17.Accu-Tell® HBcAb Rapid Test Cassette (Serum/Plasma)
Accu-Tell®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.
CATALOG
|
Product Name |
Specimen |
Catalog No. |
Quantity per box |
Certificate |
|
HBcAb Cassette |
Serum/Plasma |
ABT-IDT-B10 |
50T;25T |
KEY POINTS
Detection for:Hepatitis B Core Antibody (HBcAb) in serum or plasma;
Specimen volume:75 μL;
Reading time:15 minutes;
Relative Sensitivity:96.9% (95%CI*: 94.4%-98.5%)
Relative Specificity:96.8% (95%CI*: 92.6%-98.9%)
Accuracy:97.0% (95%CI*: 95.0%-98.3%)
INTRODUCTION
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.
INTENDED USE
ACCU-TELL®(Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B Core Antibody (HBcAb) in serum or plasma.
TEST PROCEDURE
Allow test cassette, serum or plasma specimen, and/or controls to equilibrate to room temperature (15-30℃) prior to testing.
PERFORMANCE CHARACTERISTICSof
Sensitivity and Specificity
ACCU-TELL®HBcAb Rapid Test Cassette (Serum/Plasma) was compared with a leading commercial ELISA HBcAb test, the result show that ACCU-TELL®HBcAb Cassette (Serum/Plasma) has a high sensitivity and specificity.
|
Method |
ELISA |
Total Results |
||
|
ACCU-TELL®HBcAb Cassette (Serum/Plasma) |
Results |
Positive |
Negative |
|
|
Positive |
327 |
5 |
332 |
|
|
Negative |
10 |
150 |
160 |
|
|
Total Results |
337 |
155 |
492 |
|
Relative Sensitivity: 96.9% (95%CI*: 94.4%-98.5%)
Relative Specificity: 96.8% (95%CI*: 92.6%-98.9%)
Accuracy: 97.0% (95%CI*: 95.0%-98.3%)
*Confidence Intervals
Precision
Intra-Assay
Within-run precision has been determined by using 15 replicates of three specimens containing negative, low positive and high positive. The negative and positive values were correctly identified 99% of the time.
Inter-Assay
Between-run precision has been determined by using the same three specimens of negative, low positive and high positive of HBcAb in 15 independent assays. Three different lots of ACCU-TELL® HBcAb Rapid Test Cassette (Serum/Plasma) has been tested over a 3-month period using negative, low positive and high positive specimens. The specimens were correctly identified 99% of the time.
Cross-reactivity
ACCU-TELL®HBcAb Rapid Test Cassette (Serum/Plasma) has been tested by HAMA, Rheumatoid factor (RF), HAV, Syphilis, HIV, H. Pylori, MONO, CMV, Rubella and TOXO positive specimens. The results showed no cross-reactivity
Interfering Substances
ACCU-TELL®HBcAb Rapid Test Cassette (Serum/Plasma) has been tested for possible interference from visibly hemolyzed and lipemic specimens. No interference was observed.
In addition, no interference was observed in specimens containing up to 2,000 mg/dL Hemoglobin, 1000 mg/dL Bilirubin, and 2000 mg/dL human serum Albumin.We are also and
LIMITATIONS
Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.
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