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HBsAg Test kit (Colloidal Gold)
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HBsAg Test kit (Colloidal Gold) 


INTENDED USE

HBsAg Test kit (Colloidal Gold) is used for the in vitro qualitative detection of hepatitis B virus surface antigen (HBsAg) in human serum and plasma samples.

HBsAg is the coat protein of hepatitis B virus. It is not infectious, only antigenic. But its presence is often accompanied by the presence of hepatitis B virus, so it is a sign of hepatitis B virus infection.

 

PACK FORMATS

Strip: 50 tests/box

Cassette: 20 tests/box

 

INTRODUCTION

Infection caused by HBV has brought serious public health problems. Mother-to-child transmission, sexual transmission and blood transmission are the most common routes of transmission. Early detection of infection can effectively reduce the spread of disease.

Commonly used methods to determine the HBsAg include enzyme-linked immunosorbent assay, colloidal gold, radioimmunoassay, fluorescence quantitative PCR diagnosis, etc.

 

PRINCIPLE

HBsAg Test kit (Colloidal Gold) uses colloidal gold immunochromatographic technology. The reagent is coated with HBsAg monoclonal antibody (test line T) and goat anti-mouse polyclonal antibody (control line C) on nitrocellulose membrane. The gold-labeled pad contains another HBsAg monoclonal antibody coupled with colloidal gold. When the sample containing the HBsAg is added to the sample well, the HBsAg will combine with the HBsAg monoclonal antibody conjugate to form an antigen-antibody complex.

The complex moves through the nitrocellulose membrane. When the complex encounters the HBsAg monoclonal antibody on the test line T, the complex is captured and forms a burgundy band, which confirms the positive test result. No color band in the test area indicates a negative test result.

The test kit contains a quality control line (control line C), which should show a burgundy color band of goat anti-mouse polyclonal antibody combined with the colloidal gold conjugate in the gold label pad, regardless of the color on any other test line.

 

MATERIALS SUPPLIED

HBsAg Test Strip/Cassette

Instruction for use

Dropperfor Cassette only

 

MATERIAL REQUIRED BUT NOT PROVIDED

1. Specimen collection containers

2. Timer

3. Centrifugefor serum only

 

STORAGE AND STABILITY

The kit can be stored at room temperature or refrigerated (4-30°C). The test device is stable through the

expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use.

Do not freeze.

Do not use beyond the expiration date.

After opening the sealed pouch, use the test as soon as possible within 60 minutes.

 

WARNINGS AND PRECAUTIONS

1. For professional In Vitro diagnostic use only. Do not use after expiration date.

2. These instructions must be strictly followed by a trained healthcare professional to achieve accurate

results. All users have to read the instruction prior to performing a test.

3. Do not use it if the tube/pouch is damaged or broken.

4. Wear protective gloves while handling specimens and wash hands thoroughly afterwards.

5. Avoid splashing or aerosol formation of specimen and buffer.

6. Clean up spills thoroughly using an appropriate disinfectant.

7. Decontaminate and dispose of all specimens, reaction kits and potentially contaminated materials (i.e.

dropper, test device) in a biohazard container as if they were infectious waste and dispose according to

applicable local regulations.

8. Do not mix or interchange different specimens.

9. Do not mix reagent of different lots or those for other products.

10. Do not store the test kit in direct sunlight.

11. To avoid cross-contamination, do not reuse the dropper for specimen collection.

12. Test is for single use only. Do not re-use under any circumstances.

13. Do not perform the test in a room with strong air flow, ie. electric fan or strong air-conditionin.

 

SPECIMEN COLLECTION

1. Serum and plasma can be used for testing. Among them, plasma samples of commonly used clinical

anticoagulants (EDTA, heparin, sodium citrate) do not affect the test results.

2. Collect intravenous serum and plasma under sterile conditions and avoid hemolysis of the sample.

3. If the serum or plasma sample is tested within 7 days after collection, the sample must be stored at 2-8°C, if it is longer than 7 days, it must be frozen.

4. If specimens are to be shipped, they should be packaged in accordance with local regulations

regarding the transportation of pathogens.

 

TEST PROCEDURE

Allow test cassette/strip, specimen and/or controls to equilibrate to room temperature (15-30°C) prior to

testing.

1. Remove the test cassette from the sealed foil pouch and use it as soon as possible.

2. Place the test device on a clean and level surface.

3. Use the provided dropper to draw the serum/plasma sample, and then add 3 drops80μl of the

serum/plasma sample into the sample well (avoid air bubbles). Then start the timer.

4. Wait for the result. The result should be read in 15 minutes. Do not interpret the result after 20 minutes.

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INTERPRETATION OF RESULTS

NEGATIVE:

If only the C band is present, the absence of any burgundy color in the T band indicates that no HBsAg is detected in the specimen. The result is negative.

POSITIVE:

In addition to the presence of C band, if T band is developed, the test indicates for the presence of HBsAg in the specimen. The result is HBsAg positive.

INVALID:

Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

 

LIMITATIONS

1. For best result, test specimen immediately following collection.

2. Optimal assay performance requires strictly adherence to the assay procedure described in instruction for use. Deviations may lead to aberrant results.

3. A negative result can occur if the quantity of the HBsAg antigen present in the specimen is below the detection limits of the assay, or failed to collect the HBsAg in the nasal cavity of the patient.

4. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.


Latest version 8.54.04.001 A0 lssued Date: 2021.02.07


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