One Step HBeAg Rapid Diagnostic Test , to detect hepatitis B e
antigen ,gold colloidal method, quickly and easily
Product Name:
One Step HBeAg Rapid Diagnostic Test Cassette
| Product | Cat No | Specimen | Sensitivity | Format | Kit Size |
| HBeAg | YI251S3 | Serum/Plasma | | 3mm Strip | 50T |
| YI251S4 | 4mm Strip | 50T |
| YI251C3 | 3mm Cassette | 25T |
| YI251C4 | 4mm Cassette | 25T |
Intended Use:
The One Step casstte style HBeAg Test is a chromatographic
immunoassay in-vitro diagnostic test combined with conjugated
colloid gold technology for the qualitative detection of hepatitis
B e antigen (HBeAg) in human serum specimen.Two monoclonal
antibodies are employed to identify HBeAg specifically.
Summary:
Viral hepatitis is a systemic disease primarily involving the
liver. Most cases of acute viral hepatitis are caused by Hepatitis
A virus, Hepatitis B virus (HBV) or Hepatitis C virus. Hepatitis B
e antigen is a viral protein secreted by HBV-infected cells. Its
presence indicates high levels of virus in the blood, and it is an
indicator of the infectiousness of the carrier. If this test is
negative, but a person is known to be HBsAg positive, then it
indicates low levels of virus in the blood or an "integrated phase"
of HBV in which the virus is integrated into the host’s DNA. This
test is often used to monitor the effectiveness of some HBV
therapies, whose goal is to convert an actively replicating state
to "e-antigen negative" state. The HBeAg One Step Hepatitis B e
Antigen Test Device (Serum/Plasma) is a rapid test to qualitatively
detect the presence of HBeAg in serum or plasma specimen. The test
utilizes a combination of monoclonal and polyclonal antibodies to
selectively detect elevated levels of HBeAg in serum or plasma.
This one step test is very sensitive and only takes about
10-20minutes. Test results are read visually without any
instrument.
TEST PRINCIPLE
The HBeAg test is a qualitative, solid phase, two-site sandwich
immunoassay for the detection of HBeAg in serum or plasma. The
membrane is pre-coated with anti-HBeAg antibodies on the test line
region of the strip. Du ring testing, the serum or plasma specimen
reacts with the particle coated with anti-HBeAg antibodies. The
mixture migrates upward on the membrane chromatographically by
capillary action to react with anti-HBeAg antibodies on the
membrane and generate a colored line. The presence of this colored
line in the test region indicates a positive result, while its
absence indicates a negative result. To serve as a procedural
control, a colored line will always appear in the control line
region indicating 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 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. Use the pipette to draw and slowly add 1 drop of whole
blood/serum/plasma to the sample well.
4. Hold the buffer 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 drops of buffer to the sample well.
5. Interpret test results within 10-15 minutes. Do not interpret
after 20 minutes.
Caution: The above interpreting time is based on room temperature range of
15-30℃. If your room temperature is significantly lower than 15℃,
then the interpreting time should be properly increased to 30
minutes.
INTERPRETATION OF RESULTS
Positive:
Two red lines are visible in the result window. The intensity of
the test line may be
weaker or darker than that of the control line. This still means a
positive result.
Negative:
The control line appears in the result window, but the test line is
not visible.
Invalid:
If the control line does not appear in the result window, the test
results are INVALID regardless of the presence or absence of the
line in the test region.
| ORIENT NEW LIFE MEDICAL CO., LTD. |
| Contact: | Jerry Meng |
| Email: | Jerry @ newlifebiotest .com |
| Tel. | +86 18657312116 |
| SKYPE | enetjerry |
