Portable Nucleic Acid Testing System
XCR Diagnostic’s Portable Nucleic Acid Testing System, Pyramid, utilizing XCR® technology will become an important part of integrating rapid molecular diagnostics into the patient treatment pathway. Used with the Sample Delivery System, the Pyramid detection device will perform on-demand testing providing actionable results in as few as 7 minutes, allowing clinical decisions and treatment at the patient’s initial visit.
The system can go anywhere testing is needed, making it a true near-patient testing solution. It’s compact size and flexible power requirements, standard power or rechargeable battery, make it a realistic option for central laboratories, satellite facilities, emergency rooms, doctor’s offices and field testing locations with resource limitations. By performing tests where the patient is located, delays are eliminated due to specimen transport and potential sampling errors.
Designed to perform assays that are FDA-cleared, CLIA waived, and CE-IVD, the Pyramid device uses an intuitive graphical user interface. This allows the operator to easily program the specimen, perform a test, and add notes to patient’s records.
To initiate testing, an operator is only required to:
1. Insert the specimen into the Sample Delivery System (SDS)
2. Scan the SDS barcode and scan or enter patient testing information
3. Insert the SDS into Pyramid and initialize test
In as few as 7 minutes, the operator will have an actionable test result, reported as Positive, Negative, or Invalid. The testing information is stored on the instrument and available by remote access. Security levels can be programmed allowing supervisors or administrators access to the amplification curves.
Height: 11.25” (28.56 cm)
Width: 7.8” (19.81 cm)
Depth: 9.0” (22.86 cm)
Weight: 8.3 lbs. (3.76 kg)
100-240 V AC, 50-60 HZ
Rechargeable battery with up to 4 hours uninterrupted operation.
Optic Channels: 4
Blue Tooth Printer and Keyboard
*Subject to change
Sample Delivery System (SDS)
Load and go.
The proprietary Sample Delivery System (SDS) is a single-use, self-contained device allows the operator to introduce the sample into the SDS in one, single step without any preparation or manipulation. All of the reagents needed to perform an assay, both sample preparation and amplification, are ready-to-use and contained in the SDS eliminating the need for reagent makeup. It is easy to use and safe since there is no interaction with the sample after the initial introduction. The barcode is read by the Pyramid and identifies the test to be run minimizing error and providing traceable results. The SDS can be stored at room temperature simplifying storage and making it a solution for use at the patient point of care, even in resource limited locations.
The Sample Delivery System can be used for a variety of sample types and intended for use with:
- Swabs: nasal/nasopharyngeal, throat, vaginal/cervical, rectal/rectovaginal, urethral, etc.
- Liquid: blood, serum, CSF, urine, liquid cultures, etc.
- Solid: stool, tissue, etc.
This flexibility accommodates a wide variety of assays in development to meet clinician testing needs.
After introduction of the sample into the SDS, unidirectional sample processing isolates the nucleic acid, adds the XCR® chemistry and performs amplification and detection while in the Pyramid device. All of this is completed in as few as 7 minutes without any additional operator interaction.
XCR believes that the Sample Delivery System, XCR® Chemistry and Pyramid compose a rapid and portable System capable of integrating molecular testing into the patient treatment pathway. Imagine the clinician having lab quality results in time to appropriately treat the patient at the initial visit.
Assays in development
All assays developed for the Sample Delivery System and Pyramid system will use patented Xtreme Chain Reaction (XCR®) technology, a more efficient nucleic acid amplification chemistry. XCR® is key to the ability to provide results in as few as 7 minutes.
- Group A Strep
- Chlamydia/Gonorrhea/Mycoplasma genitalium
- Influenza A/B and RSV
- Group B Strep
- C. difficile