Detection Principle

The product uses the colloidal gold and membrane chromatography technology, and measures HBsAg, HbeAg in whole blood with dual-antibody sandwich method, and measures HbsAb with dual-antigen sandwich method, and measures HbeAb and HBcAb with neutralization competitive inhibition method.

Major component ingredients

1. Hepatitis B two pairs of semi- test card

2. A copy of operating instruction

Sample requirements

1. For whole blood, collect blood into a container with anticoagulant(EDTA or heparin).

Use the specimen inside an hour.If the specimen can not be tested inside an hour, store the specimen in 4C cold closet or refrigerator,but Don't freeze. Bring the specimens to room temperature before testing. Do not freeze and thaw the specimen repeatedly.

2. The conventional anticoagulant does not affect the test results.

3.The hemolysis, viscous and high-fat blood samples do not apply to this reagent.

4.Adding 0.1% NaN3 in the samples does not aftect the result.

Test Method

Please read the instructions for the test kit completely before carrying out test.

1. Revert the test board and the testing samples to room temperature (20-30℃) .

2. The right side of the test board should be kept horizontal from the original package, from left to right, respectively corresponding to HBsAg, HBsAb, HBeAg, HBeAb, HBcAb. With a small straw to take subjects' whole blood, and add into 5 sample wells of the test board by drop(25μl per well or one drop), Then draw one drop of buffer into 5 sample well as well.

3. Observe and record the experimental result within 15 minutes. Weakly positive samples appear test line in 15-20 minutes. Determination after 30 minutes is invalid.

Note: Take out test paper from the original packaging, and it should be used within 1 hour as soon as possible, especially at room temperature above 30 C or in a highly humid environment.

Results determination

(1) HBsAg、 HbsAb、 HBeAg (Sandwich method)

Negative: Only one purple bar (control line) in the control C zone.

Positive: Detecting T zone There are two purple bars in the control C zone.

Invalld: Detecting T zone There is no purple bar in the control C zone.

(2) HBeAb HBcAb (Competition method)

Negative: Detecting T zone There are two purple bars in the control C zone.

Positive: Only one purple bar (control line) in the control C zone.(Weakly positive sample may appear a very thin response line at the test line),

Invalid: Detecting T zone There is no purple bar in the control C zone.

The interpretation of test results

1. The purple bands, which appear at the quality-control control lines, is used as the intemal control standards of the test paper strip.

2. The purple bands appear gradation phenomenon at the testing line, when testing different specimens, and this is due to high and low concentrations of surface antigen.

The limitations of the testing methods

This method is clinical auxilary diagnostic product, any of the tested positive samples should be further confirmed by application of other methods (such as EIA).

Performance indicators of products

sAg≥2ng  eAg≥2NCU  sAb≥30mlU

eAb≥1:8  cAb≥1:5

Campany information

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