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'chinese fda hiv ab panel'

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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

Intended Use HIV Ag & Ab Card (4th Generation) is a visual, rapid qualitative and sensitive solid phase immunochromatographic assay for the differential detection of HIV-1 p24 Antigen and Antibodies (IgM, IgG & IgA) to HIV-1& HIV-2 in Human Serum/ Plasma/ Whole blood (collected by venipuncture or Fingerprick). The test is a screening test for p24 antigen (HIV-1) and HIV antibodies (anti-HIV-1 & anti-HIV-2) and is for in vitro diagnostic use only. It is intended for screening of blood donors or other individuals at risk for HIV-1 & HIV-2 infection and for clinical diagnostic testing. It is a screening test for p24 antigen (HIV-1) and HIV antibodies (anti-HIV-1 & anti-HIV-2). The test is for in vitro diagnostic use only and is intended for screening of blood donors or others individuals at risk for HIV-1 and/or HIV-2 infection and for clinical diagnostic testing. Salient Features • Finger prick, rapid, visual and qualitative Immunoassay. • 4TH Generation Rapid test for differential detection of p24 Antigen & antibodies for HIV in serum/plasma /whole blood. • Ideal for Blood screening, detects sero-negative HIV Cases. • Use of gp-41, C terminus of gp120 for HIV-1 , gp-36 for HIV -2 antibodies and Anti-p24 for HIV p24 Ag detection. • Detection of Group ‘0’ & subtype ‘C’ of HIV-1, which is most prevalent in India. • Based on Immunochromatography Technique. • See through device for easy interpretation of results. • Sensitivity : 100 % & Specificity: 100% • Analytical Sensitivity of HIV p24 Ag : 100 IU/ml (traceable to p24 Antigen NIBSC Standard, U.K. Code No. 90/636) • Long Shelf life 30 months at 2-30°C • Convenient pack size: 25 T.

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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

Intended Use The HIV TRI-DOT test is a visual, rapid, sensitive and accurate immunoassay for the differential detection of HIV-1 & HIV-2 antibodies (IgG,IgM & IgA) in human serum or plasma using HIV-1 & HIV-2 Antigens immobilized on an immunofiltration membrane. The test is a screening test for Anti HIV-1 and HIV-2 and is for in vitro diagnostic use only. Salient Features Rapid visual test ,based on Flow Through Technology. Differential detection of HIV-1 & HIV-2. Detection of group ‘O’ & subtype ‘C’. Use of envelop antigens gp41& C terminus of gp120 for HIV-1 & gp36 for HIV-2. 100% sensitivity & 100% specificity as per WHO Evaluation. Shelf life 24 months at 2-8°C Available in convenient pack sizes- 50 Tests and 100 Tests. Results within 3 minutes. No instrument required. In built quality control dot.

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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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Clinical Chemistry

Find the Best Semi Automatic Biochemistry Analyzer from Accurex. Buy Acculab At 112 Plus (Semi Auto Biochemistry Analyzer) which is the best Biochemistry Machine with numerous features like Filter Check, Self-check operation for optical filters, Checks the absorbance of each of the 7 filters & free position, Ensures that all the filters are in good working condition. This Biochemistry Analyzer has Improved ergonomic touch screen display, ensures strain free viewing with End point, kinetic, fixed time & absorbance mode. FILTER CHECK • Self-check operation for optical filters. • Checks the absorbance of each of the 7 filters & free position. • Ensures that all the filters are in good working condition. WORKLIST • A unique facility by which a worklist can be prepared for every sample ID. • Printouts can be taken by sample ID or test parameters. • Print by ID : Ensures that no test is left out for a particular ID. • Print by Test : Ensures that all reagents / working solutions are prepared in correct volumes preventing wastage. • The system flags any test which is missed out for a particular ID, ensuring all assay panel is completed. LAMP SAVING • Lamp saving option available ensuring long lamp life. • The lamp can be turned off in case of sporadic sample workload ALARMS • Audio alarm is sounded when results are higher (S) or lower (L) than reference range ensuring that all abnormal samples are flagged for further review. • Improved ergonomic touch screen display, ensures strain free viewing • End point, kinetic, fixed time & absorbance mode • Single & bichromatic measurement • Memory : 3200 results • 112 programmable channels • Calibration modes – 1 standard / multi-point linear / multi-point non-linear • Easy-access maintenance chamber ensures efficient uptime management • Real-time reaction curve display • Anti-vibration & anti-disturbance optical system ensures highly accurate results • Option of 7 filters (340 – 630 nm) & 1 free position • Comprehensive quality control program with L-J graph • Lamp saving feature to prolong lamp life • Audible / visual alarm available • Easy-tear printer design Methodology: End point, kinetic, fixed time & absorbance Calibration: Single standard/multi-point linear/multi-point non-linear Programmable channels: 112 Memory: 3200 results Quality control: Comprehensive QC software with L-J graph Light source:Quartz-Halogen lamp 12V / 20W Photometric range: 0.0000 to 3.0000 Abs, Resolution : 0.0001 Abs : Drift : 0.002 Abs/hour Wavelength range: 7 standard filters: 340, 405, 492, 510, 546, 578, 630 nm & 1 free optional position ; Half Bandwidth < 8 nm : Stray light : < 1.0 % at 340 nm, Stainless steel body with quartz window; Optical path 10 mm Flowcell: Stainless steel body with quartz window; Optical path 10 mm Measuring volume: 32 μl Programmable aspiration volume:: 500-2000 μl Temperature control: Peltier elements : 25°C, 30°C & 37°C ±0.1°C Input: Ergonomic LCD touch screen display Printer: Built-in high speed thermal printer Interface: RS-232 serial port Dimension / Weight: 450 x 360 x 140 mm / 11.5 kgs Operating environment: Temperature: 15-30°C ; Humidity: 20-80 % Power requirement: AC 110-220 V ±10%, 50/60 Hz Safety Information • The position of the LCD display has been designed to reduce cervical (neck muscle) strain during continual use. • The aerial view display design makes it possible to view the screen from multiple perspectives, (standing or sitting, with equal clarity). Direction for Use • A unique facility by which a worklist can be prepared for every sample ID. • Printouts can be taken by sample ID or test parameters. • Print by ID : Ensures that no test is left out for a particular ID. • Print by Test : Ensures that all reagents / working solutions are prepared in correct volumes preventing wastage. • The system flags any test which is missed out for a particular ID, ensuring all assay panel is completed. Other Info • Improved ergonomic touch screen display, ensures strain free viewing • End point, kinetic, fixed time & absorbance mode • Single & bichromatic measurement • Memory : 3200 results • 112 programmable channels • Calibration modes – 1 standard / multi-point linear / multi-point non-linear • Easy-access maintenance chamber ensures efficient uptime management • Real-time reaction curve display • Anti-vibration & anti-disturbance optical system ensures highly accurate results • Option of 7 filters (340 – 630 nm) & 1 free position • Comprehensive quality control program with L-J graph • Lamp saving feature to prolong lamp life • Audible / visual alarm available • Easy-tear printer design

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