FAST CDV - Automated Cell Density/Viability Analyzer

The completely automated BioProfile FAST CDV analyzer was created to satisfy the demands of cell culture scientists who need measurements of cell density and viability at high throughput, quickly, and with exceptional accuracy.

The Trypan blue dye exclusion approach, along with the most advanced automated sampling preparation available in the market, allows for nearly 100% elimination of manual sample prep procedures and results in only one minute.

Two precision syringe pumps complete all required dilution stages, allowing for completely automated cell counts up to 140e⁶ vc/mL. Just 100 μL of sample volume is needed for FAST CDV analysis, and this can be done with Nova's unique sample cups. These cups are made especially to prevent cell adherence to the cup walls and improve the mixing of cultures with high cell densities.

• Throughput of over 45 samples per hour
• Small, 100 μL samples
• Automated cell counts to 140e⁶ vc/mL
• Sampling options for 96 well plates and a 32-position carousel tray
• Software that complies with 21 CFR Part 11
• Complete network integration that sends data and pictures

Fastest throughput

FAST CDV is the fastest cell density and viability analyzer with the trypan blue dye approach. Thanks to an inventive flow path, a counting chamber, and automated sample preparation procedures, around 45 samples may be processed per hour. 

Two independent precision syringe pumps and sample processing systems make interleaving analysis sequences possible. One of these systems, a high-resolution image processing system, can examine a sample while the other is mixed and diluted for analysis.

Automated cell counts to 140e⁶ cells/mL

The precision syringe pumps carry out all sample preparation procedures without the need for manual or external dilutions and can evaluate cell densities ranging from 5e⁴ cells/mL to 140e⁶ cells/mL. 

Thanks to developments in cell line generation and screening, nearly all cell culture procedures now surpass the upper limit of other automated cell counts, which is 15e⁶ cells/mL. In addition to saving labor and eliminating the need for extra pipets, tubes, and diluents, onboard automated dilutions also remove common problems that arise from manual dilutions.

Furthermore, if the diluent is not adjusted to match the sample's osmolality, automated dilutions prevent cell lysis caused by batch pre-dilution of samples.

According to studies, samples that have been batch-pre-diluted can have a 20% decrease in cell viability in just 20 minutes. FAST CDV samples are diluted, and any negative effects caused by the diluent are removed before they are examined immediately.

Sampling options

A 96-well motorized tray and a 32-position carousel tray with genuine load-and-go functionality are two alternatives for sampling. The carousel tray maximizes workflow productivity by allowing samples to be constantly loaded without requiring the removal of wasted cups. There is a 300-cup capacity garbage receptacle on board. Processors can use normal 96-well plates with the 96-well tray.

32-position carousel tray with over 45 samples per hour throughput. Image Credit: Nova Biomedical

96-well plate sampling options. Image Credit: Nova Biomedical 

Low sample volume requirements

Small-volume culture systems are becoming increasingly common in cell culture. For example, BioProfile FAST CDV only needs 100 μL of material to accurately analyze total cell density, viable cell density, cell diameter, and percent aggregate. 

21 CFR part 11 compliant software FAST CDV complies with FDA’s GMP electronic

FAST CDV complies with the FDA’s GMP electronic records guidance document, 21 CFR Part 11. The system's software architecture adheres to the highest guidelines for network security, user privileges and access, audit trails, and the retention and retrieval of electronic records. To guarantee compliance, Nova continuously updates the software and evaluates all revisions to the FDA's advice.

Highest-resolution image processing

The vast number of cells counted, along with the sophisticated software algorithms and high-resolution digital optics of FAST CDV, maximize the accuracy and precision of cell counting. 

Intuitive user interface

With an intuitive user interface, customizable sample types, and intelligent sample sequencing, conducting sample analysis becomes as simple as tapping the screen twice. Users can preserve preferred onboard dilutions, cell inspection settings, and personal settings for automatic setup information population using custom sample types.

Intelligent sample sequencing automatically indexes and assigns each sample a unique number. The 10.6-inch touchscreen display and integrated digital keyboard eliminate the need for additional accessories. Quick navigation icons enable access to the most common functions with a single touch of the screen.

The date and time, pending events, reagent status, and onboarding training courses are all instantly accessible through a notification header at the top of the user interface.

Image Credit: Nova Biomedical 

Automated maintenance

No maintenance is needed other than replacing the reagent packs. To guarantee maximum uptime, all fluid path maintenance is carried out automatically using cleaning solutions in the reagent kit.

Image Credit: Nova Biomedical 

High-capacity, cartridge-based reagent management system

RFID technology is used in FAST CDV reagent cartridges to automatically detect pack installation and log installation date, time, lot number, expiration date, and number of tests available. Reagent packets can be used for up to 90 days after installation and more than 500 samples. 

Full network capabilities

FAST CDV offers many solutions for IT data integrity and transmission. In the current network, user-defined locations can receive raw data and photos. 

A bespoke OPC server combined with FAST CDV, an OPC-compliant device, can enable bi-directional communication and add an extra layer of encryption. Using Windows Active Directory makes managing user accounts and user profiles easier. 

Specifications

Physical dimensions:

Height: 16.5", Depth: 21.5", Width: 17.5"

Parameter linear range

• Measurement range: 50,000 cells/mL to 140,000,000 cells/mL
• The analyzer performs user-selectable onboard dilutions to achieve this range.
• There is no need for manual or external dilutions.

Dilution ratios selected by the user:

• Ratio 1:1 - 0.05 to 35.00 million cells/mL
• Ratio 1:2 - 0.20 to 70.00 million cells/mL
• Ratio 1:4 - 0.40 to 140.00 million cells/mL

Viability range:

 0% to 100%

Live cell diameter range

4 to 70 μm

Accuracy specifications summary. Source: Nova Biomedical

Units of measure and resolution. Source: Nova Biomedical

Analysis time:

The Fast CDV analyzer's dual flow path, synchronized design processes samples in the following times:

• Time to complete first sample: Less than 130 seconds
• Time to process subsequent results (in queue samples): Less than 70 seconds

General safety

• EN 61000-4-2
• IEC 61010-1:2001 Electrostatic Discharge
• 21 CFR Part 11 Compliant
• EN 61000-4-3 Radiation Immunity
• EN 61000-4-8 Magnetic Field

Though not a medical device, the Fast CDV is designed to comply with the cybersecurity requirements outlined in the "Content for Premarket Submissions for Management of Cybersecurity in Medical Devices – Guidance for Industry and Food and Drug Administration Staff" from October 2^nd, 2014.