High Accuracy HBsAg Rapid Diagnostic test CassetteWhole
Blood/Serum/Plasma Specimen easily and quick operation
Product Name:
HBsAg Hepatitis B Surface Antigen Test (Cassette)
INTENDED USE
The HBsAg Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid
visual immunoassay for the qualitative presumptive detection of
HBsAg in human whole blood, serum, or plasma specimens. This kit is
intended to be used as an aid in the diagnosis of HBV infection.
INTRODUCTION
Hepatitis B virus (HBV) is the prototypic member of the
hepadnaviruses. In the lipid envelope of this small DNA virus the
hepatitis B surface antigen (HBsAg) is located. During the
replicative phase of the virus this surface antigen is produced in
excess and detectable in the blood of infected person. The antigens
HBcAg and HBeAg are parts of the nucleocapsid. The incubation
period of HBV is 6 weeks to 6 months.
PRINCIPLE
The HBsAg Rapid Test Device (Whole Blood/Serum/Plasma) has been
designed to detect the HBsAg through visual interpretation of color
development in the strip. The membrane was immobilized with
anti‐HBsAg antibodies on the test region. During the test, the
specimen is allowed to react with colored anti‐HBsAg antibodies
colloidal gold conjugates, which were precoated on the sample pad
of the test. The mixture then moves on the membrane by a capillary
action, and interact with reagents on the membrane. If there were
enough HBsAg in specimens, a colored band will from at the test
region of the membrane. Presence of this colored band indicates a
positive result, while its absence indicates a negative result.
Appearance of a colored band at the control region serves as a
procedural control. This indicates that proper volume of specimen
has been added and membrane wicking has occurred.
TEST PROCEDURE
1. Bring the pouched test device to room temperature(15-30℃) prior
to testing. Do not open the pouch until ready to perform the assay.
2. Remove the test device from the sealed pouch. Lay it on a flat,
clean and dry surface.
3. Dispense 2 drops of the specimen or control into the sample
well.
4. Hold the buffer bottle vertically and add 1 drop to the sample
well. If using a pipette, change a new one to avoid
cross-contamination. Draw and transfer 2-3 drops to the sample
well.
5. Wait for the colored lines to appear. Interpret results between
15-20 minutes. Do not
interpret results after 20 Minutes.
INTERPRETATION OF RESULTS
Positive:
Two colored lines should be observed in the result window, one in
the test region and another one in the control region. The color
intensity of the test line may be weaker or stronger than that of
the control line.
Negative:
Only the control line appears in the result window.
Invalid:
No line appears in the control region regardless of the presence or
absence of the test
line.
PERFORMANCE CHARACTERISTICS
Table: HBsAg Rapid Test vs. EIA
| | | | | | HBsAg Rapid Test | |
| Relative | Sensitivity: | 99.9% | (99.3%‐ | | | + | ‐ | Total |
| 100.0%)* | | | | | |
| Relative | Specificity: | >99.9% | (99.7%‐ | | | | | |
| + | | 820 | 1 | 821 |
| 100.0%)* | | | | |
| | | EIA | | | |
| Overall Agreement: 99.9% (99.8%‐99.9%)* | | | |
| ‐ | 1 | 2134 | 2135 |
| *95% Confidence Interval | |
| | | | | |
| | | | | | 821 | 2135 | 2956 |
| ORIENT NEW LIFE MEDICAL CO., LTD. |
| Contact: | Jerry Meng |
| Email: | Jerry @ newlifebiotest .com |
| Tel. | +86 18657312116 |
| SKYPE | enetjerry |
