Applied Biosystems™

MycoSEQ™ Mycoplasma Detection Kit

Catalog number:  4460623

 Related applications:

Contaminant & Impurity QC Testing

Error loading your content!

  Catalog number
Select a plan
Unit size
Price ({{currency}}) Availability Qty
{{product.sku}} {{product.sku}} also known as {{product.formattedSku}} 
{{product.availability.message}}
Pro add-ons

Your on-site stock

›› {{supplyCenter.scName}}({{scProduct.stockOnHand}} In stock)
›› {{supplyCenter.scName}}(Out of stock)
›› {{supplyCenter.scName}}
This item is not currently available on-site. Depending on your Supply Center settings you may be able to add the item to cart above else use the Order Non-Stocked Items' tab on the Supply Center home page.
Back to top

Description

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.

For Research Use Only. Not for use in diagnostic procedures.

Specifications

Detection Method: SYBR
PCR Method: qPCR
Product Size: 100 reactions

Contents & storage

This kit contains Power SYBR Green mix, assay mix, and discriminatory positive control/inhibition control. They are stored under various conditions (4°C and -20°C).

Documents

Manuals & protocols