Diagnpstic Kit for Antigen to Rotavirus(Latex)
Colloidal Gold
Production information| Model Number | RV | Packing | 25 Tests/ kit, 30kits/CTN |
| Name | Diagnpstic Kit for Antigen to Rotavirus(Latex) | 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 Rotavirus (RV) is classified as a member of genus rotavirus within the family reverie, which has spherical appearance and diameter of approx. 70nm. Rotavirus consists of 11 segments of double strained RNA. Rotavirus can be classified into 7 species (A-G) by antigenic diversity and genetic characteristics. Human infection of species A, B and C rotavirus have been reported. Where species A rotavirus is an important cause of severe gastroenteritis worldwide.
Intend Use This kit is applicable to qualitative detection of species A rotavirus that may exist in human stool sample, which’s suitable for auxiliary diagnosis of species A rotavirus of infantile diarrhea patients. This kit only provides species A rotavirus 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 sample collection tubes for sample collection, thorough mixing and dilution for later use. Use proof stick to take 30mg of stool, place it in Sample collection tubes 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 Sample collection tubes, 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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