Hepatitis B surface Antigen Hbsag Rapid test Machine Use
1. Usage
This kit is applicable to in vitro quantitative detection on the content of hepatitis B virus surface antigen in human serum/plasma samples as an aid in the diagnosis of hepatitis B virus infection(HBsAg). This kit provides only the results of the hepatitis B virus surface antigen test and the results obtained should be analyzed in conjunction with other clinical information. It is intended for use by medical professionals only.
2. PRODUCT SPECIFICATION
| Model No. | Hbsag |
| Methodology | Fluorescence Immunochromatographic Assay |
| Sample Type | serum/plasma |
| Time to Result | 10-15mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485 |
| MAIN KIT COMPONENTS: *Test device *solution *Instructions for Use |
Packing: *25 test /kit *Aluminum foil bag labeling *shrink wrap |
3.TEST METHOD
| 1 | Read the instruction for use and test operation manual completely before the test and restore the reagent to room temperature before the test. Do not perform the test without restoring the reagent to room temperature to avoid affecting the accuracy of the test results. |
| 2 | Select standard test mode of WIZ-A101 portable immune analyzer |
| 3 | Open the aluminum foil bag package of reagent, and take out the test device; |
| 4 | Horizontally insert the test device into the slot of immune analyzer; |
| 5 | On home page of operation interface of immune analyzer, click “Standard” to enter test interface; |
| 6 | Click “QC Scan” to scan the QR code on inner side of the kit; input kit related parameters into instrument, and select sample type; Note: Each batch number of the kit shall be scanned for one time. If the batch number has been scanned, then skip this step; |
| 7 | Check the consistency of “Product Name”, “Batch Number” etc. on test interface with information on the kit label; |
| 8 | After information consistency is confirmed, take out sample diluents, add 80µL of serum/plasma sample, and sufficiently mix;Add 80µL of above mixed solution into the sample hole of test device; |
| 9 | After complete sample addition, click “Timing” and remaining test time will be automatically displayed on the interface. |
| 10 | Immune analyzer will automatically complete test and analysis when test time is reached. |
| 11 | Result calculation and display After test by immune analyzer is completed, test result will be displayed on test interface or can be viewed through “History” on home page of operation interface. |
4.Importance of Hbsag Detection
- HIV P24 Antigen Test Kit – Importance & Role:
- The HBsAg antigen test kit plays a key role in hepatitis B screening and diagnosis by detecting HBsAg, the core marker of HBV infection, enabling early identification of infected individuals.
- It supports multiple testing scenarios—from rapid colloidal gold screening in primary care to fluorescence quantitative monitoring for treatment decisions and follow-up.
- By improving access to reliable HBsAg testing, it helps close diagnostic gaps and supports timely linkage to care.
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
