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immunoassayReagents

INTENDED USE The Finecare™ PSA Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative detemination of Prostate Specific Antigen (PSA) in human whole blood, serum or plasma. The test is used as an aid in diagnosis of prostatic cancer. STORAGE AND STABILITY 1. Store the test kit at 4~30℃ up to the expiration date 2. If removed from refrigerator, allow the test for 30 minutes to return to room temperature before testing. 3. Do not remove the device from the pouch until ready to use. The test cartridge should be used within 1 hour once opened.

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Rapid Test

Intended Use Diagnos Celiac Card is a visual, rapid, sensitive and accurate one step immunoassay for the qualitative detection of anti tTG IgA, IgG & IgM antibodies in Human Serum or Plasma. The assay is intended to be used as an aid in the recognition and diagnosis of Celiac disease. Salient Features Rapid, Visual and Qualitative Antibody Test. Excellent Sensitivity: 99.26% & Specificity: 99.50%. Results within 20 minutes. Long Shelf life 24 months at 2-8°C. Bio-hazard free, fully covered, see-through Device. No instrument required.

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Glucometer

Accu-Chek® Active blood glucose meter Personalised Diabetes Coaching Accurate, no coding, easy Item Description The Accu-Chek Active blood glucose meter packs many powerful features into a smaller size. No coding reduces handling steps, see test result averages up to 90 days, get alerts if your test strips are expired or if you’ve underdosed, re-dose within 10 seconds, set pre-and post-meal reminders to test, and more. Benefits and Features accurate: Accurate1 blood glucose measurement easy: No coding for even easier blood glucose monitoring easy-to-read display (new typeface) intuitive handling with just 2 buttons safe: Underdose detection visual double check 10 seconds re-dose option clever: Pre- and postmeal markers postprandial reminder 7,14,30 or now 90 day test averages USB interface for data transfer Remark: Previous Accu-Chek Active meter generations will be upgraded to no coding via black activation chip . Know more>> 1The Accu-Chek Active bGM system meets the DIN EN ISO 15197:2013 requirements (data on file, 2014). Additional specifications Meter type : Accu-Chek Active meter (Model GB) Catalogue no. / Serial no. : See type plate on the back of the meter Test principle : Determination of glucose in fresh capillary blood by reflectance photometry. Blood glucose values can be tested in whole blood or plasma. The meter displays blood glucose values corresponding to those in plasma. Measuring interval : 10-600 mg/dL Blood volume : 1-2 μl Measuring time : Test strip in the meter: approx. 5 seconds Test strip outside the meter: approx. 08 seconds Power supply : 1 battery (type CR2032) Battery life : approx. 1000 tests or approx. 1 year Automatic power-off : after 30 or 90 seconds depending on operating status Memory : 500 test results with time and date, as well as 7, 14, 30 and 90 days averages Temperature : During testing: +8 to +42°C During storage without battery: -25 to +70°C During storage with battery: -20 to +50°C Atmospheric humidity : During testing: up to 85% relative humidity During testing: up to 93% relative humidity Altitude: Sea level to 4000 m Dimensions : 97.8 x 46.8 x 19.1 mm Weight : Without battery: approx. 46 g With battery: approx. 50 g Display : 96-segment liquid crystal display (LCD) Interface : USB (Micro B) Safety class : III Electromagnetic compatibility : The Accu-Chek Active meter meets the electromagnetic immunity requirements and the electromagnetic emissions requirements as per EN 61326-2-6 and EN ISO 15197 Annex A. The chosen basis for electrostatic discharge immunity testing was basic standard IEC 61000-4-2. Performance analysis : Calibration and traceability: The performance data for the Accu-Chek Active bGM system was calibrated using venous blood containing various glucose concentrations. Reference values are obtained using the hexokinase method, which is calibrated using the ID-GCMS method. Accuracy performance : The Accu-Chek Active bGM system meets the DIN EN ISO 15197:2013 requirements (data on file, 2014). How to use Accu-Chek Active blood glucose meter Testing your blood glucose is an essential part of managing diabetes. The Accu-Chek Active blood glucose meter can help to make it convenient by giving you fast, hassle-free, and accurate results in 4 simple steps. Insert the glucose test strip Prick your finger with the lancet to draw out a blood drop. Carefully touch the blood drop onto the green field of the test strip. Read the blood glucose result.

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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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