BIOPIX-T PEBBLE qcLAMP Platform User manual
PEBBLE qcLAMP Platform
A point-of-care diagnostic platform for nucleic acids detection in clinical samples using real-time
quantitative colorimetric loop-meditated isothermal amplification (qcLAMP).
PPL-01-INSTRUCTIONS FOR USE | v1.1 | DATE OF
ISSUE: 10.08.2021
BIOPIX DNA TECHNOLOGY P.C.
Science and Technology Park of Crete
N. Plastira 100, Vassilika Vouton
GR-700 13, Heraklion, Greece
For in vitro diagnostics use.
For professional use only.
000057
PEBBLE qcLAMP Platform
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This Instructions for Use (IFU complies with the requirements of EN ISO 18113-3:2019, IEC 61326-2-
6:2020 and IEC 61010-2-101:2018.
The labels used and described into the next sections comply with the requirements of EN ISO 15223-
1:2016.
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Module and Software Identification
This product is accompanied by:
PEBBLE qcLAMP Platform firmware.
(01) 5210166000041 (11) 28.06.2021 (8012) 1.0.0
PEBBLE qcLAMP Platform mobile application
(01) 5210166000058 (11) 28.06.2021 (8012) 1.0.0
PEBBLE qcLAMP Platform cloud system
(01) 5210166000065 (11) 28.06.2021 (8012) 1.0.0
Warranty and Responsibility
All products of BIOPIX DNA TECHNOLOGY P.C. are tested under rigorous quality management processes.
BIOPIX DNA TECHNOLOGY P.C. guarantees to ensure the quality of the product during the warranty
period. If there are any issues related to the quality of the product, please contact BIOPIX DNA
TECHNOLOGY P.C..
BIOPIX DNA TECHNOLOGY P.C. warrants that the PEBBLE qcLAMP Platform will conform to its
specifications and performance for a period of 12 months after its shipment date from the Seller. Non-
complying with the warnings and precautions, as well as the product instructions, during the usage of the
PEBBLE qcLAMP Platform, will result to the loss of warranty.
The warranty does not cover issues that result from: a) Servicing, fixing or replacing the product, not
authorized by BIOPIX DNA TECHNOLOGY P.C., b) External causes such as accident, abuse, misuse or
problems with electrical power and c) missing or altered service tags or serial numbers.
This product complies with the requirements of the European IVD Directive 98/79/EC.
Quality Control System
All aspects of the quality management system, product creation, quality assurance, and supplier
qualifications are certified under ISO 13485:2016.
Inquiries and customer service (A/S)
For any further information of inquiries for the product please send us an e-mail ([email protected]).
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TABLE OF CONTENTS
1. INTENDED USE ............................................................................................................... 6
2. PRODUCT DESCRIPTION ................................................................................................ 7
3. COMPONENTS AND PACKAGING SPECIFICATIONS ........................................................ 7
3.1 List of components.........................................................................................................................7
3.2 List of compartments ...................................................................................................................8
4. STORAGE AND HANDLING REQUIREMENTS ................................................................... 8
5. ADDITIONAL MATERIALS AND EQUIPMENT REQUIRED BUT NOT INCLUDED................... 9
A. Sample Collection.........................................................................................................................9
B. Detection Kits ...............................................................................................................................9
C. Equipment ....................................................................................................................................9
D. Consumables ................................................................................................................................9
6. WARNINGS AND PRECAUTIONS ..................................................................................... 9
7. INSTRUMENT INSTALLATION ........................................................................................ 11
8. TEST PROCEDURE........................................................................................................ 17
9. BIOPIX-T CLOUD SYSTEM............................................................................................. 37
10. RESULTS INTERPRETATION .......................................................................................... 39
11. CLEANING INSTRUCTIONS ........................................................................................... 40
12. LIMITATIONS OF USE.................................................................................................... 40
13. TROUBLESHOOTING .................................................................................................... 41
13.1 FAILURE ASSESMENT..................................................................................................................41
13.2 TECHNICAL SUPPORT .................................................................................................................42
14. MAINTENANCE ............................................................................................................. 43
14.1 PEBBLE qcLAMP Platform ..........................................................................................................43
14.2 PEBBLE Platform Application.....................................................................................................43
15. DISPOSAL INFORMATION ............................................................................................. 43
16. SAFETY AND DISCLOSURE OF RESIDUAL RISKS ........................................................... 44
17. REFERENCES................................................................................................................ 44
18. SYMBOLS EXPLAINED .................................................................................................. 44
19. ABREVATIONS USED .................................................................................................... 47
20. DOCUMENT HISTORY CHANGE .................................................................................... 47
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1. INTENDED USE
The PEBBLE qcLAMP Platform is a point-of care diagnostic system for providing specimen examination
results for COVID-19 and Influenza A from nasopharyngeal and oropharyngeal swab specimens. The
platform can be used for decentralized testing (doctor’s office, ambulance, hotel, limited resource
areas etc.).
The PEBBLE qcLAMP Platform is intended to be used only with test kits produced by BIOPIX DNA
TECHNOLOGY P.C.; COV19 qcLAMP kit (CAT#000055) and Flu A qcLAMP kit (CAT#000056).
The PEBBLE qcLAMP Platform is intended to be used by professionals only. It is not intended to be
used by individuals for self-testing.
The platform is intended to be used for testing individuals with or without signs and symptoms
suggestive of COVID-19/Influenza A infection, regardless of gender or age, with the aforementioned
products of BIOPIX DNA TECHNOLOGY P.C.
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2. PRODUCT DESCRIPTION
The PEBBLE qcLAMP Platform is a small-size and lightweight diagnostic system that allows the
molecular rapid detection of infectious diseases (such as COVID-19 and Influenza A) at the point
of care or need. The system performs a real-time quantitative colorimetric loop-meditated
isothermal amplification (qcLAMP) by using a novel method for heating the testing vials and
reading the result.
During the process run, the color-change of the reagent within the vials is monitored via a digital
camera. The camera collects images at predefined time intervals (10 sec), analyzes the red, green,
and blue (RGB) pixel values and interprets the analysis into a graph. The graph shows the signal
of the color-change (which is expressed as color index units) versus time.
The device connects via Bluetooth to a smart device (mobile phone or tablet) and operates
through an Android application, named “PEBBLE Platform”, powered by BIOPIX DNA Technology
P.C. The application records the data sent from the PEBBLE in real-time and the user has the ability
to save them in the supporting cloud service.
The physical characteristics of PEBBLE qcLAMP Platform are 18.1 cm (length) x 10.7 cm (width) x
5.2 cm (height) and it weighs less than 300 gr, which makes it portable and ideal for the use at the
point-of-care or need.
3. COMPONENTS AND PACKAGING SPECIFICATIONS
3.1 List of components
1. 1 x PEBBLE qcLAMP Platform device (including the latest PEBBLE firmware)
2. 1 x AC/DC power supply unit
3. 1 x power plug (EU, US, or UK plug)
The PEBBLE Platform Android application is located at the Google Store. Access to BIOPIX-T’s
cloud system is achieved through the application, after registering the device to the user’s
account.
Figure 3.1: Physical components within the package
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3.2 List of compartments
Label
Description
Use
1
PEBBLE qcLAMP Platform
Main body of the device
2
Tube Holder
Removable part that accepts the vials
3
I/O Switch
Main power switch
4
Green LED Light
Switched on when system is running a test
5
Power Socket
Plugs to the power-supply, with a 5 V DC
6
Heating Element
Heats the vials
7
Camera
Records the pixels of the color-change in the vials
8
White LED Lights
Illuminates the chamber
4. STORAGE AND HANDLING REQUIREMENTS
Keep dry. Do not expose to water.
Operate at room temperature (optimum range: 23oC-27oC, functional range: 20oC-30oC) and 0%-
75% humidity. Do not refrigerate or freeze.
For long storage, please keep the system within its package at a temperature between 10oC and
30oC and dry conditions (30%-55% humidity).
During operation, keep the device away from air currents.
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5. ADDITIONAL MATERIALS AND EQUIPMENT REQUIRED BUT NOT INCLUDED
A. Sample Collection
Specimen collection depends on the kit (Please refer to instructions for use of the detection kit
[3], [4]).
B. Detection Kits
- COV19 qcLAMP kit (BIOPIX-T, CAT#000055)
-Flu A qcLAMP kit (BIOPIX-T, CAT#00056).
C. Equipment
-Android (compatible with v5.1 to v10.0) based smart device (mobile phone or tablet). It is
recommended to have a minimum of 4Gb RAM.
-Adjustable calibrated micropipettes.
D. Consumables
-Sterilized disposable filter tips appropriate for the selected pipettes.
-PCR Tubes, 0.2 ml. Technical Specifications; Height of Tube with lid: 21.6 mm-21.7 mm, outer
diameter (OD): 5.9mm-6.1mm).
6. WARNINGS AND PRECAUTIONS
-For in vitro diagnostic (IVD) use.
-For professional use only.
-It is not intended to be used by individuals for self-testing.
-State guidelines on biosafety should be followed in all circumstances.
-Use nuclease-free disposable plasticware and pipette tips.
-Testing should be performed in an appropriate equipped facility by trained personnel.
-Use the device in a non-contaminated and nuclease-free area. Non-complying with this, might
result in false outcomes.
-Do not use this instrument near sources of strong electromagnetic radiation, as these may
interfere with the proper operation of the PEBBLE qcLAMP Platform. It is advised that the
electromagnetic environment should be evaluated prior to operation of the device.
-This equipment has been designed and tested to CISPR 11 Class A. In a domestic environment
it may cause radio interference, in which case, you may need to take measures to mitigate
the interference.
-Keep clean the reaction chamber. In case of contamination, contact BIOPIX DNA Technology
-The device is neither water-resistant nor waterproof.
-Always place the device on a flat surface.
-Use only compatible kits, consumables and equipment that meets the specifications provided
by BIOPIX-T.
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-Make sure you have a strong Bluetooth connection to avoid unexpected termination of the
device’s operation.
-Ensure you have a strong and secure internet connection, to avoid connection loss with the
cloud service.
-Handle with care. If not, parts could detach, dislocate, or deform. In such case, please contact
BIOPIX DNA Technology P.C. technical support (see section 13.2).
-Do not disassemble the PEBBLE qcLAMP device as it might result to performance issues.
-Do not touch or move neither the camera nor camera lens. Sensitivity can be significantly
reduced.
-Post amplification qcLAMP reaction tubes must not be opened to avoid contamination with
DNA amplicons, which could result in false positive results.
-Dispose the used tubes as medical waste.
-Non-compliance with these warnings and precautions may result on permanent malfunction
of the system or/ and false diagnosis.
-Between runs, it is suggested to leave approximately a 10 min time-space. During this time
keep the tube holder out of the chamber of PEBBLE qc LAMP Platform.
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7. INSTRUMENT INSTALLATION
7.1 ACTIONS UPON DELIVERY
STEP
DESCRIPTION
IMAGE
7.1.1
Check package. If it is damaged do
not open and contact BIOPIX-T
technical support.
7.1.2
Unbox PEBBLE components. Take
out PEBBLE qcLAMP Platform,
power supply body and power plug.
Check the items. If they are
damaged do not use the system
prior to contacting BIOPIX-T.
7.1.3
Assemble power supply
Insert power plug in designated
position on the power supply body,
push and secure in place.
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7.2 INSTALLATION OF APPLICATION AND REGISTRATION
7.2.1
Open Google Play Store on your
Android device. Search for the PEBBLE
Platform application powered by
BIOPIX-T, download and install it.
7.2.2
Run application
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7.2.3
Locate Choose Language option.
7.2.4
Choose language (current available
languages are English and Greek)
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7.2.5
Locate Register button
7.2.6
Fill in the fields with the requested info.
In order to be able to register, user has
to accept the terms of use and privacy
policy of BIOPIX DNA TECHNOLOGY.
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7.2.7
Click on the REGISTER button. A
verification code will be sent to your
registered e-mail account.
7.2.8
To verify and activate your account,
click on the Activate button.
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7.2.9
Fill in your email assigned to the
account and the received activation
code.
7.2.10
Click on VERIFY
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7.2.11
After verifying your account, fill-in your
e-mail and password and click LOGIN.
Contact information of BIOPIX DNA
Technology P.C. are located in section
13.2 Technical Support.
8. TEST PROCEDURE
Please read carefully the Instructions for Use for both the kit and the PEBBLE
qcLAMP Platform before starting the test.
Ensure that your PEBBLE qcLAMP Platform device will be operating in environmental
conditions as described in section 4. STORAGE AND HANDLING REQUIEREMENTS
and is not exposed directly to air currents.
Make sure you have a strong and secure internet connection during testing.
Clickable buttons are depicted as either bright Blue or bright Red. When buttons are
disabled, their color are either grey, light blue, or light red.
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8.1 POWERING ON PEBBLE qcLAMP Platform
STEP
DESCRIPTION
IMAGE
8.1.1
Ensure that the device is switched off
before plugging the power supply.
When Ois pressed, the device is OFF.
When Iis pressed, the device is ON.
8.1.2
Turn on the device.
8.1.3
You need to wait approximately two to
three minutes (2-3 min) for the system
to boot in order to be detected via
Bluetooth.
If it is the first time that you turn on the
system, you will have to wait for 5-6min.
8.1.4
Run PEBBLE Platform application on your
smart device.
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8.1.5
Once the application is active, user must
login by inserting the registered e-mail
and password.
Make sure that you have enabled the
Bluetooth option on your smart device.
8.1.6
After login, you will be redirected to the
home menu.
Your smart-device will ask to allow
Pebble Platform application to access
device’s location via a popup window. To
use the application, location permissions
must be allowed.
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8.1.7
Click on option Connect.
8.1.8
Available devices will show up
automatically. You can also scan for
devices by clicking on the blue search
button on the bottom right corner of the
screen.
Table of contents
