TELIMMUNE PLASMA SEPARATION CARDS
Plasma is the preferred specimen for most in-vitro analytical methods used to identify and quantify biomarkers.
Traditional analysis has been done through a fractionation process requiring venipuncture, cold chain transport, biohazard mitigation, and centrifugation – an expensive, invasive, and time-consuming endeavor.
Our cards were founded under the premise that there must be a better way.
After a simple fingerstick, a drop or two of blood is applied to the card, then plasma is automatically fractionated from a whole blood specimen, delivering ≈ 3uL of plasma (per disc) in 3 minutes. The collection disc may be air-dried to stabilize the sample which may then be inexpensively and safely transported for in-vitro analysis
Simultaneous Cell Partition Technology (SCPT) eliminates metabolic effects associated with standard liquid phlebotomy samples
FDA class 1 medical device
Compatible with standard 96 well formats
Volumetric precision: < 5% variation
24-month shelf life
HIGH SENSITIVITY ANALYTICAL TECHNIQUES
STUDIES, LITERATURE, INSTRUCTIONS
"Duchenne muscular dystrophy (DMD) is a rare and fatal genetic disorder that primarily affects boys and results in deterioration of their skeletal, heart and lung muscles. Most children are diagnosed between ages 3-5, lose their ability to walk in their early teens and start having serious heart and lung complications in their late teens or early twenties.
Our clinical trial is the first to receive funding from the FDA Orphan Product division. Since DMD boys’ veins are challenging to phlebotomize and given the painful hardship multiple PK blood draws poses, we collaborated with a team of experts to rapidly develop and validate a novel method using the Telimmune dry plasma card which requires only two drops of whole blood from a finger stick!
This innovative tool will provide exceptional precision and stability for measuring the PK of our drug product and its metabolite thereby circumventing the pain and inconvenience of multiple venipunctures for DMD boys. We couldn’t be more thrilled by the results of our validation and stability analyses using the dry plasma cards and look forward to using them in our DMD clinical trial.”
Ines Macias-Perez, Ph.D
Principle Scientist, Product Development
Known uses for our plasma separation cards include but are not limited to:
• Global and local clinical trials
• Therapeutic drug monitoring
• Accessibility in the developing world
• Neonatal screening
• Population-based research
• Toxicokinetic/pharmacokinetic studies
• Biomarker analysis
• Animal research
• SARS-CoV-2 antibodies (ELISA)
TELIMMUNE™ PLASMA SEPARATION CARD QUALITY
Telimmune Plasma Separation cards undergo extensive testing to ensure quality.
Telimmune cards are packaged in a hermetically sealed barrier pouch to protect the device from possible environmental factors. Each lot of cards undergoes quality assurance testing to ensure consistent performance prior to being released to market. An internal standard is used to correct for sample volume variations.
PLASMA VOLUME PRECISION
Telimmune plasma collection discs are weighed to ensure that a consistent amount of plasma is collected. Plasma volume is tested to ensure that each production lot of cards can provide a similar amount of plasma. Plasma volume precision is typically less than 5% for the standard Telimmune card.
The major challenge in preparing plasma by filtration is to prevent hemolysis. Forcing blood through a membrane often causes severe hemolysis. The resulting plasma is pink if not red in color due to contamination by hemoglobin. This level of contamination can interfere with subsequent analyses. The Telimmune card uses capillary action to slowly pull the blood through the membrane, resulting in less than 1% hemolysis.