BioGX pixl Manuale
Real-Time PCR Platform
Instructions for Use Manual
For Windows® Operating Software
Version 1.0
pixl Real-Time PCR Platform
Instructions for Use Manual
Page 2 of 37 pixl Real-Time PCR Instructions for Use Manual
Rev. 01-28JUL2021
Table of Contents
SAFETY AND REGULATORY COMPLIANCE ...................................................................................................... 3
PRODUCT OVERVIEW .................................................................................................................................... 5
HARDWARE SET-UP GUIDE ............................................................................................................................ 9
PLATFORM CLEANING REQUIREMENT .......................................................................................................... 11
WARRANTY .................................................................................................................................................. 11
STEP-BY-STEP SOFTWARE GUIDE .................................................................................................................. 12
TROUBLESHOOTING GUIDE .......................................................................................................................... 21
APPENDIX A: PCR DATA PROCESSING – POSITIVE/NEGATIVE DETERMINATION AND CT CALCULATION. ....... 24
APPENDIX B: CHANNEL CROSS TALK SUPPRESSION TECHNIQUES ................................................................. 31
REVISION HISTORY ....................................................................................................................................... 35
SYMBOLS ..................................................................................................................................................... 36
pixl Real-Time PCR Platform
Instructions for Use Manual
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Rev. 01-28JUL2021
Safety and Regulatory Compliance
Please read these instructions before operating the pixl Real-Time PCR platform.
Packaging, Storage and Transportation Identification
Symbol
Description
Explanation
Places where
symbol is located
Handle with care
Product is a precision instrument
and should be handled with care.
On the carton
Upward
Instrument must be kept upward in
the process of handling, storage,
and use.
On the carton
Avoid Moisture or
Liquid
Instrument should not be stored in
a humid environment or exposed to
liquids.
On the carton
pixl Real-Time PCR Platform
Instructions for Use Manual
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Operation Requirements
● Operation of the BioGX pixl Real-Time PCR Platform should be limited only to skilled
personnel.
● This instrument is an electromechanical device. If not used strictly in accordance
with the provisions of the Operation Manual, instrument malfunction and/or
physical injury may occur.
● The instrument nameplate is marked with the manufacturer's name, product
name and model, product standard number, factory number, factory date,
power supply voltage, frequency, and input current.
● Operate in strict accordance with the safety instructions provided on the instrument
and within the instructions for use.
● Accessories and replacement parts must be procured from BioGX or its agent.
● Do not open the instrument during use.
● Do not touch/operate the touch screen when the instrument is in operation.
● The instrument must be placed in a clean and ventilated environment to avoid
corrosive gas and strong magnetic field interference, to avoid direct sunlight and
strong light source.
● Instrument working conditions should remain between 0°C and 35°C, with relative
humidity below 85%.
● Appropriate PPE (Personal Protective Equipment) must be worn when dealing with
toxic, corrosive, or contagious substances.
● Local safety regulations must be followed when handling or discarding such waste.
In case of spatter or leakage, disinfect immediately with appropriate disinfectant to
prevent contamination of laboratory personnel and equipment.
● Only technicians from the manufacturer are authorized to repair, replace or
otherwise reconfigure any components.
Electrical Safety
Take proper precautions when handling and electrical equipment. NEVER work on live
circuits, fixtures, receptacles, or switches. The safety design protection grade of the BioGX
pixl Real-Time PCR Platform is classified as a Class I (IEC) device.
pixl Real-Time PCR Platform
Instructions for Use Manual
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Rev. 01-28JUL2021
Safety rules you should follow whenever working with any electrical appliance includes:
● Connect instrument to power adapter with a three-core grounding socket
conforming to safety standards of 120V～(60Hz).
● Confirm power is off when connecting the power cord.
● Confirm the voltage and frequency of the AC power is consistent with instrument
requirements.
● Ensure hands are dry when operating the power switch.
● Power off instrument before removing the power cord.
● Do not allow power cord to touch hot surfaces of the instrument.
● Power off the instrument before cleaning.
● Power off the instrument when no longer in use.
Electromagnetic Compatibility
The BioGX pixl Real-Time PCR Platform conforms with emission and disturbance
immunity requirements specified in EN60601-1-2. It is the manufacturer's responsibility
to provide the customer or user with the electromagnetic compatibility information of
the real-time PCR platform. The user is responsible for ensuring the electromagnetic
compatibility for proper function of the real-time PCR platform.
It is recommended that the electromagnetic environment be evaluated prior to the
use of real-time PCR platform.
Do not use the real-time PCR platform next to strong radiation sources (such as unshielded
RF sources), otherwise it may interfere with the normal operation.
Product Overview
The BioGX pixl Real-Time PCR Platform is a portable, high performance real time
quantitative PCR system equipped with a 4-channel fluorescence optical system, powered
by ultra-low-light Complementary Metal Oxide Semiconductor (CMOS) bio-imaging sensor.
pixl Real-Time PCR Platform
Instructions for Use Manual
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Rev. 01-28JUL2021
The platform is optimally suited for applications where portability, and fast time-to-result is
required. Applications of pixl are point-of-care molecular diagnostics test (POCT; Clinical
clearance required), food safety and environment testing, agriculture, or research lab use
where bench space is limited.
Figure 1. BioGX pixl Real-Time PCR Platform.
pixl Real-Time PCR Platform
Instructions for Use Manual
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Rev. 01-28JUL2021
Features
● Compact and rugged design. No internal moving parts, and no need for calibration.
● Multi-wavelengths 4-channels fluorescence sensing capability.
● Equipped with ultra-low-light sensitive CMOS-based fluorescent imager.
● Cross platform software for Windows® and Android® OS, with cloud-ready
connectivity.
● Low power requirement. External supply with ~90W active power.
● Battery-backup option for outdoor use and power loss protection.
Key Parameters
Capacity (# of wells)
16
Channels (# of Fluorophores per well)
4
(FAM/SYBR Green; JOE/HEX/VIC/TET;
ROX/Texas Red; CY5/LIZ/Cy5.5)
Multiplex capability
Up to 4 targets per well
Minimum detection threshold
4 copies
Dynamic range
>1.0E9
Signal Interface
USB 2.0, Bluetooth® 2.0
Excitation Source
High endurance LED
Detector
Ultra-low-light CMOS Bio-imaging chip
Thermal system
Solid-state, Peltier-based
Tube/plate formats
8-tube strip (0.2mL)
Reaction volume
10µL – 60µL
Filters:
4 sets exchangeable*
Excitation Range
460nm – 670nm
Emission Range
510nm – 720nm
DNA probes supported*
DNA binding dyes (e.g. SYBR Green), hydrolysis
probes (e.g. TaqMan probe) and hybridization
probes (e.g. FRET probes).
pixl Real-Time PCR Platform
Instructions for Use Manual
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Rev. 01-28JUL2021
Temperature Uniformity
+-0.2°C
Temperature control resolution
+-0.1°C
Temperature Ramp Rate
5.5°C/s heating; 4°C/s cooling
Size and weight
247mm (L) x 188mm (W) x 133mm (H).
Weight
1350g
Power supply
DC 16V, 90W (Adapter provided that accepts
110V/240V AC)
*Wavelength characteristics may be modified by changing filter modules.
Applications
● Point-of-care molecular diagnostics (Clinical clearance required)
● Research and educational lab use
Instrument External Dimensions
Figure 2. BioGX pixl Real-Time PCR Platform Dimensions.
List of Components
● BioGX pixl Real-Time PCR Platform
● Power Cord
pixl Real-Time PCR Platform
Instructions for Use Manual
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Rev. 01-28JUL2021
● USB Cable
● External Battery pack (Optional accessory)
● Carrying Case (Optional accessory)
Hardware Set-up Guide
Starting the BioGX pixl Real-Time PCR Platform
The platform is powered through an external AC/DC power adapter. The power adapter
accepts AC input ranging 110V to 240V and produces DC output of 16V.
The DC power input connector port is located at the back of the instrument. Once the
power is provided, the green power indicator light will turn on.
Figure 3. BioGX pixl Real-Time PCR Platform highlighting USB (port for computer
connection) and Power Connections (Note: rear view of instrument).
pixl Real-Time PCR Platform
Instructions for Use Manual
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Rev. 01-28JUL2021
Connect to personal computer (PC) via USB
The BioGX pixl Real-Time PCR Platform is equipped with an USB port that supports direct
connection to a Windows® based PC via the supplied USB cable.
Light Indicator States
There are two LED indicator lights. The green light is used to indicate power supply. As long
as the instrument is powered, the green LED indicator will stay on.
qPCR tube/plasticware requirement
BioGX pixl Real-Time PCR Platform requires the use of transparent 0.2 mL qPCR tubes with
flat optical caps. Vendors that supply compatible qPCR tubes include:
1. EasyStrip™ Plus Tube Strip with Attached Ultra Clear Caps
Thermo Fisher Product number: AB2005
2. Axygen® 0.2 mL Polypropylene PCR Tube Strips and attached Flat Cap Strips, 8
Tubes/Strip
Corning Product Number: PCR-0208-AF-C
Figure 4. Example of 0.2 mL 8-tube strip qPCR tubes compatible with BioGX pixl Real-Time
PCR Platform.
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