| Type: | IVD Instrument |
|---|---|
| Test Parameter: | Adenovirus |
| Result Time: | 15 Mins |
| Accuracy: | 98.8% |
| Shelf Life: | 24 Months |
| Transport Package: | Cartons |
| Samples: |
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| Customization: |
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Audited Supplier INTENDED USE
The Adenovirus Rapid Test (Feces) is a rapid visual immunoassay for the qualitative presumptive detection of adenovirus in human fecal specimens. This kit is intended to be used as an aid in the diagnosis of adenovirus infection.
INTRODUCTION
Acute diarrheal disease in young children is a major cause of morbidity worldwide and is a leading cause of mortality in developing countries. Research has shown that enteric adenoviruses, primarily Ad40 and Ad41, are a leading cause of diarrhea in many of these children, second only to the rotaviruses. These viral pathogens have been isolated throughout the world, and can cause diarrhea in children year round. Infections are most frequently seen in children less than two years of age, but have been found in patients of all ages. Further studies indicate that adenoviruses are associated with 4-15% of all hospitalized cases of viral gastroenteritis.
Rapid and accurate diagnosis of gastroenteritis due to adenovirus is helpful in establishing the etiology of gastroenteritis and related patient management. Other diagnostic techniques such as electron microscopy (EM) and nucleic acid hybridization are expensive and labor-intensive. With the self-limiting nature of adenovirus infection, such expensive and labor-intensive tests may not be necessary.
MAIN CONTENTS
Rapid Test Cassette
Buffer
Disposable dropper
Package insert
STORAGE AND STABILITY
Store at 2 ~ 30 º C in the sealed pouch for 24 months.
The test must remain in the sealed pouch until use.
Keep away from direct sunlight, moisture and heat.
Do not freeze.
SAMPLE COLLECTION
1. The Adenovirus Rapid Test (Feces) is intended only for use with human fecal specimens.
2. Viral detection is improved by collecting the specimens at the onset of the symptoms. It has been reported that the maximum excretion of adenovirus in the feces of patients with gastroenteritis occurs 3-13 days after onset of symptoms. If the specimens are collected long after the onset of diarrheic symptoms, the quantity of antigen may not be sufficient to obtain a positive reaction or the antigens detected may not be linked to the diarrheic episode.
3. Perform the testing immediately after the specimen collection. Do not leave the specimens at room temperature for prolonged periods. Specimens may be stored at 2-8°C for up to 72 hours.
4. Bring specimens to room temperature prior to testing.
5. Pack the specimens in compliance with applicable regulations for transportation of etiological agents, in case they need to be shipped.
TEST PROCEDURE
Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.
1. Specimen collection and pre-treatment:
1) Use the specimens collection container provided in the kit for specimens collection. Follow the operation procedure written on it for instructions. Other clean dry containers could also be used for the same purpose. Best results will be obtained if the assay is performed within 6 hours after collection.
2) For solid specimens: Unscrew and remove the dilution tube applicator. Be careful not to spill or spatter solution from the tube. Collect specimens by inserting the applicator stick into at least 3 different sites of the feces to collect approximately 50 mg of feces (equivalent to 1/4 of a pea).
For liquid specimens: Hold the pipette vertically, aspirate fecal specimens, and then transfer 2 drops (approximately 50 µL) into the specimen collection tube containing the extraction buffer.
3) Place the applicator back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.
4) Shake the specimen collection tube vigorously to mix the specimen and the extraction buffer. Specimens prepared in the specimen collection tube may be stored for 6 months at -20°C if not tested within 1 hour after preparation.
2. Testing
1) Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. To obtain a best result, the assay should be performed within one hour.
2) Using a piece of tissue paper, break the tip of the dilution tube. Hold the tube vertically and dispense 2 drops of solution into the specimen well (S) of the test device.
Avoid trapping air bubbles in the specimen well (S), and do not drop any solution in observation window.
As the test begins to work, you will see color move across the membrane.
3. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.
Note: If the specimen does not migrate (presence of particles), centrifuge the extracted specimens contained in the extraction buffer vial. Collect 80 µL of supernatant, dispense into the specimen well (S) of a new test device and start afresh following the instructions mentioned above.
INTERPRETATION
POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read 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.
| Manufacturer | Dewei Medical Equipment Co., Ltd |
| Product Categories | IVD Test |
| Principle | Rapid Colloidal Gold Immunochromatography |
| Detection | Qualitative |
| Storage | 2~30 º C |
| Component | Rapid Test |
| Package | 25T/box, 50T/Box, 100T/Box |
| Trademark | Dewei |
| Origin | China |
DEWEI Medical Equipment Co., Ltd is a leading and professional manufacturer of IVD products,it is a high-tech enterprise specialized in developing, manufacturing and marketing of IVD products.
DEWEI products are widely used in hospital clinics, disease control centers, blood banks, veterinary clinics, scientific research center and college laboratories. Qulity is primary concern, DEWEI team is strict on quality control systems thus our products have CE, ISO, CFDA and other international standards certificates.
The view of DEWEI is to be the most professional and respected enterprise in IVD field, DEWEI will go on providing best service to you by the outstanding R&D and cost-effective products.
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