Real-Time PCR: Analyte-Specific Reagents versus FDA-Approved Kits

Abstract

In the January 2006 issue of the Clinical Microbiology Reviews, Espy et al. published a detailed comprehensive review on real-time PCR in clinical microbiology (M. J. Espy, J. R. Uhl, L. M. Sloan, S. P. Buckwalter, M. F. Jones, E. A. Vetter, J. D. C. Yao, N. L. Wengenack, J. E. Rosenblatt, F. R. Cockerill, and T. F. Smith, Clin. Microbiol. Rev. 19:165–256, 2006). This new technology is revolutionizing laboratory diagnosis of human pathogens. The authors covered extensively the literature on real-time PCR as well as the wide array of commercially available analyte-specific reagents (ASR) and products for research use only for real-time PCR but did not provide adequate coverage of available rapid real-time PCR diagnostic kits for detection of bacterial pathogens that are approved by the Food and Drug Administration (FDA). Currently, there are two FDA-approved real-time PCR kits that can replace standard culture (H. D. Davies, M. A. Miller, S. Faro, D. Gregson, S. C. Kehl, and J. A. Jordan, Clin. Infect. Dis. 39: 1129–1135, 2004; D. K. Warren, R. S. Liao, L. R. Merz, M. Eveland, and W. M. Dunne, J. Clin. Microbiol. 42:5578– 5581, 2004) and which are both commercialized by GeneOhm Sciences (a BD Company). The first, IDI-Strep BTM, was approved by the FDA in March 2003 for detection of group B streptococci from vaginal/anal swab specimens obtained from pregnant women during delivery (Davies et al., Clin. Infect. Dis. 39:1129–1135, 2004; F. J. Picard and M.G. Bergeron, Eur. J. Clin. Microbiol. Infect. Dis. 23:665–671, 2004). The second, IDIMRSATM, was approved in March 2004 for detection of methicillin-resistant Staphylococcus aureus from a nasal swab specimen (M. G. Bergeron, A. Huletsky, F. J. Picard, and M. Boissinot, Nature 430: 141, 2004; A. Huletsky, R. Giroux, V. Rossbach, M. Gagnon, M. Vaillancourt, M. Bernier, F. Gagnon, K. Truchon, M. Bastien, F. J. Picard, A. van Belkum, M. Ouellette, P. H. Roy, and M. G. Bergeron, J. Clin. Microbiol. 42:1875–1884; Warren et al., J. Clin. Microbiol. 42:5578– 5581, 2004).