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'assay panel'

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immunoassayReagents

INTENDED USE The Finecare™ cTn I/NT-proBNP Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of cardiac Troponin I (cTn I) and N-terminal prohormone of brain natriuretic peptide (NT-proBNP) in human whole blood, serum or plasma. This test is used as an aid to assist in the diagnosis of myocardial infarction and suspected congestive heart failure. STORAGE AND STABILITY 1. Store the test kit at 4℃~30℃ up to the expiration date printed on package. 2. If removed from refrigerator, allow the test kit for 30 minutes to return to room temperature before testing. 3. Do not remove the Test Cartridge from the pouch until use. The Test Cartridge should be used within 1 hour once opened.

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Clinical Chemistry

The ADVIA® 1800 Clinical Chemistry System pushes the limit of productivity. Its extensive menu allows integration of testing for clinical chemistry, drugs-of-abuse, therapeutic drug monitoring (TDM) and specific proteins such as cystatin C and CardioPhase® hsCRP. The ADVIA 1800 Clinical Chemistry System offers: Throughput of up to 1,800 tests per hour to keep pace with workload peaks 200 basic metabolic panels per hour to meet turnaround-time demands Large onboard reagent capacity and optional concentrated reagents to reduce interruptions Optimal standardization of reagents and systems for efficient consumable usage Refrigerated onboard storage of controls and reagents for extended stability and increased productivity Automation-ready design: no additional hardware required Features & Benefits The ADVIA 1800® Clinical Chemistry System pushes the limit of productivity in the core lab and meets the turnaround-time (TAT) goals of today’s laboratories. Its extensive menu allows integration of general clinical chemistry testing with testing for drugs-of-abuse, TDM, special chemistry, and specific proteins such as cystatin C and CardioPhase® hsCRP. Automation-ready design Point-in-space aspiration enables connectivity to a track, VersaCell® System. Redundant sample loading provides built-in backup and easy handling of non-routine samples. Direct sampling from track prevents tubes being detained at an analyzer and reduces aliquoting. Peak productivity Throughput of up to 1,800 tests per hour provides the speed to keep pace with workload peaks. Throughput of 200 basic metabolic panels per hour helps to meet turnaround-time demands. Automatic Sample Retain technology lets you perform reruns and dilutions without the need to retrieve primary tubes. Consolidate chemistry testing on one system with a comprehensive menu, consistent cycle times, speed, and open application capability. Total system reliability Minimal-maintenance ISEs Robust hardware and simplified software design, with automatic calibration validation and tracking Advances in reagent onboard stability, calibration frequency, interference reduction and assay linearity expansion Direct water connection Remote diagnostics and Inter-Laboratory Quality Control (ILQC) options Easy efficiency Large onboard reagent capacity and optional concentrated reagents reduce interruptions. High-resolution touchscreen delivers push-button operation. Reagent pause capability and onboard Sample Pause button make loading easy. Minimal maintenance requirements, including no-maintenance oil bath, reduce hands-on time. Sample integrity checking, include serum indices reporting, short-sample flagging, and clot detection, reducing the need for manual intervention.

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Clinical Chemistry

The SAL 9000 Modular System delivers high throughput of chemistry and immunoassay testing by integrating Mindray BS-2000 Chemistry Analyzer and CL-6000i Chemiluminescence Immunoassay Analyzer, and new Sample Processing line SPL 2000. With patented automatic serum analysis design, SAL 9000 not only helps you optimize the management of lab space and manpower, it also offers highly reliable test results. Product Specification Automation Fully Automatic Brand Mindray Model Name/Number SAL 9000 Assays Clinical Chemistry Power Supply 230 V Reaction Cuvette Reusable Cuvette Storage 300000 Samples Features Seamless Integration Usage/Application Lab Wavelength 5000nm Number Of Reagent Positions 4 Weight 130kg Frequency 50 Hertz Power 45 Watt Product Description The SAL 9000 Modular System delivers high throughput of chemistry and immunoassay testing by integrating Mindray BS-2000 Chemistry Analyzer and CL-6000i Chemiluminescence Immunoassay Analyzer, and new Sample Processing line SPL 2000. With patented automatic serum analysis design, SAL 9000 not only helps you optimize the management of lab space and manpower, it also offers highly reliable test results. Features Maximize laboratory efficiency Integration: Optimize your lab’s customized arrangement with better automation system Efficiency: High-throughput chemistry and immunology modules for longer walk-away time Reliability: Ingenious and comprehensive analytic system provides reliable and accurate results Easy operation: Fully automated design,user-friendly operation interface and intelligent software function

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Clinical Chemistry

The SAL 6000 modular system delivers fast throughput and powerful integration across immunoassay and chemistry systems. Broad assays can be tested with one sample tube, which can maximize operation efficiency and increase lab productivity. Product Description SAL 6000 Modular System delivers fast throughput and seamless integration of CL-2000i Chemiluminescence Immunoassay System and BS-800 Modular System. In conjunction with the SPL 1000 Sample Processing System, this scalable platform not only provides optimized workflow, it also offers satisfactory operator experience. Features · Seamless integration, workflow optimization · Uniform software interface, easy of operation · One tube sampling, flexible to test · Technology and quality heritage · Flexible scalability, on-site upgrading · Comprehensive test menu Product Specification Automation Fully Automatic Brand Mindray Model Name/Number SAL 6000 Assays Clinical Chemistry Power Supply 220 V Usage/Application Hospital Frequency 50 Hz

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Laboratory Usage

Using best-in-class technology, the Mindray CL-6000i is a chemiluminescence immunoassay analyzer with high throughput, high performance and high reliability. Features Throughput: up to 480 tests per hour Measurement principle: enhanced ALP-AMPPD method Reagent carousel: 36 reagent positions with non-stop refrigerating Sample handling: up to 300 samples can be loaded in one batch, sample loading and offloading continuously by sample racks, fast prioritizing STAT samples Sample volume: 5-110 μL Continuously loading of reagents, substrate, cuvettes, wash buffer and waste bags Zero daily maintenance Product Specification Model Name/Number CL-6000i Usage/Application Hospital Brand Mindray Sample Volume Range 5-110 microlitre Throughput up to 480 tests per hour Measurement Principle enhanced ALP-AMPPD method Reagent Carousel 36 reagent positions with non-stop refrigerating Sample Handling up to 300 samples can be loaded in one batch,sample loading and offloading continuously by sample r

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Rapid Test

The OnSite HBV-5 Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B e-antigen (HBeAg), hepatitis B e-antibody (HBeAb), and hepatitis B core antibody (HBcAb) in human serum or plasma. It is intended to be used by healthcare professionals to aid in the diagnosis of infection with hepatitis B virus (HBV). Any use or interpretation of this preliminary test result must also rely on other clinical findings and the professional judgment of healthcare providers. Alternative test method(s) should be considered to confirm the test results obtained by this device. Panel format cassette to conveniently test for five targets at once Utilize all markers to help distinguish between acute and chronic infections Result in 15 minutes Individually sealed foil pouches containing: One cassette device One desiccant Plastic droppers Package insert (instruction for use) CTK Products at a Glance Inserts Poster U.S. CDC: hepatitis B Virus FAQs for Health Professionals WHO: Health Topic for Hepatitis

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Rapid Test

The OnSite HIV 1/2 Ab Plus Combo Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of HIV-1 and HIV-2 antibodies (IgG, IgM, IgA) in human serum, plasma or whole blood. 3rd Generation, double-antigen based test to increase the sensitivity in early detection Requires only 20 µL of specimen Use serum, plasma or whole blood Results available within 15 minutes to allow prompt action to be taken at the point of care Performance validated with BBI low titre panel and Chinese FDA HIV Ab panel Individually sealed foil pouches containing: One cassette device One desiccant Capillary tubes (20 uL) Sample diluent (REF SB-R0011, 5 mL/bottle) Package insert (instruction for use) CTK Products at a Glance Flyer Inserts TB-HIV Rapid Test Presentation U.S. CDC HIV Homepage: About HIV WHO: Health Topic for HIV U.S. CDC HIV Testing 101

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Rapid Test

The OnSite Duo HSV-1/2 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for qualitative detection and differentiation of antibodies (IgG and IgM) to herpes simplex virus 1 (HSV-1) and herpes simplex virus 2 (HSV-2) in human serum, plasma or whole blood. This test can be performed in 10 minutes by minimally skilled personnel without the use of laboratory equipment. This test is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of infection with HSV-1 and/or HSV-2. The OnSite Duo HSV-1/2 IgG/IgM Rapid Test uses HSV-1 glycoprotein G1 and HSV-2 glycoprotein G2 for the specific detection and differentiation of IgG and IgM antibodies to HSV-1 and HSV-2 in serum, plasma and whole blood. An HSV-1 and/or HSV-2 IgM positive result indicates an active infection, which may be primary or recurrent. An HSV-1 and/or HSV-2 IgG positive result indicates a recent or past infection. However, a negative test result does not preclude the possibility of infection with HSV-1 and/or HSV-2. Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this device. Clinical accuracy: 90.6% sensitivity and 91.4% specificity for anti-HSV-1 IgG detection 93.8% sensitivity and 96.0% specificity for anti-HSV-2 IgG detection 85.0% overall agreement for anti-HSV-1 IgM detection comparing to commercial ELISA 100% overall agreement for anti-HSV-2 IgM detection comparing to BBI Panel (PTH202) Positive rate on random clinical specimens:8% for IgG anti-HSV-1 and 4.9% for IgM anti-HSV-1 (n=10,000); 4.6% for anti-HSV-2 IgG and 1.7% for anti-HSV-2 IgM Cross reactivity: no cross reactivity with the following disease states or special conditions, respectively: palladium, H. pylori, Dengue, Malaria, Typhoid, Toxoplasma, Rubella, CMV, hCG, TB, HAV, HBV, HCV, HEV, HIV, ANA, HAMA, RF (up to 1,000 IU/mL) Interference: No interference was seen with Albumin 60 g/L , Hemoglobin 2 g/L, Bilirubin 20 mg/dL, Heparin 3,000 U/L, Creatinine 442 µmol/L, Salicylic acid 4.24 mmol/L, EDTA 3.4 µmol/L, Sodium citrate 8%, Glucose 55 mmol/L Shelf life: 24 months Individually sealed foil pouches containing: One cassette device One desiccant Capillary tubes (10 µL) Sample diluent (REF SB-R0203, 5 mL/bottle) Package insert (instruction for use) Individually sealed foil pouches containing: One cassette device One desiccant Capillary tubes (10 µL) Sample diluent (REF SB-R0203, 5 mL/bottle) Package insert (instruction for use)

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Immunology Analyzer

Fully Automated Chemiluminescence Immunoassay Analyzer Introducing iFlash 1200, a chemiluminescence immunoassay analyzer that offers fully automated immunoassay analysis using Magnetic particle-based Direct Chemiluminescence technology. With a high throughput of up to 120 tests per hour and a first result available in just 13 minutes, iFlash 1200 is one of the fastest and most efficient immunoassay analyzers available on the market. The instrument features continuous STAT sample loading capacity with 16 sample positions, continuous reagents loading capacity with 15 reagent positions, and continuous loading of reaction vessels with a capacity of 500 cuvettes. Additionally, iFlash 1200 uses Acridinium Ester Labeled Direct Chemiluminescence for highly accurate and reliable results, and comes with ready-to-use reagents in convenient 2 x 50 tests pack size for simplified testing. Overall, iFlash 1200 is an innovative and versatile immunoassay analyzer that is perfect for laboratories that require high throughput and rapid turnaround times. iFlash 1200 chemiluminescence immunoassay analyzer Key Features: 1.Continuous loading of reagents with convenient pack size of 2 x 50 tests 2.Continous loading of 500 reaction cuvettes for longer walkaway time 3. 4 step magnetic separation for achieving high precision and quality results 4.Non contact vortex mixer-Highly Efficient technology to prevent carryover & cross contamination Additional information General Information Throughput : upto 120 tests/hour Time to First Results :13 minutes Detection Principle Magnetic particle Based Direct Chemiluminescence Chemiluminescence Label :Acridinium Ester Sample System Sample Position :16 sample position Types of Sample tube :Microcup & blood collecting tubes Sample Volume :5~150μL Reagent System Reagent Position :15 reagent positions with onboard refrigeration Reagent Carousel Temp :2-8 °C Reagent Detection :Reagent Level Tracking Reagent Pack : 2 x 50 tests Reagent Carousel Incubation Capacity :48 reaction vessels Incubation Temperature :37°C+-0.3°C Mixing System :Non-Contact Vortex Mixer Operating Conditions Power Supply :100~240V, 50/60HZ Power Consumption :600VA Temperature :10~30°C Weight :120 Kg Reagents iFlash 1200 reagents iFlash 1200 reagents Pack size 2 x 50 Tests 28 days On board reagent stability 28 days Calibration stability Built in Calibrators for all Parameters

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