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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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immunoassayReagents

INTENDED USE The Finecare™ S100β Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for quantitative determination of S100β in human serum, plasma or whole blood. The test is used as an aid to the assessment of the level of cerebral injury. 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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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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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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Glycohemoglobin Analysis

Xpress Gluco strips make the testing experience better. These Glucometer strips are designed for self-testing, for both professional and home use. Accurex Blood Glucose test strips provide accurate results in just 5 seconds. Buy Xpress Gluco Test Strips (Pack of 100 Strips) Online from Accurex Point of Care (POC) Diagnostics. The Sugar machine strips do not require any coding & are compatible with Accurex glucometers only. Sample size: 0.5uL, System Measurement Range: 20-800 mg/dL, Hemocrit Range: 25-55 %, Works only with Accurex Glucometer. TEST PRINCIPLE: ELECTROANALYTICALAMPEROMETRY When blood is added to the Xpress Gluco test strip, the chemicals within the strip react with the blood to create a tiny electrical current. Your meter will read that current and display you the blood glucose level. • Accurex test strips make the testing experience better. • Longer shelf life and clearly marked expiry date. • Designed for self testing for both professional and home use. • Accurate results in just 5 seconds. • Works only with Accurex Glucometer. • Uses only 0.5uL blood sample size • Alternate site testing possible • No-coding required • Compatible with Accurex glucometers only CHEMICAL COMPOSITION: Each Xpress Gluco test strip contains: • Enzyme Glucose Oxidase (Aspergillus Sp.) ≥ 1IU • Other ingredients (Mediator, Surfactant, Stabilizing agents etc.) ≥ 200μg • Xpress Gluco Test Strips are used to measure glucose in Capillary whole blood outside of the body (in vitro diagnostic use). • Use Xpress Gluco Test Strips only with the Xpress Gluco Blood Glucose Test System. • Xpress Gluco Test Strips are plasma calibrated to allow easy comparison of results with laboratory methods. • This system is not intended for use in the diagnosis of diabetes mellitus. • This system is not recommended for Neonates Blood samples. Result interpretation: • Xpress Gluco Meter delivers plasma equivalent results and are displayed in mg/dL. • The measurement range of the meter is 20-800mg/dL. • Your blood glucose values will vary due to such things as diet, time of day and what you are doing. Your healthcare professional will help you to understand these variations. You should set your own range of expected blood glucose values, testing times, and discuss your blood glucose results with your healthcare professional. • When blood is added to the Xpress Gluco test strip, the chemicals within the strip react with the blood to create a tiny electrical current. • Your meter will read that current and display you the blood glucose level. • Use fresh whole blood sample only. • Sample size: 0.5uL • Analysis time: 5 seconds • System Measurement Range: 20-800 mg/dL • Hemocrit Range: 25-55 % UNEXPECTED RESULTS: Very high or very low blood glucose readings can indicate a serious medical condition. Repeat the test if you see an unusual reading. If these results are still unusual, or do not match your symptoms, contact your health care professional for advice. Hi or Low readings may indicate hyper or hypoglycemia and should be treated immediately. ABOUT ALTERNATIVE SITE TESTING: Test can be done on alternative site (other than fingertip). However, there are limitations. Please consult your physician before perfoming AST.

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Glycohemoglobin Analysis

XPRESSGLUCO+ strips make the testing experience superior. These Glucometer strips are for self-testing by people with diabetes at home and health care professionals in a clinical setting to monitor glucose concentrations in capillary whole blood drawn from the fingertips, forearm, upper arm, palm, calf or thigh Accurex Blood Glucose test strips provide accurate results in just 5 seconds. Buy Xpress Gluco + Test Strips (Pack of 100 Strips) Online from Accurex Point of Care (POC) Diagnostics. The Sugar machine strips require a sample volume of 0.5 μL and taking just 5 seconds to return a test result. XPRESSGLUCO+ Blood Glucose Test Strips are used with the XPRESSGLUCO+ Blood Glucose Meters. They are intended for self-testing by people with diabetes at home and health care professionals in a clinical setting to monitor glucose concentrations in capillary whole blood drawn from the fingertips, forearm, upper arm, palm, calf or thigh. They are for testing outside the body (in vitro diagnostic use only). Donot use them for diagnosis of diabetes or testing on neonates. Specification Glucose in the blood samples mixes with a special chemical in the test strip and produces a small electric current. The amount of current produced changes with the amount of glucose in the blood. The glucose meter measures the strength of the current and displays the results as a blood glucose level. Specification Glucose in the blood samples mixes with a special chemical in the test strip and produces a small electric current. The amount of current produced changes with the amount of glucose in the blood. The glucose meter measures the strength of the current and displays the results as a blood glucose level. Safety Information • Discard used test strips and lancets responsibly according to your local regulations. • Keep test strips vial away from children. A child could choke on the test strips. The test strips and their vial contain agents that may be harmful if swallowed. If they are swallowed, promptly see a doctor for immediate assistance. Do not change medication based on the test results without the advice of a physician or healthcare professional. Other Info Each test strip is plasma-calibrated†, requiring a sample volume of 0.5 μL and taking just 5 seconds to return a test result. The test range is 20 to 600 mg/dL (or 1.1 to 33.3 mmol/L) with resolution at 1 mg/dL (0.1 mmol/L). †Plasma-calibrated: Test results produced on capillary whole blood samples by XPRESSGLUCO+ System are compared with the results of the corresponding plasma samples tested by the YSI 2300 Glucose Analyzer, calibrated by YSI 2747 Glucose Standard (a NIST traceable glucose standard). The margin of error of the YSI 2300 Glucose Analyzer measurement is 0.289 mg/dL when the blood glucose concentration is higher than 100 mg/dL, or 0.029 mg/dL when the blood glucose concentration is lower than 100 mg/dL. (1 mmol/L= 18 mg/dL).

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Clinical Chemistry

Autozyme Albumin 100 Diagnostic Reagent (Pack Size : 2 x 50 ml) from Accurex. Albumin reagent is used for determination of albumin in serum or plasma based on BCG method, can be determined in 1 minute at room temperature. BCG reagent and standard should be stored at temperature indicated on the bottle label. Accurex has gained considerable expertise in manufacturing & marketing of In-vitro Diagnostic reagents. Serum albumin in the presence of Bromocresol-green under acidic condition forms a green colored complex. Albumin normal range is 3.4 to 5.4 g/dL (34 to 54 g/L). About Autozyme Albumin is a reagent set for determination of albumin in serum or plasma based on BCG method Autozyme Albumin is a single reagent system, ready to use. Autozyme Albumin is linear up to 6 gm% Albumin can be determined in 1 minute at room temperature The shelf-life of Autozyme Albumin is 18 months Pack Size : 2 x 50 ml Principle Serum albumin in the presence of Bromocresol-green under acidic condition forms a green coloured complex, The absorbance of this complex is proportional to the albumin concentration in serum or plasma. Quality Control To ensure adequate quality control, it is recommended that each batch should include a normal and an abnormal commercial reference control serum,. it should be realized that the uSe of quality control material checks both instrument and reagent functions together. Factors which might affect the performance of this test include proper instrument function, cleanliness of glassware and accuracy of pipetting. Other Details The reagents are for in vitro diagnostic use. BCG reagent and standard should be stored at temperature indicated on the bottle label.

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Clinical Chemistry

XL 1000 with the throughput of upto 1040 tests per hour is the ideal instrument for centralizing the complete biochemistry testing load on a single fully automated platform. Increased walk away productivity and less human intervention make it an ideal analyzer for large laboratories. Equipped with all necessary advanced features that one expects from a high end fully automated chemistry analyzer; sample loading through rack system, cooled calibrator and control carousel, low reading volume of 150 µL, diffraction grating with 15 wavelengths from 340 nm to 800 nm and user-friendly software, to optimize and reliably run the daily lab workload. XL 1000 is a "dream come true" workhorse for laboratories with increased workload and the perfect solution. Fully Automatic, Discrete, Patient prioritized, Random Access Clinical Chemistry Analyzer with throughput of 1040 tests/hour 3 Reagent capabilities 147 long life Hard Glass cuvettes Separate Carousel for STAT samples Onboard refrigeration for reagents Extensive database for storing patient data and Q.C. results Primary tube sampling with bar code identification 9 stage laundry for cuvettes wash 150 samples can be loaded at a time through rack system System Discrete, open, automated, random access, patient prioritized, 1/2/3 reagent system DISPENSING OF SAMPLES AND REAGENTS Sample volume: 2-60 µl (0.1 µl step), 70 µl with ISE Reagent volume: 120 µl – 550 µl 3 dispensing probes ( R1, R2/R3) equipped with liquid -level sensor and crash detector Auto-dilution of samples and calibrators Clot detection Samples Serum, urine, plasma, CSF and other Economy Minimum reaction volume: 180 µl Reusable reaction cuvettes Mixing System 2 independent stirrers 3 user selectable mixing speeds Quality Control 4 levels of control material can be used Levey-Jennigs graphs Twin Plot diagrams for monitoring of systematic and random error Reaction unit with wash station 147 reusable hard glass cuvettes Possibility of replacement of individual cuvette Wash station – cuvette rinsing and drying in nine-step procedure Automatic cuvette blank measurement before analysis Sample Autoloader 23 racks 115 sample positions on automatic autoloader Primary tubes 5, 7 and 10 ml, vacuum system tubes Barcode reader for sample identification 2 Reagent trays With 43 cooled position each Barcode reader for reagent identification 20 ml, 50 ml reagent containers, 5 ml tube with adaptor Option to use one reagent for several test simultaneously Stat Tray 45 positions Can be used for blank, controls, STAT samples Software Convenient user interface Connection to LIS Programmable auto-start from sleep mode including automatic daily maintenance Statistical methods of processing results Data export in selected format Measurement Monitoring Colour indication of sample analysis Possibility of monitoring the reaction in real time Reagent volume monitoring Informative reports on ongoing analyzer status

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