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Hematology

n large laboratories, rows of instruments are seen working tirelessly like miniature factories – only they produce not commodities but medical test results. Mindray CAL 8000 new-generation cellular automation line is one of them, but unlike a typical workhorse, it is intelligent. It is a highly automated workstation for smarter, faster, and more accurate cellular analysis. It can perform competently in the face of these challenges. The workstation can hold up to four units of BC-6800 automated hematology analyzer, which utilizes the advanced SF Cube technology and 3-D scatter grams to help doctors better differentiate blood cell populations and reveal abnormal cells undetectable by conventional techniques. With 125 CBC tests per hour per unit, BC-6800 brings the process rate of the workstation to 20–30 percent higher than other similar models, effectively alleviating laboratory's stress during the peak processing hours. On CAL 8000, the hematology analyzer, slide maker and stainer, CRP analyzer, and HbA1c analyzer are all integrated into one seamless production line through automated track modules and trolley. Simply by loading a single tube of blood sample onto the automation system, one can get all the test results. This innovative walk-away automation functionality has made possible the CBC+CRP+HbA1c testing all in one streamlined workstation for the first time in the industry. It offers a smart solution, or rather, a smart expert – the labX pert 2.0. It is a software that can automatically sort out the suspected samples for manual validation. The pathologist then decides if rerun or microscopic review is warranted based on their clinical experience. It avoids wasting slides and reduces extra work. Moreover, the onboard automated re-exam functionality also helps enhance work efficiency. The CMU software The touch screen is the “brain” of CAL 8000. It optimizes the distribution of workload between each analyzer unit and decides which sample requires a blood smear. It displays the status of each analyzer or SC-120 installed on CAL 8000 as well as the volume of balance reagent. This intuitive software can tell the users all necessary information of CAL 8000 at any given time. Consequently, the users spend less time operating CAL 8000 and can arrange their working schedule better. Multi “R” tests The CAL 8000 can automatically distribute the samples with “Repeat”, “Rerun” and “Reflex” criteria which are pre-defined by users.The re-exam criteria on CAL 8000 can be defined by many conditions, such as time, patient’s age, gender, department, etc. This helps minimize the number of blood smears. Special tube racks The special tube racks utilize different barcodes to differentiate specific testing purposes, such as “QC”, “Slide making & staining only” and “RET test only”. The special tube racks can carry the tubes to perform these specific functions in the simplest way.

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Laboratory Testing Analyzer

For smaller Laboratories Smaller, but with full functionality Compact size Full functions and performance in a compact size. *Size comparison with HA-8180V Accuracy HPLC technology provides accurate results-inluding detailed chromatogram. it will be shown in both IFCC and NGSP units. Cap-piercing method ADAMS Lite uses a cap-piercing method which enables the placement of capped blood samples. This not only reduces the workload but also helps protect lab technicians from infection. Easy-to-maintain No special tools are required for daily maintenance. Exchanged parts are hand-tightened, minimizing the workload of users. Specifications Measurement objects Whole blood or hemolysis sample Measured items Fast Mode: HbA1c (Stable HbA1c, S-A1c) and HbF Variant Mode: HbA1c (Stable HbA1c, S-A1c) and HbF (HbS and HbC separation and HbE and HbD detection can be performed). Measurement principle Reversed-phase cation exchange chromatography Measurement wavelength 420 nm/500 nm (Dual-wavelength colorimetry) Resolution 0.1% Ratio, 1 mmol/mol Measurement range HbA1c: 3 - 20%, 9 - 195 mmol/mol HbF: 0 - 100% Processing speed Variant mode: 160 seconds/test Fast mode: 100 seconds/test Sample consumption Whole blood sample: Approximately 4µL Anemia sample: Approximately 8 µL Hemolysis sample: Approximately 350 µL Sample container Sample tube: (12.3 or 15 mm in outer diameter) × (75 to 100 mm in height) Sample cup: 500 µL Sample supply Piercing sampling Compatible rack type ARKRAY racks (for 5 samples) Operating environment Temperature: 10 - 30°C; Humidity: 20 - 80% RH (No condensation) Display 20 digits × 2 lines LCD Printer For use with 58-mm width thermal printer paper Number of measurement samples Maximum 10 samples Power requirements AC 100 - 240 V±10%, 50/60 Hz Dimensions 330 (W) × 515 (D) × 485 (H) mm (Not including protrusions, eluent packs and hemolysis washing solution bottle)

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Clinical Chemistry

ADVIA 2400 Chemistry System The right balance of speed and efficiency The ADVIA® 2400 Clinical Chemistry System manages the most demanding workloads and meets high turnaround-time (TAT) goals. Its menu includes methods for testing drugs-of-abuse, therapeutic drugs (TDM) and new assays such as cystatin C and CardioPhase® hsCRP. The ADVIA 2400 Clinical Chemistry System offers: High throughput of up to 2400 tests/hour (1800 photometric and 600 ISE) to manage heavy workloads Rapid, consistent, 2-second cycle time for faster tube speed and test throughput User-defined automatic repeat, dilution, and reflex testing Large onboard reagent capacity and optional concentrated reagents help to minimize intervention demands Refrigerated onboard storage of controls and reagents for extended stability and increased productivity Automation-ready design: no additional hardware required Features & Benefits The ADVIA 2400 Clinical Chemistry System meets today’s high turnaround-time goals with a throughput of up to 2400 tests/hour. In addition to assays for general and specialty chemistries, its menu includes assays for specific protein measurement, drugs-of-abuse testing (DAT), and therapeutic drug monitoring (TDM). Interesting new assays such as cystatin C, HbA1c with automated sample pretreatment, and CardioPhase® hsCRP can now be included in your routine testing. The ADVIA 2400 Chemistry System pushes productivity levels while maintaining the reliability and stability that keep laboratories up and running. A rapid, 2-second probe cycle time maximizes tube speed and test throughput and combines with the system’s efficient automation-readiness to provide the turnaround time needed for high-volume laboratories Superior Speed and Productivity Throughput of up to 2400 tests/hour (1800 photometric and 600 ISE) to manage the heaviest workloads Rapid, consistent, 2-second cycle time Throughput of 200 tubes per hour, even when running three ISE tests and nine photometric tests per sample Automatic Sample Retain technology, auto-repeat, auto-dilution, and auto-reflex testing Automation-ready Point-in-space aspiration enables connectivity to a track. 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. Minimal Need for Operator Intervention Minimal-maintenance ISEs Large onboard reagent capacity and optional concentrated reagents for fewer interruptions No-maintenance, 37°C incubation oil bath Auto-calibration and auto-QC from refrigerated onboard calibrators and controls Microvolume technology with 32,000 tests onboard and up to 60 days' onboard stability for improved walkaway time. Concentrated reagents for increased maximum capacity. Remote diagnostics and Inter-Laboratory Quality Control (ILQC) options Exceptional Reliability Sample integrity check for icterus, hemolysis, and lipemia Sample probe with automatic clot/clog detection, liquid-level sensing, short-sample detection, and crash protection Advances in onboard reagent stability, calibration frequency, reduction in interferences, and expanded assay linearity

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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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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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Rapid Test

The OnSite HSV-2 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of antibodies (IgG and IgM) to herpes simplex virus 2 (HSV-2) in human serum, plasma or whole blood. Unique test that utilizes glycoprotein G2 to differentiate between HSV-1. and HSV-2 that allows for an early start of treatment action. Immediate determination of either acute or chronic infection by detecting and differentiating IgG and IgM anti-HSV-2. High confidence as test is in agreement with market leading European ELISA: 95.3% IgG; 100% IgM. Flexible specimen types including serum, plasma, or whole blood which allows testing at any time without special specimen preparation. Small sample volume (10 µL) enables multiple testing on the same specimen without having to re-draw the patient. Initial treatment action can begin during patient’s visit as test results are available in 10 minutes. Easily transported, and can be stored for 24 months, 2-30oC. Individually sealed foil pouches containing: One cassette device One desiccant Capillary tubes (10 µL) Sample diluent (REF SB-R0213, 5 mL/bottle) Package insert (instruction for use) CTK Products at a Glance HSV-1 & HSV-2 Flyer Insert U.S. CDC HSV Homepage: Genital Herpes Fact Sheets WHO: Herpes Simplex Virus Fact Sheets

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Rapid Test

The OnSite HSV-1 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of antibodies (IgG and IgM) to herpes simplex virus 1 (HSV-1) in human serum, plasma or whole blood. Type-specific detection by utilizing glycoprotein G1. Single test that detects and differentiates IgG and IgM anti-HSV-1. High confidence as test is in agreement with market leading ELISA test: 90.7% IgG; 85.0% IgM. Flexible specimen types including serum, plasma, or whole blood which allows testing at any time without special specimen preparation. Small sample volume (10 µL) enables multiple testing on the same specimen without having to re-draw the patient. Initial treatment action can begin during the patient’s visit as test results are available in 10 minutes. Easily transported, and can be stored for 24 months, 2-30oC. 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) CTK Products at a Glance HSV-1 & HSV-2 Flyer Insert U.S. CDC HSV Homepage: Genital Herpes Fact Sheets WHO: Herpes Simplex Virus Fact Sheets

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Rapid Test

The OnSite Chikungunya IgM Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgM anti-chikungunya (CHIK) virus in human serum, plasma or whole blood. Uses serum, plasma or whole blood specimen Utilizes recombinant antigen derived from the CHIK structure protein IgM immunoassay is the most practical lab method Distinguish from dengue infection which presents with similar symptoms Clinical performance: Sensitivity: 90.4% Specificity: 98.0% comparing to a commercial ELISA Cross-Reactivity: no cross-reactivity found on 10-40 specimens from the 14 disease states and special conditions, such as dengue, Zika, malaria, HIV, TB, HAV, pregnant woman and others No interference with some common substances, such as Acetominophen (20 mg/dL), Heparin (3000 U/L), Ascorbic acid (20 mg/dL), Human IgG (1000 mg/dL), Bilirubin (20 mg/dL), Glucose (55 mmol/L), Creatinine (442 μmol/L), Salicylic acid (4.34 mmol/L), EDTA (3.4 μmol/L), Sodium citrate (3.8%) Individually sealed foil pouches containing: One cassette device One desiccant Capillary tubes (5 μL) Sample diluent (REF SB-R0066, 5 mL/bottle) One package insert (instruction for use) CTK Products at a Glance Inserts U.S. CDC Chikungunya Virus Homepage: (Transmission, Prevention, etc.) WHO: Chikungunya Virus Fact Sheets

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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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