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Colloidal GoldInfectious Disease Test KitHBsAg Rapid Test Kit

SKU: IVD testing kits 4, One Step HBsAg Rapid Test

Key Words: NewScen Hepatitis B Surface Antigen Diagnostic Kit (Colloidal Gold), HbsAg (Serum/Whole Blood Test) Rapid Test, HBsAg ELISA kit

Sample type: Serum, Plasma, or Whole Blood

Detection type: Qualitative

Method: Colloidal Gold Rapid Test

Usage/Application:  Laboratory / Hospital / Pathology

Function: Diagnose

Certificate: ISO9001/ ISO13485/ CE by TUV

Format: Strip, Cassette, Midstream

Sensitivity: 96%

Specificity: 100%

Total Accuracy: 99.6%

Reading time: 15 minutes

Packaging Details:

Pouch+Box+Carton packaging

(1) With our company’s Logo

(2) With the natural package

(3) With OEM package

(4) ODM


1.Product Description:

Hepatitis B Virus Surface Antigen Test Kit (Colloidal Gold) is intended for the qualitative detection of hepatitis B virus surface antigen (HBsAg) in human serum or plasma, applying to the auxiliary diagnosis of hepatitis B virus infection.

HBsAg Rapid Test Kit

2. Intended Use:

The HBsAg Rapid Test is a Chromatographic immunoassay (CIA) for the direct qualitative detection of Hepatitis B type virus surface antigen (HBsAg) in human serum /plasma and whole blood.


3. Principle:

The HBsAg RST is a chromatographic immunoassay (CIA) for the detection of surface antigens of Hepatitis B in human serum/plasma and whole blood. Specific antibody against HBsAg is pre-coated onto the membrane as a capture reagent on the test region. During the test, the specimen is allowed to react with the colloidal gold particles, which have been labeled with another specific antibody. If HBsAg is present, a pink-colored band will develop on the membrane in proportion to the amount of HBsAg present in the specimen. The absence of this pink-colored band in the test region suggests a negative result. To serve as a procedural control, a pink-colored band in the control region will always appear regardless of the presence or absence of HBsAg.


4. Procedure of NewScen HBsAg Rapid Test Kit:

4.1. Serum or Plasma Sample. Add 70-100ul or 2-3 drops of serum or plasma into the sample well. Observe the result in 15 minutes.

4.2Whole Blood Sample. Add 1 drop of whole blood into the sample well, after all, blood is completely absorbed. Add 2 drops of whole blood diluent. Observe the result in 15 minutes.


5. Result Interpretation:


Negative: No band in the test region (T), only one pink band appears in the control region (C). This indicates that no HBsAg have been detected.

Positive: In addition to the band in the control region (C), another pink band will appear in the test region (T). This indicates that the specimen contains HBsAg.

Invalid: If no band appears in the control region(C), regardless of the presence or absence of line in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.



A total of 400 samples from susceptible subjects were tested by the HBsAg Rapid Test and by HBsAg ELISA kit with the test sensitivity at 1.0 ng/mL. The data showed the following.

Relative Sensitivity: 96%

Relative Specificity: 100%

Overall Agreement: 99.6%


7. CE Qualified: