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'lateral flow immunochromatography principle'

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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 HBsAg Rapid Card Test (50 Tests) Online from Accurex. HBsAg means Hepatitis B surface antigen which is a protein on the surface of hepatitis B virus. It can be detected in high levels in serum during acute or chronic hepatitis B virus infection. HBsAg positive indicates that the person is infectious. The hbsag test kit is a one-step immunochromatographic assay based on the antigen capture, or Sandwich principle. HBsAg positive treatment may include Antiviral medications. AccuTest HBsAg Card Test Hepatitis BHepatitis B is a viral infection that attacks the liver and can cause both acute and chronic disease. An estimated 240 million people are chronically infected with hepatitis B (defined as hepatitis B surface antigen positive for at least 6 months). Laboratory diagnosis of hepatitis B infection focuses on the detection of the hepatitis B surface antigen HBsAg. Hepatitis B surface antigen (HBsAg) consists of lipid carbohydrate and protein elements; the protein moiety provides a marker for identification of chronic, infectious BBV infections. Hepatitis B is transmitted sexually or intravenously and has an incubation period of six months. If not diagnosed properly and in time, it can develop into acute or chronic infection, liver cirrhosis and fulminant hepatitis. This test is very useful for screening blood donors, to find out whether they are HBsAg positive before collection of blood. Principle: AccuTest HBsAg is a qualitative test based on immunochromatography sandwich principle. The test card includes a combination of monoclonal anti-body gold conjugate (colloidal gold) and polyclonal solid phase antibodies which selectively binds Hepatitis B surface antigen with high degree of sensitivity. The HBsAg test is a one-step immunochromatographic assay based on the antigen capture, or Sandwich principle. The method uses monoclonal antibodies conjugated to colloidal gold and polyclonal antibodies immobilized on a nitrocellulose strip in a thin line. The test sample is introduced into well and flows laterally through an absorbent pad where it mixes with the signal reagent. If sample contains HBsAg, the colloidal gold-antibody (mouse) conjugate binds to the antigen, forming an antigen-antibody-colloidal gold complex. The complexes then migrate through the nitrocellulose strip by capillary action, which are stopped by an immobilized antibody zone forming a purple band. The formation of the first purple band (T zone) is indicative of hepatitis positive. To serve as a procedural control, an additional line of antibody antimouse IgG has been immobilized on the card. If the test is performed correctly, this will result in the formation of purple and upon contact with the conjugate as a control line. Safety Information AccuTest HBsAg test kit is designed lor detection of Hepalitis B Surface Antigenin the specimen. As with all diagnostic tests, il is recommended to interpret all the results in line wilh clinical manifestations, other lest resulls & clinicians’s view colleclively. If the lest device is showing stagnancy in flow on chromalography, it is most likely due lo problem in the sample. In this case, relest with a fresh sample or diluted sample. 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 (25 ul), wait for few seconds till the Whole blood absorbed by sample pad (approx. 30 second), 4. Add 2-3 drops of buffer (60 ul) into the sample well. (If needed add one more drop of assay buffer). 5. Let reaction proceed until the appearance of positive line and control line or up to 20 minutes. 6. Read results after 20 minutes, strong positive reaction may visible within 5 minutes. 7. If negative or questionable results are obtained, the HBV infection is suspected, the test should be repeated ona fresh serum specimen. Storage: AccuTest HBsAg 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 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 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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immunoassayReagents

INTENDED USE The Finecare™ cTn I/NT-proBNP Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of cardiac Troponin I (cTn I) and N-terminal prohormone of brain natriuretic peptide (NT-proBNP) in human whole blood, serum or plasma. This test is used as an aid to assist in the diagnosis of myocardial infarction and suspected congestive heart failure. 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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