Diagnostic kit for Antigen to Respiratoy Adenoviruses
Colloidal Gold
Production information| Model Number | AV | Packing | 25 Tests/ kit, 30kits/CTN |
| Name | Diagnostic kit for Antigen to Respiratoy Adenoviruses | Instrument classification | Class I |
| Features | High sensitivity, Easy opeation | Certificate | CE/ ISO13485 |
| Accuracy | > 99% | Shelf life | Two Years |
| Methodology | Colloidal Gold | OEM/ODM service | Avaliable |
Summary Adenoviruses have 51 serotypes in total, which can be divided into 6 species (A-F) by immunological and biochemical characteristics. Adenoviruses (AV) can infect respiratory tract, intestinal tract, eyes, urinary bladder, and liver, and cause epidemic propagation. Most adenoviruses appear in stool of gastroenteritis patients 3-5 days upon incidence of disease and 3-13 days upon occurrence of symptom respectively. People with normal immunity usually produce antibodies after being infected with adenovirus and heal themselves, but for patients or children with suppressed immunity, adenovirus infection can be fatal.Intend Use This kit is applicable to in vitro qualitative detection of adenovirus (AV) antigen that may exist in human stool sample, which’s suitable for auxiliary diagnosis of adenovirus infection of infantile diarrhea patients. This kit only provides adenovirus antigen test results, and results obtained shall be used in combination with other clinical information for analysis. It must only be used by healthcare professionals.
The WIZ BIOTECH reagent test will be compared with the control reagent: | Test result of wiz | Test result of reference reagents | Positive coincidence rate:98.54%(95%C.I.94.83%~99.60%) Negative coincidence rate:100%(95%C.I.97.31%~100%)Total compliance rate: 99.28%(95%C.I.97.40%~99.80%) | ||
| Positive | Negative | Total | ||
| Positive | 135 | 0 | 135 | |
| Negative | 2 | 139 | 141 | |
| Total | 137 | 139 | 276 | |
Test procedure | 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). |
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