High Accuracy Dengue IgG/IgM Rapid Diagnostic test, easily and quick operation, Gold Colloidal meth

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High Accuracy Dengue IgG/IgM Rapid Diagnostic test, easily and quick operation, Gold Colloidal method Product Name: Dengue IgG / IgM Rapid Test (Cassette) INTENDED USE: Dengue IgG / IgM Rapid Test is a qualitative test for the detection of IgM and IgG antibodies to dengue virus in human whole blood, serum or plasma. This test is for in-vitro diagnostic use only. BACKGROUND The Dengue Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Dengue virus in human whole blood, serum, or plasma as an aid in the diagnosis of primary and secondary Dengue infections. Dengue is a flavivirus, transmitted by Aedes aegypti and Aedes albopictus mosquitoes. It is widely distributed throughout the tropical and subtropical areas of the world,1 and causes up to 100 million infections annually.2 Classic Dengue infection is characterized by a sudden onset of fever, intense headache, myalgia, arthralgia and rash. Primary Dengue infection causes IgM antibodies to increase to a detectable level in 3 to 5 days after the onset of fever. IgM antibodies generally persist for 30 to 90 days.3 Most Dengue patients in endemic regions have secondary infections,4 resulting in high levels of specific IgG antibodies prior to or simultaneous with IgM response.5 Therefore, the detection of specific anti- Dengue IgM and IgG antibodies can also help to distinguish between primary and secondary infections. The Dengue Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid test that utilizes a combination of Dengue antigen coated colored particles for the detection of IgG and IgM Dengue antibodies in human whole blood, serum, or plasma. Test Principle The Dengue Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative membrane-based immunoassay for the detection of Dengue antibodies in whole blood, serum, or plasma. This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in IgG test line region. During testing, the specimen reacts with Dengue antigen-coated particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in IgG test line region. If the specimen contains IgG antibodies to Dengue, a colored line will appear in IgG test line region. In the IgM component, anti-human IgM is coated in IgM test line region. During testing, the specimen reacts with anti- human IgM. Dengue IgM antibodies, if present in the specimen, reacts with the anti-human IgM and the Dengue antigen- coated particles in the test cassette, and this complex is captured by the anti-human IgM, forming a colored line in IgM test line region. Therefore, if the specimen contains Dengue IgG antibodies, a colored line will appear in IgG test line region. If the specimen contains Dengue IgM antibodies, a colored line will appear in IgM test line region. If the specimen does not contain Dengue antibodies, no colored line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred. TEST PROCEDURE 1. Bring the pouched test device to room temperature(15-30) prior to testing. Do not open the pouch until ready to perform the assay. 2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface. 3. Use the pipette to draw and slowly add 1 drop of whole blood to the sample well. 4. Hold the buffer bottle vertically and add 1-2 drops to the sample well./ If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well. 5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes. Caution: The above interpreting time is based on room temperature range of 15 - 30C. If your room temperature is significantly lower than 15 C, then the interpreting time should be properly increased to 30 minutes. INTERPRETATION OF RESULTS IgG Positive: The control line and IgG line (T1) are visible in the result window. The test is positive for IgG antibodies. This indicates a past dengue infection. IgM Positive: The control line and IgM line (T2) are visible in the result window. The test is positive for IgM antibodies. This indicates a primary dengue infection. IgM and IgG Positive: The control line, IgM (T2)and IgG (T1) lines are visible in the result window. The test is positive for IgM and IgG antibodies. This indicates a secondary dengue infection. Negative: The control line is the only line visible in the result window. No IgG or IgM antibodies have been detected. The result does not exclude dengue infection. If symptoms persist, a new specimen should be drawn from the patient in 3-5 days and then should be retested (see the limitations section). Invalid: If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region. PERFORMANCE STUDY The Dengue IgG/IgM Rapid Test cassette (Whole Blood/Serum/Plasma) has correctly identified specimens of seroconversion panel and has been compared to a leading commercial ELISA Dengue IgG test and Eliza Dengue IgM test using clinical specimens. The results show that the relative sensitivity of the Dengue IgG Rapid Test cassette (Whole Blood/Serum/Plasma) is 86.91% , the relative specificity is 97.59% and an accuracy of 89.53%. - - - - Method | | | | ELISA Dengue IgG | | | | | | | | Total Result | | Results | | Positive | | Negative | | | | | Dengue IgG | | | | | | | Positive | | 445 | | 4 | 449 | (Whole Blood/Serum/Plasma) | | | | | | | | | | | | | | | | | Negative | | 67 | | 162 | 229 | | | | | | | | Total Result | | | 512 | | 166 | 678 | | | | | | | | Relative Sensitivity: 86.91% | | | | | | Relatively Specificity: 97.59%. | | | | | | Accuracy:89.53% | | | | - - - - The results show that the relative sensitivity of the Dengue IgM Rapid Test cassette (Whole Blood/Serum/Plasma) is 84.83% ,the relative specificity is 86.91% and an accuracy of 91.45%. - - - - Method | | | | ELISA Dengue IgM | | | | | | | | Total Result | | Results | | Positive | | Negative | | | | | Dengue IgM | | | | | | | Positive | | 246 | | 14 | 260 | (Whole Blood/Serum/Plasma) | | | | | | | | | | | | | | | | | Negative | | 44 | | 374 | 418 | | | | | | | | Total Result | | | 290 | | 388 | 678 | | | | | | | | Relative Sensitivity: 84.83% | | | | | | Relatively Specificity: 86.91%. | | | | | | Accuracy:91.45% | | | | - - - - Conclusion: The sample correlation results show that the relative sensitivity of the Dengue IgG Rapid Test cassette is 86.91% , the relative specificity is 97.59% and an accuracy of 89.53% to be compared with a commercial available Dengue IgG ELISA test. The sample correlation results show that the relative sensitivity of the Dengue IgM Rapid Test cassette is 84.83% ,the relative specificity is 86.91% and an accuracy of 91.45% to be compared with a commercial available Dengue IgM ELISA SET. NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.

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Oriental New Life Medical Device Technology Co.,Ltd.

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