the
device
E. Fill the appropriate fields and press Start
F. START the measurement and then add 20μl of the sample onto channels 1- 6
with a multichannel or single-channel automatic pipette 
ATTENTION, if the lines on the chart do not appear after pressing the
start button do not add the sample. Stop the measurement and start it again
(a). Ensure that the lines are visible in the chart and they all start at 0
mV before adding the sample (b). In case lines do not start at 0 mV (c) stop
the measurment and start it again. 
G. Once the first minute
has passed, immediately start adding 20μL of the biosensors onto the same
channels as above hence the final volume in each channel will be 40μL.
After the END of the
measurement, the result will appear on your mobile screen and the data will be
uploaded automatically.
H. By pressing the “View Details” command a new slide will open with the
details of the result. By pressing the “Share via Email” command a new slide
will open where you can fill in your details and send the test result as a
report via email. For a new measurement press NEW and then EDIT to the enter
the new information for the next sample in order to be ready for a new
measurement. 
Warnings and precautions
- For in vitro diagnostic use.
- Do not use the biosensors beyond the expiration date.
- Use appropriate precautions in the collection, handling, storage, and disposal of samples.
- Use of Nitrile, Latex (or equivalent) gloves is recommended when handling samples.
- Test electrodes are for one use only.
- The user should not open the tube containing the biosensors exposing it to the ambient environment until is ready for immediate use.
- If the biosensor solution contacts the skin or eye, flush with copious amounts of water.
- To obtain accurate results, the Package Insert instructions must be followed.
- Inadequate or inappropriate sample collection, storage, and transport may yield false test results.
- Sample collection and handling procedures require specific training and guidance.
- Use the appropriate Fixed Volume Pipette in accordance with test procedures.
- To obtain accurate results, the test should not be used inside a laminar flow hood or in a heavily ventilated area.
- Testing should be performed in an area with adequate ventilation.
- Dispose of containers and unused contents in accordance with local regulatory requirements.
- Wear suitable protective clothing, gloves, and eye/face protection when handling the contents of this kit.
- Wash hands thoroughly after handling.
Troubleshooting
| Faults | Actions |
|---|---|
| User enters false Credentials | Error message appears. User must enter the |
right credentials.
User forgot his password| Can press “Forgot Password?” button to restore the
password.
User (email) already exists| Error message appears. Must use a different
password.
Wrong password. a) Password does not meet the requirements (e.g. short length)
b) Confirm password does not match.| Error message appears. Must enter
Password that meets the requirements.
Wrong information accidentally entered| Completed measurements can be found in
the results tab. Edit is available.
---|---
Bluetooth is off| Turn on Bluetooth
Location Permission disabled| User must navigate to app permissions and enable
Location.
No results found| Check if there are active BELD devices nearby. Beld device
must not be connected to another mobile app.
Cannot connect to BELD device| a) BELD Must not run on low battery b) BELD
device must be in close proximity (<2m) to the mobile phone and no obstacles
located between them c) If a and b does not fix the problem then restart both
the BELD and mobile app.
Accidentally wrong parameters| a) Sample code and Sample Level can be edited
after the measurement has finished. b) If the sample is incorrect, the
measurement must run again (each sample corresponds to a different algorithm)
c) Measurement time must be >3 minutes.
The chart remains empty after the start button is pressed| a) Stop measurement
and check if BELD is still connected. If it is connected press start again. If
it is disconnected or pressing start does not fix the problem then start again
with a new measurement.
Result is stuck in “Uploading”| a) Check your internet connection b) If no
result appears in 2 minutes, the measurement must be taken from the beginning.
User enters wrong email data| Ιf “share via email screen” is still open a new
email can be sent, otherwise the measurement must be taken from the
beginning.
User enters wrong phone number| Ιf “share via email screen” is still open a
new sms can be sent, otherwise the measurement must be taken from the
beginning.
Email or SMS has not arrived| Email and phone must be in the correct form.
Possibility of accessing the user’s data| Only non-sensitive data is stored
and encrypted in the database. Communication via the application is also
encrypted via SSL.
Kit storage and stability
Store the kit at 4°C temperature. On the day of the test let the biosensors and samples warm up to room temperature. Cold samples can lead to erroneous or invalid results.
Symbols glossary
| **** | **** Temperature limitation |
|---|
| Manufacturer
| Catalogue Number
| Contains sufficient for 12 or 24 or 48 Tests
| “CE Mark “. This product fulfils the requirements of the European
Directive 98/79/EC on in vitro diagnostic medical devices.
| Lot Number
| Use-by Date – indicates the date after which the unopened
IVD/Quality Control Material cannot be used
| **** Do not re-use
| **** Refer to instructions for use
EMBIO Diagnostics Ltd customer services:
For product enquiries please contact EMBIO Diagnostics Ltd Customer Services
at info@embiodiagnostics.eu or for further
contact details please visit
embiodiagnostics.eu. Any adverse results
experienced with the use of this product and/or quality problems should also
be reported to EMBIO Diagnostics Ltd Customer Services by email:
k.loizou@embiodiagnostics.eu.
Return policy:
Please contact EMBIO Diagnostics Ltd Customer Services for terms and
conditions.
Limited warranty:
Please contact EMBIO Diagnostics Ltd Customer Services for terms and
conditions.
Manufacturer Information:
EMBIO Diagnostics Ltd, Athalassas Avenue 8B, Nicosia, Cyprus.
“CE Mark” applies to EMBIO Diagnostics Ltd BELD device, Disposable electrodes and Biosensor
USR-02
Issue: 3 30/08/2021 Pages: 11
Prepared by: Theofylaktos Apostolou
Approved by: Konstantinos Loizou
Documents / Resources
|
EMBIO DIAGNOSTICS Research Lab Starters
Kit
[pdf] User Manual
Research Lab Starters Kit, Lab Starters Kit, Research Lab Starters, Lab
Starters, Starters
---|---
References
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