CE-IVD Products
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PEBBLE qcLAMP Platform
(CAT#000057)
PEBBLE is our leading IVD solution. It is a compact, lightweight diagnostic platform designed for rapid molecular detection of infectious diseases.
It is intended to be used only with test kits produced by BIOPIX DNA TECHNOLOGY S.A. such as the COV19 qcLAMP kit (CAT#000055), the Flu A qcLAMP kit (CAT#000056) and other upcoming IVD kits developed by BIOPIX-T.
It is the only portable and affordable device that enables real-time, quantitative colorimetric LAMP reactions, delivering reliable results directly to your device within just a few minutes.
The PEBBLE qcLAMP Platform is intended to be used by professionals only. It is not intended to be used by individuals for self-testing.
Applications
The platform can be used for decentralized testing (laboratories, hospitals, clinics, doctor's office, ambulance, hotel, limited resource areas etc.). It is intended to be used only with test kits produced by BIOPIX-T such as the COV19 qcLAMP kit (CAT#000055) and Flu A qcLAMP kit (CAT#000056).
Use
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-T. 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 PEBBLE qcLAMP Platform is intended to be used by qualified personnel and healthcare professionals. It is not intended to be used by individuals for self-testing. Pebble-R can be operated only after scanning a QR code provided by BIOPIX-T which allows the PEBBLE-R to execute a number of individual reactions.
Dimensions
The dimensions of PEBBLE are: 18.1cm x 10.7cm x 5.2cm and its weight is <300 gr which makes it easily portable and ideal for the use at the point-of-care or need. It runs with low power (5V, 2.4 A). PEBBLE comes in five different color variations: White, Ciel,, Green, Orange, Purple.
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COV19 qcLAMP Kit (X100 reactions)
(CAT#000055)
The COV19 qcLAMP Test is a Nucleic Acid Amplification Test (NAAT) kit based on the real-time quantitative colorimetric LAMP method (qcLAMP) for the detection of SARS-CoV-2 N-gene RNA target.
The test is performed in the Pebble qc LAMP platform which controls the reaction temperature, timing and facilitates the real-time digital colorimetric analysis of the amplification reactions.
The COV19 qcLAMP kit does not require RNA extraction and can be used directly with nasopharyngeal and oropharyngeal swab specimens. Alternatively, the kit can also be used with extracted RNA.
Components
2X Enzyme mix, 5X COV19 Primer mix, 5X Control Primer mix, 2X BPX sample buffer, Mineral oil, Nuclease-free water
Usage
Total duration of the test in the PEBBLE platform is 30 minutes for assessing a negative result. Time-to-positive can range between 10 and 27 minutes depending on the initial target concentration. The COV19 qcLAMP Test uses saliva, nasal or pharyngeal swab specimens, collected from individuals suspected of COVID-19 by their healthcare provider. The kit can be used either with extracted RNA or directly from a crude sample.
Quantity
Each kit contains 100 reactions which correspond to 100 tests using crude samples or extracted RNA.
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FLU A qcLAMP Kit (X100 reactions)
(CAT#000056)
The Flu A qcLAMP kit is a Nucleic Acid Amplification Test (NAAT) kit based on the real-time quantitative colorimetric LAMP method (qcLAMP) for the detection of H1N1 & H3N2 Influenza A HA-gene RNA target.
The test is performed in the Pebble qc LAMP platform which controls the reaction temperature, timing and facilitates the real-time digital colorimetric analysis of the amplification reactions.
The Flu A qcLAMP kit does not require RNA extraction and can be used directly with nasopharyngeal and oropharyngeal swab specimens. Alternatively, the kit can also be used with extracted RNA.
Components
2X Enzyme mix, 5X Flu A Primer mix, 5X Control Primer mix, 2X BPX sample buffer, Mineral oil, Nuclease-free water
Usage
Tests are performed in the PEBBLE qcLAMP Platform, which controls the reaction temperature, timing and facilitates the real-time digital colorimetric analysis of the amplification reactions. Total duration of the test in the PEBBLE qcLAMP Platform is 30 minutes for assessing a negative result. Time-to-positive can range between 10 and 20 minutes depending on the initial target concentration.
Quantity
Each kit contains 100 reactions which correspond to 100 tests using crude samples or extracted RNA.
Research Use Only products
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PEBBLE-R qcLAMP Platform
(CAT#000058 )
PEBBLE-R qcLAMP is a platform intended for Research Use Only (RUO), designed to bring laboratory-quality molecular testing to any environment.
It is the only portable and affordable device that enables real-time, quantitative colorimetric LAMP and other isothermal reactions, providing results directly to your iOS or Android device within a few minutes.
Its open architecture allows researchers to use the reagents of their choice, ensuring full experimental flexibility. It is fully compatible with widely used colorimetric dyes, including Phenol Red and HNB, offering versatility without the need for complex instrumentation.
Pebble-R can be operated after scanning a data matrix code (QR code).
You can enhance the performance of PEBBLE-R using the Universal Mastermix (Cat#000054).
Applications
The platform can be used for Research Use Only. It is designed for use by researchers, diagnostic companies, and laboratories who seek to develop and optimize their own molecular assays directly on the platform. PEBBLE is also ideal for deployment in remote or resource-limited settings. The PEBBLE -R qcLAMP Platform is not intended to be used as a medical device.
Use
The device connects via Bluetooth to a smart device (mobile phone or tablet) and operates through an Android / IOS application, named “PEBBLE RUO”, powered by BIOPIX-T. The application records the data sent from the PEBBLE-R in real-time and the user has the ability to save them in the supporting cloud service. Results (it can display up to 6 curves simultaneously) are analyzed in real-time via an Android / IOS device and data are automatically uploaded and stored in a (the BIOPIX-T) cloud system Pebble-R can be operated only after scanning a QR code provided by BIOPIX-T which allows the PEBBLE-R to execute a number of individual reactions.
Dimensions
The dimensions of PEBBLE-R are: 18.1cm x 10.7cm x 5.2cm and its weight is <300 gr which makes it easily portable and ideal for the use at the point-of-care or need. It runs with low power (5V, 2.4 A). PEBBLE-R comes in five different color variations: White, Ciel,, Green, Orange, Purple.
Instructions for use
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Universal Mastermix
(CAT#000054)
Now available as RUO —IVD version coming soon to unlock clinical potential.
Discover our Universal Mastermix, the all-in-one solution for real-time quantitative, colorimetric LAMP analysis of DNA/RNA samples.
It’s a ready-to-use optimized mix, containing all the essential components (excluding primers and nucleic acid template) for fast and efficient reaction setup. Formulated with a robust enzyme mix (Bst polymerase & Reverse Transcriptase), it enables rapid amplification with high sensitivity and specificity, even from low-copy targets.
The product is in the process of IVDR certification and will soon be available for In Vitro Diagnostic (IVD) use.
Components
2x Universal Mastermix, HNB dye, Mineral oil
Usage
The Universal Mastermix is a ready-to-use 2X reagent mix containing all essential components for robust LAMP amplification. Users simply thaw the mix and dye, combine with primers and template DNA or RNA and overlay with mineral oil to prevent evaporation. The reaction runs at 65°C for about 30 minutes, producing a visible color change that can be read by eye or in real-time using the PEBBLE-R qcLAMP platform.
Quantity
Each kit contains 100 reactions.
Instructions for use
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Pebble-R runs
(CAT#000059)
Each QR code is exclusively compatible with the PEBBLE-R qcLAMP Platform and enables 100 individual reactions.
Please note: QR codes are not compatible with the diagnostic PEBBLE qcLAMP
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AmpliPan Malaria Kit
The AmpliPan Malaria Test Kit stands out as a reliable, innovative, and field-ready diagnostic tool in the global fight against malaria.
Designed for real-time colorimetric detection, using qcLAMP technology, it allows the simultaneous identification of all five Plasmodium species that infect humans, making it one of the most comprehensive solutions currently available.
The kit includes all necessary reagents and components, making sample collection and analysis straightforward and efficient. The kit is lyophilized (no need for cold chain transportation).
By combining affordability, ease of use and lab-quality performance, the AmpliPan Malaria Test Kit offers a powerful tool for expanding access to timely and reliable malaria diagnostics, especially in endemic and resource-limited settings.
Performance Highlights
Sample Type Specificity Sensitivity Accuracy Limit of Detection Genomic DNA 100% 96.9% 97.5% <10 parasitized cells/μL Whole Blood (WB) 100% 94.4% 95.2% 25 parasitized cells/μL Dried Blood Spots 100% 97.2% 97.7% <10 parasitized cells/μL Components
Test bead, Water, Mineral oil, Finger needle, Blood collector
Usage
The AmpliPan Malaria Kit operates using a colorimetric LAMP reaction that amplifies Plasmodium DNA directly from whole blood or dried blood spots. No DNA extraction is required. After adding the sample to the lyophilized bead with water and mineral oil, the reaction runs in BIOPIX-T’s Point-of-Care devices such as the Pebble-R Platform, delivering visual results in 9-15 minutes.
Quantity
Every kit equals one reaction
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Clostridium difficile Test Kit
The Clostridium difficile multiplex Test Kit is a research-use-only (RUO) molecular kit. Based on qcLAMP amplification, this test ensures high specificity and sensitivity for target detection, with rapid and robust performance suitable for modern molecular workflows.
The kit can be used with extracted DNA. However, it can also be used with crude samples.
The test kit is fully compatible with the PEBBLE-R platform and other Biopix-T devices, enabling integrated, real-time detection and quantitative analysis.
Components
2X Enzyme mix, Water, Mineral oil, Clostridium primer mix
Usage
The Clostridium difficile Test Kit is a molecular diagnostic tool designed for the rapid and reliable detection of C. difficile DNA in clinical or environmental samples. It utilizes the qcLAMP method on isolated DNA, offering a fast and straightforward workflow. The reaction is set up with an enzyme mix, specific primers and mineral oil to prevent evaporation. The kit is optimized for all BIOPIX-T Point-of-Care devices, such as the Pebble-R, delivering clear digital curves through real-time color change in the reaction tube. Results are available in just 30 minutes, enabling rapid and accurate monitoring of contamination sources and outbreaks.
Quantity
Each kit contains 100 reactions.