Diagnostic Kit for Antigen to Norovirus
Colloidal Gold
Production information| Model Number | Rorovirus | Packing | 25 Tests/ kit, 30kits/CTN |
| Name | Diagnostic Kit for Antigen to Norovirus (Colloidal Gold) | 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 Norovirus, which’s also known as norwalk-like virus, belongs to caliciviridae. It’s mainly spread through contaminated water, food, contact, or aerosol formed by contaminant. It has been recognized as primary pathogen that leads to viral diarrhea and gastroenteritis among adults.Noroviruses can be divided into 5 genomes (GI, GII, GIII, GIVand GV), GI and GIIare the two main genomes that cause acute gastroenteritis of human beings, GIV may also infect human beings, but it’s hardly detectable.This product is for detection of GI antigen and GIIantigen to norovirus.
Intend Use This kit is applicable to in vitro qualitative detection of norovirus antigen (GI) and norovirus antigen (GII) in human stool sample, and it’s suitable for auxiliary diagnosis of norovirus infection of cases with diarrhea. This kit only provides norovirus antigen GI and norovirus antigen GIItest 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 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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