INTENDED USE
The Dengue IgG/IgM/NS1 Combo Rapid Test Device is a lateral flow chromatographic immunoassay for the qualitative detection of dengue IgG/ IgM and virus antigen (Dengue Ag) in human whole blood, serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with Dengue viruses. Any reactive specimen with the Dengue IgG/IgM/NS1 Combo Rapid Test Device must be confirmed with alternative testing method(s) and clinical findings.
REAGENTS AND MATERIALS PROVIDED
1.Each foil pouch contains with three items inside:
a. One cassette device with Dengue IgG/IgM and Ag NS1 test strips.
b. One plastic dropper.
c. One desiccant.
2.Sample Diluent
3.One package insert (instruction for use).
ASSAY PROCEDURE
Step 1: Bring the specimen and test components to room temperature if refrigerated or frozen. Mix the specimen well prior to assay once thawed.
Step 2: When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.
Step 3: Be sure to label the device with specimen’s ID number.
Step 4: For whole blood samples:
Fill the dropper with the specimen then add 10µL of specimen and 2 drops of buffer into the IgG/ IgM sample well and 2 drops of specimen and 1 drops of buffer into NS1 sample well, making sure that there are no air bubbles.
For Plasma/ Serum samples:
Fill the plastic dropper with the specimen. Holding the dropper vertically, dispense 5 µL of specimen and 2 drops of buffer into the IgG/ IgM sample well and 2 drop of specimen and 1 drops of buffer into the NS1 sample well, making sure that there are no air bubbles.
Step 5:Set up a timer.
Step 6: Results can be read in 15 minutes. Positive results can be visible in as short as 1 minute.
Don’t read results after 30 minutes. To avoid confusion, discard the test device after interpreting the result.
INTERPRETATION OF RESULTS
Dengue IgG/ IgM Rapid Test:
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POSITIVE RESULT:
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IgG Positive:The colored line in the control line region (C) appears and a colored line appears in test line region 1 (G). The result is positive for Dengue virus specificIgG and is probably indicative of secondary Dengue infection.
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IgM Positive:* The colored line in the control line region (C) appears and a colored line appears in test line region 2 (M). The result is positive for Dengue virus specific-IgM antibodies and is indicative of primary Dengue infection.
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IgG and IgM Positive:* The colored line in the control line region (C) appears and two colored lines should appear in test line regions 1 and 2 (G and M). The color intensities of the lines do not have to match. The result is positive for IgG & IgM antibodies and is indicative of secondary Dengue infection.
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*NOTE: The intensity of the color in the test line region(s) (G and/or M) will vary depending on the concentration of Dengue antibodies in the specimen. Therefore, any shade of color in the test line region(s) (G and/or M) should be considered positive.
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NEGATIVE RESULT:
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The colored line in the control line region (C) appears. No line appears in test line regions 1 or 2 (G or M).
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INVALID RESULT:
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Control band fails to appear. Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the procedure with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
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Dengue NS1 Rapid Test:
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POSITIVE RESULT:
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Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (NS1).
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NEGATIVE RESULT:
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Only one colored band appears in the control region (C). No apparent colored band appears in the test region (NS1).
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INVALID RESULT:
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Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
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PERFORMANCE CHARACTERISTICS
Clinical Performance
Dengue IgG/IgM Rapid Test:
The specimens obtained from a population of symptomatic and asymptomatic individuals. Results were confirmed by a leading commercial Dengue ELISA test.
Dengue IgG/IgM Rapid Test vs. ELISA
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Dengue Infection
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Result
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Ig M
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IgG
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Primary Infection
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Positive
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14
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0
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Negative
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3
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17
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Total
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17
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17
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Relative Sensitivity
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82.4%
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0%
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Secondary Infection
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Positive
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39
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55
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Negative
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16
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0
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Total
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55
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55
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Relative Sensitivity
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70.9%
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>99.0%
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Non-Dengue Infection
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Positive
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0
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0
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Negative
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378
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378
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Total
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378
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378
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Relative Specificity
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>99.0%
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>99.0%
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For the primary and secondary infection, the overall sensitivity is 95.8%, the overall specificity is >99.0% and the overall accuracy is 99.3%.
Dengue NS1 Rapid Test:
A total of 114 patient samples from susceptible subjects were tested by the Dengue NS1 Rapid Test Strip and by a commercial EIA. Comparison for all subjects is showed in the following table:
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Dengue NS1 Rapid Test
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Dengue Ag EIA Test
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Positive
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Negative
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Total
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Positive
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66
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3
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69
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Negative
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2
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43
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45
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Total
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68
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46
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114
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Relative Sensitivity: 95.6%, Relative Specificity: 95.5%, Overall Agreement: 95.6%
bio-equip.cn
Zhuhai Encode Medical Engineering Co.,Ltd (herinafter referred to as Encode) was established in 1994, as one of the earliest
and largest manufacturers of in-vitro diagnostic field in China. Encode specializes in R&D, production and distribution of in-vitro diagnostic products. As a hi-tech and innovative enterprise, we have researched and developed series of microbiological diagnostic productds and immunology diagnostic rapid tests, which are used for diagnosis of infection disease, cardiac markers, tumor markers, fertility test, durgs of abuse and sexual transmitted disease.
Encode occupies a land of 15,000 m2 in Zhuhai. There are 2,000 GMP standard clean workshops of microbiology diagnostic products, colloidal gold diagnostic products and molecular with automatic manufacturing lines and passed the quality management system evaluation by SFDA and GDFDA.
Encode has established extensive cooperation with research centers in universtities, such as Lanzhou University, South China University of Technology, Jinan University and Shanghai Plumonary Hospital, etc. Whith strong R&D and technological innovation capability. Encode ranks leading level in terms of IVD industries field in China. We have also obtained ISO 13485:2003, ISO 9001:2001, CE and have been granted the title of national hi-tech enterprise.
Today, we provide medical products and health care solution to clients not only in China, but also worldwide, such as Europe, Africa, Middle East, South East, Asia etc.
With the experience and dedication of the scientific staffs, Zhuhai Encode Medical Engineering Co.,Ltd will continue our endeavor to provide professional in-vitro diagnostic products and health care solutions to the worldwide and make our contributions to the career of human health.
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