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The 鲎 test microbial rapid detection system is a uranium test for bacterial endotoxin and fungal (1,3)-β-D-glucan quantitative detection instruments that are FDA GMP-compliant. The system has the following features:
1. Powerful: It can detect a variety of items: bacterial endotoxin test, fungal (1-3)-β-D-glucan test and enzyme-linked immunosorbent assay.
2. Suitable for a variety of analytical methods: dynamic turbidity method, dynamic color method and endpoint color method. Simultaneous detection by dynamic turbidity method and dynamic chromogenic method is supported.
3. High throughput: 96 samples were tested simultaneously.
4. The wavelength range is 340-900nm, which can be used for UV detection and visible light detection.
5. Equipped with 6-bit filter wheel, the standard configuration contains 5 filters (340, 405, 450, 540 and 630nm), which meets the needs of various sputum test quantitative detection methods and enzyme label tests. The optimal detection wavelength of the dynamic turbidity method is 630 nm; the optimal detection wavelength of the endpoint chromogenic method is 405 or 540 nm; the optimal detection wavelength of the dynamic chromogenic method is 405 nm.
6. Temperature control up to 50 °C, patented 4-Zone TM temperature control system, closed detection space, free from external environment, rapid heating rate, uniform temperature between holes. The temperature setting accuracy is 0.1 °C.
7. Detection time: dynamic turbidity method and dynamic color method are 1 hour; end point color method is as short as 16 minutes.
8. Sensitivity: bacterial endotoxin test: 0.001 EU/ml; fungal (1,3)-β-D-glucan assay: 5 pg/ml.
9. Minimum reagent consumption: 0.05ml.
10. The detection container is an international standardized 96-well microplate, which minimizes the influence of the difference in diameter and thickness of the detection container; 96 samples are simultaneously tested; multi-channel pipettes can be used for up to 12 holes simultaneously; and can be equipped with automatic operation System to improve work efficiency and eliminate human error. The system is equipped with consumables to eliminate the heat-containing dextran 8-hole independent packaging slats, reducing the amount of consumables used.
11. Support multi-wavelength synchronous measurement; support single and dual-wavelength dynamics detection; set reference wavelength to eliminate interference.
12. With oscillating function: 4-speed oscillation, adjustable time, which is conducive to uniform mixing of samples and reagents.
13. The instrument manufacturer has passed ISO13485:2003, ISO9001:2008 quality system certification; the instrument has passed CE certification; each instrument is equipped with a quality guarantee that meets the requirements of the US FDA GMP.
14. The system is equipped with powerful professional analysis software for simultaneous detection of bacterial endotoxin and fungi (1,3)-β-D-glucan; automatic calculation of bacterial endotoxin and fungi (1,3)-β-D - Glucan content, automatic calculation of sample recovery rate, automatic deduction of sample control; all data can be exported to MS Excel, can be connected to hospital LIS system; support multiple standard curve synchronization operations; any data read in the experiment (including Dynamics detects each read data) real-time backup.
Application range:
1. Detection of bacterial endotoxin and fungal (1,3)-β-D-glucan in clinical human or animal body fluids (blood, urine, ascites, cerebrospinal fluid, etc.).
2. Drug testing: The Pharmacopoeia stipulates the detection of injections, biological products, vaccines, and blood products that require bacterial endotoxin testing.
3. Production monitoring: endotoxin testing of raw and auxiliary materials, intermediate products and end products of pharmaceutical enterprises; multi-point monitoring of bacterial endotoxin contamination and pre- and post-injection verification and daily monitoring of water for injection.
4. Endotoxin testing of implantable medical devices such as blood transfusions and infusions.
5. Blood station blood preservation solution, empty blood bag endotoxin detection.
6. Toxin detection in dialysate, dialysate, and dialyzer.
7. Detection of endotoxin (pyrogen) such as stem cell suspension and cell culture medium.
8. Endotoxin detection of molecular biological products such as proteins and nucleic acids such as antibodies and plasmids.
Application areas:
1. Hospital: ICU, Hematology, Nephrology, Laboratory, Burns, Infectious Diseases (Hepatology, etc.), Pediatrics, Gastroenterology, Respiratory, etc.
2. Pharmaceutical manufacturers, medical device manufacturers: R&D department, production department, quality department QC, laboratory
3. Drug inspection agency
4. Third party testing and certification body
5. Clinical inspection center
6. Research institutes, life science research institutions
7. Center for Disease Control and Prevention (CDC) and Health Surveillance
8. Blood station, blood center
9. Stem Cell Research and Treatment Agency
Catalog number
Product name
KPR808
鲎Test microbial rapid detection system, model: ELx808 (supporting IU)