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'vitro diagnostic procedure'

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Clinical Chemistry

Acid Phosphatase Diagnostic Reagent (Pack size: 8 x 1 ml) from Accurex. Acid Phosphatase is used in accordance with ISO 14189 to detect acid phosphatase from Clostridium perfringens. Autozyme Acid Phosphate reagent is set for determination of Acid Phosphatase activity based on Kinetic method using a-naphthyl phosphate. In acidic pH of the buffer system, the reagent hydrolyses a-naphthyl phosphate to a-naphthol & phosphate. Accurex has gained considerable expertise in manufacturing & marketing of In-vitro Diagnostic reagents. About Autozyme Acid Phosphate is a reagent set for determination of Acid Phosphatase activity based on Kinetic method using a-naphthyl phosphate Autozyme Acid Phosphate is a single reagent system using one step procedure Autozyme Acid Phosphate can be determined in just 8 minutes at 37 degree C Acid Phosphate can be used on any Spectrophotometer, Discrete semi automated and Automated Analyzer. Programme can be designed for any specific analyzer upon request. Pack Size : 8 x 1 ml Principle In acidic pH of the buffer system, Acid Phosphatase hydrolyses a-naphthyl phosphate to a-naphthol and phosphate. The o-naphthol is then coupled with Diazotized Fast Red TR to form a Diazo dye which has strong absorbance at 405 nm. The increase in absorbance is directly proportional to the level of acid phosphatase in serum. The addition of L-Tartrate inhibits prostatic acid phosphatase but does not inhibit other isoenzymes. The activity of Prostatic Acid Phosphatase is obtained by subtracting the result of Non prostatic Acid phosphatase (Determination with Tartrate) from Total Acid Phosphatase (without tartrate). Quality Control To ensure adequate quality control it is recommended that each batch should include a normal and an abnormal commercial reference control serum. It should be realized that the use of quality control material checks both instrument and reagent functions together. Factors which might affect ne performance of this test includes proper instrument function, temperature control, cleanliness of glassware and accuracy of pipetting.

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Rapid Test

Intended Use Advantage Typhi IgM & IgG Card is a rapid solid phase immuno-chromatographic test for the qualitative differential and simultaneous detection of salmonella typhi (S. typhi) IgM and IgG antibodies in human serum / plasma. This test is for in vitro diagnostic use only and is intended as an aid in the earlier diagnosis of typhoid infection and in the determination of recent and past infection. Salient Features Rapid qualitative test for differential detection of Salmonella typhi (S.typhi) IgM and IgG Antibodies in Human Serum / Plasma Determination of both recent and past infection Results within 20 minutes Bio-hazard free, fully covered, see-through Device Simple & Easy to use Test Procedure No Instruments required Long Shelf Life: 30 months at 2-30ºC Convenient Pack size: 50 Tests

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Rapid Test

This product performs qualitative analysis on NS1 antigens of Dengue virus in serum, plasma and whole blood. Intented Use STANDARD Q Dengue NS1 Ag Test is an immunochromatographic assay for the detection of NS1 antigens in human serum, plasma, or whole blood samples. This test kit is for use in in-vitro diagnostic procedures. Specification Specimen Whole blood, serum, plasma Test time 15-20mins (Inaccurate results after 20 minutes) Sensitivity 92.9% (184/198) Specificity 98.7% (222/225) Storage temperature 2-40℃ / 36-104℉ Advantage Getting fast results In 15 ~ 20 minutes Wide storage range of 2~40℃ (36~104℉) Easy and convenient testing process Effective in detecting the antigen(NS1 protein) Suitable for Point of Care Testing No need for using extra equipment

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

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Rapid Test

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

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