We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us

Download Mobile App




Disposable Cartridge-Based Test Delivers Rapid and Accurate CBC Results

By LabMedica International staff writers
Posted on 19 May 2025

Complete Blood Count (CBC) is one of the most commonly ordered lab tests, crucial for diagnosing diseases, monitoring therapies, and conducting routine health screenings. More...

However, more than 90% of physician offices in the U.S. lack the necessary infrastructure to perform on-site CBC testing, often resulting in delayed results and missed diagnostic opportunities during patient consultations. Now, a new cartridge-based CBC test is expanding access to quick results in physician offices, pharmacies, and home care settings, making data-driven diagnostics more accessible.

CytoChip’s (Irvine, CA, USA) CitoCBC is a cartridge-based CBC system that allows healthcare professionals to quickly perform accurate CBC testing not only in hospitals but also in physician offices, pharmacies, nursing homes, and other places where CBC testing was previously unavailable. CitoCBC is designed to offer both ease of use and high performance. The self-contained cartridge simplifies the testing process, providing a comprehensive 5-part differential CBC with a turnaround time of just eight minutes. On-screen, step-by-step instructions guide users through the process, even if they have no laboratory experience. The system includes advanced features, such as Optical Fluorescent Platelet (OFP) detection, which surpasses the capabilities of many traditional lab analyzers. The analyzer also conducts periodic self-checks to ensure its functionality. Test results can be displayed on-screen, printed out, or transmitted via connection to a laboratory information system (LIS). In comparisons to state-of-the-art CBC solutions used in hospitals and clinical labs, the performance of CitoCBC has proven to be substantially equivalent. The CBC counts produced meet the rigorous CLIA 2024 Proficient Testing standards for hematology.

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance and a CLIA Waiver for CitoCBC, making it the first cartridge-based CBC test to achieve this milestone. This breakthrough significantly increases access to CBC testing in decentralized healthcare environments like physician offices, pharmacies, and home care settings. The CLIA Waiver eliminates testing barriers, allowing for fast, reliable CBC results in a compact device, which ultimately improves patient care and supports better clinical decision-making. With FDA clearance and a CLIA waiver, CitoCBC ensures accuracy and reliability, allowing non-laboratory personnel to operate the system effectively. Overall, CitoCBC provides state-of-the-art testing with a small footprint, requiring minimal staff training and lower capital investment. The product will first launch in the United States and later expand to select European countries upon obtaining the CE Marking.

"Achieving CLIA Waiver for a CBC test is a major step forward in improving access to diagnostics at the point of care," said Dr. Wendian Shi, CEO of CytoChip. "This milestone not only fills a critical gap among CLIA Waived testing but also expands diagnostic accessibility in underserved areas."

Related Links:
CytoChip


New
Gold Member
Immunochromatographic Assay
CRYPTO Cassette
POC Helicobacter Pylori Test Kit
Hepy Urease Test
New
Sperm Quality Analyis Kit
QwikCheck Beads Precision and Linearity Kit
New
Gold Member
Cardiovascular Risk Test
Metabolic Syndrome Array I & II
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Molecular Diagnostics

view channel
Image: The cell-based tests bring artificial intelligence to transplant outcome care (Photo courtesy of iStock)

AI-Enhanced Cell-Based Blood Tests to Improve Predictive Accuracy for Complex Transplant Outcomes

Managing immunosuppressive drugs in transplant patients is a delicate challenge. Insufficient medication can lead to rejection, which may be cell- or antibody-mediated, while excess immunosuppression raises... Read more

Immunology

view channel
Image: PD-1 protein blockade is the standard treatment for advanced melanoma among the different types of immunotherapy (Photo courtesy of 123RF)

Precision Tool Predicts Immunotherapy Treatment Failure in Melanoma Patients

Melanoma, though accounting for only about 4% of skin tumors, is the deadliest form of skin cancer due to its high potential to metastasize. While immunotherapy, especially PD-1 protein blockade, has revolutionized... Read more

Pathology

view channel
Image: Researchers have developed a novel method to analyze tumor growth rates (Photo courtesy of Adobe Stock)

Novel Method To Analyze Tumor Growth Rates Helps Tracks Progression Between Diagnosis and Surgery

Patients diagnosed with breast cancer often worry about how quickly their tumors grow while they wait for surgery, and whether delays in treatment might allow the disease to spread beyond the point of cure.... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.