ntented Use STANDARD F H. pylori Ag FIA is a fluorescent immunoassay for the detection of H.pylori antigen in human fecal specimens. Specification Specimen Feces Test time 10 minutes Specimen volume 40 - 70mg Sensitivity 100% (5/5) Specificity 100% (150/150) Storage temperature 2-30℃ / 36-86℉

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.

Intended Use Covid 19 Ag Card Test is designed for in vitro qualitative detection of Covid 19 antigen in human nasopharyngeal, nasal swab specimens. The kit is intended for professional use and as a screening test and is an aid in early diagnosis of SARS COV-2 infection in patients with clinical symptoms. Salient Features Rapid Visual Test for the Qualitative Detection of Covid-19 (SARS-COV-2) antigen in Human nasopharyngeal and nasal swab specimens. Based on Sandwich Immunoassay principle. Results within 20 minutes. Single step test procedure. Evaluated & Validated by ICMR Centre ; Sensitivity -91.5% (<30 CT) & Specificity -100% against RT-PCR. Long Shelf life:30 months at 2-30° C. No Instruments required. Convenient pack sizes . 10T,25T,50T,100T & 200T.

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.

STANDARD Q Filariasis Ag Test is an immunochromatographic assay for the detection of Wuchereria bancrofti antigens in human serum, plasma, or whole blood specimens. This test kit is for in vitro diagnostics use only. This is intended for professional use, only for an initial screening test.

The STANDARD Q COVID/Flu Ag Combo Test is a rapid chromatographic immunoassay for the qualitative detection of specific antigens to SARS-CoV-2 and Influenza A and Influenza B present in human nasopharyngeal specimens. The STANDARD Q COVID/Flu Ag Combo Test for rapid detection of SARS-CoV-2, Influenza A and Influenza B is a differentiated test, such that SARS-CoV-2 viral antigens can be distingushed from Influenza A or Influenza B viral antigens from a single specimen using a single device.

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

The OnSite hCG Combo Rapid Test is a lateral flow chromatographic immunoassay for the early detection of pregnancy, by providing a quick direct visual test for the placental hormone, hCG in human serum, plasma and urine. It can be performed within 5-10 minutes by minimally skilled personnel, and without the use of laboratory equipment. The OnSite hCG Combo Rapid Test is not intended for quantitative results, nor for over the counter (OTC) sales. It is intended to meet all requirements for yielding rapid, easily read, qualitative results for the purpose of early pregnancy detection via assay of hCG, a placental hormone that may be present in human serum, plasma or urine. The hCG detection limit the OnSite hCG Combo Rapid Test is 12.5 mIU/mL in serum or plasma specimen, and 25 mIU/mL in urine specimen. It is designed for professional use only, and provides only preliminary analytical data. For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result. Clinical accuracy: In comparison with a reference chemiluminecsence or ELISA, hCG detection is 100% sensitivity and 100% specificity in urine specimens 100% sensitivity and 99.5% specificity in serum specimens Analytical sensitivity: 100% positive detection rate at 12.5 mIU/mL in serum/plasma specimens and 100% positive detection rate at 25 mIU/mL in urine specimens Analytical specificity: no cross reactivity with 1,000 mIU/mL human luteinizing hormone (hLH), 1,000 mIU/mL human follicle stimulating hormone (hFSH), and 1,000 mIU/mL human thyroid stimulating hormone (hTSH) Dose hook effect: no dose hook effect was observed for hCG at concentrations up to 500,000 mIU/mL in urine specimens Interference: No interference was seen with 35 biological and chemical analytes commonly found in OTC, prescriptions or abuse drugs in urine or serum/plasma specimens, as well as pH 4-9 (see detail in the package insert) Shelf life: 24 month Kit box package: 1. Individually sealed foil pouches containing; a. One dip strip device b. One desiccant 2. One package insert (instruction for use) Tube package: 1. Strip Package 2. One desiccant 3. One package insert (instruction for use) CTK Products at a Glance Drugs.com: Overview of Human Chorionic Gonadotropin Inserts

The OnSite Leptospira IgG/IgM Combo Rapid Test is a lateral flow chromatographic immunoassay that can be performed within 15-20 minutes by minimally skilled personnel, and without the use of laboratory equipment. This test is intended to be used for the simultaneous detection and differentiation of IgG and IgM antibodies to Leptospira interrogans (L. interrogans) in human serum, plasma or whole blood. It is intended to be used as a screening test by professionals, and provides a preliminary test result to aid in the diagnosis of infection with L. interrogans. Any interpretation or use of this test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Recommended for use: Any person presenting with clinical signs or symptoms consistent with acute infection with interrogans including: high fever, headache, chills, muscle aches, vomiting, jaundice, red eyes, abdominal pain, diarrhea, skin rash After exposure to a known contaminated source Accuracy: 100% specificity and 100% sensitivity in comparison with a reference rapid test on the market Cross Reactivity: No false positive results were observed on specimens from TP, HIV, Dengue, TB, Typhoid Ab , HBsAg, HCV Ab, HEV Ab, H.P Ab, HAV, HCG, RF, ANA, HAMA Interference: No interference were seen with substances: Salicylic acid: 4.34 mmol/L; Glucose: 55 mmol/L; Sodium citrate: 3.8 %; Heparin: 3,000 U/L; Creatinine: 442 μmol/L; Bilirubin: 20 mg/dL; EDTA: 3.4 μmol/L; Hemoglobin: 2g/L; Human IgG: 1000 mg/dL; AlbuminL 60 g/L Shelf life: 24 month Individually sealed foil pouches containing: One cassette device One desiccant 5 μL capillary tubes Sample diluent (REF SB-R0101, 5 mL/bottle) One package insert (instruction for use) CTK Products at a Glance Inserts U.S. CDC Leptospira Homepage: About Leptospira WHO: Leptospirosis Fact Sheets