HbSag Antigen Infectious Rapid Test Kit Uncut sheet
1. INTEDED USE
The HBsAg Antigen Rapid Test Device (the “Uncut Sheet” format for manufacturing use) is a rapid Colloidal Gold intended for the qualitative detection of hepatitis B virus surface antigen (HBsAg) in human serum, plasma, or whole blood specimens.
This test is intended for in vitro diagnostic professional use and serves as an aid in the screening and early diagnosis of hepatitis B virus (HBV) infection in patients with clinical signs and symptoms suggestive of HBV infection, or for screening individuals at risk of hepatitis B exposure
HBsAg is the first serologic marker to appear in the blood of patients infected with hepatitis B, typically detectable 2–4 weeks prior to elevation of liver enzyme (ALT) levels and 3–5 weeks before the onset of symptoms . Its detection is the most commonly used method for diagnosing HBV infection
This product is intended for use by trained healthcare professionals or laboratory personnel. This product is for manufacturing use only and is intended for further processing into final device format.
2. PRODUCT SPECIFICATION
| Model No. | HbSag Uncut sheet |
| Methodology | Colloidal Gold |
| Sample Type | Whole blood /Serum/Plasma |
| Time to Result | 15~20mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485 |
|
Feature • High sensitive • result reading in 15-20 minutes • Easy operation • High Accuracy |
PACKING * 20 bags /CTN * Aluminum foil bag labeling * shrink wrap
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3.TEST METHOD
| 1 | Remove test device from aluminum foil pouch, lie it on a horizontal workbench, and do a good job in marking. |
| 2 | For serum and plasma samples, take 2 drops and add them to the spiked well; however, if the sample is a whole blood sample, take 2 drops and add them to the spiked well and need to add 1 drop of sample diluent. |
| 3 | Interpret result within 10-15 minutes, and detection result is invalid after 15 minutes (see detailed results in result interpretation). |
4.RESULT EVALUATION AND EXPLANATION
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
