EDAN ClariLight CL30 Molecular Diagnostic Analysis System

The EDAN ClariLight CL30 is a compact, point-of-care molecular diagnostic analyzer built on Loop-Mediated Isothermal Amplification (LAMP) technology. It delivers qualitative nucleic acid detection from anterior nasal or oropharyngeal swab samples in as little as 15 minutes, with hands-on time under 1 minute and no requirement for nucleic acid extraction or cartridge rewarming—making it suited for emergency departments, fever clinics, and resource-limited point-of-care settings.

The CL30 is not a PCR system. LAMP amplifies nucleic acids under isothermal conditions, which allows the instrument to operate without the thermal cycling hardware, complex fluidics, and longer turnaround times associated with conventional PCR platforms. The result is a zero-maintenance, fanless benchtop device that runs single-use, enclosed test cartridges through six independent reaction channels, supporting up to 6 tests per run and stat-sample insertion without batching delays.

The system is controlled through a 10.1-inch color touchscreen (1280 × 800) with graphical, glove-compatible operation, and includes a built-in barcode scanner for cartridge and sample tube identification. Results and fluorescence curves are displayed in real time, with positive samples automatically flagged, and data can be transmitted simultaneously to LIS/HIS/DMS systems via 4G, Wi-Fi, Ethernet, or USB.

The single-use test cartridge has an enclosed structure to prevent contamination, supports up to 5 parameters per test, and is stable for 12 months at 2°C–28°C, with transport tolerance from −20°C to 37°C. The sample collection tube system supports 100-test and 200-test configurations, with or without NP or OP swabs, and is priced per set as shown in the pricing table below.

Regulatory status: The CL30 carries China NMPA registration for qualitative RNA detection from human nasal and oropharyngeal swab samples when used with EDAN’s compatible assay reagents. No FDA 510(k) clearance or CLIA waiver specific to the ClariLight CL30 was identified in the public FDA database during preparation of this page. The available assay menu in the public documentation covers SARS-CoV-2, Influenza A/B, Influenza A/B & SARS-CoV-2, and Influenza A/B & RSV, with STI (CT/NG, HPV, TV), HAI (C. Diff, MRSA), and other targets (MTB, Monkeypox) listed as under development. Availability, assay registration, and cleared claims vary by market; confirm local registration and intended use before purchase.

The CL30 is built for clinical laboratories, emergency and fever clinics, and point-of-care testing sites that need rapid, extraction-free molecular results for respiratory and infectious disease pathogens—without the infrastructure and turnaround time of a central PCR laboratory.

Key Features & Benefits

LAMP Technology: Extraction-Free, Isothermal, and Fast

The CL30 uses Loop-Mediated Isothermal Amplification, a method that amplifies nucleic acids under constant temperature rather than thermal cycling. LAMP is robust and tolerant of inhibitors, allowing crude sample preparation and minimal nucleic acid purification—which is why the CL30 can operate without an extraction step. This translates to hands-on time under 1 minute, no cartridge rewarming, and turnaround time as short as 15 minutes from sample to result.

6-Channel Cartridge Architecture for Scalable Throughput

The instrument has six independent reaction channels behind a front-loading circular bay. Each single-use cartridge is inserted directly, and the system can run up to 6 tests per run—supporting stat-sample insertion and mixed-batch flexibility without waiting for a full plate to fill. The enclosed cartridge structure is designed to prevent contamination and support safe handling of amplified products.

10.1-Inch Touchscreen with Integrated Barcode Scanning

The 10.1-inch color touchscreen (1280 × 800) provides a graphical, glove-operable interface that displays real-time fluorescence curves, signal values, consumable status, LIS connection status, and positive/negative interpretation. Positive results are automatically highlighted in red for rapid identification. The built-in barcode scanner reads cartridge barcodes and sample tube barcodes, reducing manual entry errors and accelerating workflow.

Zero-Maintenance, No-Fluidics Benchtop Design

The CL30 has no complex fluid lines, no wash solutions, and no waste reservoir—only the single-use cartridge is replaced between tests. This zero-maintenance design supports operation by staff without specialized molecular biology training, and the compact benchtop footprint fits laboratory benches, emergency department counters, and fever clinic stations.

Real-Time Data Transmission to LIS/HIS/DMS

Connectivity includes 4G, Wi-Fi, Ethernet, and USB, with simultaneous report transmission to LIS, HIS, and DMS systems. On-board storage can retain thousands of test records, and the system supports integration into existing laboratory information workflows where configured.

Single-Use Cartridge with Room-Temperature Storage

The single-use cartridge supports up to 5 parameters per test and is stable for 12 months at 2°C–28°C, with transport tolerance from −20°C to 37°C. This room-temperature storage profile reduces cold-chain logistics requirements compared with PCR reagents, supporting deployment in settings with limited refrigeration.

Sample Collection Tube Configurations

The CL30 sample collection system is available in 100-test and 200-test configurations, with options without swabs, with NP swabs, or with OP swabs. Each set includes the collection tubes, and the pricing table below lists the per-set prices and test quantities as provided in the EDAN price documentation.

Assay Menu and Test Cartridges

The CL30 assay menu in the available public documentation includes the following respiratory panels. All cartridges are sold in sets of 100 minimum order quantity (MOQ), with 25 cartridges per pack, 4 packs per set, and 4 pairs of controls per cartridge unless otherwise noted.

Additional targets under development (not yet available for purchase): STI (CT/NG, HPV, TV), HAI (C. diff, MRSA), and Others (MTB, Monkeypox).

Sample Collection Tube Pricing

The CL30 sample collection tubes are available in 100-test and 200-test set configurations, with or without swabs. The table below lists the per-set price, test quantity, and part number as provided in the EDAN price documentation.

100-Test Configuration

200-Test Configuration

Technical Specifications

Why Choose the EDAN ClariLight CL30?