SuperFlex GXM Cryptococcal Capsular Polysaccharide Detection Kit — New Product Launch
In August 2025, the cryptococcal capsular polysaccharide (GXM) detection kit developed and produced independently by Suzhou Chuanglan Biology received China's Class III medical device registration certificate (NMPA registration no. 20253401540). The product is the first cryptococcal antigen detection product approved by the NMPA that can test both cerebrospinal fluid and blood sample types, aiding the diagnosis of cryptococcal meningitis and cryptococcosis.
The GXM detection kit runs on the SuperFlex® single-test chemiluminescence platform. Built around two defining strengths — precision and flexibility — SuperFlex focuses on acute and critical care, providing clinicians with a rapid point-of-care testing (POCT) solution. This collaboration further enriches VirtueDx's test menu beyond cardiac, inflammation and reproductive-health testing.
As the national strategic partner of Suzhou InnowaveDX cryptococcal capsular polysaccharide (GXM) detection kit, VirtueDx will work alongside InnowaveDX to deliver reliable diagnostic evidence for a wider range of cryptococcosis through magnetic particle chemiluminescence, and the two parties will jointly advance the application of magnetic particle chemiluminescence in fungal infection diagnosis.
Product Advantages
- Enables raw-tube loading and fully automated testing of both blood and cerebrospinal fluid samples.
- Based on an acridinium ester chemiluminescence method, with a linear range of 0-1000 ng/mL that meets the needs of dynamic monitoring.
- First approved to aid the diagnosis of cryptococcal meningitis and cryptococcosis, covering a broad disease scope.
- A study published in Frontiers in Cellular and Infection Microbiology shows that the SuperFlex GXM product has high clinical diagnostic concordance with IMMY GXM; dynamic concentration data from patients with cryptococcal meningitis further show that SuperFlex GXM can indicate treatment response more promptly and accurately.
- Short turnaround time (TAT): results in just 15 minutes.
- Adopt single-test chemiluminescence reagent strip with no fluid-path system, avoiding waste.
- SuperFlex platform menu covers cardiac markers, inflammation markers and maternal and child health testing items.
Application Areas
The kit is designed to support differential diagnosis across a range of clinical departments:
| Department | Typical clinical scenario |
|---|---|
| Respiratory medicine | Patients with pulmonary symptoms such as cough, chest pain and dyspnoea, and with lung lesions or pulmonary nodules on imaging, who need to be distinguished from other pneumonia, pulmonary tuberculosis and lung cancer. |
| Neurology | Patients with unexplained fever, headache, blurred vision, confusion or restlessness, who need to be distinguished from other central nervous system infections and autoimmune encephalitis. |
| Infectious disease | Screening in patients with HIV/AIDS, and in patients with immunocompromise from pigeon keeping, long-term poultry contact or other chronic infections, who present with the symptoms above. |
| Oncology, organ transplantation and endocrinology | Patients undergoing organ transplantation or on long-term steroids or immunosuppressants who present with the symptoms above and require differential diagnosis. |
| Dermatology | Patients with unexplained skin pustules or rash that need to be distinguished from other skin infections. |
| Others | Any other patient in whom cryptococcosis is clinically suspected. |
SuperFlex Single-Test POCT Chemiluminescence Detection System
Patented Upward-Aspiration Magnetic-Bead Transfer Technology
Acridinium ester direct chemiluminescence is efficient and stable, comparable to large chemiluminescence platform instruments. The original patented upward magnetic-bead transfer technology completes the immunoassay simply by moving the magnetic rod sleeve.
Single-Test Integrated Reagent Strip
An independently packaged reagent strip allows reagents and samples to be added quickly, shortening the overall reaction time of the test item.
12 Independent Reaction Channels
An innovative design with 12 completely independent reaction channels means emergency samples can be processed the moment they arrive, with no queueing and fast result reporting.
Fast and Smart Operation
Raw-tube loading with automatic scanning, one-click test running, and result printing or output to the LIS (laboratory information system).
The Partners Behind the Product
SuperFlex is a sub-brand of Revvity Inc., produced and registered in China by its subsidiary Suzhou Xinbo Biology. From January 1, 2024, VirtueDx obtained the global exclusive distribution rights from Revvity for the instruments, reagents and consumables of its time-resolved fluorescence (TRF) immunoassay platform, its PCR platform for infectious disease diagnosis (excluding blood-station business), and its POCT platform for cardiac and inflammation markers (SuperFlex).
Suzhou InnowaveDX is a biomedical high-tech enterprise integrating research and development, production, sales and after-sales service. Its R&D team brings together senior clinical microbiology, proteomic, cellular and molecular biology, and bioinformatics experts, and focuses on developing new technologies, products and innovative solutions in the field of pathogen infection. Chuanglan aims to become a specialist in infection diagnostics, bringing clinicians accurate, effective, convenient and affordable innovative diagnostic products.
