Retrospective Evaluation of Accelerate Pheno™ System (AXDX, Version 1.1) for Identification/Antimicrobial Susceptibility Testing (ID/AST) of Gram-Negative Bacilli (GNB) including Carbapenemase-Producing Organisms (CPO) from Seeded Blood Culture Bottles (SBCB) Tested using AXDX PhenoTestTM BC Kits
Bibliographic record
Abstract
AXDX reports ID/AST in <7h from positive blood cultures. Prospective pre-FDA clinical trials were conducted in areas where CPO bacteremia was rare. This study challenged AXDX to detect CPO from SBCB. 53 GNB including 31 CPO (10 KPC, 8 OXA48-type, 4 NDM, 3 GES5, 3 VIM, 1 VIM/GES5, 1 IMP7, 1 SME) were tested in AXDX post SBCB incubation in BacT/Alert® (bioMérieux). Seeding suspensions were parallel-tested by CLSI M100-S27 broth microdilution (BMD) for cefazolin (CFZ), ceftriaxone (CRO), ceftazidime (CAZ), piperacillin/tazobactam (TZP), ertapenem (ETP), meropenem (MEM), ciprofloxacin (CIP), gentamicin (GM), tobramycin (TOB), and amikacin (AN). With GNB-genera combined, AXDX-AST were assessed vs BMD using Cumitech 31A for ≥90% agreements [essential (EA); categorical (CA)] and errors [very major (VME) <3%; combined major/minor (ME/mE) <7%]. AXDX produced evaluable results (ID-correct/AST-reported) for 83% GNB (19 Klebsiella species; 13 Escherichia coli; 5 Pseudomonas aeruginosa; 4 Enterobacter cloacae, 2 Proteus mirabilis; 1 Serratia marcescens) tabulated below. Limits were exceeded for underlined values, but 95% confidence intervals (CI) overlapped acceptable limits except in values marked with astericks [95% CI: EA (CRO:58.8–85.6; ETP:31.6–61.4; MEM:62.8–87.3; GEN:48.8–76.3); VME (MEM:11.7–45.2); ME/mE (CAZ:7.8–30.3)]. Of 31 CPO, by BMD/AXDX respectively, 2 (6.5%; P. mirabilis NDM, E. coli KPC)/4 (12.9%; same 2 plus E. cloacae KPC, S. marcescens SME) were ETP+MEM=S, 23 (74.2%)/17 (54.8%) were ETP+MEM=I/R and 6 (19.4%; 5 OXA48; 1 KPC)/12 (38.7%; same plus 14 KPC, 1 NDM, 1 SME) were ETP = I/R but MEM=S. If ETP-I/R alone predicted CPO, BMD/AXDX detected 93.5% (95% CI: 78.3–99.2)/87.1% (95% CI: 70.5–95.5) CPO, respectively (P = 0.6713, NS). But as 3/5 (60%) ETP=R non-CPO were also MEM=S by BMD+AXDX, this rule would incur MEM ME. Expert rules based on ETP enabled detection of 87.1% (70.5–95.5%) CPO by AXDX in <7h. But while this rule mitigates MEM VME, it risks introducing MEM ME. Further optimization of AXDX algorithms to distinguish challenging CPO growth patterns associated with low carbapenem MIC from non-CPO is underway. More CPO/non-CPO should be tested to tighten 95% CI obtained in this promising study. B. M. Willey, Mount Sinai Hospital: Investigator, Educational support S. M. Poutanen, Accelerate Diagnostics: Research Contractor and Scientific Advisor, Consulting fee and Research support
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.009 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 teacher head, 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".