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Clinical Chemistry

The ADVIA® 1800 Clinical Chemistry System pushes the limit of productivity. Its extensive menu allows integration of testing for clinical chemistry, drugs-of-abuse, therapeutic drug monitoring (TDM) and specific proteins such as cystatin C and CardioPhase® hsCRP. The ADVIA 1800 Clinical Chemistry System offers: Throughput of up to 1,800 tests per hour to keep pace with workload peaks 200 basic metabolic panels per hour to meet turnaround-time demands Large onboard reagent capacity and optional concentrated reagents to reduce interruptions Optimal standardization of reagents and systems for efficient consumable usage Refrigerated onboard storage of controls and reagents for extended stability and increased productivity Automation-ready design: no additional hardware required Features & Benefits The ADVIA 1800® Clinical Chemistry System pushes the limit of productivity in the core lab and meets the turnaround-time (TAT) goals of today’s laboratories. Its extensive menu allows integration of general clinical chemistry testing with testing for drugs-of-abuse, TDM, special chemistry, and specific proteins such as cystatin C and CardioPhase® hsCRP. Automation-ready design Point-in-space aspiration enables connectivity to a track, VersaCell® System. Redundant sample loading provides built-in backup and easy handling of non-routine samples. Direct sampling from track prevents tubes being detained at an analyzer and reduces aliquoting. Peak productivity Throughput of up to 1,800 tests per hour provides the speed to keep pace with workload peaks. Throughput of 200 basic metabolic panels per hour helps to meet turnaround-time demands. Automatic Sample Retain technology lets you perform reruns and dilutions without the need to retrieve primary tubes. Consolidate chemistry testing on one system with a comprehensive menu, consistent cycle times, speed, and open application capability. Total system reliability Minimal-maintenance ISEs Robust hardware and simplified software design, with automatic calibration validation and tracking Advances in reagent onboard stability, calibration frequency, interference reduction and assay linearity expansion Direct water connection Remote diagnostics and Inter-Laboratory Quality Control (ILQC) options Easy efficiency Large onboard reagent capacity and optional concentrated reagents reduce interruptions. High-resolution touchscreen delivers push-button operation. Reagent pause capability and onboard Sample Pause button make loading easy. Minimal maintenance requirements, including no-maintenance oil bath, reduce hands-on time. Sample integrity checking, include serum indices reporting, short-sample flagging, and clot detection, reducing the need for manual intervention.

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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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Rapid Test

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

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Rapid Test

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 of 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 99.1% 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 Individually sealed foil pouches containi a. One cassette device b. One plastic dropper c. One desiccant One package insert (instruction for use) CTK Products at a Glance Drugs.com: Overview of Human Chorionic Gonadotropin Inserts CATALOG # PRODUCT QUANTITY SPECIMEN R1001C hCG Combo Rapid Test CE 30/kit S/Urine OTHER PRODUCTS YOU MIGHT BE INTERESTED IN.. CATALOG # PRODUCT QUANTITY SPECIMEN R1001S hCG Combo Rapid Test (Strip) CE 50/kit, 100/kit S/Urine

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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 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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Rapid Test

Buy Dengue NS1 Antigen test (Pack of 5 test) from Accurex. This NS1 Antigen Rapid test contains: A Test device in aluminum pouch with a desiccant, Disposable dropper & Pack Insert. Dengue NS1 antigen test utilizes the human serum / plasma followed by solid-phase immuno-chromatographic technology for the qualitative detection of dengue virus NS1 antigen. Dengue NS1 Antigen kit is for professional use and only for the initial screening test & reactive samples should be confirmed by a supplemental assay such as nucleic acid test & other immunological assays. EXPLANATION OF THE TEST Dengue NS1 antigen test utilizes the human serum / plasma followed by solid-phase immuno-chromatographic technology for the qualitative detection of dengue virus NS1 antigen. The membrane strip of the kit contains pre-coated anti-dengue NS1 monoclonal antibody on the test band region (T), and goat anti-mouse IgG is pre-coated on the control band region (C). During testing, if the sample containing dengue NS1 Ag, the complex of the antibody-dengueNS1 Ag-gold conjugate moves laterally on the membrane by capillary action. In this case, the colored band will appear on the membrane in test line (T). Control line (C) should always appear if the test procedure is performed properly Safety Information 1. For in-vitro diagnostic use only. Do not re-use the test device. 2. The instruction must be followed exactly to get accurate results. 3. Anyone performing an assay with this product must be trained in its use and must be experienced in laboratory procedures. 4. Do not eat or smoke while handling specimens. 5. Wear protective gloves while handling specimens. Wash hands thoroughly afterwards. 6. Avoid splashing or aerosol formation. 7. Clean up spills thoroughly using an appropriate disinfectant. 8. Decontaminate and dispose of all specimens, reaction waste, in a biohazard container. 9. Do not mix and interchange different specimen. 10. The presence of humidity may decrease the stability of the tests. Thus, carry out the test immediately after removing the device from the foil pouch. 11. Do not use it beyond the expiration date. Direction for Use 1. Place all specimens, test device and solution. Allow them to room temperature prior to testing (15~30 min.) 2. Please perform the test immediately after removing the device from the foil pouch. 3. With a disposable dropper, load 2-3 drops (50 to 75µl) of specimen into the sample well (S) in the test device. 4. Interpret the test results between 15~20 minutes. Do not read the results after 20 minutes. Other Info 1) Dengue NS1 Antigen test should be stored between 4~30 ºC 2) Expiration date of this kit is 24 months after its manufacture date. LIMITATIONS OF THE TEST Dengue NS1 antigen test is designed for primary screening test of dengue virus NS1 antigen. Although this can provide fast and easy way to get a result, the testing do not completely exclude the possibility of false positive or negative result caused by various factor. So, refer to the result of the kit, please make a final decision with clinical manifestation, other test results and doctor’s view collectively.

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Rapid Test

Buy Dengue NS1 Antigen test (Pack of 10 test) from Accurex. This NS1 Antigen Rapid test contains: A Test device in aluminum pouch with a desiccant, Disposable dropper & Pack Insert. Dengue NS1 antigen test utilizes the human serum / plasma followed by solid-phase immuno-chromatographic technology for the qualitative detection of dengue virus NS1 antigen. The membrane strip of the kit contains pre coated anti-dengue NS1 monoclonal antibody on the test band region (T), & goat anti-mouse IgG is pre-coated on the control band region (C). EXPLANATION OF THE TEST Dengue NS1 antigen test utilizes the human serum / plasma followed by solid-phase immuno-chromatographic technology for the qualitative detection of dengue virus NS1 antigen. The membrane strip of the kit contains pre-coated anti-dengue NS1 monoclonal antibody on the test band region (T), and goat anti-mouse IgG is pre-coated on the control band region (C). During testing, if the sample containing dengue NS1 Ag, the complex of the antibody-dengueNS1 Ag-gold conjugate moves laterally on the membrane by capillary action. In this case, the colored band will appear on the membrane in test line (T). Control line (C) should always appear if the test procedure is performed properly PRECAUTIONS 1. For in-vitro diagnostic use only. Do not re-use the test device. 2. The instruction must be followed exactly to get accurate results. 3. Anyone performing an assay with this product must be trained in its use and must be experienced in laboratory procedures. 4. Do not eat or smoke while handling specimens. 5. Wear protective gloves while handling specimens. Wash hands thoroughly afterwards. 6. Avoid splashing or aerosol formation. 7. Clean up spills thoroughly using an appropriate disinfectant. 8. Decontaminate and dispose of all specimens, reaction waste, in a biohazard container. 9. Do not mix and interchange different specimen. 10. The presence of humidity may decrease the stability of the tests. Thus, carry out the test immediately after removing the device from the foil pouch. 11. Do not use it beyond the expiration date. SPECIMEN COLLECTION AND STORAGE Direction for Use 1. Place all specimens, test device and solution. Allow them to room temperature prior to testing (15~30 min.) 2. Please perform the test immediately after removing the device from the foil pouch. 3. With a disposable dropper, load 2-3 drops (50 to 75µl) of specimen into the sample well (S) in the test device. 4. Interpret the test results between 15~20 minutes. Do not read the results after 20 minutes. Other Info STORAGE & EXPIRATION 1) Dengue NS1 Antigen test should be stored between 4~30 ºC 2) Expiration date of this kit is 24 months after its manufacture date. LIMITATIONS OF THE TEST Dengue NS1 antigen test is designed for primary screening test of dengue virus NS1 antigen. Although this can provide fast and easy way to get a result, the testing do not completely exclude the possibility of false positive or negative result caused by various factor. So, refer to the result of the kit, please make a final decision with clinical manifestation, other test results and doctor’s view collectively.

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