BLOOD COMPONENTS: Screening of single‐donor apheresis platelets for bacterial contamination: the PASSPORT study results
Bibliographic record
Abstract
BACKGROUND: The PASSPORT study was an FDA-mandated surveillance of outdated 7-day apheresis platelets (APs) to assess the bacterial culture release test (RT) performance and the chance of transfusing APs containing viable bacteria compared to untested 5-day APs. STUDY DESIGN AND METHODS: Aerobic and anaerobic culture bottles were inoculated with 4 to 5 mL from APs 24 to 36 hours postcollection. APs were released after 24 hours if no growth was observed. Released APs were recalled for RT positives, and clinical services were notified. Day 8 APs were recultured (surveillance test [ST]). Initially positive RTs and STs were confirmed by AP reculture. RESULTS: A total of 388,903 RTs were accrued September 2005 through January 2008 from 52 regional blood centers: RT-positive APs interdicted before transfusion, 76 true positive (TP; 195/million; 95% confidence interval [CI], 154-244/million) and 57 indeterminate (IN); and RT-positive APs transfused, 14 TP and 242 IN. There were 14 reported septic transfusion reactions (STRs) from 13 AP collections (23 units) transfused on Days 3 through 7; three STRs were from Day 6 or 7 APs. There were two false-negative RTs causing STRs in three patients. No deaths were reported. STs had four TPs of 6039 tested (662/million; 95% CI, 180-1695/million). CONCLUSIONS: RT culturing prevents issuance of some bacterially contaminated APs. ST culture data and clinical reports suggest that this screening fails to detect all contaminated units. No fatalities were reported related to AP transfusion. Additional actions or testing may be required to further reduce the residual STR risk of RT APs, even with a 5-day storage limitation.
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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 | 0.005 | 0.008 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.001 |
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".