AssayStable® & PCRstable®

Precise positioning and controlled release of assay reagents not achievable by lyophilization

AssayStable and PCRstable are ambient temperature chemistries that allows assay manufacturers to precisely position, preserve, and release their assay reagents in any format using Biomatrica’s unique reagents with a simple air-dry process. PCRstable was developed for PCR-based assays, and AssayStable was developed for all other assays.

Assay Manufacturers:

  • Air-dry any assay reagent in-house and store at room temperature
  • No lyophilization and no low humidity chambers needed
  • Virtually any reagent stabilized by patented stabilizers

Assay Users:

  • Prepare any assay in a dry-stable format
  • Add template and go; no mixing needed
  • Rapid rehydration upon template addition

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  • GenMark Diagnostics: Valve-Free Positioning and Preserving of Sample-to-Answer Diagnostic Devices
  • Thermo Fisher Ion AmpliSeq™: Preservation of High Throughput Next Generation Sequencing Arrays
  • Focus Diagnostics: Enabling decentralized, point-of-care diagnostics through chemical biostabilization
  • Extending shelf-life of one-step, liquid RT-PCR assays for point of care
  • Instantaneous Preservation of Rare Cells in Blood to Evaluate Cancer Therapy Selection
  • PCR Assay Mastermix Ambient Stabilization Without Lyophilization
  • Stabilization of Multiplexed Panel for Next-Generation Sequencing

Stabilization of qPCR assay

Included in dry-down:

  • Taq
  • Primers
  • Reverse Transcriptase
  • Dye (SYBR® Green)/Taqman®
  • dNTPs
  • Salts and Detergent

Stabilization of qPCR assay at ambient temperature

Figure 1: Components of qPCR assay, including Taq DNA polymerase, dNTPs, primers for RNase P, SYBR Green dye and PCR buffer were dried down in the presence of Biomatrica’s stabilizing formulation (Protected) or Non-Protected, and stored under high stress conditions at 45°C. At determined time points, samples were rehydrated with water and MgCl2 with the specified amount of genomic DNA template. Real time PCR amplification of a RNase P fragment was performed on the ABI 7300 Real-Time PCR System, using the equivalent amount of DNA with qPCR reagents stored at -20°C as a positive control. Data shown is for samples stored for 6 months at 45°C, corresponding to 2 years of ambient temperature storage, based on accelerated aging.

Stabilization of RT-qPCR assay at ambient temperature

Figure 2: All components of a RT-qPCR assay, including Taq DNA polymerase with reverse transcriptase activity, dNTPs, aptamer and PCR buffer including metal co-factor were dried down in the presence of Biomatrica’s stabilizing formulation (Protected) or Non-Protected, and stored under high stress conditions at 45°C. At determined time points, samples were rehydrated with water, primers and TaqMan probes, and a known input of RNA template was added. Reverse transcription and real time PCR amplification were performed on ABI 7300 Real-Time PCR System, using the equivalent amount of RNA samples with RT-qPCR reagents stored at -20°C as a positive control. Data shown is for samples stored for 3 weeks at 45°C, corresponding to 3 months of ambient temperature storage, based on accelerated aging.

qPCR Stabilized

Figure 3: Taq + dNTPs stabilized for 4 years at room temperature(based on accelerated aging).

Stabilization of a Limiting Quantity of Reverse Transcriptase

Figure 4: Stabilization of a limiting amount of reverse transcriptase for rapid screening ability.

Ambient Shipping: Stress Testing

Figure 5: Biomatrica stabilizers protected all samples, while non-protected shows complete degradation below 10 ng.

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For information on these products, please inquire.

As a “drop in” reagent, PCRstable® can be incorporated into any manufacturing workflow. Biomatrica works closely with each customer to help implement PCRstable® in their manufacturing processes.

The service timeline varies based on the assay and customer requirements. Typically, the process requires a minimum of 90 days.

Please see the PCRstable® Concept to Product Overview, which outlines the process for a PCRstable service, or call Biomatrica and we would be happy to walk you through it.

Lyophilization is the process of creating a stable preparation of a substance by rapid freezing and dehydration of the frozen product under high vacuum. PCRstable® overcomes the manufacturing challenges of producing cartridges using lyophilized reagents. Unlike lyophilization, PCRstable® reagents are prepared at ambient temperatures and stable in higher humidity. They are amenable to any chip, cartridge, or cassette platform, and don’t require difficult handling with tweezers like lyospheres.

PCRstable® chemistry can stabilize any type of PCR-based assay, including, molecular diagnostic, point-of-care and lab-on-a-chip assays with unique formats.

No. PCRstable® is a custom service that screens a library of proprietary chemical stabilizers to identify the optimal formulation for long-term, temperatureindependent, stability of wet or dry PCR reagents in your unique assay.

PCRstable® is service that will develop custom chemical stabilizers as an alternative to lyophilization for PCR-based assay stabilization. Manufacturers add PCRstable® chemical stabilizers to any PCR reagent, from polymerases up to complete master mixes, and the PCR reagents remain stable for years at room temperature. It’s ideal for developing point-of-care, molecular diagnostic platforms or next gen cartridge/chip-based instruments.

The PCRstable® service screens a library of chemical stabilizers to identify the optimal formulation for long-term stability of your wet or dry PCR reagents at any temperature. You simply add the formulation to your reagent mix in any vessel ─ plastic, chip, cartridge ─ air dry if specified, and store or ship at any temperature.

BIOMATRICA
5627 Oberlin Drive
Suite 120
San Diego, CA 92121
Tel: 858-550-0308
Fax: 858-678-0597
Email: orders@biomatrica.com