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Clinical Chemistry

Best Semi Automatic Biochemistry Analyzer AT Smart from Accurex. AT SMART is a Biochemistry/Clinical Analyzer with a user-friendly and the human interface is via touch screen. It measures the optical densities of samples & calculates the sample concentration which are used for biochemical investigation. This Biochemistry Machine operates from near UV to visible range. Semi Auto Analyzer AT SMART is CE certified and has undergone rigors testing before being delivered to customers. About •SMART MAINTENANCE •SMART LIS •SMART INVENTORY MANAGEMENT REDUCED ERRORS: IT allows for the accurate collection of data, automated workflows & minimized waste. SAVES TIME: Patient monitoring can be done in real-time, saves engineers visiting time. BETTER PATIENT EXPERIENCE: A connected laboratory system creates an environment that meets each patient’s needs. INSTRUMENT BREAKDOWN MANAGEMENT: Real-time data helps to monitor instrument performance. ONLINE REACTION CURVES: • Real time reaction curve with special • Flagging gives confidence in patient reports. INTELLECTUAL SOFTWARE: • User friendly Device. • 150 Direct access test keys gives freedom to select parameters easily. • Availability of different assay modes. DRY BATH INCUBATOR: • Dry bath incubator with 12 test tube positions • Mini size with 15 minutes start up time FEATURES: •Remote access & monitoring via Internet •150 test parameters •Built-in thermal printer to print results, enzymatic curves and standard calibration curves •Large graphic display with real time graph display for enzymatic reaction •Touch screen interface with dynamic test access key SPECIFICATIONS: Methodology- • Absorbance • Endpoint with standard, factor, sample blank & diffrential • Two-point (fixed time) and multi point kinetics • Multi standard calibration • Mono or bi-chromatic reading • Turbidimetry Optical System- • Principle: photometry • Range of measurement: 0.0-3.0A • Spectral range selection: Automatic via filter wheel • Filters: 340, 405, 505, 546, 578 and 630 nm plus two free position • Bandwidth:10nm (+/- 2nm) • Light source: Life Long Halogen lamp • Blanking: Automatic • Detector: Silicon Photodiode Photometer- • Peltier regulated 25ºC, 30ºC and 37ºC • Flow cell of 18 µ L • Continuous flow system with peristaltic pump • Programmable Sipping Volume Memory- • 150+ User Defined Test Programs • 1000 test results in instrument memory and unlimited test resultresult storage via cloud • Reagent Blank • 2 Level of QC Quality Control- • Levy-Jennings chart using westgard’s rules • 30 Normal and abnormal QC values for selected test User Interface- • Graphic LCD back Lit 240×64 pixels • Touch Screen input • Data port and cloud connectivity • Type : Graphic thermal printer Power & Dimensions- • Voltage : 220 V • Frequency : 50 Hz • Maximum power : < 150 VA • Maximum relative humidity : 75% • Compact form factor • Weight: < 6kgs Safety Information Precautions • Instrument should be operated only by authorised or trained personnel • For any reasons, unauthorised personnel should not be engaged for servicing or removing the cabinet • Power source should be regulated either by voltage stabilizer or regulated power back up (UPS). If inverter is been used, please ensure there exists a voltage stabilizer • Reagents recommended by the company to be preferably used • Flow cell needs to be rinsed regularly with the company recommended flow cell cleaning solution • User is requested not to use any other pointing devices other than being supplied by company while operating touch screen • The operating environment should be clean and protected from direct sunlight • During the day at the end of the work, it should be ensured that flow cell is always filled with distilled water • During transport / longer duration of shut down, th Direction for Use Please ensure that the power source is properly grounded and voltage between Line and Ground is less than 2V AC – 5V AC. • Please ensure that the instrument is placed on a firm table, clean environment, and sufficient ventilation space. • Switch On the instrument. • Instrument will run its own internal diagnostic routines, to ensure proper working of critical functions. • Allow the instrument to stabilize for 10 minutes. • During the stabilization time, please wash the flow cell with cleaning solution and distilled water for at least two times. • During shut down, ensure that the flow cell is cleaned with flow cell cleaning solution and rinsed thoroughly using distilled water. • For overnight shutdown, please ensure flow cell is filled with distilled water. • Cover the instrument with the given dust cover Other Info GENERAL INFORMATION While installing and setting up the instrument, few safety warnings and general precautions described in the further sections must be observed. A. Power Supply : • Power source should be grounded and have either servo stabilizer or regulated power back up • Power cord should be CE , CSA and UL marked • Voltage : 115 – 230 Volts ± 10% 50 – 60 Hz • Grounding: Make sure that electrical power source is properly grounded.

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Rapid Test

Buy AccuTest COVID-19 IgG/IgM Rapid Test (Pack of 10 Tests) Online. COVID-19 IgG/IgM Rapid Test Kit is a qualitative immuno chromatographic assay for the detection of IgG & IgM antibodies produced against COVID-19 virus in human whole blood/Serum/ Plasma. COVID-19 IgG/IgM Rapid Test Kit is only intended for initial screening and reactive samples should be confirmed by a supplemental assay. Intended Use: COVID-19 IgG/IgM Rapid Test Kit is a qualitative immuno chromatographic assay for the detection of IgG & IgM antibodies produced against COVID-19 virus in human whole blood/Serum/ Plasma. COVID-19 IgG/IgM Rapid Test Kit is only intended for initial screening and reactive samples should be confirmed by a supplemental assay. SUMMARY & TEST DESCRIPTION: COVID-19 [Coronavirus Disease- 2019] is an infectious disease caused by SARS-CoV2 [Severe Acute Respiratory Syndrome coronavirus 2] virus, which is a contagious, novel strain of CoronaVirus that emerged from Wuhan, China in December 2019, which grew as a pandemic threatening human survival across the globe. The virus is thought to be of zoonotic origin and likely to have spread from large seafood and animal markets by human-animal contact in the city of Wuhan, where consumption of such products is in large. The virus causes respiratory infection with symptoms including fatigue, fever, shortness of breath, respiratory failure, renal failure and death. Patients can become infected with SARS-CoV-2 virus by person-person contact (through contact with a contaminated environment or person). The young and old (and other immune-compromised individuals) are most at risk of serious complications; however, approximately 20% of those infected can develop a critical condition. COVID-19 IgG/IgM Rapid Test device utilizes Anti-human IgG and Anti-human IgM antibodies as the capture molecules. COVID-19 Recombinant Antigens-colloidal gold conjugate are used as detection antigen. Intended Use: COVID-19 IgG/IgM Rapid Test Kit is a qualitative immuno chromatographic assay for the detection of IgG & IgM antibodies produced against COVID-19 virus in human whole blood/Serum/ Plasma. COVID-19 IgG/IgM Rapid Test Kit is only intended for initial screening and reactive samples should be confirmed by a supplemental assay. SUMMARY & TEST DESCRIPTION: COVID-19 [Coronavirus Disease- 2019] is an infectious disease caused by SARS-CoV2 [Severe Acute Respiratory Syndrome coronavirus 2] virus, which is a contagious, novel strain of CoronaVirus that emerged from Wuhan, China in December 2019, which grew as a pandemic threatening human survival across the globe. The virus is thought to be of zoonotic origin and likely to have spread from large seafood and animal markets by human-animal contact in the city of Wuhan, where consumption of such products is in large. The virus causes respiratory infection with symptoms including fatigue, fever, shortness of breath, respiratory failure, renal failure and death. Patients can become infected with SARS-CoV-2 virus by person-person contact (through contact with a contaminated environment or person). The young and old (and other immune-compromised individuals) are most at risk of serious complications; however, approximately 20% of those infected can develop a critical condition. COVID-19 IgG/IgM Rapid Test device utilizes Anti-human IgG and Anti-human IgM antibodies as the capture molecules. COVID-19 Recombinant Antigens-colloidal gold conjugate are used as detection antigen. PRECAUTIONS & WARNING 1. This package insert must be read completely before performing thetest. Failuretofollow directions in insert may yield inaccurate test results. 2. Test results should be read between 10 and 15 minutes after aspecimenisapplied to the sample well. Results read after 20 minutes may giveerroneousresults.3. Do not open the sealed pouch until you are ready to conduct theassay.Onceopened, the cassettes should be used immediately. 4. Do not use expired devices. 5. Bring all reagents to room temperature (15-30°C) prior to use. 6. Do not mix components from different kits. Use only the buffer suppliedalongwith the kit. 7. Wear protective clothing and disposable gloves while handling thekit reagentsand clinical specimens. Wash hands thoroughly after performing thetest. 8. Do not smoke, drink, or eat in areas where specimens or kit reagents arebeinghandled. 9. Dispose of all specimens and materials used to performthe test as biohazardouswaste. 10. Handle the negative and positive controls in the same manner as patientspecimens for operator protection. 11. Do not perform the test in a room with strong air flow, i.e. an electricfanorstrong air-conditioning. 12. Do not touch result window. 13. Use only for in-vitro diagnostic purpose.

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Rapid Test

Buy AccuTest Vitamin D Rapid Card Test (10 Tests) Online from Accurex. The Vitamin D test kit consists of 25 AccuTest Vitamin D individually packed test, devices in foil pouches, 25 pipettes for collecting 10 ul of whole blood, 25 lancets, 1 Buffer Vial (Buffer 5 mL) with stabilizers and, thimerosal, 1 Package Insert. Vitamin D Fast test kit is a rapid chromatographic immunoassay for the semi quantitative detection of Vitamin D levels in human blood/serum. This Vitamin D test provides a preliminary screening test result. INTENDED USE AccuTest Vitamin D is a rapid chromatographic immunoassay for the semi quantitative detection of Vitamin D levels in human blood/serum. This assay provides only a preliminary screening test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. The performance characteristics of this assay have not been established in a pediatric population. PRINCIPLE AccuTest Vitamin D is based on the principle of a competitive enzyme immunoassay. The assay is based on the competition for 25-OH Vitamin D present in blood/serum sample and Vitamin D present on the test line for fixed number of antibody-gold conjugate. Depending upon the concentration of Vitamin D in blood/serum, there will be free antibody-gold conjugate molecules that will bind to Vitamin D on the test strip and will show a colored line in the test line zone. A control line is present in the test window to work as procedural control. PRECAUTIONS 1. For in vitro diagnostic use only. 2. The test is designed for use with human blood/serum only. 3. Reagents must be at room temperature (8⁰C – 30 ⁰C). 4. Do not use if test device packaging is open or damaged. 5. Do not use the product beyond expiration date. 6. Handle all specimens as potentially infectious. Proper handling and disposal methods should be used according to good laboratory practices. 7. Read test results for 10 minutes as required. Results may deteriorate and may not be consistent after 10 minutes. 8. In order to avoid variable results, mix the blood sample thoroughly. 9. A serum sample subjected to repeated freeze thaw cycles may give variable results Direction for Use PROCEDURE 1. Remove the cassette from the sealed pouch and place it on a hard flat surface with the view window facing up (use the cassette as soon as possible). 2. Using a micropipette, add 10 µl of whole blood or 5ul of serum sample directly into the rectangular specimen well (marked with Red drop) of the cassette. 3. Add 3 full drops of Buffer into the square buffer well of the cassette (Do not move the cassette after addition of buffer). 4. Let the cassette sit for 10 minutes and read your results immediately. Results may deteriorate after the 10 minute mark. Other Info STORAGE AND STABILITY The test device should be stored at 8 ⁰C – 30 ⁰C and will be stable until the expiration date stated on the package. The product is humidity sensitive and should be used immediately after being open. INTERPRETATION OF RESULTS Match the color of the test line with the chart provided.

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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 Malaria Pf(HRP II)/Pv Rapid Card Test (50 Tests) Online from Accurex. This Malaria test is a rapid qualitative, chromatographic immunoassay for the detection of malaria infection in human blood sample indicating differential diagnosis between Plasmodium falciparum and Plasmodium vivax species. This Malaria parasite test kit has test strips coated with Monoclonal Anti-p LDH antibodies (test line Pv) specific to the lactate dehydrogenase of P. vivax species and the other (test line Pf) with Monoclonal Anti-HRP-II which is specific to the Histidine Rich Protein-II of P. falciparum. AccuTest Malaria Pf(HRP II)/Pv is a rapid qualitative, chromatographic immunoassay for the detection of malaria infection in human blood sample indicating differential diagnosis between Plasmodium falciparum and Plasmodium vivax species. PRINCIPLE: AccuTest Malaria Pf (HRP II)/Pv test utilizes the principle of immuno-chromatography. It has the test strip coated with Monoclonal Anti-pLDH antibodies (test line Pv) specific to the lactate dehydrogenase of P.vivax species and the other (test line Pf) with Monoclonal Anti-HRP-II which is specific to the Histidine Rich Protein-II of P.falciparum. As the test sample flows through the membrane assembly of the device after addition of the buffer solution, the colored colloidal gold, anti-pLDH antibody and the anti-HRP-II antibody conjugate complexes with the lysed blood sample. The Malaria antigens get immobilized on the respective test lines on the nitrocellulose membrane which leads to the formation of red/purple colored band/s. The un-reacted conjugate and unbound complex if any moves further on the membrane and are subsequently immobilized at the control “C” region forming a red/purple band. This control band serves to validate the test performance and should always appear. This test is intended for professional use and must be used by trained personnel. Related products Safety Information PRECAUTIONS: 1. For in-vitro diagnostic use only. 2. The device is sensitive to humidity as well as to heat. So, it’s very important to take out the device from the sealed pouch just before use. 3. Do not use the kit after the expiration date. 4. Dispose all the samples and kits properly after test, in accordance with GLP. 5. Do not pipette reagent or blood by mouth. Direction for Use Procedure: 1. Disinfect with alcohol swab 2. Punture by lancet 3. Collect blood upto marking on sample dropper Other Info STORAGE AND EXPIRATION: 1. AccuTest Malaria Pf(HRP II)/Pv test kit should be stored between 4 – 30ºC. 2. Expiration date of this kit is 18 months after its manufacture date.

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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 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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