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'high sensitivity'

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Intended Use The 4th Generation HCV TRI-DOT is a rapid, visual, sensitive and qualitative in vitro diagnostic test for the detection of (IgM,IgG & IgA) antibodies to Hepatitis C virus in human serum or plasma. It has been developed and designed with increased sensitivity for core and NS3 antibodies using a unique combination of modified HCV antigen. Salient Features Based on “Flow Through Technology”, which is similar to Elisa technology because of involvement of washing steps at various levels to enhance the specificity. Use of highly purified HCV antigens for Core, NS3, NS4, NS5 immobilized on the device. Detection of all the subtypes of HCV. Results within 3 minutes. In built quality control dot which validates the test. 100% Sensitivity & 98.9% Specificity as per WHO evaluation. Shelf life : 24 months at 2-8°C

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Rapid Test

Intended Use Diagnos Dengue card is a rapid solid phase Immuno-chromatographic test for the qualitative differential detection of IgM and IgG antibodies to dengue virus in Human serum /Plasma. This test is for in vitro diagnostic use only and is intended as an aid in for presumptive diagnosis between primary and secondary dengue infection. Salient Features Rapid, visual and qualitative Immunoassay. Differential detection of IgM & IgG Antibodies. Detection of all the 4 Dengue serotypes (DEN-1, DEN-2, DEN-3 and DEN-4). See through device for easy interpretation of results. Unique sample processing method ensures highest accuracy in results. Results with in 20 minutes. Longer shelf life : 30 months at 2-30°C. Convenient pack size : 10 tests Sensitivity-95% and Specificity- 97%. Principle

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Hematology

BC-6800 Today, laboratories not only need more reliable routine CBC plus 5-part diff WBC testing by way of high processing speed, but are also looking for options that extend the analyzer's output in form of Reticulocytes, Nucleated RBCs, Fluorescent Platelet counts etc. for wider clinical application and research. On the other hand, they are restricted by limited budgets. BC-6800 can help to meet all these needs just perfectly and even exceed the expectations. Additional parameters for further clinical applications IMG(#,%) parameters provide information about immature granulocyte, including promyelocytes, myelocytes and metamyelocytes. HFC*(#,%) parameters represent high fluorescent cell population, such as blasts and atypical lymphocytes. RET(#,%) extend valuable help in the differential diagnosis and/or therapeutic monitoring of anemias. IRF is parameter concerning immature reticulocytes, which can assist in early diagnosis of anemia and monitoring the bone marrow response to therapy. InR*(#,‰) are parameters regarding infected red blood cell. The red blood cells may infected by plasmodium, which can cause malaria. * means research parameters SF Cube Technology SF Cube is a pathbreaking technology for reliable blood cell analysis, including WBC differential, Reticulocytes and NRBC with efficient flagging. After reaction with proprietory reagents, the targeted blood cells undergo 3D analysis using information from scatter of laser light at two angles and fluorescence signals. The 3D scattergram builds the power to better identify and differentiate blood cell populations, especially to reveal abnormal cell population undetected by other techniques. Minimizing interference to ensure more accurate results NRBCs are counted in a dedicated channel by SF cube method, which automatically corrects total WBC count and 5-part Diff results when NRBCs are detected. The Focusing Flow-DC method minimizes the interference traditionally encountered in DC technology to produce near gaussian histograms. PLT-O result avoids the interference from microcytic and fragmented RBCs, large platelets and/or platelet clumps by fluorescent stain, and enhances the results accuracy and sensitivity. High automation to minimize the workload Throughput for 125 tests/hour, autoloader for 100 sample tubes capacity Bi-directional LIS with HL7 or ASTM communication protocol Customizable re-exam rules allow users to define their re-exam criterion according to lab’s practice

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Medical Equipment

Since the company was founded, Mindray has been continuously exploring new ways to improve diagnostic confidence. Powered by the most revolutionary ZONE Sonography® Technology, Resona 7’s new ZST+ platform brings ultrasound image quality to a higher level by zone acquisition and channel data processing. As well as the premium level image quality, Resona 7 also enhances clinical research capabilities with the revolutionary V Flow for vascular hemodynamic evaluation, and the most intelligent plane acquisition from 3D datasets for fetal CNS diagnosis. Combining the most intuitive gesture-based multi-touch operation and all the essential clinical features, Resona 7 is truly leading new waves in ultrasound innovation. With core platform advantages of ZST+ The channel data based ZST+ is an extraordinary innovation, representing an ultrasound evolution. Transforming ultrasound metrics from conventional beamforming to channel data based processing, ZST+ is able to deliver multiple imaging advances: Advanced Acoustic Acquisition, Dynamic Pixel Focusing, Sound Speed Compensation, Enhanced Channel Data Processing and Total Recall Imaging. Advanced features V Flow V Flow (Vector Flow) is a novel approach for vascular hemodynamic analysis. V Flow uses color coded vector arrows to indicate the velocity’s magnitude and direction of blood cells. With ultra-high frame rates, it provides extremely accurate and angle-independent visualization of complex vascular hemodynamic profiles. With comprehensive data information, V Flow is the most valuable tool for vascular clinical research. resona-7-fig3-1-pc UWN+ Contrast Imaging UWN+ (Ultra-Wideband Non-linear Plus) CEUS enables the Resona 7 to detect and utilize both the 2nd harmonic and non-linear fundamental signals, generating significantly enhanced images, resulting in greater sensitivity of minor signals and longer agent duration with lower MI. Forwarding smart to clinical intelligence The Resona 7 elevates clinical intelligence with a complete solution that enables clinicians to manage both routine and advanced studies more efficiently,consistently, and accurately, from acquisition to calculation. As an example, Smart Planes CNS shows exceptional intelligence in accurate diagnosis and analysis of the fetal central nervous system (CNS) Smart Planes CNS Mindray’s exclusive pioneering technology positions the Resona 7 as the industry’s first ultrasound system to allow fully automatic and accurate detection of the most significant planes and frequently used measurements of fetal CNS, leading to intelligent diagnosis, improved throughput, and reduced user dependence. Smart Planes CNS provides a user-friendly tool that greatly improves scanning efficiency through increased accuracy coupled with automated operation. With a simple button click on a 3D fetal brain volume image, the standard CNS scanning planes (MSP, TCP, TTP and TVP) and a range of related anatomical measurements (BPD, HC, OFD, TCD, CM and LVW) are obtained immediately. Smart Face Acquiring an optimal view of the fetal face in 3D ultrasound is cumbersome and time-consuming. In some cases, it is impossible to get rid of the occlusions such as cord, placenta, uterus and extremities. The new Resona 7 with Zone Intelligence provides a fast and intelligent optimization for fetal face with simply one-touch. It can immediately remove occlusions in the volume data, eliminate unwanted noise information, and generate an optimal view of the fetal face with minimal effort. Ergonomics The Resona 7 is designed around you. Gesture-based operation opens up a new trend in cart-based ultrasound with an agile, smart, and intuitive user experience beyond your expectations. Gel warmer’s three level temperature and swiveling angle adjustment of the control panel delivers great patient comfort and user convenience.

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Rapid Test

STANDARD F Chikungunya IgM/IgG FIA qualitatively analyzes Chikungunya virus specific IgM and IgG antibodies in serum, plasma and whole blood using fluorescent immunoassay. Screening test results can be obtained within 15 minutes with high sensitivity and specificity. Intented Use This product performs qualitative analysis on Chikungunya virus specific IgM and IgG antibodies in serum, plasma and whole blood. Advantage Able to perform qualitative analysis with high sensitivity and specificity by using fluorescent substance Objective result - Eliminates the subjectivity of a visual result Automatic strip recognition by reading the information stored in 2D barcode

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Rapid Test

The OnSite Troponin I Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of cardiac Troponin I (cTnI) in human serum, plasma or whole blood at a level equal to or higher than 1 ng/mL. It can be performed within 15 minutes by minimally skilled personnel, and without the use of laboratory equipment. The OnSite Troponin I Combo Rapid Test is intended to be used by healthcare professionals as an aid in the diagnosis of acute myocardial infarction (AMI). Any use or interpretation of this preliminary test result must also rely on patient’s symptoms and the professional judgment of a physician. A more precise test method such as an instrument method must be used to confirm the test result obtained by this device. Normally the level of cTnI in the blood is very low. cTnI is released into the blood stream in forms of free cTnI and cTnI-C-T complex at 4-6 hours after myocardial cell damage. The elevated level of cTnI could be as high as 50 ng/mL during 60-80 hours after AMI and remains detectable for up to 10-14 days post AMI. Therefore, circulating cTnI is a specific and sensitive marker for AMI. Clinical performance: Relative Sensitivity: 95.8% (95% CI: 91.5-97.9%) compared to a reference CLIA Relative Specificity: 99.7% (95% CI: 98.8-99.9%) Analytical sensitivity: The detection limit of cTnI is 1.0 ng/mL or greater in serum, plasma or whole blood specimen Cross-reactivity: No cross reactivity with 10 µg/mL skeletal muscle TnI, 2,000 ng/mL cardiac muscle TnT, 20 µg/mL cardiac muscle Myosin Dose hook effect: No hook effect was observed for cTnI at concentrations up to 3,521 µg/mL Interference: No interference was seen with 20 mg/dl Acetaminophen, 20 mg/dl Acetylsalicylic acid, 10.5 g/dl Albumin, 20 mg/dl Ascorbic acid, 1,000 mg/dl Bilirubin, 20 mg/dl Caffeine, 800 mg/dl Cholesterol, 200 mg/dl Creatinine, 20 mg/dl Gentistic acid, 1,000 mg/dl Hemoglobin, 600 mg/dl Oxilic acid, 1,600 mg/dl Triglycerides Shelf life: 24 months Individually sealed foil pouches containing: One cassette device One desiccant Plastic droppers Sample diluent (REF SB-R3002, 5 mL/bottle) One package insert (instruction for use) CTK Products at a Glance Insert MedlinePlus: Troponin Test Poster

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Rapid Test

The OnSite Typhoid IgG/IgM Combo Rapid Test is a lateral flow immunoassay for the detection and differentiation of IgG and IgM anti-Salmonella typhi (S. typhi) and paratyphi in human serum, plasma or whole blood. Utilizes O antigen and H antigen from both typhi and paratyphi serovars to maximize sensitivity Differentiates between IgG and IgM to determine stage of infection One step procedure minimizes operator error due to sample preparation Test result within 15 minutes allows medical professionals to take immediate action High level of reproducibility Test kits can be used and stored in a wide range of temperatures Individually sealed foil pouches containing: One cassette device One desiccant Plastic droppers Sample Diluent (REF SB-R0161, 5 mL/bottle) Package insert (instruction for use) CTK Products at a Glance Flyer Inserts U.S. CDC Typhoid Homepage: About Typhoid WHO: Health Topic for Typhoid

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