Mycoplasma pneumoniae Chlamydophila pneumoniae - Mikrogen

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DIAGENODE MYCOPLASMA PNEUMONIAE / CHLAMYDOPHILA PNEUMONIAE REAL-TIME PCR USER MANUAL
Product Use Limitations
• All reagents must exclusively be used for in vitro diagnostics.
• A strict compliance with the user manual is required for optimal results.
• Reliable results are dependent on adequate specimen collection, transport, storage and
processing procedures.
• This test has been validated for use with with bronchoalveolar lavage, vesicular fluid,
ocular fluid, swabs corneal scraping, cerebrospinal fluid, amniotic fluid, plasma, serum,
tissue/biopsy.
• This test has been validated for use with the ABI 7000-7300-7500-7900/ Roche Lc480-
Lc2.0 / Biorad iCycler-IQ5-CFX96 / Stratagene MX3000P-3500P / Qiagen Rotor-Gene /
Cepheid SmartCycler II real Time PCR systems.
Quality Control
Diagenode has obtained ISO 9001 and ISO 13485 certifications for the design, the production and
the sale of clinical diagnostic kits based on the real time PCR technology.
Mycoplasma/Chlamydophila pneumoniae Real-Time PCR is tested against predetermined
specifications to ensure the product quality.
References
Loens, K., T. Beck, et al. (2006). "Two quality control exercises involving nucleic acid amplification
methods for detection of Mycoplasma pneumoniae and Chlamydophila pneumoniae and carried
out 2 years apart (in 2002 and 2004) ." J Clin Microbiol 44(3): 899-908.
Templeton, K. E., S. A. Scheltinga, et al. (2003). "Comparison and evaluation of real-time PCR,
real-time nucleic acid sequence-based amplification, conventional PCR, and serology for
diagnosis of Mycoplasma pneumoniae ." J Clin Microbiol 41(9): 4366-71.
Templeton, K. E., S. A. Scheltinga, et al. (2005). "Improved diagnosis of the etiology of communityacquired
pneumonia with real-time polymerase chain reaction ." Clin Infect Dis 41(3): 345-51.
Welti, M., K. Jaton, et al. (2003). "Development of a multiplex real-time quantitative PCR assay
to detect Chlamydia pneumoniae, Legionella pneumophila and Mycoplasma pneumoniae in
respiratory tract secretions ." Diagn Microbiol Infect Dis 45(2): 85-95.
Europe Diagenode sa / CHU - Tour GIGA - B34 - 3 e étage // Avenue de l’Hôpital, 1 // 4000 Liège (Sart Tilman) // Belgium // Phone: (+32) 4 364 20 50 // Mail: info@diagenode.com