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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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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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Laboratory Testing Analyzer

The ADAMS A1c, HA-8180T is a fully automated Glycohemoglobin analyzer based on HPLC (High Performance Liquid Chromatography) and is highly effective for ß-thalassemia testing. Measurement speed: 3.5 minutes/test Measurement Item as below HbA2 HbF HbA1c (Stable HbA1c, S-A1c), HbS, HbC, HbE and HbD can be detected. Column design with no more pre-filter change. Color LCD with reagent level, graphs on screen. Samples Whole blood or hemolysis sample Measurement items HbA1c(Stable HbA1c, S-A1c), HbA2 and HbF (HbS, HbC, HbE and HbD can be detected.) Reagents *1 ELUENT 80A, ELUENT 80B, ELUENT 80CT and HEMOLYSIS WASHING SOLUTION 80H Column *2 COLUMN UNIT 80T Measurement principle Reversed-phase cation exchange chromatography Detection method Dual-wavelength colorimetry (wavelengths measured: 420nm/500nm) Resolution 0.1% Ratio, 1 mmol/mol Measurement range *3 HbA1c : 3-20%, 9-195 mmol/mol HbA2 : 2-10% HbF : 0-100% Guaranteed measurement range *4 HbA1c : 4.2-12.9%, 22-117 mmol/mol HbA2 : 2.4-6.3% HbF : 0.1-14.3% Processing speed 210 seconds per sample Sample consumption Approx.14μL(whole blood) Sample container Blood collection tube (12.3 to 15mm diameter) × ( 75 to 100mm length) Sample cup(500μL) Sampling method Cap-Piercing Rack type ARKRAY racks Number of measurement samples One-way transportation (factory set) : Maximum 50 samples Loop transportation : Maximum 100 samples Column temperature Approx. 39℃ Display Color graphic LCD with backlight Memory capacity 500 test results ( including calibration results ) Built-in Printer Termal printer, 58mm thermal paper External output Serial 1 port (Can be optionally used as an Ethernet port.) Measurement conditions Temperature : 15-30℃ Humidity : 20-80% relative humidity (non-condensing ) Required sample volume Blood collection tube : Minimum 10mm away from the bottom Sample cup : 400μL or more Warm-up time Maximum 30 min. Dimensions 530(W)×530(D)×530(H)mm (Not including the hemolysis washing solution bottle) Weight Analyzer: Approx. 39kg, Sampler: Approx. 4kg Power supply AC100V-240V ±10% 50/60Hz Power consumption Max. 300 VA *1, *2 Reagents and column are sold separately from HA-8180T analyzer. *3 Error-free measurement ranges. *4 Guaranteed ranges for obtaining results equivalent to those from HA-8160 TP mode measurement. ※Design and specications may be changed without prior notice

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Laboratory Testing Analyzer

The ADAMS A1c, HA-8180 is a fully automated Glycohemoglobin (HbA1c) analyzer based on HPLC (High Performance Liquid Chromatography). HbA1c is a good parameter for long-term blood glucose monitoring in patients suffering from diabetes mellitus. Measurement Speed: 48 sec/test for Fast Mode and 90 sec/test for Variant mode. Measurement items are as follows. HA-8180V, Fast Mode HbA1c (Stable HbA1c, S-A1c) and HbF HA-8180V, Variant Mode  HbA1c (Stable HbA1c, S-A1c) and HbF HbS and HbC separation and HbE and HbD detection can be performed. ・Column design with no more pre-filter change ・Economical - improved aluminium reagents for more efficient reagent supply ・Color LCD with reagent level, graphs on screen Specifications Configuration Main body, sampler (with sample tube spinning unit) and accessories Measurement objects Whole blood or hemolysis sample Column COLUMN UNIT 80 Reagents ELUENT 80A, ELUENT 80B, ELUENT 80CV and HEMOLYSIS WASHING SOLUTION 80H Measurement 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 ranges *1 HbA1C: 3 - 20%, 9 - 195 mmol/mol HbF: 0 - 100% Guaranteed measurement ranges *2 HbA1C: 4 - 16%, 20 - 151 mmol/mol HbF: 0.3 - 5% Measurement principle Reversed-phase cation exchange chromatography Measurement wavelength 420 nm / 500 nm (Dual-wavelength colorimetry) Sample supply Sampler Resolution 0.1 % Ratio, 1 mmol / mol Processing speed Variant mode : 90 seconds / test Fast mode : 48 seconds / test Sample consumption Approximately 14 μL (Whole blood) Required sample volume Sample tube : Minimum 10 mm away from the bottom Sample cup : 400 μL or more Sample container Sample tube : (12.3/15 mm diameter) × (75 to 100 mm length) Sample cup: 500 μL Compatible rack type ARKRAY racks Number of measurement samples One-way transportation (factory-set) : Maximum 50 samples Loop transportation : Maximum 100 samples Column temperature Approximately 40°C Warm-up time Maximum 30 minutes Display Large color LCD with backlight Printer For use with 58-mm width thermal printer paper Memory capacity 900 measurement results (including calibration results) External output Serial 1 port (Can be optionally used as an Ethernet port.) Communication system RS-232C compliant (Switchable between one-way and two-way communications.) Transmission speed RS-232C : Selectable from 300, 600, 1200, 2400, 4800, 9600 and 19200 bps Ethernet: 10BASE-T Dimensions 530 (W) × 530 (D) × 530 (H) mm (Not including the hemolysis washing solution bottle) Weight Main body: Approximately 39 kg, Sampler: Approximately 4 kg Power requirements 100 - 240 V AC ± 10 %, 50 / 60 Hz Power input Maximum 300 VA *1 Error-free measurement ranges *2 Guaranteed ranges for obtaining results equivalent to those from HA-8160 VP mode measurement

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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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Glycohemoglobin Analysis

Accurex Xpress A1c Glycohemoglobin Analysis System Kit . The Kit contains HbA1c Meter, 1 Sampler, 1 box of 25 test strips, Buffer A, Buffer B. Glycohemoglobin Analyzer It is used for testing glycohemoglobin concentration as an aid to monitor the risk of developing diabetes & control the status of diabetes. Buy Xpress A1c Meter Kit Online from Accurex Point of Care (POC ) Range – The HbA1c analyzer is specifically designed to be used with the corresponding test strip. HbA1c analyzer Hemoglobin A1C is a common blood test that measures blood glucose levels over the past two to three months. •Glycohemoglobin Analyzer •Handheld HbA1c Meter •Battery Operated •No Pipetting, No Lysing •Lab like Accuracy •Battery Operated •Truly Portable •Voice prompt for •User Guidance • Accurate result with cv <3% •Lab like accuracy with 95% •No interference of HB Variant •No pipetting •No lysing •Reagent: Suitable to store at room temperature (upto 30º C) The Power of HbA1c in your Hand esting Principle: Boronate Affinity Chromatography Testing Parameter: Glycohemoglobin (HbA1c) Measuring Range: 4.0% – 14.0% Precision: CV <3% (HbA1c: 4.0% – 6.5%) Blood Sample: Finger Prick or Venous Blood ( EDTA Anticoagulant) Blood Volume: About 3ul Testing Time: About 5 minutes Data Unit: Set in Advance the Data Unit • NGSP%; IFCC mmol/mol; eAG* mmol/l Voice Prompt: Voice Prompt to Guide the user Data Storage: 1000 Testing Data Data Port: Mini USB data interface can be connected with HIS/LIS; System Thermal Printer Power Required: AAA Battery x 4 Analyzer Dimension: 61.6 x 122.9 x 24.5 mm Screen Size: 47 x 32 mm” Safety Information LIMITATION AND WARNING: 1. This product is used for In Vitro Diagnostics only, not for in vivo use. 2. This product should not be used past the expiration date. 3. If there is evidence of microbial contamination or browning, discard the vial. 4. This product is not intended to be used as an HbA1c standard. 5. Preservatives contained in the control, rinse with water if splash into the mouth or eyes, and seek medical help as soon as possible. 6. Potential biological risk. Direction for Use This product should be run in accordance with instructions accompanying BioHermes Glycohemoglobin Test Kit and Glycohemoglobin Analyzer. (1) Dissolution: Open the cap of the vial, and then add 2 drops of Buffer A. Close the cap, and slightly shake the vial until the powder dissolved completely. And please shake it well before using it. (2) Testing in accordance with instructions accompanying BioHermes Glycohemoglobin Test Kit and Glycohemoglobin Analyzer. Please refer to the B Other Info Storage: 1. This product will be stable for 24 months when stored tightly capped at 2-8℃. 2. After dissolved, the product can be stable for 8 hours at 10-30℃, or 5 days at 2-8℃. Do not freeze it. COMPOSITION: This product is prepared from human blood and contains normal hemoglobin, preservatives and stabilizers. The control is provided in lyophilized powder form for increased stability. The kit contains two levels of control, level 1 is with yellow cap, and level 2 is with green cap.

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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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