ONECHIP
CitoCBC® The First CLIA Waived CBC in Cartridge Format
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CitoCBC ® The First CLIA Waived CBC in Cartridge Format
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CitoCBC® is the world first cartridge-based CBC that is granted CLIA Waived status by FDA. It helps healthcare professionals to deliver rapid and accurate CBC testing, not only in hospitals, but also in physician offices, pharmacy store, nursing homes or other places where CBC was not previously available.
CitoCBC® (a.k.a. CitoDX® in Europe) provides CBC with 5-Part Differential, which has performance substantially equivalent to state-of-the-art solutions for clinical laboratories, e.g. Sysmex XN Hematology Analyzer, as determined by FDA’s 510(k) process.
Above performance is available for the first time, in the format of a desktop device with small footprint and minimal maintenance. In U.S., it has been granted the CLIA Waived status by FDA, which allows untrained operators who has a high school diploma or equivalent to perform the test. In Europe, it obtained the CE Mark for Near-Patient Testing by healthcare professionals.
The Cito “Chip”
The “Chip” is a disposable cartridge integrating microfluidics and reagents, which enables a simple-and-easy test procedure using minimal sample volume. It contains IQC material to check the reliability of each test. Furthermore, the “Chip” supports room temperature storage.
The Cito Analyzer
Each CitoCBC® analyzer is factory-calibrated and requires minimal maintenance. Step-by-step on-screen instructions are designed to guide operators without lab experiences. The Analyzer periodically performs a self-check to ensure function integrity. Test results can be available in several ways, e.g. on-screen display, a printed hardcopy and via connectivity with laboratory-information-System (LIS).
SUPPORTED SAMPLE TYPLE
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In U.S., the CitoCBC has been approved by FDA for testing of Venous whole blood in K2EDTA vacutainer. In Europe, the system has obtained CE Mark for testing either Venous or Capillary whole blood anticoagulated with EDTA. Meanwhile, we are working to obtain regulatory clearance for testing Direct Capillary blood (not approved yet).
TEST PERFORMANCE
Test performance of CitoCBC has been compared to a state-of-art solution for hospitals and clinical laboratories (e.g. Sysmex XN hematology analyzer) and found to be substantially equivalent. The accuracy of the CBC counts meets the stringent CLIA 2025 Proficient Testing criteria for hematology. Some advanced features, such as the Optical Fluorescent Platelet (OFP) detection, exceed the capability of many main lab analyzers. Overall, CitoCBC enables state-of-the-art testing with small footprint, minimal staff training, and less capital investment.
