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'rapid visual antigen based test'

Items tagged with 'rapid visual antigen based test'

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immunoassayReagents

INTENDED USE The Finecare™ PSA Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative detemination of Prostate Specific Antigen (PSA) in human whole blood, serum or plasma. The test is used as an aid in diagnosis of prostatic cancer. STORAGE AND STABILITY 1. Store the test kit at 4~30℃ up to the expiration date 2. If removed from refrigerator, allow the test for 30 minutes to return to room temperature before testing. 3. Do not remove the device from the pouch until ready to use. The test cartridge should be used within 1 hour once opened.

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Rapid Test

Intended Use Dengue NS1 Antigen FP is a rapid solid phase immuno- chromatographic test for the qualitative detection of Dengue NS1 Antigen in human Whole Blood/ Serum/ Plasma. This test is for in vitro diagnostic use only and is intended as an aid in the earlier diagnosis of dengue infection. Salient Features Rapid ,visual test for the qualitative detection of Dengue NS1 Antigen in whole blood/serum/Plasma. Sample can be taken from Finger prick and sample required is 4µl. Based on Sandwich principle. Detection of Dengue in Seronegative stage i.e From Day 1 of fever. Detection of all 4 serotypes of dengue virus. Reliable diagnosis of both primary and secondary infection. 100% Sensitivity & 99.96 % Specificity. Shelf life: 24 month at 2-30 °C Convenient pack Size: 10 Test. Evaluated By Referral Medical college / Hospitals /Research institutes / Labs.

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Rapid Test

Intended Use Dengue NS1 Antigen self-test is a rapid solid phase immune-chromatographic test for the qualitative detection of Dengue NS1 Ag in human whole blood/serum/plasma. This test is intended to be for home use with self-collected whole blood specimens from individuals aged 18 years or above( or collected by adults for individuals below 18 years of age) as well as for professional use with venous Whole blood/Serum/Plasma samples. This test is for in-vitro diagnostic use only & is designed as an aid in the early diagnosis of dengue infection patients with clinical symptoms. Salient Features Rapid, Visual, Home test for qualitative detection of Dengue NS1 antigen detection in human whole blood/serum/plasma. Finger prick sample can be used. Single test pack. All material to perform the test & its disposal are provided with the kit. Based on Sandwich principle.\ Detection of Dengue in Seronegative stage i.e. from Day 1 of fever. Detection of all 4 serotypes of dengue virus. Reliable diagnosis of both primary and secondary infection. 100% Sensitivity & 100 % Specificity. Shelf life: 30 month at 2-30 °C.

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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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Instruments

The new and improved RTR-1 uses an image processing method. During measurement, the lateral flow device is captured using a 5-mega pixel camera and the picture is analyzed using image processing algorithms for identification of either presence or absence of test line bands or test line band intensity levels. The reader converts the image into a grayscale and then classifies the intensity levels of the image in 0 to 255 grayscale range. The image processing algorithm undergoes various levels of filtering and segmentation to yield the correct intensity levels from the picture. Based on the preconfigured intensity levels, the reader classifies the band intensity and reads out the results as either positive or negative. ACCURACY: Less than 3% intra-run CV Eliminates subjective interpretation by operator FLEXIBILITY: Single mode for low volume test setting Batch mode allows for high volume test setting Result output as semi-quantitative line intensity and visual image EASE-OF-USE: Built in barcode reader provides faster test setup Touch screen interface for easy operation Lightweight (0.7kg) and portable DATA MANAGEMENT: Results presented on screen, on a printout or uploaded to reader database Storage capacity of 1,000 test results (including images) Laboratory Information System (LIS) and Wi-Fi compatible Human Machine Interface 4-inch resistive touch screen Camera 5 mega pixel CMOS camera Barcode Scanner Integrated 1 dimensional barcode scanner Printer 48 mm inbuilt thermal printer Mode Single mode and batch mode operations Port/USB Data export and software upgrade through 2 USB ports Storage Storage capacity of 1000 test results (including images) Result output “Positive or Negative” as well as quantitative test line intensity Power 12V 2A Processor ARM Cortex-A53 Platform Embedded Linux Dimension 220 mm X 170 mm X 110 mm (L x B x H) Weight 0.7 kg (Approx CATALOG # PRODUCT RTR-1 Rapid Test Reader OTHER PRODUCTS YOU MIGHT BE INTERESTED IN.. CATALOG # PRODUCT ADX-110 ELISA Reader ADX-120 Microplate Washer

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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

Buy AccuTest HCV Rapid Card Test (30 Tests) Online from Accurex. HCV means Hepatitis C Virus which is a is a small, enveloped, positive-sense, single-stranded RNA virus. Hepatitis C symptoms are fever, fatigue, decreased appetite, nausea, vomiting, abdominal pain, dark urine, pale feces, joint pain and jaundice. HCV test is a rapid Chromatographic Immunoassay work on principle of the double antigen sandwich technique, Qualitative detection of antibodies generated against proteins that are encoded by conserved sequence of core NS3, NS4, NS5 parts of HCV genome in human whole blood/serum or plasma. AccuTest HCV Test is a rapid Chromatographic Immunoassay for the Qualitative detection of antibodies generated against proteins that are encoded by conserved sequence of core NS3, NS4, NS5 parts of HCV genome in human whole blood/serum or plasma. Hepatitis C Virus (HCV) is a small, enveloped, positive-sense, single-stranded RNA virus. Antibody to HCV is found in over 80% of patients with well documented non-A, non-B hepatitis. Conventional methods fail to isolate the virus in cell culture or visualize it by electron microscope. Cloning the viral genome has made it possible to develop serologic assays that use recombinant antigen, multiple antigens using recombinant protein and/or synthetic peptides have been added in new serologic tests to avoid nonspecific cross-reactivity to increase the sensitivity of HCV antibody tests. Storage and Stability: AccuTest HCV should be stored at 4-30C. However, the card may be stored at room temperature not exceeding 30C in the original sealed pouch. Test Procedure: 1. Allow the test, specimen and or control to room temperature prior to the testing 2. Remove one test card from the pouch and place it on a clean flat surface 3. Using the dropper provided one drop of serum/plasma or W. blood sample (30ul) then two drops of buffer (40ul) immediately into the sample well. Avoid overflowing 4. Read results within 15 minutes. Strong positive reaction may visible within 5 minutes. Do not read results after 15 minutes. 5. If negative or quest Principle: AccuTest HCV Rapid Hepatitis C Virus Test (Serum/Plasma/Whole Blood) is a lateral flow chromatographic immunoassay based on the principle of the double antigen-sandwich technique. The membrane is coated with recombinant HCV antigen on the test line region of the device. During testing, the serum/plasma or W.Blood specimen reacts with HCV antigen coated particles. The mixture migrates upward on the membrane chromatographically by capillary action to react with recombinant HCV antigen or membrane and generate a colored line. Presence of this colored line indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear at the control line region, indicating that the correct volume of specimen has been added and membrane wicking has occurred. Storage and Stability: AccuTest HCV should be stored at 4-30C. However, the card may be stored at room temperature not exceeding 30C in the original sealed pouch. Test Procedure: 1. Allow the test, specimen and or control to room temperature prior to the testing 2. Remove one test card from the pouch and place it on a clean flat surface 3. Using the dropper provided one drop of serum/plasma or W. blood sample (30ul) then two drops of buffer (40ul) immediately into the sample well. Avoid overflowing 4. Read results within 15 minutes. Strong positive reaction may visible within 5 minutes. Do not read results after 15 minutes. 5. If negative or questionable results are obtained, the HCV infection is suspected, the test should be repeated ona fresh serum specimen. Safety Information •Positive: If a distinct purple line is formed at the test one marked ‘T’ (Test Line) and the Control Zone marked ‘C’ (Control Line) the test result is positive, indicating the sample contains Hepatitis C antibody. The interpretation of test results (+ve for hepatitis) remains unchanged even if there is a difference in intensity of color in positive line and control line as is many a time found. •Negative: If a distinct purple line is formed only at the control zone marked ‘C’ (control line) the test result is negative • Invalid: A total absence of color in both © and (T) regions or no colored band appears on the control © region is an indication of procedure error and/or the test reagent has deteriorated. Repeat with a new test kit. Direction for Use Test Procedure 1. Allow the test, specimen and or control to room temperature prior to the testing 2. Remove one test card from the pouch and place it on a clean flat surface 3. Using the dropper provided one drop of serum/plasma or W. blood sample (30ul) then two drops of buffer (40ul) immediately into the sample well. Avoid overflowing 4. Read results within 15 minutes. Strong positive reaction may visible within 5 minutes. Do not read results after 15 minutes. 5. If negative or questionable results are obtained, the HCV infection is suspected, the test should be repeated ona fresh serum specimen. Other Info Storage and Stability AccuTest HCV should be stored at 4-30C. However, the card may be stored at room temperature not exceeding 30C in the original sealed pouch.

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Rapid Test

Buy AccuTest H Pylori AB Rapid Card Test (50 Tests) Online from Accurex. The Helicobacter Pylori is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies to H.pylori in human Whole Blood/Serum/Plasma. H Pylori test provides an aid in the diagnosis of infection with H.pylori. H.pylori is implicated in the etiology of a variety of gastrointestinal diseases, including duodenal and gastric ulcer, non-ulcer dyspepsia and active and chronic gastritis. h pylori symptoms are an ache or burning pain in your stomach (abdomen), Nausea, Loss of appetite, Frequent burping, Bloating & Unintentional weight loss NTENDED USE The H.pylori Antibody Rapid Test Card is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies to H.pylori in human Whole Blood/Serum/Plasma. It provides an aid in the diagnosis of infection with H.pylori. INTRODUCTION H.pylori is implicated in the etiology of a variety of gastrointestinal diseases, including duodenal and gastric ulcer, non-ulcer dyspepsia and active and chronic gastritis. H.pylori infection is found in more than 90% of duodenal ulcer patients and in around 75% of all peptic ulcer sufferers. H.pylori infection is also more common in gastric cancer patients. The risk of gastric cancer has been estimated to be six-fold higher in H.pylori infected populations than in uninfected populations. H.pylori infections occur in human populations throughout the world. In developed countries, about 50% of the population may have H.pylori infection by the age of 60 years, while only 10-20% of adults in the third decade of life have it. Transmission is most probably by the fecal-oral or oral-oral route. Both invasive and non-invasive methods are used to diagnose H.pylori infection in patients with symptoms of gastrointestinal disease. Invasive methods include culture of gastric biopsy samples, histologic examination of stained biopsy specimens, or direct detection of the urease activity in the biopsy (CLO test). These methods need to obtain a biopsy sample by endoscopy.which is expensive,and usually results discomfort and risk to the patient.noninasive techniques include urea breath tests and serological methods. Urea breath test requires expensive laboratory equipment and moderate radiation exposure. Serologic tests are employed to detect antibodies as human immune response to H.pylori, for example the ELISA and the Western immunoblot. The H.pylori Antibody Rapid Test Card detect antibodies to H.pylori infection in human Whole Blood/Serum/Plasma. It is a noninvasive method and does not use radioactive isotopes. The test is easy to perform and requires no specialized equipment. Visual interpretation provides an accurate qualitative result. It is a useful on-site aid in the diagnosis of H.pylori infection. Diagnosis of H.pylori infection by antibody immunoassay can reduce the number of patients requiring endoscopy. PRINCIPLE The H.pylori Antibody Rapid Test Card is an immunoassay based on the principle of the double antigen-sandwich technique. During testing, a Whole Blood/Serum/Plasma specimen migrates upward by capillary action. The antibodies to H.pylori if present in the specimen will bind to the H.pylori conjugates. The immune complex is then captured on the membrane by the pre-coated H.pylori antigens, and a visible pink-purple line will show up in the test line region indicating a positive result. If antibodies to H.pylori are not present or are present below the detectable level, a pink-purple line will not form in the test line region indicating a negative result. To serve as a procedural control, a pink-purple line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred. Safety Information The H.pylori Antibody Rapid Test Card is limited to provide a qualitative detection. The intensity of the test line does not necessarily correlate to the concentration of the antibody in the blood. x The results obtained from this test are intended to be an aid in diagnosis only. Each physician must interpret the results in conjunction with the patient’s history, physical findings, and other diagnostic procedures. x A negative test result indicates that antibodies to H.pylori are either not present or at levels undetectable by the test. Direction for Use TEST PROCEDURE 1. Remove the test cassette from the sealed pouch and use it as soon as possible. 2. Place the test cassette on a clean and level surface. 3. For serum or plasma specimen: Hold the dropper vertically and transfer 3 drops of serum or plasma to the specimen well (S) of the test cassette, then start the timer. See illustration below. 4. For whole blood specimens: Hold the dropper vertically and transfer 1 drop of whole blood (approximately 30μl) to the specimen well(S) of the test cassette, then add 2 drops of buffer (approximately 70μl) and start the timer. 5. Read results at 15 minutes. Do not interpret the result after 20 minutes. Other Info STORAGE AND STABILITY x Store as packaged in the sealed pouch at 4-40℃. The kit is stable within the expiration date printed on the label. x Once open the pouch, the test should be used within one hour. Prolonged exposure to hot and humid environment will cause product deterioration.

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