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'hiv u s cdc hiv testing'

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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

Buy AccuTest Typhoid IgG/IgM Rapid Card Test (5 Tests) Online from Accurex. The Typhoid IgG/IgM Rapid Test is used for detection & differentiation of anti-Salmonella typhi (S. typhi) IgG and IgM in human whole blood / serum / plasma. This Typhoid test is used as a screening test and as an aid in the diagnosis of infection with S. typhi. Salmonella typhi bacteria causes typhoid Typhoid fever, typhoid symptoms symptoms are likely to develop gradually – appearing one to three weeks after exposure to the disease. There are various typhoid treatment & typhoid vaccine which can be opted after the detetction of Typhoid. Typhoid fever is caused by S. typhi, a Gram-negative bacterium. Worldwide an estimated 17 million cases and 600,000 associated deaths occur annually. Patients who are infected with HIV are at significantly increased risk of clinical infection with S. typhi. Evidence of H. pylori infection also presents an increased risk of acquiring typhoid fever. 1-5% of patients become chronic carrier harboring S. typhi in the gall bladder. The clinical diagnosis of typhoid fever depends on the isolation of S. typhi from blood, bone marrow or a specific anatomic lesion. In the facilities that can not afford to perform this complicated and time-consuming procedure, Filix-Widal test is used to facilitate the diagnosis. However, many limitations lead to difficulties in the interpretation of the Widal test. In contrast, the Typhoid IgG/IgM Rapid Test is a simple and rapid laboratory test. The test simultaneously detects and differentiates the IgG and the IgM antibodies to S. typhi specific antigen thus to aid in the determination of current or previous exposure to the S. typhi. PRINCIPLE The Typhoid IgG/IgM Rapid Test is a lateral flow immunochromatographic assay. The test cassette consists of: 1) a pink-purple colored conjugate pad containing recombinant S. typhi H antigen and O antigen conjugated with colloid gold (Typhoid conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing two test region (Test line M and G) and a control region (control line). The test line ‘M’ is pre-coated with monoclonal anti-human IgM for the detection of IgM anti-S. typhi, test line ‘G’ is pre-coated with monoclonal anti-human IgG for the detection of IgG anti-S. typhi , and the C band is pre-coated with goat anti rabbit IgG. When an adequate volume of test specimen is dispensed into the sample well of the cassette, the test specimen migrates by capillary action across the test cassette. Anti-S. typhi IgM if present in the patient specimen will bind to the Typhoid conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody at test region ‘M’, forming a pink-purple line at ‘M’ region, indicating a S. typhi IgM positive test result. Anti-S. typhi IgG if present in the patient specimen will bind to the Typhoid conjugates. The immunocomplex is then captured by the pre-coated reagents on the membrane, forming a pink-purple line at test region ‘G’, indicating a S. typhi IgG positive test result. Absence of any pink-purple line at test region (M and G) suggests a negative result. The test contains an internal control (control line) which should exhibit a pink-purple line of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the test region. Otherwise, the test result is invalid and the specimen must be retested with another device. PRECAUTION 1. This package insert must be read completely before performing the test. Failure to follow the insert gives inaccurate test results. 2. Do not open the sealed pouch, unless ready to conduct the assay. 3. Do not use expired devices. 4. Bring all reagents to room temperature (15°C-30°C) before use. 5. Do not use the components in any other type of test kit as a substitute for the components in this kit. 6. Do not use hemolized blood specimen for testing. Wear protective clothing and disposable gloves while handling the kit reagents and clinical specimens. Wash hands thoroughly after performing the test. 7. Users of this test should follow the US CDC Universal Precautions for prevention of transmission of HIV, HBV and other blood-borne pathogens. 8. Do not smoke, drink, or eat in areas where specimens or kit reagents are being handled. 9. Dispose of all specimens and materials used to perform the test as biohazardous waste. 10. Handle the Negative and Positive Control in the same manner as patient specimens. 11. The testing results should be read within 15 minutes after a specimen is applied to the sample well or sample pad of the device. Read result after 15 minutes may give erroneous results. 12. Do not perform the test in a room with strong air flow, ie. an electric fan or strong air-conditioning. Other Info STORAGE AND STABILITY Typhoid IgG/IgM test card should be stored at 4-40°C. The card may be stored at room temperature but not exceeding 40°C in the original sealed pouch. The shelf life or expiry of the card is printed on Pouch as well as carton label. The test kit should be kept away from direct sunlight, moisture and heat.

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Rapid Test

Buy AccuTest HIV – 1/2 Ab Rapid Card Test (50 Tests) Online from Accurex. This Rapid HIV test is a visual, solid phase immunochromatographic assay for qualitative in-vitro diagnostic detection of antibodies against HIV-1 and HIV-2 in human serum/plasma. This HIV test may be used as an aid in diagnosis of HIV infection. In the HIV blood test – A reactive result should be confirmed by supplemental testing as part of a validated HIV testing algorithm. INTENDED USE: AccuTest HIV – 1/2 Ab test is a visual, solid phase immunochromatographic assay for qualitative in-vitro diagnostic detection of antibodies against HIV-1 and HIV-2 in human serum/plasma. The product may be used as an aid in diagnosis of HIV infection. A reactive result should be confirmed by supplemental testing as part of a validated HIV testing algorithm. INTRODUCTION: The Human Immunodeficiency Virus (HIV) is a retrovirus that infects cells of the immune system, destroying or impairing their function. The most advanced stage of HIV infection is Acquired Immunodeficiency Syndrome (AIDS). The general method of detecting infection with HIV is to observe the presence of antibodies to the virus by an EIA method followed by confirmation with any confirmation method. AccuTest HIV – 1/2 Ab is a simple, visual qualitative test that detects antibodies in human serum/plasma. The test is based on immunochromatography and can give a result within 15 minutes. PRINCIPLE: AccuTest HIV – 1/2 Ab employs chromatographic lateral flow device in a cassette format. Colloidal gold conjugated recombinant antigens (Au-Ag) corresponding to HIV-1 (gp120 + gp41) and HIV-2 (gp-36) are dry-immobilized at the end of nitrocellulose membrane strip. HIV-1 & HIV-2 antigens are bound at the Test Zone (1 & 2) respectively. Goat Anti-Mouse IgG antibodies are bound at the Control Zone(C). When the sample is added, it migrates by capillary diffusion rehydrating the gold conjugate. If there are HIV-1 or HIV-2 antibodies in sample, they will bind with the gold conjugated antigens forming particles. These particles will continue to migrate along the strip until the Test Zone (1 or 2) where they are captured by the HIV-1 or HIV-2 antigens generating a visible purple line. If the specimen contains antibodies to HIV-1, the specimen will bind to the 1 test line and produce line. If specimen contains antibodies to HIV2, the specimen will bind to the 2 test line. If there are no HIV-1 or HIV-2 antibodies in sample, no purple line is formed in the Test Zone. The gold conjugate will continue to migrate alone until it is captured in the Control Zone (C) by the Goat Anti Mouse IgG antibodies aggregating in a purple line, which indicates that the migration of liquid has been successful. The control line must be present for the test to be valid. PRECAUTIONS: 1. For best results, adhere to instructions provided. 2. All specimens should be handled as potentially infectious. 3. The test device is sensitive to humidity as well as heat. 4. Do not use beyond expiration date. 5. Do not use test kit if pouch is damaged or seal is broken. 6. Use test device immediately after removing from the pouch. 7. The components (test device and assay diluents) in this kit have been quality control tested as a standard batch unit. Do not mix components from different lot numbers. 8. The AccuTest HIV – 1/2 Ab Test devices should be stored at 4 to 30 °C. Do not expose the kit to temperature over 30 °C. 9. Specimen with extremely high concentrations of red blood cells, fibrin should be recentrifuged before use. 10. AccuTest HIV – 1/2 Ab Test Device (Serum/Plasma) is for in vitro diagnostic use only. 11. AccuTest HIV – 1/2 Ab Test Device (Serum/Plasma) will only indicate the presence of antibodies to HIV-1/2 in the specimen and should not be used as the sole criteria for the diagnosis of HIV-1, HIV-2, and/or HIV-1 subtype O infection. 12. For confirmation of reactive test results, specimens should undergo further testing using different assays, such as rapid diagnostic tests, EIA and/or Western blotting in accordance with a validated HIV testing algorithm. 13. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician. 14. Results should not be used to determine the serotype of HIV infections TEST PROCEDURE: 1. Allow the test device, buffer and specimen to reach room temperature (15-30 °C) prior to testing. 2. Remove the test device from the foil pouch and use the test device as soon as possible (within one hour). 3. Place the device on a flat, dry surface. Label with specimen ID. 4. Holding the sample dropper vertically above the test disk, slowly transfer 1 drop (10µl) of sample in to the sample well, then add 2 drops of assay diluent (about 75 µl) and start the timer. 5. As the test begins to work, you will see purple color moving across the result Window in the center of the Test Disk. 6. Wait for the colored lines to appear. Interpret test results at 15 to 20 minutes. Do not interpret test result after 20 minutes. STORAGE AND STABILITY Store as packaged in the sealed pouch at 4-30 °C (storage in refrigerator is permitted). Do not store in the freezer. Protect the test kit from humidly. The test device is stable until the expiration date printed on the test kit and/or sealed test device pouch. Do not use beyond the expiration date. The test device must remain in the sealed pouch until use.

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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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Clinical Chemistry

Best Fully Automated Clinical Chemistry Analyzer – Sphera M from Accurex. This chemistry analyzer is made in Italy & provides Accurate, Precise and Rapid Testing Solution. Sphera M is a Compact, fully automated, open random-access analyzer. The Minimum reaction volume is 210 µl, Minimal < 1L/h water consumption, 80 reusable UV transmitting Bionex® plastic cuvettes, 8-step wash station. It has Removable refrigerated tray with 30 open reagent positions for 50 ml or 20 ml bottles. Multiple virtual reagent disks can be programmed. The Chemistry analyser also does Auto-wash of inner & exterior probe surface. QUALITY CONTROL & CALIBRATION QUALITY CONTROL: • Levey-Jennings plots and Westgard multi rules • Upto 3 QC levels per test • QC monitor and reports • Method statistics: Test counter, CV%, mean, graphical trend analysis CALIBRATION: • Method and reagent monitor (volumes, available tests, calibration, QC status) • Automatic pre-dilution for calibrators • Upto 8 calibrators per method • Auto recalculation of result using last calibration. UNIQUE SOFTWARE DESIGN AND ARCHITECTURE: • Software designed for touch screen use • Intuitive user interface • Continuous loading of samples and reagents • Random-access and STAT • Free choice of execution order • Extended walk-away capability • Results archive with cumulative charts • Programmable automatic start up routine • Multiple work lists INTERFACE: • Bi-directional LIS, ASTM, over ethernet port of the external PC • Positive identification of samples with internal barcode reader (optional) • Printing on any Windows 7®/8® compatible printer • Method defined washing programs SYSTEM PACKS FOR SPHERA™ Accurex has developed dedicated system packs for Sphera™. Our biochemistry reagents have been intensively evaluated and validated to achieve the highest performance in Sphera™. Accurex recommends the use of these system packs according to instructions and applications validated by Accurex. Safety Information 8-step wash station for thorough cleaning of each cuvette (Needles: 6 dispensing, 6 aspiration, 1 cleaning) • Two types of systemic and special washing solutions for removing obstinate probe residues Direction for Use QUALITY CONTROL • Levey-Jennings plots and Westgard multi rules • Upto 3 QC levels per test • QC monitor and reports • Method statistics: Test counter, CV%, mean, graphical trend analysis CALIBRATION • Method and reagent monitor (volumes, available tests, calibration, QC status) • Automatic pre-dilution for calibrators • Upto 8 calibrators per method • Auto recalculation of result using last calibration Other Info Accurex has developed dedicated system packs for Sphera™. Our biochemistry reagents have been intensively evaluated and validated to achieve the highest performance in Sphera™. Accurex recommends the use of these system packs according to instructions and applications validated by Accurex.

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Diabetes

Product Features: Better precision, CV < 2.5 % Patented CLE technology enables complete elimination of labile glycohemoglobin ensuring accurate HbA1c results. HbA1c test results in 3.5 minutes with HbA2/HbF flagging. Separation of hemoglobin fractions Complete removal of labile fraction up to 10% No interference of HbF up to 10% No interference of lipemia or icterus, can run on non-fasting patient samples HbA1c reportability presence of HbS, HbC, HbD and HbE Compact bench top model User friendly touch screen operation Sampling from multiple sized primary tubes, including microcapillary collection tubes On board QC functions with Levey-Jennings and statistical calculations Unlimited storage of calibration, QC data and chromatograms No sample preparation required Simple reagent and column replacement Automated maintenance RFID reagent identification and tracking Automatic barcode identification of samples NGSP certified Calibrators and Controls IFCC traceable Complete kit with buffers, calibrator and column Product Application: Hba1c Testing Sampler Handler: 10 Position Rack Loader, positive identification by internal barcode reader Sample Type: Whole blood on EDTA K3 or K2 anticoagulant Haemolysate from EDTA whole blood samples Time for Analysis: Throughput approximately 3.5 minutes between samples Interferences: Complete removal (not separation) of labile up to 10% Sampling System: Sample Aspiration Probe coupled with a high precision, Sample Aspiration Volume: 14.5 µl in whole blood, 670 µl in lysate mode. Pump: 2 high pressure syringe pumps Detector Type: UV-Vis Reagent Traceability: RFID Printer: Built- in thermal printer with possibility to connect to external printer

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Clinical Chemistry

As the workload and test menu increase, simultaneous management of multiple ELISA protocols can become challenging. The LisaXL has been designed with an open architecture to meet various laboratory needs, providing all the tools necessary for hands-free ELISA processing, increasing the reliability and reproducibility, improving throughput, and freeing the laboratory staff from repetitive steps. LisaXL allows running multiple parameters for over 250 samples in a single batch. Equipped with dual probes and dedicated workstations, drastically improve ELISA workflows. LisaXL is a complete walkway system that minimizes manual errors while improving the accuracy and turnaround time for critical tests. LisaXL provides the flexibility to build and run virtually any ELISA assays. Product Features: Lisa XL is a true walk-away system for any laboratory needs. High Throughput with 6 plates, can process up to 576 tests. A dynamic scheduler ensures optimized system usage and turnaround times by processing 6 plates and up to 12 assays in each plate Onboard flexibility with sample capacity up to 272 and 20 interchangeable racks for reagents and samples. Dual probe processing ensures speed and reliability. "Zero" carryover with high-quality disposable tips. Six individually controlled incubators and shakers with variable temperature, time, and speed settings. Efficient washing with super sweep mode ensures minimum residual volume, with up to 6 different wash buffers. Easy to use touchscreen graphic user interface Product Applications: ELISA Physical Specifications 1 Dimensions Length 1375 mm 55" Height 845 mm 33" Width 850 mm 33.5" Weight 195 kgs (Approx) Power Supply Voltage 100 - 240 Volts Frequency 50 / 60Hz Power consumption 700 W General Specifications Assay per plate Up to 12 Number of ELISA plates Up to 6 Sample capacity Up to 272 Sample / Reagent capacity Total 20 racks Single rack holds 16 sample / reagent tubes Double rack holds 6 x 60 ml reagent bottles (can be used interchangeably) Tip / Dilution box Total 11 locations of 96 capacity each (can be used interchangeably) Reader Specifications Reading Range 0.0 - 3.5 O.D Reading Channels 8 Filter wheel 8 positions 405 nm, 450 nm, 492 nm, 620 nm std* 578 nm and 700 nm optional + 2 open Light source Halogen Lamp Reading mode Single, Dual, ORR Reading time < 1 min (for single filter) Linearity Up to 3.0 O.D (450 nm) Washer Specifications Manifold configuration 16 needles - 8 aspiration & 8 dispensing Precision < 5 % at 300 μl Wash cycle Programmable Residual volume < 5 μl / well Soak time Programmable Washer buffer capacity 6 × 2.25 L Waste water container 1 × 20 L Incubator Specifications Number of incubators Up to 6 Temperature range RT + 5°C up to 50°C Temperature stability ± 1°C Incubation time Programmable Time to set temperature < 6 min Shaking 200 to 800 RPM Shaking Method Orbital Pipetting Specifications Number of probes 2 Tips 300 µl / 1000 µl, Auto / Manual selected Multi-dispensing (Reagent) Minimum volume 4 μl Serum dispensing time < 14 min Reagent dispensing time < 5 min Sample mixing Yes (Automatic) Precision Sample & Reagent Sample Dispensing with 300 µl tip: 3% above 10 µl ± 0.5 µl for 10 µl & less Reagent Dispensing with 300 µl tip: 3% for 25 µl & above Reagent Dispensing with 1ml tip: 5% for 75 µl & above" Process Security Liquid level sensing Well fill verification Clot detection Onboard sample identification Onboard reagent identification Strip verification Buffer sensing Alarms Software Operating System Windows 10 (Embedded) LIS interface Bi-directional, Serial / TCPIP USB Port Graphic load interface Graphical work list Data processing Quantitative, Semi-Quantitative & Qualitative Multi password access Ability to archive data Computer (Base configuration considered, higher configuration can be considered for upgrade after testing) Intel Core i3, 4 GB RAM, 1 TB hard disk Monitor 22" Full HD touch screen

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Biochemistry Analyzer

Overview A fully automated POC Auto Dry Biochemistry Analyzer called Mispa Chem Dx, With Just 3 to 4 drops (100ul) of whole blood to test up to 19 General and Special chemistry tests in less than 12 minutes. Mispa Chem Dx works on absorption spectroscopy where a change in absorbance is detected by an absorption spectrum and an algorithm is used to calculate the end concentration of the sample in the reagent dry disc. The reagent disc consists of lyophilized reagent beads, diluent, and calibration details in the QR code. The reagent disc contains an intelligent internal quality control system IQC which continuously monitors the disc function to ensure reaction stability and optimal disc performance, IQC is the engine that drives the Mispa Chem Dx accurately and precisely Low Sample Consumption Easy to Use Maintenance Free Accurate Result Disposable reagent disc Sample volume: 100µl Testing time: 12 minutes / sample Temperature: 37°C ± 0.3°C Resolution: 0.001Abs Absorbance: 0-3.0Abs Sample type: Heparinized whole blood, serum, plasma (heparin) QC&Calibration: IQC (Intelligent Quality Control/Calibration) Work condition: Temperature:10-30°C Humidity: 30%-70% Testing method: End point, kinetic, fixed time, turbidmetry etc Light source: 12V/20W, Halogen tungsten lamp with life span over 2500 hours Power supply: AC 100V-240V, 50-60Hz Display: Android 7.0 inch 800*480, multi-point capacitive touch screen Storage: 500,000 results Printer: Built-in thermal printer Interface: 4 USB ports, 1 LAN port Dimension: 315*375*475mm. 4.2kg(N.W.), 7kg(G.W.)

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