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Microsart® ATMP Mycoplasma Detection Kit

Mycoplasma contamination sources can vary and be difficult to trace. Common sources include human contamination and contaminated laboratory equipment. The Microsart® ATMP Mycoplasma is your perfect solution for performing Mycoplasma testing of cell-based therapeutics.

Top Features

  • Time-to-result within three hours
  • Specificity in PCR detection system through TaqMan® probes
  • Easy handling and high security

Popular Applications

  • Lab research
  • Quality control (QC)
  • Mycoplasma contamination testing according to EP 2.6.7 in cell-based therapeutics

Item no.:  SMB95-1003

 

Fast detection of Mycoplasma contamination in Advanced Therapy Medicinal Products (ATMP) is very important. With the Microsart® ATMP Mycoplasma, testing time can be reduced from weeks to just three hours. Additionally, the TaqMan® probe adds high specificity to the PCR system and minimizes result interpretation. The Microsart® ATMP Mycoplasma has been effectively validated according EP 2.6.7 in combination with EP 2.6.21 with respect to the detection limit for all listed Mycoplasma species, specificity and robustness for autologous cell transplants (e.g. chondrocytes).

Efficient Applications

Mycoplasma are present in most cell culture facilities and tissue culture labs. It is estimated that Mycoplasma are responsible for up to 60% of cell culture contamination. The Microsart® ATMP Mycoplasma real-time PCR kit is specially designed for hospitals, institutions and companies involved in testing Mycoplasma contamination according to EP 2.6.7 in cell-based therapeutics. It can be used to directly detect Mollicutes (Mycoplasma, Acholeplasma, Spiroplasma) in cell cultures and cell culture-derived biologicals, ATMPs.

High Performance

Mycoplasma are detected explicitly by amplifying a highly conserved rRNA operon, or more precisely, a 16S rRNA coding region in the mycoplasma genome. The mycoplasma-specific amplification is detected at 520 nm (FAM channel). The kit includes a ready-to-use Mastermix containing polymerase, primers and FAM- and ROX - labeled probes, which allow specific detection of mollicute species and an internal control. A detection limit of less than 10 CFU/mL for all Mycoplasma species mentioned in the European Pharmacopoeia fulfills its requirements for sensitivity and specificity and robustness.

Contamination Prevention

The kit contains dUTP instead of dTTP, so the option is available to degrade amplicons from previous analyses using uracil-DNA glycosylase (UNG). Thus, the occurrence of false-positive results can be minimized. UNG is not included in the kit. The internal amplification control detects False-negative results due to PCR inhibitors or improper DNA extraction. The Internal Control DNA can be added directly to the PCR master mix to act as a PCR control or monitor the extraction process. The amplification of the internal control is detected at 610 nm (ROX channel). Using uracil-DNA glycosylase (UNG), the kit contains dUTP instead of dTTP to degrade amplicons from previous analysis by using uracil-DNA glycosylase (UNG). This minimizes the occurrence of false-positive results.

Catalog

Products for Microbiological Control (US and Canada)
en 5.2 MB

Datasheet

Microsart® ATMP Mycoplasma — Rapid Real-time PCR Mycoplasma Detection Kit for testing ATMPs
en 368.9 kB

Flyer

Mycoplasma Assays for qPCR
en 573.6 kB

User Manual

Microsart® ATMP Mycoplasma — Mycoplasma Detection Kit for qPCR
en 980.3 kB

Product Information

  • Pack Size
    25
Microsart® Validation Standard Mycoplasma orale

Microsart® Validation Standards are quantified CFU preparations, containing 10 CFU per vial, optimized for validating the robustness and sensitivity of NAT-based tests.

Microsart® Validation Standard Mycoplasma fermentans

Microsart® Validation Standards are quantified CFU preparations, containing 10 CFU per vial, optimized for validating the robustness and sensitivity of NAT-based tests.

Microsart® Validation Standard Acholeplasma laidlawii

Microsart® Validation Standards are quantified CFU preparations, containing 10 CFU per vial, optimized for validating the robustness and sensitivity of NAT-based tests.

Microsart® Calibration Reagent Mycoplasma arginini

Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific Mycoplasma species per vial.

Microsart® Calibration Reagent Spiroplasma citri

Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific Mycoplasma species per vial.

Microsart® Validation Standard Mycoplasma gallisepticum

Microsart® Validation Standards are quantified CFU preparations, containing 10 CFU per vial, optimized for validating the robustness and sensitivity of NAT-based tests.

Microsart® Validation Standard Mycoplasma

$355.00

Microsart® Validation Standards are quantified CFU preparations, containing 10 CFU per vial, optimized for validating the robustness and sensitivity of NAT-based tests.

Microsart® Calibration Reagent Mycoplasma pneumoniae

Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific Mycoplasma species per vial.

Microsart® RESEARCH Mycoplasma

The Microsart® RESEARCH Mycoplasma real-time PCR kit is optimized for fast and reliable direct screening of cell cultures, cell culture supernatants and media most applicable in research and development and in-process in biopharma.

Microsart® Calibration Reagent Mycoplasma gallisepticum

Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific Mycoplasma species per vial.

Microsart® Calibration Reagent Mycoplasma orale

Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific Mycoplasma species per vial.

Microsart® AMP Mycoplasma
Item no.
SMB95-1001

Reduce your testing time from weeks to 3 hours with the Microsart® AMP Mycoplasma. With the ability to be very flexible in sample volume (up to 18 ml) and sample preparation, the kit is specifically designed for: the control of raw materials, for in-process control, and for lot release testing of finished products.

Microsart® Calibration Reagent Mycoplasma hyorhinis

Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific Mycoplasma species per vial.

Microsart® RESEARCH Mycoplasma

The Microsart® RESEARCH Mycoplasma real-time PCR kit is optimized for fast and reliable direct screening of cell cultures, cell culture supernatants and media most applicable in research and development and in-process in biopharma.

Microsart® Calibration Reagent Mycoplasma fermentans

Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific Mycoplasma species per vial.

Microsart® AMP Mycoplasma
Item no.
SMB95-1002

Reduce your testing time from weeks to 3 hours with the Microsart® AMP Mycoplasma. With the ability to be very flexible in sample volume (up to 18 ml) and sample preparation, the kit is specifically designed for: the control of raw materials, for in-process control, and for lot release testing of finished products.

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