Better Be on the Safe Side! Better Be Fast! With Our Rapid qPCR Detection Kits Microsart Mycoplasma & Bacteria

Microsart® Mycoplasma

Microsart® Bacteria

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Perfect for Mycoplasma release testing of biopharmaceuticals & bacterial contamination control of short shelf life ATMPs

Don’t Worry About False Positives – Instead Obtain Reliable Results Within 3 Hours:

  • Time-saving by avoiding lengthy 14 day (for sterility) or 28 days (for Mycoplasma) cultivation protocols.
  • Ensures the highest level of qPCR specificity through use of TaqMan® probes.
  • No need to perform uncertain melting curve analysis.



Microsart® Bacteria: The Revolution in Regenerative Medicine - Ensure ATMPs are Bacteria-Free

Prior to Treatment:

  • qPCR methodology is used in combination with a special sequence for detecting the full range of bacterial contaminants.
  • Ensure patient safety and help to reduce prophylactic treatment with antibiotics: Only bacteria-free cell therapy products are used for patient treatment.

Ensure Validated Quality Test Results in Compliance With International Standards:

  • Developed in close cooperation with authorities.
  • Microsart® AMP & ATMP Mycoplasma Kits are validated according to EP 2.6.7 for sensitivity, specificity and robustness and fulfill international criteria of international authorities like USP and JP.
  • Microsart® ATMP Bacteria is validated according to EP 5.1.6 and USP <1223> for sensitivity, specificity and robustness.

Eliminate Contamination Risks by Using The Only Kit With Non-Infectious Bacterial Cells:

  • Validation standards for required bacterial species are lyophilized to render them non-infectious.
  • Detailed step-by-step guidance for matrix-specific validation provided by Sartorius qPCR experts.
  • Avoid the risk of cross-contamination: Individually packaged patient-specific vials. (only for Microsart Bacteria)

Let The Master Mix do The Internal Control And Reduce Tedious Pipetting Steps:

  • The DNA-sequence for internal control is included in the ready-to-use master mix.
  • Minimize false-negative results and the number of reactions.

Start Testing Right Away Using Your Existing Equipment:

  • The kits can be used with any type of qPCR cycler able to detect the fluorescent dyes FAM® and ROX®.
  • Clear, color-coded reagents guide through the short and simple protocol.
  • Lyophilized reagents ensure consistent quality without the need for freezer storage.
Applications

  • qPCR

  • validation

  • sterility control

  • quality control

  • bacteria detection

  • mycoplasma detection

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