Point-of-Care Therapeutic Drug Monitoring System Using Mass Spectrometry

The PaperSpray Ambient Ionization system can rapidly analyze complex samples including whole blood in 3 to 5 minutes with no sample preparation. The automated system is being developed by Purdue University and Omnica for use in the clinical laboratory and other research applications.

The platform was developed to analyze minimal sample volumes of whole blood, urine, saliva, and fresh tissue samples (biopsy and tissue homogenate) to determine drug levels within minutes of blood collection. It is particularly useful for oncology patients who have been administered small-molecule chemotherapeutic agents.

The Omnica team developed and production-transferred the entire system, including cassette, reagent injectors, high-voltage system, automated magazine, status display, and the Graphical User Interface software (for protocol parameter setting and remote diagnostic capability) - in 12 months.

PaperSpray Cassette

• Custom injection-molded thermoplastic cassette

• Preserves electrical field characteristics for use in mass spectrometry

• Uses minimal sample volume of whole blood

• Design ensures safe and reliable introduction of solvents and high voltage required to generate the paper spray ionization.

Ion Source Instrument

• Automated sample introduction system for the mass spectrometer.

• Holds 40 test cassettes in a magazine

• Quantitated spectral analysis with minimal handson time.

• Barcode for sample tracking

• Capability to configure system for running custom assay protocols

PaperSpray Ambient Ionization

The PaperSpray Ambient Ionization offers a simple method for clinical laboratories to quickly analyze small samples ( ~10μL) of biological fluids.

1. no sample preparation - Sample is deposited directly onto the cassette.

2. Direct quantitation at the ppb (ng/mL) level

3. Low-cost, easy-to-use disposable packaging

4. Minimal waste product (~200μL of solvent per analysis)

5. results in less than 5 minutes.

Direct analysis of whole blood, urine, saliva, and fresh tissue samples (biopsy and tissue homogenate) have demonstrated lower limits of PaperSpray-based assays of small molecule compounds (MW<1000 Da) to be in the low ppb (1-10 ng/mL).

Therapuetic Drug Monitoring

The PaperSpray / Ion Source Instrument, when combined with a miniature mass spectrometer, has resulted in a Point-of-Care Therapeutic Drug Monitoring (POC-TDM) device that can revolutionize cancer treatment by solving a major problem in oncology.

When administering small-molecule chemotherapeutic agents, health care professionals should strive to optimize the dose to therapeutic efficacy, but below toxic levels. Within minutes, POC-TDM provides clinicians real-time feedback on the patient's drug levels. It offers the possibility of an improved clinical outcome by personalizing drug levels over a period of time.

As stated by a leading oncologist:

"The use of POC-TDM will create a paradigm shift, replacing Dose to Toxicity with Intelligent Dosing".


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