One Step HBcAb Rapid Diagnostic Test , to detect Hepatitis B Core
Antibody ,gold colloidal method
Product Name:
One Step HBcAb Rapid Diagnostic Test Cassette
| Product | Cat No | Specimen | Sensitivity | Format | Kit Size |
| HBcAb | YI231S3 | WB / S / P | See Insert | 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 e antibody is a viral protein secreted by HBV-infected
cells. The presence of antibody against hepatitis B viral e antigen
is used as an indicator for early HBs antigenemia before the peak
of viral replication and early convalescence when HBeAg has
declined below detectable levels. It is also useful to confirm a
seroconversion. The seroconversion from HBeAg positive to anti-Hbe
positive indicates a reduced level of infectious virus because
virus replication has decreased. The HBeAbRapid Test Cassette
(Serum/Plasma) is a rapid test to qualitatively detect the presence
of HBeAb in serum or plasma specimen. The test utilizes a
combination of monoclonal and polyclonal antibodies to selectively
detect elevated levels of HBeAb in serum or plasma. This one step
test is very sensitive and only takes about 10-20minutes. Test
results are read visuallywithout 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.
Performance
Sensitivity and Specificity
The HBcAb Rapid Test Cassette (Serum/Plasma) was compared with a
leading commercial ELISA HBcAb test, the result show that the HBcAb
Rapid Test Cassette (Serum/Plasma) has a high sensitivity and
specificity.
| Method | | ELISA | Total |
| HBcAb Rapid Test | | Results | Positive | Negative | Results |
| Positive | 358 | 4 | 362 |
| Cassette(Serum/Plasma) | |
| Negative | 8 | 167 | 175 |
| |
| Total Results | | 366 | 171 | 537 |
Relative Sensitivity: 97.8% (95%CI*: 95.7%-99.1%)
Relative Specificity: 97.7% (95%CI*: 94.1%-99.4%)
Accuracy: 97.8% (95%CI*: 96.1%-98.8%)
*Confidence Intervals
| ORIENT NEW LIFE MEDICAL CO., LTD. |
| Contact: | Jerry Meng |
| Email: | Jerry @ newlifebiotest .com |
| Tel. | +86 18657312116 |
| SKYPE | enetjerry |
