affigene® Cp/Mp tracer

affigene® Cp/Mp tracer is an in-vitro diagnostic assay intended for separate detection of Chlamydophila pneumoniae (Cp) and Mycoplasma pneumoniae (Mp) DNA from human throat swab or broncho alveolar lavage (BAL) samples with real-time PCR detection.

The Cp and Mp bacteria are known to cause respiratory disease often referred to as atypical pneumonia. This multiplex assay with high sensitivity for both Chlamydophila pneumoniae and for Mycoplasma pneumoniae enables efficient testing of patients with respiratory symptoms.

The affigene® Cp/Mp tracer assay is CE labelled for the complete process, from sample preparation to result. It is the only commercially available real-time PCR assay which has passed external approval by a notified body for Cp and Mp detection. As this is a listed assay according to the IVD directive, external approval is required for CE-labeling of the product. Review and approval of affigene® Cp/Mp tracer has been handled by Lloyds Register Quality Assurance Limited.

An internal control is introduced during sample preparation to avoid false negative results, due to inhibition. To avoid false positive results all reagents are single-use and ready-to-use, and UDG technology is included.

The affigene® Cp/Mp tracer assay uses the same PCR profile as all other affigene® trender/ tracer assays and can be analyzed in the same run as any other product in the family in any combination.

Results are given by the affigene® analysis software for convenience, objectivity and security.

Flexibility

• CE labelled flexible solution for sample preparation from different sample matrices such as throat swabs and BAL
• CE labelled for manual as well as automated sample preparation (validated in combination with the NucliSens easyMAG system)
• CE label valid on multiple real-time PCR platforms for flexible detection possibilities:
  - Mx3000P/3005P (Stratagene, La Jolla, USA)
  - iCycler iQ/iQ5 (BioRad Laboratories Inc, Hercules, CA, USA)
  - Rotor-Gene 3000/6000 (Corbette Research, Sydney, Australia)
  - ABI 7300 (Applied Biosystems, Foster City, USA)