Shop All Mycoplasma Detection Kits

MycoSEQ™ Mycoplasma Detection Kit (Applied Biosystems™)

The MycoSEQ Mycoplasma Detection Kit is a real-time PCR assay designed and validated to meet the requirements of European Pharmacopeia Chapter 2.6.7. The primers were designed using a proprietary bioinformatics pipeline to detect >90 mycoplasma species with high specificity and no cross-reactivity to closely-related bacterial species. The assay's sensitivity has been demonstrated by internal and external validations to detect 10 cfu/mL or the genomic equivalent of 10 GC/mL as recommended by regulatory guidance.

Real-time PCR provides rapid results, making this assay ideal for in-process testing or part of a microbial risk mitigation strategy across a bioprocess workflow, including cell line characterization, raw material tests, etc. Additionally, it allows for rapid lot release testing across multiple biotherapeutic modalities (e.g., biologics, vaccines, cell therapy products) and has been widely used and accepted by regulatory authorities following the required validation.

Unlike other mycoplasma kits available, the MycoSEQ kit includes a proprietary Discriminatory Positive Control to differentiate a true positive from any potential cross-contamination positives. This is a key feature in avoiding false positive results from mycoplasma controls used during validation or routine testing.

To date, there are more than ten global manufacturers of therapies subject to U.S. Food and Drug Administration, European Medicines Agency, and/or local regulatory agency review that have received regulatory acceptance for accelerated lot release protocols that specify the Thermo Fisher Scientific MycoSEQ method.

MycoFluor™ Mycoplasma Detection Kit (Invitrogen™)

The MycoFluor™ Mycoplasma Detection Kit provides an ultrasensitive, rapid, and simple fluorescence microscopic assay for the visual identification of mycoplasma infection in laboratory cell cultures. In order to detect mycoplasma, the fluorescent MycoFluor™ reagent is added directly to the culture medium, with or without cells, and the stained sample is then examined under a fluorescence microscope.

MycoSEQ™ Mycoplasma Detection Kit, with PrepSeq™ sample preparation (Applied Biosystems™)

The MycoSEQ Mycoplasma Detection Kit is a real-time PCR assay designed and validated to meet the requirements of European Pharmacopeia Chapter 2.6.7. The primers were designed using a proprietary bioinformatics pipeline to detect >90 mycoplasma species with high specificity and no cross-reactivity to closely-related bacterial species. The assay's sensitivity has been demonstrated by internal and external validations to detect 10 cfu/mL or the genomic equivalent of 10 GC/mL as recommended by regulatory guidance.

Real-time PCR provides rapid results, making this assay ideal for in-process testing or part of a microbial risk mitigation strategy across a bioprocess workflow, including cell line characterization, raw material tests, etc. Additionally, it allows for rapid lot release testing across multiple biotherapeutic modalities (e.g., biologics, vaccines, cell therapy products) and has been widely used and accepted by regulatory authorities following the required validation.

The PrepSEQ nucleic acid extraction module included with this version of the kit offers a robust and easy workflow to overcome complex matrix challenges to ensure the required sensitivity. Unlike other mycoplasma kits available, the MycoSEQ kit also includes a proprietary Discriminatory Positive Control to differentiate a true positive from any potential cross-contamination positives. This is a key feature in avoiding false positive results from mycoplasma controls used during validation or routine testing.

To date, there are more than ten global manufacturers of therapies subject to U.S. Food and Drug Administration, European Medicines Agency, and/or local regulatory agency review that have received regulatory acceptance for accelerated lot release protocols that specify the Thermo Fisher Scientific MycoSEQ method.

PrepSEQ™ 1-2-3 Mycoplasma Nucleic Acid Extraction Kit (Applied Biosystems™)

The Applied Biosystems® PrepSEQ™ 1-2-3 Nucleic Acid Extraction Kit rapidly extracts Mycoplasma genomic DNA from 100µl sample volumes of research cell lines, stem cell lines, and cell and tissue therapy samples. In the PrepSEQ™ 1-2-3 Kit protocol, a rapid procedure recovers DNA from total lysate of the test sample using magnetic-bead based technology. The Myco Scan Kit is optimized for use with the PrepSEQ 1-2-3 Kit.

- High recovery of Mycoplasma genomic DNA from mammalian cell culture samples
- Rapid easy to use protocol results in under 2 hours
- Compatible with the Myco Scan Mycoplasma Detection assay
- Protocol available for automated sample preparation

High DNA Recovery Sample Preparation
Optimized for use with the Myco Scan Kit, the PrepSEQ 1-2-3 Nucleic Acid Extraction Kit uses proprietary magnetic bead-based separation technology to extract Mycoplasma DNA from mammalian cell lines. The PrepSEQ 1-2-3 Kit extracts Mycoplasma genomic DNA from research cell lines, stem cell lines, cellular and tissue therapy samples with high efficiency.

The protocol is recommended for use with samples with a starting volume of 100 µl with a maximum cell density of 106 cells. The PrepSEQ 1-2-3 Kit provides an easy to use procedure consisting of 1) RNase treatment 2) Proteinase treatment and 3) DNA extraction using the magnetic bead technology (Figure 1). The kit isolates Mycoplasma genomic DNA with high sensitivity from total lysate of test sample. The PrepSEQ 1-2-3 Kit and the Myco Scan Kit allow routine screening of high-value cell lines using an easy, rapid and sensitive protocol. Figure 2 demonstrates how a sample that was spiked with low levels of Mycoplasma bovoculi DNA was found negative for Mycoplasma contamination using a commercially prepared kit. When using the PrepSEQ 1-2-3 Kit and the Myco Scan Kit, the correct positive call for Mycoplasma contamination was made.

Cell Culture Contamination Detection Kit (Invitrogen™)

The Cell Culture Contamination Detection Kit is a simple and effective procedure for screening tissue cultures for contamination by microorganisms. The kit not only detects contaminants, but it also identifies the contaminant type. Three fluorescent dyes distinctly stain yeast (and other fungi), gram-positive and gram negative bacteria by slide preparation.