Real-Time PCR: Analyte-Specific Reagents versus FDA-Approved Kits
Bibliographic record
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).
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.071 | 0.041 |
| Meta-epidemiology (narrow) | 0.003 | 0.002 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.006 | 0.004 |
| Science and technology studies | 0.001 | 0.006 |
| Scholarly communication | 0.010 | 0.012 |
| Open science | 0.004 | 0.003 |
| Research integrity | 0.008 | 0.010 |
| Insufficient payload (model declined to judge) | 0.004 | 0.006 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".