Diagnostic kit for Antigen to Rotavirus Latex
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 |
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.
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| 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.
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| 3 |
Remove test device from aluminum foil pouch, lie it on a horizontal workbench, and do a good job in marking.
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| 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
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| 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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Note: each sample shall be pipetted by clean disposable pipette to avoid cross contamination.
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.
Summary
Feature:
• High sensitive
• result reading in 15 minutes
• Easy operation
• Factory direct price
• Do not need extra machine for result reading
Result reading
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 | |
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