One Step HBcAb Rapid Diagnostic Test for detecting Hepatitis B Core
Antibody, gold colloidal method, high accuracy
Product Name: One Step HBcAb Rapid Diagnostic Test Cassette
| Product | Cat No | Specimen | Sensitivity | Format | Kit Size |
| HBcAb | YI231S3 | Serum/Plasma | | 3mm Strip | 50T |
| YI231S4 | 4mm Strip | 50T |
| YI231C3 | 3mm Cassette | 25T |
| YI231C4 | 4mm Cassette | 25T |
Intended Use:
The HBcAb Rapid Test Cassette (Serum/Plasma) is a rapid
chromatographic immunoassay for the qualitative detection of
Hepatitis B Core Antibody (HBcAb) in serum or plasma.
Summary:
Viral hepatitis is a systemic disease primarily involving the
liver. Most cases of acute viral hepatitis are caused by Hepatitis
A virus (HAV), Hepatitis B virus (HBV) or Hepatitis C virus (HCV).
Hepatitis B core antibody 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 HBcAb
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. The HBcAb Rapid Test Cassette (Serum/Plasma) is a rapid
test to qualitatively detect the presence of HBcAb in serum or
plasma specimen. The test utilizes a combination of monoclonal
antibodie and antigen to selectively detect elevated levels of
HBcAb 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 HBcAb test is immunoassay based on the principle of competitive
binding. During testing, the mixture migrates upward on the
membrane chromatographically by capillary action. The membrane is
pre-coated with anti-HBcAg on the test line region of the strip.
During testing, if HBcAb present in the specimen, will compete with
particle coated HBcAg antibody for limited amount of anti-HBcAg on
the membrane. No line will form in the test region. And a visible
colored line will form in the test region if there is no HBcAb in
the specimen because all the antibody coated particles will be
captured by the antigen coated in the test line region. 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 |
