Uncut sheet for Antigen to Adenoviruses
1. INTEDED USE
The Adenovirus Antigen Rapid Test Device (the "uncut sheet" format for manufacturing use) is y intended for the qualitative detection of adenovirus antigen in human fecal specimens.
This test is intended for in vitro diagnostic professional use and serves as an aid in the diagnosis of adenovirus-associated acute gastroenteritis in patients, particularly children, presenting with clinical signs and symptoms suggestive of viral gastroenteritis, such as acute diarrhea, vomiting, and abdominal pain.
Adenoviruses are non-enveloped double-stranded DNA viruses associated with a wide range of clinical diseases. Enteric adenovirus types 40 and 41 are recognized as major causes of acute gastroenteritis, particularly in infants and young children, accounting for 5–20% of acute gastroenteritis cases in this population. The test employs a double antibody sandwich immunochromatographic assay using colloidal gold conjugation to capture adenovirus antigens present in the fecal specimen
The device provides presumptive (preliminary) screening test results. The test result should be interpreted in conjunction with patient history, clinical presentation, and other laboratory findings.
This product is intended for use by trained healthcare professionals or laboratory personnel. This product is for manufacturing use only and is intended for further processing into final device format.
2. PRODUCT SPECIFICATION
| Model No. | AV Uncut sheet |
| Methodology | Colloidal Gold |
| Sample Type | Faces |
| Time to Result | 15~20mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485, CE Certificate, UCKA MHRA Certificate |
|
Feature • High sensitive • result reading in 15-20 minutes • Easy operation • High Accuracy |
PACKING * 20 bags /CTN * Aluminum foil bag labeling * shrink wrap
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3.TEST METHOD
| 1 | Use sampling tube for sample collection, thorough mixing, and dilution for later use. Use proof stick to take approx. 30mg of stool, place it in sampling tube loaded with sample diluent, screw the cap tightly, and thoroughly shake it for later use. |
| 2 | In case of thin stool of patients with diarrhea, use disposable pipette to pipette sample, and add 3 drops (approx.100μL) of sample dropwise to sampling tube, and thoroughly shake sample and sample diluent for later use. |
| 3 | Remove test device from aluminum foil pouch, lie it on a horizontal workbench, and do a good job in marking. |
| 4 | Discard first two drops of diluted sample, add 3 drops (approx. 100μL) of bubble-free diluted sample dropwise to well of test device vertically and slowly, and start counting time. |
| 5 | Interpret result within 10-15 minutes, and detection result is invalid after 15 minutes (see detailed results in result interpretation). |
4.RESULT EVALUATION AND EXPLANATION
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
6.EXHIBITION
