ArticleJournal of clinical microbiology2019
Comprehensive Evaluation of Compendial USP<71>, BacT/Alert Dual-T, and Bactec FX for Detection of Product Sterility Testing Contaminants.
Article in Journal of clinical microbiology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed.
- A decade of innovation in healthcare: Automation, bio-printing and digital twin technologies for personalized therapies.International journal of pharmaceutics: X · 2026Review
- One-day rapid sterility test for human-derived biopharmaceuticals.Nature biomedical engineering · 2026Article
- Evaluation of an automated blood culture detection system for sterility testing of cellular and gene therapy products.Microbiology spectrum · 2026Article
- Dean migration mechanisms: facilitating the control of microbial contaminants in cell therapy product manufacturing.Microsystems & nanoengineering · 2026Article
- Reply to "Finding the middle way: rethinking cGMP for sterility testing of cellular therapy products in minimal manipulation settings".Journal of clinical microbiology · 2025Article
- Comparative Evaluation of Temperature, Bottle Type, and Amphotericin B on Fungal Detection in Corneal Preservation Media Using the BACT/ALERT SystemMicroorganisms · 2025Article
- Machine learning aided UV absorbance spectroscopy for microbial contamination in cell therapy products.Scientific reports · 2025Article
- Considerations for the development of iPSC-derived cell therapies: a review of key challenges by the JSRM-ISCT iPSC Committee.Cytotherapy · 2024Review
- Optimized preparation pipeline for emergency phage therapy against Pseudomonas aeruginosa at Yale University.Scientific reports · 2024Article
- Basics of advanced therapy medicinal product development in academic pharma and the role of a GMP simulation unit.Immuno-oncology technology · 2023Review
- Sterility Testing for Hematopoietic Stem Cells.Journal of clinical microbiology · 2023Review
- The ratio of nicotinic acid to nicotinamide as a microbial biomarker for assessing cell therapy product sterility.Molecular therapy. Methods & clinical development · 2022Article
- Principles and Protocols For Post-Cryopreservation Quality Evaluation of Stem Cells in Novel Biomedicine.Frontiers in pharmacology · 2022Review
- Comprehensive Study Identifies a Sensitive, Low-Risk, Closed-System Model for Detection of Fungal Contaminants in Cell and Gene Therapy Products.Journal of clinical microbiology · 2021Article
- Use of 27G needles improves sensitivity and performance of ATCC anaerobe reference microorganism detection in BacT/Alert system.Molecular therapy. Methods & clinical development · 2021Article
- Regulatory considerations for developing a phase I investigational new drug application for autologous induced pluripotent stem cells-based therapy product.Stem cells translational medicine · 2021Review
- Raman spectra-based deep learning: A tool to identify microbial contamination.MicrobiologyOpen · 2020Article
- Sterility Testing for Cellular Therapies: What Is the Role of the Clinical Microbiology Laboratory?Journal of clinical microbiology · 2020Review
- Microbiological Control of Cellular Products: The Relevance of the Cellular Matrix, Incubation Temperature, and Atmosphere for the Detection Performance of Automated Culture Systems.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2020Article
- Validation of an automated quality control method to test sterility of two advanced therapy medicinal products: Mesenchymal stromal cells and their extracellular vesicles.Hematology, transfusion and cell therapyArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
The emergence of cell therapy programs in large academic centers has led to an increasing demand for clinical laboratories to assist with product sterility testing. Automated blood culture systems have shown promise as alternatives to the manual USP<71> compendial method, but current published data are limited by small organism test sets, particularly for molds. In 2015, failure of the Bactec FX system to detect mold contamination in two products prompted us to evaluate three test systems (compendial USP<71>, Bactec FX, and BacT/Alert Dual-T) over seven different culture combinations, using 118 challenge organisms representative of the NIH current good manufacturing practice (cGMP) environment. At <96 h and <144 h for bacterial and fungal detection, respectively, the compendial USP<71> method significantly outperformed the Bactec FX system (84.7% versus 64.4%;
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.