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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 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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immunoassayReagents

H-FABP Rapid Quantitative Test Finecare™ H-FABP Rapid Quantitative Test is a fluorescence immunoassay for quantitative measurement of Heart-type Fatty Acid Binding Protein (H-FABP) in human whole blood, serum or plasma. It is used for diagnosis of myocardial infarction.With original qualify control. 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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immunoassayReagents

INTENDED USE The Finecare™ 2019-nCoV RBD Antibody Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for qualitative and semi-quantitative detection of spike receptor-binding domain (RBD) antibodies of novel coronaviruses (2019-nCoV) in human fingerstick whole blood, venipuncture whole blood, serum or plasma specimen. The 2019-nCoV RBD antibodies are protective antibody produced by the human body after inoculation with 2019-nCoV vaccine or infection with 2019-nCoV. The test is intended as an aid to assess the adaptive humoral immune response to the 2019-nCoV RBD protein. STORAGE AND STABILITY 1. Store at 4~30°C in the sealed pouch up to the expiration date printed on the package. Do not freeze. 2. The test device should be used within 1 hour after taking out from the foil envelope. 3. Keep away from sunlight, moisture and heat. 4. Kit contents are stable until the expiration date printed on the outer box.

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Immunoassay Reagents

INTENDED USE The Finecare™ 2019-nCoV lgM/lgG Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for qualitative detection of IgG and IgM antibodies of novel coronaviruses (2019-nCoV) in human whole blood, serum and plasma specimen. Clinically, the test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by 2019-nCoV. The test provides preliminary test results. Negative results cannot exclude the possibility of 2019-nCoV infection and they cannot be used as the sole basis for treatment or other management decision. STORAGE AND STABILITY 1. Store at 4-30°C in the sealed pouch up to the expiration date printed on the package. Do not freeze. 2. The test device should be used within 1 hour after taking out from the foil envelope. 3. Keep away from sunlight, moisture and heat. 4. Kit contents are stable until the expiration date printed on the outer box.

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Rapid Test

The OnSite HSV-2 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of antibodies (IgG and IgM) to herpes simplex virus 2 (HSV-2) in human serum, plasma or whole blood. Unique test that utilizes glycoprotein G2 to differentiate between HSV-1. and HSV-2 that allows for an early start of treatment action. Immediate determination of either acute or chronic infection by detecting and differentiating IgG and IgM anti-HSV-2. High confidence as test is in agreement with market leading European ELISA: 95.3% IgG; 100% IgM. Flexible specimen types including serum, plasma, or whole blood which allows testing at any time without special specimen preparation. Small sample volume (10 µL) enables multiple testing on the same specimen without having to re-draw the patient. Initial treatment action can begin during patient’s visit as test results are available in 10 minutes. Easily transported, and can be stored for 24 months, 2-30oC. Individually sealed foil pouches containing: One cassette device One desiccant Capillary tubes (10 µL) Sample diluent (REF SB-R0213, 5 mL/bottle) Package insert (instruction for use) CTK Products at a Glance HSV-1 & HSV-2 Flyer Insert U.S. CDC HSV Homepage: Genital Herpes Fact Sheets WHO: Herpes Simplex Virus Fact Sheets

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Rapid Test

The OnSite HSV-1 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of antibodies (IgG and IgM) to herpes simplex virus 1 (HSV-1) in human serum, plasma or whole blood. Type-specific detection by utilizing glycoprotein G1. Single test that detects and differentiates IgG and IgM anti-HSV-1. High confidence as test is in agreement with market leading ELISA test: 90.7% IgG; 85.0% IgM. Flexible specimen types including serum, plasma, or whole blood which allows testing at any time without special specimen preparation. Small sample volume (10 µL) enables multiple testing on the same specimen without having to re-draw the patient. Initial treatment action can begin during the patient’s visit as test results are available in 10 minutes. Easily transported, and can be stored for 24 months, 2-30oC. 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) CTK Products at a Glance HSV-1 & HSV-2 Flyer Insert U.S. CDC HSV Homepage: Genital Herpes Fact Sheets WHO: Herpes Simplex Virus Fact Sheets

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Rapid Test

The OnSite Troponin I Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of cardiac Troponin I (cTnI) in human serum, plasma or whole blood at a level equal to or higher than 1 ng/mL. It can be performed within 15 minutes by minimally skilled personnel, and without the use of laboratory equipment. The OnSite Troponin I Combo Rapid Test is intended to be used by healthcare professionals as an aid in the diagnosis of acute myocardial infarction (AMI). Any use or interpretation of this preliminary test result must also rely on patient’s symptoms and the professional judgment of a physician. A more precise test method such as an instrument method must be used to confirm the test result obtained by this device. Normally the level of cTnI in the blood is very low. cTnI is released into the blood stream in forms of free cTnI and cTnI-C-T complex at 4-6 hours after myocardial cell damage. The elevated level of cTnI could be as high as 50 ng/mL during 60-80 hours after AMI and remains detectable for up to 10-14 days post AMI. Therefore, circulating cTnI is a specific and sensitive marker for AMI. Clinical performance: Relative Sensitivity: 95.8% (95% CI: 91.5-97.9%) compared to a reference CLIA Relative Specificity: 99.7% (95% CI: 98.8-99.9%) Analytical sensitivity: The detection limit of cTnI is 1.0 ng/mL or greater in serum, plasma or whole blood specimen Cross-reactivity: No cross reactivity with 10 µg/mL skeletal muscle TnI, 2,000 ng/mL cardiac muscle TnT, 20 µg/mL cardiac muscle Myosin Dose hook effect: No hook effect was observed for cTnI at concentrations up to 3,521 µg/mL Interference: No interference was seen with 20 mg/dl Acetaminophen, 20 mg/dl Acetylsalicylic acid, 10.5 g/dl Albumin, 20 mg/dl Ascorbic acid, 1,000 mg/dl Bilirubin, 20 mg/dl Caffeine, 800 mg/dl Cholesterol, 200 mg/dl Creatinine, 20 mg/dl Gentistic acid, 1,000 mg/dl Hemoglobin, 600 mg/dl Oxilic acid, 1,600 mg/dl Triglycerides Shelf life: 24 months Individually sealed foil pouches containing: One cassette device One desiccant Plastic droppers Sample diluent (REF SB-R3002, 5 mL/bottle) One package insert (instruction for use) CTK Products at a Glance Insert MedlinePlus: Troponin Test Poster

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