16-Parameter CBC
5-Part WBC Differential
Flag messages provide detailed guidance for abnormal results
Results in 8 mins
Cartridge-based test
Monthly QC
16-Parameter CBC
5-Part WBC Differential
Flag messages provide detailed guidance for abnormal results
Results in 8 mins
Cartridge-based test
Monthly QC
CitoCBC™ The First CLIA Waived CBC in Cartridge Format
CitoCBC™ is the world’s first cartridge-based CBC system to receive CLIA-Waived status from the FDA. It enables healthcare professionals to deliver rapid and accurate CBC testing not only in hospitals, but also in physician offices, pharmacies, nursing homes, and other settings where CBC testing was previously unavailable.
CitoCBC™ (marketed as CitoDX® in Europe) provides a complete blood count with 5-Part Differential, with performance substantially equivalent to state-of-the-art laboratory analyzers such as the Sysmex XN Hematology Analyzer, as confirmed through the FDA’s 510(k) clearance process.
This level of performance is available for the first time in a compact desktop device with a small footprint and minimal maintenance requirements. In the U.S., it has been granted CLIA-Waived status by the FDA, allowing personnel with only a high school diploma or equivalent to perform the test. In Europe, it has obtained the CE Mark for near-patient testing by healthcare professionals.
The “Chip” is a disposable cartridge that integrates microfluidics and reagents, enabling a simple-and-easy test procedure using only a minimal sample volume. It incorporates built-in internal quality control (IQC) material to check the reliability of each test. Furthermore, the “Chip” supports room temperature storage.
The test performance of CitoCBC™ has been compared with state-of-the-art solutions used in hospitals and clinical laboratories (e.g., the Sysmex XN Hematology Analyzer) and has been found to be substantially equivalent. Its CBC accuracy meets the stringent CLIA 2024 Proficiency Testing criteria for hematology. Moreover, advanced features such as Optical Fluorescent Platelet (OFP) detection exceed the capabilities of many core laboratory analyzers. Overall, CitoCBC delivers state-of-the-art testing in a compact system that requires minimal staff training and significantly less capital investment.
SUPPORTED SAMPLE TPYES
In the U.S., CitoCBC™ has been cleared by the FDA for testing venous whole blood collected in K₂EDTA vacutainers. In Europe, the system has obtained CE Mark approval for testing either venous or capillary whole blood anticoagulated with EDTA. In parallel, we are pursuing regulatory clearance for direct capillary blood testing.
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 2024 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.
