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'first line testing kit'

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Glycohemoglobin Analysis

Buy Xpress Glucometer Plus Kit Online, it’s a smart Glucometer Machine kit. This Digital Glucometer consists of 1 Blood Glucose Meter, 10 Test Strips, 1 Multilet Lancing Device, 10 Sterile Lancets, 1 Carry Pouch, 1 Warranty Card, Test Strip Insert Sheet, 1 Battery (3V) Gluco Plus Meter is intended for use in the home & in clinical settings. There are different types of Glucometers in Point of Care (POC). XPRESSGLUCO + meter measures the strength of the electrical current, calculates your blood glucose level and then displays your result in either milligrams of glucose per deciliter (mg/dL) or millimoles of glucose per liter (mmol/L). The system is intended for use outside the body (in vitro diagnostic use only). It should be used only for self-testing blood glucose (blood sugar) and only with fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, calf or thigh. The system is intended for use in the home and in clinical settings. The system should not be used for the diagnosis of diabetes or for the testing of newborns. Blood glucose is measured by an electrical current that is produced when a blood samples mixes with the reagent (special chemicals) of the test strip. The electrical current changes with the amount of glucose in the blood sample. The XPRESSGLUCO+ meter measures the strength of the electrical current, calculates your blood glucose level and then displays your result in either milligrams of glucose per deciliter (mg/dL) or millimoles of glucose per liter (mmol/L). Safety Information 1. The user should not take any decision of medical relevance without first consulting his or her medical practitioner. 2. Call your doctor immediately if you experience symptoms that are not consistent with your blood glucose test results. 3. High altitudes above than 3,402 meter (11,161 ft) may affect the test results. 4. Temperatures outside the range of 10°C to 40°C (50°F to 104°F) may affect the test results. Do not test beyond of temperature range. 5. Do not perform servicing and maintenance while the meter is in use. 6. No modification of this equipment is allowed. 7. Do not use this meter near cellular or cordless telephones in a call, walkie-talkies, garage door openers, radio transmitters, or other electrical or electronic equipment that are sources of electromagnetic, radiation, as these may interfere with the proper operation of the meter. Direction for Use 1. Wash you hands and puncture sit: Wash your hands in warm, soapy water. Rinse and dry completely . Warm your fingers to increase blood flow. 2. Insert Test Strip : Remove a new test strip from vial. Be sure to tightly replace vial cap after removing test strips. Insert a test strip with the contact bar end entering into the test strip slot first. Push the test strip as far as it will go without bending it. The meter turns on automatically. 3. Hold the prepared lancing device firmly against the side of your fingertip. Press the release button. (NOTE : If you want to do alternative site testing, please refer to the “About Alternative Site Testing (AST)” section. Please consult your healthcare professional before obtaining blood from site other than your fingertip.) 4. Obtain a Blood Sample : Gently massage your finger or puncture site to obtain the required blood volume. To perform the test, you need only 0.5 μL of blood sample. Do not smear the blood sample. To obtain best accurate result, wipe off the first drop of blood and gently squeeze another drop of blood. 5. Apply Blood Sample : When the meter shows the “ ” symbol, apply blood to the opening of the absorbent channel of the test strip where it meets the narrow channel. Blood will be drawn into the test strip. If the test strip confirmation window is full, you will hear a beep. 6. Read Your Result : After the meter counts down from 5 to 1, your blood glucose test result appears along with the unit of measure, date and time. Test result is lower than the target range Test result is within the target range. Test result is higher than the target range *The default target range is 70 mg/dl to 180 mg/dl. 7. Turn Off the Meter : This blood glucose result is automatically stored in the meter memory. Turn the meter off by removing the test strip. Discard the used test strip carefully to avoid contamination. 8. After use, twist off the Lancing Device Cap. Push the exposed tip of the lancet into its Protective Cap. 9. Slide the Lancet Ejector forward and disposing the used lancet in an approved container. Discard the used lancet according to your country’s safety regulations. Replace the Lancing Device Cap. Other Info •Use only XPRESSGLUCO+ Control Solution with your XPRESSGLUCO+ meter. •Check the expiration date on the bottle. Do not use if expired. •Use within a period of 90 days from the date that you first open it. Record the discard date on the control solution bottle when you first open it to serve as a reminder to discard after 90 days. •The control solution ranges are printed on the label of the XPRESSGLUCO+ Blood Glucose Test Strip vial. They are not recommended target ranges for your blood glucose. •For in vitro diagnostic use. •Do not add any liquid to the XPRESSGLUCO+ Control Solution. •Do not take internally or inject.

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Rapid Test

Intended Use Dengue Day 1 Test is a rapid solid phase immuno-chromatographic test for the qualitative detection of Dengue NS1 Antigen and differential detection of IgM and IgG antibodies to Dengue virus in Human serum/plasma. This test is for in vitro diagnostic use only and is intended as an aid in the earlier diagnosis of Dengue infection & presumptive diagnosis between primary and secondary Dengue infection. Salient Features First line testing kit for detecting dengue infection from day 1 using NS1 Antigen & differential detection of IgM & IgG Antibodies. Diagnosis of both Primary & Secondary Infection. Detection of all the 4 Dengue serotypes (DEN-1, DEN-2, DEN-3 and DEN-4). Highly Sensitive & Highly Specific Long shelf life: 30 months at 2-30°C. Convenient pack sizes: 10 Tests, 30 Tests & 50 Tests.

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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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Glycohemoglobin Analysis

Accurex Xpress A1c Glycohemoglobin Analysis System Kit . The Kit contains HbA1c Meter, 1 Sampler, 1 box of 25 test strips, Buffer A, Buffer B. Glycohemoglobin Analyzer It is used for testing glycohemoglobin concentration as an aid to monitor the risk of developing diabetes & control the status of diabetes. Buy Xpress A1c Meter Kit Online from Accurex Point of Care (POC ) Range – The HbA1c analyzer is specifically designed to be used with the corresponding test strip. HbA1c analyzer Hemoglobin A1C is a common blood test that measures blood glucose levels over the past two to three months. •Glycohemoglobin Analyzer •Handheld HbA1c Meter •Battery Operated •No Pipetting, No Lysing •Lab like Accuracy •Battery Operated •Truly Portable •Voice prompt for •User Guidance • Accurate result with cv <3% •Lab like accuracy with 95% •No interference of HB Variant •No pipetting •No lysing •Reagent: Suitable to store at room temperature (upto 30º C) The Power of HbA1c in your Hand esting Principle: Boronate Affinity Chromatography Testing Parameter: Glycohemoglobin (HbA1c) Measuring Range: 4.0% – 14.0% Precision: CV <3% (HbA1c: 4.0% – 6.5%) Blood Sample: Finger Prick or Venous Blood ( EDTA Anticoagulant) Blood Volume: About 3ul Testing Time: About 5 minutes Data Unit: Set in Advance the Data Unit • NGSP%; IFCC mmol/mol; eAG* mmol/l Voice Prompt: Voice Prompt to Guide the user Data Storage: 1000 Testing Data Data Port: Mini USB data interface can be connected with HIS/LIS; System Thermal Printer Power Required: AAA Battery x 4 Analyzer Dimension: 61.6 x 122.9 x 24.5 mm Screen Size: 47 x 32 mm” Safety Information LIMITATION AND WARNING: 1. This product is used for In Vitro Diagnostics only, not for in vivo use. 2. This product should not be used past the expiration date. 3. If there is evidence of microbial contamination or browning, discard the vial. 4. This product is not intended to be used as an HbA1c standard. 5. Preservatives contained in the control, rinse with water if splash into the mouth or eyes, and seek medical help as soon as possible. 6. Potential biological risk. Direction for Use This product should be run in accordance with instructions accompanying BioHermes Glycohemoglobin Test Kit and Glycohemoglobin Analyzer. (1) Dissolution: Open the cap of the vial, and then add 2 drops of Buffer A. Close the cap, and slightly shake the vial until the powder dissolved completely. And please shake it well before using it. (2) Testing in accordance with instructions accompanying BioHermes Glycohemoglobin Test Kit and Glycohemoglobin Analyzer. Please refer to the B Other Info Storage: 1. This product will be stable for 24 months when stored tightly capped at 2-8℃. 2. After dissolved, the product can be stable for 8 hours at 10-30℃, or 5 days at 2-8℃. Do not freeze it. COMPOSITION: This product is prepared from human blood and contains normal hemoglobin, preservatives and stabilizers. The control is provided in lyophilized powder form for increased stability. The kit contains two levels of control, level 1 is with yellow cap, and level 2 is with green cap.

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Hematology

n large laboratories, rows of instruments are seen working tirelessly like miniature factories – only they produce not commodities but medical test results. Mindray CAL 8000 new-generation cellular automation line is one of them, but unlike a typical workhorse, it is intelligent. It is a highly automated workstation for smarter, faster, and more accurate cellular analysis. It can perform competently in the face of these challenges. The workstation can hold up to four units of BC-6800 automated hematology analyzer, which utilizes the advanced SF Cube technology and 3-D scatter grams to help doctors better differentiate blood cell populations and reveal abnormal cells undetectable by conventional techniques. With 125 CBC tests per hour per unit, BC-6800 brings the process rate of the workstation to 20–30 percent higher than other similar models, effectively alleviating laboratory's stress during the peak processing hours. On CAL 8000, the hematology analyzer, slide maker and stainer, CRP analyzer, and HbA1c analyzer are all integrated into one seamless production line through automated track modules and trolley. Simply by loading a single tube of blood sample onto the automation system, one can get all the test results. This innovative walk-away automation functionality has made possible the CBC+CRP+HbA1c testing all in one streamlined workstation for the first time in the industry. It offers a smart solution, or rather, a smart expert – the labX pert 2.0. It is a software that can automatically sort out the suspected samples for manual validation. The pathologist then decides if rerun or microscopic review is warranted based on their clinical experience. It avoids wasting slides and reduces extra work. Moreover, the onboard automated re-exam functionality also helps enhance work efficiency. The CMU software The touch screen is the “brain” of CAL 8000. It optimizes the distribution of workload between each analyzer unit and decides which sample requires a blood smear. It displays the status of each analyzer or SC-120 installed on CAL 8000 as well as the volume of balance reagent. This intuitive software can tell the users all necessary information of CAL 8000 at any given time. Consequently, the users spend less time operating CAL 8000 and can arrange their working schedule better. Multi “R” tests The CAL 8000 can automatically distribute the samples with “Repeat”, “Rerun” and “Reflex” criteria which are pre-defined by users.The re-exam criteria on CAL 8000 can be defined by many conditions, such as time, patient’s age, gender, department, etc. This helps minimize the number of blood smears. Special tube racks The special tube racks utilize different barcodes to differentiate specific testing purposes, such as “QC”, “Slide making & staining only” and “RET test only”. The special tube racks can carry the tubes to perform these specific functions in the simplest way.

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Hemoglobin Meter

Buy Accurex H12 Hemoglobin Test Strips Online – for better result & accuracy. These Hemoglobin strips are used with URIT Hemoglobin Meter, for the quantitative measurement of total hemoglobin in capillary and venous whole blood. These hb strips are to be used by health care professionals only, not to be used for patient self-testing. Accurex HB Test Strips come with a pack size of 50 strips. The Accrues test strip utilizes Dry Chemistry Colorimeter Method (Azido methemoglobin Method). Meter’s optical detectors automatically measure the change in the membrane Buy Accurex H12 Hemoglobin Test Strips Online – for better result & accuracy. These Hemoglobin strips are used with URIT Hemoglobin Meter, for the quantitative measurement of total hemoglobin in capillary and venous whole blood. These hb strips are to be used by health care professionals only, not to be used for patient self-testing. Accurex HB Test Strips come with a pack size of 50 strips. The Accrues test strip utilizes Dry Chemistry Colorimeter Method (Azido methemoglobin Method). Meter’s optical detectors automatically measure the change in the membrane Operation Principle: The test strip utilizes Dry Chemistry Colorimeter Method (Azido methaemoglobin Method). When a drop of whole blood is applied to the test spot on the strip, blood immediately disperses within the membrane, contacting the reagent. The meter’s optical detectors avtomatically measure the change in membrane reflectance. The intensity of reflectance is inversely proportional to the hemoglobin concentration. Blood Sample Collection: Fresh or EDTA-anticoagulated capillary or venous whole blood may be used. If an EDTA – treated sample is refrigeratted to come to the room temperature before testing. EDTA treated blood samples should be mixed using end to and inversions at least 8 times prior to use, and should be tested within 24nours Do not use the haemolytic sample anticogulants other than EDTA are not recommended for use. Caution: 1. Same as all diagnostic tests, hemoglobin test results should be evaluated with the specific patient’s condition. Any results demonstrating the inconsistency with the patient’s clinical status should be repeated or supplemented with additional test data. 2. Do not touch the test membrane by hand 3. H12 Hemoglobin Test Strips are one-off product, do not use again Storage & Preparation: 1.H12 Hemoglobin Test Strips should be stored at O C-30 C dry and dark places, 2 C – B C is the best storage environment emperatures recommended. Keep away from direct sunlight and heat, must not be frozen, If the container was stored in refrigerated before first use, please don’t take it back into the refrigerator again after first use. 2. H12 Hemoglobin Test Strips are ready to use. No additional preparation is required 3. Enclosed desiccants with lest strip. Remove only those strips needed for testing. The remaining lest strips should be resealed in their onginal container and used up in 3 months after first use. Do not use lest strips and throw away alter expiry date. 4. Use the strip immediately once taking it out af the container, otherwise the result will be incorrect 5. Do not fold or cut the test strip. 6. Used lest strips cannot be used again, dispose them as normal medical waste Direction for Use Operating Instructions: 1. URIT Hemoglobin Meter, H12 Hemoglobin Test Strip, Lancing Device, and disposable blood taking needle. 2. Test steps: 1) Turn the meter on and input the Code Card. Check the Code Card displaying on the meter to ensure it to match the Code Card printed on the lest strip container. Otherwise, the result is incorrect. 2) Massage the patient’s finger from the knuckle up to the tip to stimulate blood flow. Clean the sample area with alcohol and wipe it dry with a sterile gauze pad. 3) Insert the lest strip into the strip holder with the notched end in first and the hole facing up. 4) Puncture the skin on the lower side of fingertip with blood collection needle, and remove 13-15 TIL of whole biood with capillary or other micro blood collection apparatus. While waiting for the instrument to display the blood drop symbol, quickly add the drops to the test hole on the reagent sheet. Please make sure that the blood drop volume can completely cover the test hole but not overflow the test hole. 5) The meter starts the test automatically after the blood sample disperses Once the lest is in process do nol disturb or move the meter or test strip, or press any key. The test result will display within 12 seconds. Qualtiy Control Procedure: Use only H12 Hemoglobin Test Strip with QC substance to perform QC. The range of QC substance is the numerical range indicated on the label of the QCsubstance or test strips. When to do a QCtest: 1. Whenever you suspect that the meter or test strips are not working properly. 2. If your hemoglobin test results are not consistent with how you feel. Other Info Limitations of test Method: H12 Hemoglobin Test Strip is only suitable for testing fresh or whole capillary blood or whole venous blood containing EDTA anticoagulants. Do not use serum, plasma or arterial blood

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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 Syphilis Rapid Card Test (50 Tests) Online from Accurex. This Syphilis test is a special test kit designed to detect Syphilis (Treponema Pallidum- IgA, IgM, IgG) antibodies in serum/plasma. Syphilis is caused by the bacterium Treponema pallidum. There different types of test like VDRL test, RPR test, FTA-ABS, etc. AccuTest Syphilis Test Kit is easy to use at home and gives you 99% accurate result in just 5 -20 minutes, with sensitivity & specificity of 99.67%. Recombinant syphilis antigen (17KDa, 15KDa, 47KDa) is immobilized in the lest line region of the device. AccuTest Syphilis Rapid Test is a special test kit designed to detect Syphilis (Treponema Pallidum- IgA, IgM, IgG) antibodies in serum/plasma. This kit is easy to use at home and gives you 99% accurate result in just 5 -20 minutes, with sensitivity and specificity of 99.67%. 1. AccuTest Syphilis is a chromatographic immunoassay kit for rapid qualitative detection of Treponemal antibodies (IgA, IgM, IgG) generated against Treponema pallidum Antigens (17KDa, 15KDa, 47KDa) in human serum or plasma with high sensitivity and specificity. 2. Results just in 5-20 minutes 3. Accu Test Syphilis exhibits sensitivity and specificity of 99.67%. Features: Based on Chromatographic Immunoassay assay for detection of Treponema pallidum antigens Sample: Human Serum or Plasma 2-3 drops of Serum/Plasma sample required for testing Fast: 1 step method, result in just 5 to 20 minutes Excellent sensitivity and specificity of 99.67% Store unused kit at 2-30C Pack size: 50 T Recombinant syphilis antigen (17KDa, 15KDa, 47KDa) is immobilized in the lest line region of the device. After the specimen is added to the specimen well in the device, it reacts with syphilis antigen coated particles in the test. The mixture migrates chromatographically along the length of the test strip and interacts with the immobilized syphilis antigen. The double antigen test format can detect IgA, IgG & IgM in specimens. If the specimen contains TP antibodies a coloured band will appear in the lest line region indicating a positive result. In the absence of TP antibodies a coloured band will not appear in the region indicating a negative result. To serve as a procedural control, a coloured band will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred. Based on Chromatographic Immunoassay assay for detection of Treponema pallidum antigens Sample: Human Serum or Plasma 2-3 drops of Serum/Plasma sample required for testing Fast: 1 step method, result in just 5 to 20 minutes Excellent sensitivity and specificity of 99.67% Store unused kit at 2-30C Pack size: 50 T Direction for Use Procedure: 1. Bring the pouch to room temperature before opening to avoid condensation of moisture on the membrane of the device. Also bring the specimen to R.T. prior to testing. 2. Label the device with patient’s identification. 3. Add 2-3 drops (approx. 30 pl) of sample into the sample well of the test device. Avoid overflowing. 4. Wait for 5 – 20 minutes and read the result. It is important that the background is clear beforg the result is read. Note: Do not read the result after 30 minutes since specimen back flow may cause false result. STORAGE, STABILITY & HANDLING 1. The kit should be stored at 2 – 30° C. Do not freeze. 2. Do not use the kit past the expiration date stated on label. 3. Take off the device from the sealed pouch just before use as the device is sensitive to humidity and heat.

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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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