Accu-Tell® HBeAb Rapid Test Cassette (Serum/Plasma)
ACCU-TELL® HBeAb Rapid Test Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of HBeAb in serum or plasma.
CATALOG
|
Product Name |
Specimen |
Catalog No. |
Quantity per box |
Certificate |
|
HBeAb Cassette |
Serum/Plasma |
ABT-IDT-B8 |
50T/25T |
KEY POINTS
Detection for:HBeAb in serum or plasma;
Specimen volume:75 μL;
Reading time:15 minutes;
Relative Sensitivity:95.9% (95%CI*: 90.8%-98.7%)
Relative Specificity:97.5% (95%CI*: 95.2%-98.9%)
Accuracy:97.1% (95%CI*: 95.1%-98.4%)
*Confidence Intervals
INTRODUCTIONof
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 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.
INTENDED USE
ACCU-TELL®HBeAb Rapid Test Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of HBeAb in serum or plasma.
TEST PROCEDURE
PERFORMANCE CHARACTERISTICSof
Sensitivity and Specificity
ACCU-TELL®HBeAb Rapid Test Cassette (Serum/Plasma) was compared with leading commercial EIA HBeAb tests; the results show that ACCU-TELL®HBeAb Rapid Test Cassette (Serum/Plasma) has a high sensitivity and specificity.
|
Method |
EIA |
Total Results |
||
|
ACCU-TELL®HBeAb Cassette (Serum/Plasma) |
Results |
Positive |
Negative |
|
|
Positive |
118 |
8 |
126 |
|
|
Negative |
5 |
318 |
323 |
|
|
Total Results |
123 |
326 |
449 |
|
Relative Sensitivity: 95.9% (95%CI*: 90.8%-98.7%)
Relative Specificity: 97.5% (95%CI*: 95.2%-98.9%)
Accuracy: 97.1% (95%CI*: 95.1%-98.4%)
*Confidence Intervals
Precision
Intra-Assay
Within-run precision has been determined by using 15 replicates of three specimens containing negative, low positive, high positive of HBeAb. 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, high positive of HBeAb in 15 independent assays. Three different lots of ACCU-TELL®HBeAb 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®HBeAb 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®HBeAb 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 .
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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