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Clinical Chemistry

EM 360 is a Fully Automated Clinical Chemistry Analyser which is time tested and proven technology. It is designed to provide the most demanding productivity, speed and operational ease. EM 360 with a throughput of 360 tests/hour offers flexibility in operation and rugged performance to win against high workload, tight deadlines, multiple tasks and complexity of testing. It yields high quality results for virtually any biochemistry test to deliver quick, efficient and consistent performance. Product Features: Automated, Discrete, Patient prioritized, Floor model Based on proven technology, Diffraction Grating Separate probes for Reagent R1 & R2 and dedicated probe for sample Low reading volume of 200 µl only Onboard cooling for reagents to enhance the reagent stability Barcode for reagents & samples (Optional) Wide test menu Product Applications: End Point Reactions: Glucose, Cholesterol, Triglycerides, Albumin, Total Protein, Uric Acid, Calcium, Magnesium, Bilirubin Total, Bilirubin Direct Kinetic Reactions: SGOT, SGPT, GGT, LDH, CK, CK MB, ALP, ACP, Amylase, Lipase Two Point Rate Reactions: Urea, Creatinine Immunoturbidimetric Chemistries: RA, CRP, ASO, Direct HDL, Direct LDL, Apo A, ApoB, Lp (a) Special Chemistries: HbA1c, Iron, Ferritin, Phosphorus, Microprotein, Ammonia, Bicarbonates System Type: Discrete, automated, random access, patient prioritized clinical chemistry analyzer Throughput: 360 tests / hour photometric and 600 tests / hour with ISE* (*optional ISE with Na+, K+, Cl-, Li+) Analytical Methods: 1-Point, 2-Point, Rate-A, Rate-B, Direct Potentiometry (optional) Barcode Reader: For reagents and samples (optional) Reaction Tray: 60 hard glass cuvettes Reaction Mixing: Stirrer with variable speed Minimum reaction Volume: 150 μl with maximum 200 μl reading volume On-board Laundry: 5 stage cleaning, 2 stage drying Photometer: Multi-wavelength diffraction grating with 12 wavelengths (340, 376, 415, 450, 480, 505, 546, 570, 600, 660, 700, 750 nm) OD Range: 0.0 - 3.0 Light Source: Halogen lamp Detector: Silicon photo-diode Water Consumption: < 10 litres Programmable Parameters: Default system pack parameters + upto 99 user defined parameters, Unlimited profile and unlimited calculation items Quality Control: QC plot data with QC rules. Provision for lab mean. Twin plot Calibration: K-Factor, Linear (1, 2 point & multipoint), 4P and 5P Logit-log, cubic spline, exponential, polynomial, On-board serial dilution for calibrator Power Requirement: AC 220 V ± 10 %, 50 Hz or AC 110 V ± 10 %, 60 Hz Power Consumption: 800 VA Dimension (mm): Approx. 675 (W) x 840 (D) x 1120 (H) Weight: Approx. 150 kgs. SAMPLE HANDLING Sample: Serum, Plasma, Urine, CSF, Whole blood, other Sample Unit: 82 positions for samples, blank , controls, calibrators, STAT sample Sample Pipetting: 2 - 70 µl (adjustable in 0.1 µl step) for Biochemistry, 70 µl fixed for ISE Capacitance probe with liquid level sensing & vertical obstruction detection, serum indices Auto Rerun: Repeat with same, increased or decreased volume ( upto 1:150) Sample Tubes /Cups: Primary tubes of 5 ml, 7 ml, 10 ml and sample cups REAGENT HANDLING Reagent Tray: 50 positions for reagents with onboard cooling Reagent Pipetting: R1: 50 - 300 µl (adjustable in 1 µl step) R2: 10 - 200 µl (adjustable in 1 µl step) Capacitance probe with level sensing & vertical obstruction detection SYSTEM INTERFACE: Analyzer-PC: USB PC - Host Computer: Bidirectional TCP / IP & RS - 232 PC - Printer: USB Operating System: Windows Based Database: Unlimited Results

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Hematology

The BC-3600 Hematology analyzer features closed tube sampling via a single push button. A built-in large 10.4 inch color touchscreen allows maximum visibility. Hemoglobin analysis is performed using cyanide-free reagent. The analyzer processes up to 60 samples per hour and stores up to 40,000 results with histograms. The barcode reader and optional LIS connectivity enable seamless sample data transmission. Nearly all scheduled maintenance procedures are automated by touch buttons. The intuitive software enhances workflow efficiency and provides operators with a pleasant user experience. Key Features CBC plus 3-part differential, 16 parameters + 3 histograms 60 samples per hour, 1 min per CBC Closed tube sampling, minimize operational biohazard Built In diluent dispenser for predilution mode All-in-one CBC result screen display; results at a glance Touch button maintenance procedures One maintenance reagent only – probe cleaner Storage capacity of 40,000 results with histograms Uploadable QC files; ensure accuracy and time efficiency Parameters WBC, Lymph#, Mid#, Gran#, Lymph%, Mid%, Gran%, RBC, HGB, HCT,MCV, MCH, MCHC, RDW,PLT, MPV and histograms for WBC, RBC, PLT Principles Electrical impedance method for cell counting and Cyanide - free for hemoglobin Sample Volume Prediluted 20µL Whole Blood 21µL Carryover WBC/RBC/HGB≤0.5% PLT≤1.0% Connectivity 4 USB ports (for external printer, software upgrade, barcode reader,keyboard and mouse), LAN port (1), RS232 (1) Printout Thermal recorder, 50mm width paper, various printout formats, external printer (optional) Product Specification Brand Mindray Differential Type 3-Part Model Name/Number BC 3600 Display Type Large color touch screen Resolution 800x600 Usage/Application Hospital Throughput 60 samples per hour Power Supply AC 100-240V,50/60 +-1Hz Weight 62 lbs Dimension 16 in(W) x 18 in(H) x 18 in(D) Humidity 30%-85% Temperature 15 ~30 Deg C Minimum Order Quantity 1

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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 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 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 AccuTest HCV Rapid Card Test (30 Tests) Online from Accurex. HCV means Hepatitis C Virus which is a is a small, enveloped, positive-sense, single-stranded RNA virus. Hepatitis C symptoms are fever, fatigue, decreased appetite, nausea, vomiting, abdominal pain, dark urine, pale feces, joint pain and jaundice. HCV test is a rapid Chromatographic Immunoassay work on principle of the double antigen sandwich technique, Qualitative detection of antibodies generated against proteins that are encoded by conserved sequence of core NS3, NS4, NS5 parts of HCV genome in human whole blood/serum or plasma. AccuTest HCV Test is a rapid Chromatographic Immunoassay for the Qualitative detection of antibodies generated against proteins that are encoded by conserved sequence of core NS3, NS4, NS5 parts of HCV genome in human whole blood/serum or plasma. Hepatitis C Virus (HCV) is a small, enveloped, positive-sense, single-stranded RNA virus. Antibody to HCV is found in over 80% of patients with well documented non-A, non-B hepatitis. Conventional methods fail to isolate the virus in cell culture or visualize it by electron microscope. Cloning the viral genome has made it possible to develop serologic assays that use recombinant antigen, multiple antigens using recombinant protein and/or synthetic peptides have been added in new serologic tests to avoid nonspecific cross-reactivity to increase the sensitivity of HCV antibody tests. Storage and Stability: AccuTest HCV should be stored at 4-30C. However, the card may be stored at room temperature not exceeding 30C in the original sealed pouch. Test Procedure: 1. Allow the test, specimen and or control to room temperature prior to the testing 2. Remove one test card from the pouch and place it on a clean flat surface 3. Using the dropper provided one drop of serum/plasma or W. blood sample (30ul) then two drops of buffer (40ul) immediately into the sample well. Avoid overflowing 4. Read results within 15 minutes. Strong positive reaction may visible within 5 minutes. Do not read results after 15 minutes. 5. If negative or quest Principle: AccuTest HCV Rapid Hepatitis C Virus Test (Serum/Plasma/Whole Blood) is a lateral flow chromatographic immunoassay based on the principle of the double antigen-sandwich technique. The membrane is coated with recombinant HCV antigen on the test line region of the device. During testing, the serum/plasma or W.Blood specimen reacts with HCV antigen coated particles. The mixture migrates upward on the membrane chromatographically by capillary action to react with recombinant HCV antigen or membrane and generate a colored line. Presence of this colored line indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear at the control line region, indicating that the correct volume of specimen has been added and membrane wicking has occurred. Storage and Stability: AccuTest HCV should be stored at 4-30C. However, the card may be stored at room temperature not exceeding 30C in the original sealed pouch. Test Procedure: 1. Allow the test, specimen and or control to room temperature prior to the testing 2. Remove one test card from the pouch and place it on a clean flat surface 3. Using the dropper provided one drop of serum/plasma or W. blood sample (30ul) then two drops of buffer (40ul) immediately into the sample well. Avoid overflowing 4. Read results within 15 minutes. Strong positive reaction may visible within 5 minutes. Do not read results after 15 minutes. 5. If negative or questionable results are obtained, the HCV infection is suspected, the test should be repeated ona fresh serum specimen. Safety Information •Positive: If a distinct purple line is formed at the test one marked ‘T’ (Test Line) and the Control Zone marked ‘C’ (Control Line) the test result is positive, indicating the sample contains Hepatitis C antibody. The interpretation of test results (+ve for hepatitis) remains unchanged even if there is a difference in intensity of color in positive line and control line as is many a time found. •Negative: If a distinct purple line is formed only at the control zone marked ‘C’ (control line) the test result is negative • Invalid: A total absence of color in both © and (T) regions or no colored band appears on the control © region is an indication of procedure error and/or the test reagent has deteriorated. Repeat with a new test kit. Direction for Use Test Procedure 1. Allow the test, specimen and or control to room temperature prior to the testing 2. Remove one test card from the pouch and place it on a clean flat surface 3. Using the dropper provided one drop of serum/plasma or W. blood sample (30ul) then two drops of buffer (40ul) immediately into the sample well. Avoid overflowing 4. Read results within 15 minutes. Strong positive reaction may visible within 5 minutes. Do not read results after 15 minutes. 5. If negative or questionable results are obtained, the HCV infection is suspected, the test should be repeated ona fresh serum specimen. Other Info Storage and Stability AccuTest HCV should be stored at 4-30C. However, the card may be stored at room temperature not exceeding 30C in the original sealed pouch.

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