Hepatitis B Virus Surface Antigent Test kit
Hepatitis B Surface Antigen Rapid Test
Methodology: Colloidal Gold
Production information
| Model Number | HBsAg | Packing | 25 Tests/ kit, 30kits/CTN |
| Name | Hepatitis B Surface Antigen Test kit | Instrument classification | Class III |
| Features | High sensitivity, Easy opeation | Certificate | CE/ ISO13485 |
| Accuracy | > 99% | Shelf life | Two Years |
| Methodology | Colloidal Gold | OEM/ODM service | Avaliable |
Test procedure
Read the instruction for use and in strict conformity with instruction for use required operation to avoid affecting the accuracy of the test results
| 1 | Before the test, the kit and the sample are taken out from the storage condition and balanced to room tempera-ture and mark it. |
| 2 | Tearing the packaging of the aluminum foil pouch, take out the test device and mark it, then place it horizontal-ly on the test table. |
| 3 | take 2 drops and add them to the spiked well; |
| 4 | Result shall be interpreted within 15~ 20 minutes, and detection result is invalid after 20 minutes. |
Note:each sample shall be pipetted by clean disposable pipette to avoid cross contamination.
Intended USE
This Test kit is suitable for qualitative detection of hepatitis B surface antigen in Human Serum/plasma/whole blod sample in vitro,which is used for auxiliar diagnosis of hepatitis B virus infection.The test resule should be analyzed in combination with other clinical information
Superiority
The kit is high accurate,fast and can be transported at room temperature, easy to operate
Specimen type :Seruam/Plasma/whole blood samples, easy to collect samples
Testing time:10-15mins
Storage:2-30℃/36-86℉
Methodology:Colloidal Gold
Feature:
• High sensitive
• High Accuracy
• 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:
| WIZ Result | Test Result of Reference reagent | Positive coincidence rate：99.10% (95%C.I. 96.79%~99.75%）
Negative coincidence rate：98.37%（95%C.I.96.24%~99.30%） Total coincidence rate：98.68% (95%C.I.97.30%~99.36%） |
||
| Positive | Negative | Total | ||
| Positive | 221 | 5 | 226 | |
| Negative | 2 | 302 | 304 | |
| Total | 223 | 307 | 530 | |
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